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Lilly Presents Positive Results for Taltz (ixekizumab) in Pediatric Patients with Moderate to Severe Plaque Psoriasis at the 28th Annual European…

INDIANAPOLIS, Oct. 12, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area and Severity Index score (PASI 75) and 81 percent of patients treated with Taltz achieved a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1). Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain. Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.

"Results from our study indicate that Taltz may have the potential to clear skin and reduce itch in pediatric patients with moderate to severe plaque psoriasis," said study investigator Kim Papp, MD, PhD, Probity Medical Research, Inc., Waterloo, Ontario, Canada. "While it is estimated that up to one third of people with psoriasis first develop symptoms during childhood, there are limited medications available for pediatric patients. This study provides encouraging data supporting the potential for Taltz to become another treatment option for this patient population."

The co-primary endpoints of the study were the proportion of patients achieving a significant 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS 4) among patients with baseline Itch NRS 4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children's Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients 17 years old) at Week 12 was also evaluated.

"We recognize that psoriasis can have a significant impact on children and adolescents, causing challenging symptoms and affecting their self-esteem and ability to connect to peers," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We're pleased to see positive results for Taltz in pediatric patients. These results build on more than five years of safety and efficacy data in adults and support the potential for Taltz in this new population, pending regulatory approvals."

A total of 201 patients aged 6 to <18 years of age with moderate to severe plaque psoriasis were randomized to receive Taltz (20 mg for <25 kg, 40 mg for 25-50 kg or 80 mg for >50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference (P<0.001), including:

Taltz also met all major secondary endpoints in the study (P<0.001).

In this trial, the overall safety profile of Taltz was consistent with previously reported results. The Taltz safety profile has been studied across 15 clinical trials in plaque psoriasis and psoriatic arthritis, with 6,989 patients receiving Taltz, with a total exposure of 16,586 patient-years.1,2,3

INDICATIONS AND USAGE FOR TALTZTaltz is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also approved for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.

IMPORTANT SAFETY INFORMATION FOR TALTZ

CONTRAINDICATIONSTaltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONSInfectionsTaltz may increase the risk of infection. In clinical trials of patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of patients with psoriatic arthritis and ankylosing spondylitis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

HypersensitivitySerious hypersensitivity reactions, including angioedema and urticaria (each 0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel DiseaseDuring Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz 80 mg Q2W group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn's disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn's disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

ImmunizationsPrior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONSMost common adverse reactions (1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 23AUG2019

About TaltzTaltz (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.4 IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.4

About Moderate to Severe Plaque Psoriasis Psoriasis is a chronic, immune disease that affects the skin.5 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis affects approximately 125 million people worldwide, approximately 20 percent of whom have moderate to severe plaque psoriasis.5,6 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.5 Patients with plaque psoriasis often have other serious health conditions, such as diabetes and heart disease and experience negative impact on their quality of life.5

About the Phase 3 Pediatric Study This study is a Phase 3, multicenter, randomized, double-blinded, placebo controlled study to evaluate safety, tolerability and efficacy of Taltz in patients from 6 to <18 years of age with moderate to severe plaque psoriasis. The co-primary endpoints of the study were the proportion of patients achieving a 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA 0 and PASI 100 at Week 12, and at least a four-point improvement in Itch numeric rating scale (Itch NRS 4) among patients with baseline Itch NRS 4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children's Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients 17 years old) at Week 12 was also evaluated.

About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Eli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a potential treatment for pediatric patients with moderate to severe plaque psoriasis, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that Taltz will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertake no duty to update forward-looking statements to reflect events after the date of this release.

1 Data on file. Lilly USA, LLC. TAL20171211A.2 Data on file. Lilly USA, LLC. DOF-IX-US-0019.3 Mease P, Roussou E, Burmester GR, et al. Safety of ixekizumab in patients with psoriatic arthritis: results from a pooled analysis of three clinical trials. Arth Care Res. 2018 (Epub). doi:10.1002/acr.23738.4 Taltz Prescribing Information, 2019.5 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed September, 2019.6 Skin conditions by the numbers. American Academy of Dermatology website. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed September, 2019.

SOURCE Eli Lilly and Company

https://www.lilly.com/

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Lilly Presents Positive Results for Taltz (ixekizumab) in Pediatric Patients with Moderate to Severe Plaque Psoriasis at the 28th Annual European...

AbbVie Announces New Data from its Dermatology Portfolio and Pipeline at the 28th European Academy of Dermatology and Venereology (EADV) Congress -…

- Twenty new abstracts underscore AbbVie's commitment to advancing standards of care for people living with serious skin diseases

- Results from the LIMMitless trial evaluating continued safety and efficacy with SKYRIZI (risankizumab) in patients with moderate to severe plaque psoriasis at 2.5 years will be presented

- Safety and efficacy data up to 24 weeks will be presented from risankizumab Phase 2 investigational studies for the treatment of active psoriatic arthritis

- New data from a Phase 2b investigational study evaluating time to treatment response with upadacitinib for patients with atopic dermatitis

NORTH CHICAGO, Ill., Oct. 9, 2019 /PRNewswire/ -- AbbVie (ABBV), a research-based global biopharmaceutical company, today announced that it will present new results evaluating the safety and efficacy of SKYRIZI (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as additional data on HUMIRA (adalimumab) and the investigational JAK inhibitor upadacitinib, at the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid.

"Leveraging more than two decades of clinical experience with HUMIRA, AbbVie recently expanded its dermatology portfolio with the approval of SKYRIZI for patients living with moderate to severe plaque psoriasis," said Marek Honczarenko, MD, PhD, vice president, global immunology development, AbbVie. "The new data presented at EADV will advance the knowledge around new and existing treatments for serious skin diseases, like psoriasis, as well as diseases with high levels of unmet need, such as atopic dermatitis and hidradenitis suppurativa."

In addition to sharing new long-term data from the LIMMitless open-label extension study in moderate to severe plaque psoriasis, AbbVie will share results from its ongoing investigational Phase 2 program evaluating risankizumab for the treatment of psoriatic arthritis. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

In addition, Phase 2b results evaluating time to treatment response with upadacitinib, an oral JAK inhibitor, under investigation for patients with moderate to severe atopic dermatitis will be shared as an oral presentation. Upadacitinib is not approved for atopic dermatitis by any regulatory authority, and its safety and efficacy have not been established in this indication.

Additional presentations include efficacy and safety results further evaluating HUMIRA in hidradenitis suppurativa.

"Chronic skin diseases can have a significant physical and psychosocial impact on patients," said Jean-Marie Meurant, board president of the International Alliance of Dermatology Patient Organizations. "While progress has been made to improve the lives of patients, many still do not have access to the treatment and care they need and deserve. It's critical that the scientific community build upon current research to better understand these diseases and continue to keep the patient experience at the forefront of their efforts."

AbbVie Data at EADV

Risankizumab Abstracts Psoriasis

Psoriatic arthritis

Upadacitinib AbstractsAtopic dermatitis

HUMIRA AbstractsPsoriasis

Hidradenitis suppurativa

Disease State AbstractsHidradenitis suppurativa

About SKYRIZI (risankizumab) in the EU1

SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information1

SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in clinically important active infections. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

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The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information. See the full summary of product characteristics (SmPC) at http://www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an investigational, oral, small molecule JAK inhibitor being studied for moderately to severely active rheumatoid arthritis and other immune-mediated inflammatory diseases.2-15 Phase 3 trials of upadacitinib in psoriatic arthritis, Crohn's disease, atopic dermatitis and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis and giant cell arteritis.10-15

About HUMIRA in the EU16

HUMIRA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

HUMIRA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.

Important EU Safety Information16

HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

This is not a complete summary of all safety information. Globally, prescribing information varies; refer to the individual country product label for complete information.

Full summary of product characteristics is available at: http://www.ema.europa.eu

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at http://www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

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AbbVie Announces New Data from its Dermatology Portfolio and Pipeline at the 28th European Academy of Dermatology and Venereology (EADV) Congress -...

Scots psoriasis sufferer opens up on how skin condition can affect mental health and leave her not wanting to – The Scottish Sun

A SCOTS psoriasis sufferer has told how the condition has impacted her relationship by leaving her not wanting to be "touched, cuddled or kissed".

Jude Duncan, 26, has had the irritating skin condition for six years and says it can affect intimate relationships and dating.

4

The marketing officer, who is a 'Skinfluencer' on Instagram has been with her boyfriend for two years and says she is lucky that he is very supportive.

But she also has moments where her itchy and flaky skin affects her mental health and leaves her not wanting intimacy.

Psoriasis, which affects around 2 per cent of people in the UK, is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.

Jude, from Gourock, told the Scottish Sun: "Im very lucky to have a supportive partner but I know that if I'm not having a great nights sleep, and tossing and turning, then hes not getting a great nights sleep and that can have an impact on them as well.

"Actually having that communication with a partner is really important but it can be really difficult as well for people to open up.

"I'm in a lucky position where I feel very confident with my psoriasis but also sometimes it has felt like if I'm having a flare up I dont want to be touched, I dont want to cuddled, I dont want to be kissed. So it does have that impact on it.

4

"I wouldn't say that because Im with someone I havent had those difficulties."

She added: "Its very hard to get your partner to understand what you're going through mentally as well as the physical aspect of it.

"And the fact that they cant do anything to help puts a strain on it, so its just different."

Jude also had a period of time before she was in a relationship where she was trying to date - but potential suitors were put off by her condition.

She has hit out at the 'Insta perfect' world which means people can be very shallow and focus on a person's perceived flaws.

She said: "On every date I would be asked 'what's wrong with your face' and stuff like that, so it was definitely a topic of conversation.

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"It was the elephant in the room, like when is this going to be brought up.' And thats not how it should be.

"It shouldnt matter if I have a bit of psoriasis on my face or not whether you want a second date, but it really did impact that a lot.

"We live in this Insta perfect world where people with flaws or differences arent seen to be good enough and people dont want to be seen with someone like that.

"But to be honest with you if you have a problem with how I look, I dont really want to date anyone that treats people like that anyway."

Negative affect on Mental Health

Speaking on Mental Health day, Jude explained how various factors surrounding the condition can affect a person's mental wellness.

That includes the discomfort itself, but also the negative impact of how other people treat you.

Stats show that 67 per cent of sufferers believe that the condition can have an affect on your mental health.

Jude said: "If you are uncomfortable and thats causing you to not sleep then thats going to have an affect on your mental health, but also just that uncomfortableness all the time, being in a constant state of irritation, not being able to relax - that is going to have a toll on your mental health.

"A lot of people are like oh lets focus on treating the skin but they dont look at surrounding factors such as mental health.

"Because its such a visual condition it can make you incredibly insecure and really lonely and isolated because it's not really talked about. So that can also have an impact on your mental health because you feel like youre bottling it up and not talking about it.

"If youre not getting any sleep that means the next day you're not going to be functioning to your full potential, and you're stressing yourself out because you're not maybe getting as much done as you want and that's going to result in you stressing out more, which is going to affect your sleep, which is going to affect your mental health and its just a really vicious cycle.

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"I think for me as well, when people stare or make comments, sometimes they mean well but that can really also play on your mental health."

She added: "I definitely had comments in the past. I've had people say really horrible things to my face.

"But I'm OK that in that I'm in a position where I'm confident enough. There's so many people out there that arent and a situation like that would knock their confidence.

"I was in a position that I was able to move on and deal with it but thats not always the case."

If you are affected by any of the issues raised in this article, please call the Samaritans on (free) 116123.

We pay for your stories and videos! Do you have a story or video for The Scottish Sun? Email us at scoop@thesun.co.uk or call 0141 420 5300

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Scots psoriasis sufferer opens up on how skin condition can affect mental health and leave her not wanting to - The Scottish Sun

Lilly to Unveil New Data for the Treatments of Complex Dermatological Conditions at the 28th Annual European Academy of Dermatology and Venereology…

Research from Taltz, Olumiant and mirikizumab highlight the impact Lilly's medicines may have for patients around the world

INDIANAPOLIS, Oct. 8, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that it will present new data for Taltz (ixekizumab), Olumiant (baricitinib) and mirikizumab at the 28th annual European Academy of Dermatology and Venereology (EADV) Congress taking place Oct. 9-13 in Madrid, Spain. The research being highlighted at this year's meeting reinforces Lilly's commitment to developing treatments for individuals living with dermatological conditions such as psoriasis, psoriatic arthritis, atopic dermatitis and alopecia areata.

"Lilly is proud to showcase data from our dermatology portfolio at EADV this year. Our scientific expertise in dermatology has helped increase the number of available treatment options for patients around the world living with skin-related diseases," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We aspire to raise expectations as to how these diseases are treated so people can live their lives without compromise."

Lilly will present findings from a Phase 3 trial of Taltz for pediatric patients with moderate to severe psoriasis as a late-breaking oral presentation at this year's meeting. The company also will be sharing results from a patient survey evaluating treatment expectations and burden of disease for patients living with psoriasis.

For baricitinib, Lilly will present a late-breaking presentation of the BREEZE-AD7 clinical trial. BREEZE-AD7 is an investigational study measuring the efficacy and safety of baricitinib in combination with topical corticosteroids for the treatment of moderate to severe atopic dermatitis (AD) in adults. Lilly and Incyte Corporation (NASDAQ: INCY) are partners in the clinical development of baricitinib. Further, Lilly will present data findings from a real-world study assessing how elements of an individual's quality of life (both functional and emotional) may be impacted by AD.

Posters to be shared around Lilly's investigational compound, mirikizumab, include research from a study measuring patient outcomes and health-related elements of quality of life for individuals with moderate to severe psoriasis.

Studies, along with the times and locations for the data sessions, are highlighted below.

Taltz Data

Oral Presentations

Thursday, October 10

Saturday, October 12

Poster Presentations

Baricitinib Data

Oral Presentations

Saturday, October 12

Poster Presentations

Mirikizumab Data

Poster Presentations

INDICATIONS AND USAGE FOR TALTZTaltz is approved for the treatment of adults with adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Taltz is also approved for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.

IMPORTANT SAFETY INFORMATION FOR TALTZ

CONTRAINDICATIONSTaltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS InfectionsTaltz may increase the risk of infection. In clinical trials of patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of patients with psoriatic arthritis and ankylosing spondylitis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for TuberculosisEvaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

HypersensitivitySerious hypersensitivity reactions, including angioedema and urticaria (each 0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel DiseaseDuring Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz 80 mg Q2W group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn's disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn's disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

ImmunizationsPrior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONSMost common adverse reactions (1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea and tinea infections. Overall, the safety profiles observed in patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

Please see accompanying Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 23AUG2019

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patientsOLUMIANT (baricitinib) 2 mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS

WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

WARNINGS AND PRECAUTIONS

SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

Viral Reactivation Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

THROMBOSIS: Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

LABORATORY ABNORMALITIES: Neutropenia Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Lymphopenia Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

Anemia Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

Liver Enzyme Elevations Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases to 5x and 10x upper limit of normal were observed for both ALT and AST in patients in Olumiant clinical trials.

Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

Lipid Elevations Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

VACCINATIONS: Avoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

ADVERSE REACTIONSAdverse reactions (1%) include: upper respiratory tract infections (16.3%, 14.7%, 11.7%), nausea (2.7%, 2.8%, 1.6%), herpes simplex (0.8%, 1.8%, 0.7%) and herpes zoster (1.0%, 1.4%, 0.4%) for Olumiant 2 mg, baricitinib 4 mg, and placebo, respectively.

USE IN SPECIFIC POPULATIONSPREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with moderate or severe renal impairment.

Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

BA HCP ISI 01JUN2018

About Taltz Taltz (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.1 IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.1

About OLUMIANT OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.2 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.3 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.2 OLUMIANT is approved in more than 60 countries.

About Mirikizumab Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. Mirikizumab is being studied for the treatment of immune diseases, including psoriasis, ulcerative colitis and Crohn's disease.

About Moderate to Severe Plaque Psoriasis Psoriasis is a chronic, immune disease that affects the skin.4 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis affects approximately 125 million people worldwide, approximately 20 percent of whom have moderate to severe plaque psoriasis.4,5 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.4 Patients with plaque psoriasis often have other serious health conditions, such as diabetes and heart disease and experience negative impact on their quality of life.4

About Atopic DermatitisAtopic dermatitis (AD), a serious form of atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.6 AD is a heterogeneous disease both clinically and biologically, but may be characterized by chronic baseline symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.7,8 AD affects approximately 1-3 percent of adults worldwide.9

Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.10 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.11

About BREEZE-AD7The BREEZE-AD7 clinical trial is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of baricitinib in combination with topical corticosteroids in adult patients with moderate to severe atopic dermatitis. Two doses were evaluated separately such that the primary objective of the study could be met if one or both doses achieved the primary endpoint. The primary endpoint evaluated significant improvement in disease activity as determined by the proportion of patients on baricitinib achieving clear (0) or almost clear skin (1) with a greater than or equal to 2-point improvement as measured by the validated 5-point Investigator's Global Assessment for AD (vIGA) scale at 16 weeks of treatment. BREEZE-AD7 is the third of five Phase 3 studies that make up the BREEZE-AD program. Lilly previously announced results for BREEZE-AD1 and BREEZE-AD2 earlier this year.

About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Eli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab), OLUMIANT (baricitinib), and mirikizumab, and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that mirikizumab will receive regulatory approval, that Taltz or OLUMIANT will receive additional regulatory approvals, or that any will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

_______________________________1 Taltz Prescribing Information, 2019.2 Olumiant Prescribing Information, 2018.3 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.4 Psoriasis media kit. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed September, 2019.5 Skin conditions by the numbers. American Academy of Dermatology website. https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers. Accessed September, 2019.6 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.7 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.8 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.9 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.10 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.11 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

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SOURCE Eli Lilly and Company

Company Codes: NASDAQ-NMS:INCY, NYSE:LLY

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Public awareness on psoriasis increasing: health expert – pna.gov.ph

PSORIASIS AWARENESS CAMPAIGN. Dr. Victoria P. Guillano, MD, FPDS, president of the Psoriasis Foundation of the Philippines, Inc. (PFPI) speaks with stakeholders and patients during the World Psoriasis Day celebration in Davao City on Wednesday (Oct. 9, 2019). Guillano says the stigma associated with psoriasis remains but notes that public awareness has continued to increase in the past years. (PNA photo by Digna Banzon)

DAVAO CITY -- The stigma associated with psoriasis disease remains but public awareness continues to increase, a health expert said.

in an interview during the World Psoriasis Day celebration on Wednesday here, Dr. Victoria P. Guillano, MD, FPDS, president of the Psoriasis Foundation of the Philippines, Inc. (PFPI), attributed the increase to more patients seeking treatment .

Guillano said that according to psoriasis patients, the public has slowly learned to understand them.

She said psoriasis is a chronic, immune-mediated inflammatory disease that causes physical, emotional and social burdens.

The presence of associated itch and lesions on visible and sensitive body areas in psoriasis patients are closely related to decreased psychosocial well-being and impact on the quality of life,' she said.

Davao City Mayor Sara Z. Duterte, whose message was read during the celebration, encouraged stakeholders to raise awareness and information on the proper treatment of the disease.

Sara commended the organizing committee of the Southern Philippines Medical Center (SPMC) Department of Dermatology for spearheading the awareness campaign and creating a platform where people with psoriasis can share their experiences and have their voices heard.

I hope this celebration be instrumental in giving the people with psoriasis the access of affordable and appropriate treatment, the mayor said.

Meanwhile, Guillano said psoriasis remains incurable but the skin can be cleared--its treatment ranging from PHP17,000 to PHP250,000 depending on the severity of the case.

"Our campaign includes lecture and wellness programs for the patients and the public as well," she said. (PNA)

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Public awareness on psoriasis increasing: health expert - pna.gov.ph

Kim Kardashian Shares Pic Of ‘Extremely Bad’ Psoriasis On Her Face – HuffPost

Kim Kardashian got candid about her battle with psoriasis and dealing with her new psoriatic arthritis diagnosis in a revealing personal essay for sister Kourtney Kardashians wellness site,Poosh.

The reality star spoke about her first outbreak at 25 and detailed the rollercoaster of emotions shes faced in dealing with the chronic skin condition. Kardashian said that shes learned to deal with the patch of skin her right leg that gets the most frequent flare-ups, though it often spreads.

Earlier this year is when it got extremely bad it covered my whole face and a majority of my entire body, she wrote. She also spoke about finding out she suffered from psoriatic arthritis after waking up and not being able to use her hands.

One night, I woke up to use the restroom and I physically couldnt pick up my phone. I thought it was strange but maybe I just slept on my hands weird and I was so tired, I didnt need to be checking my phone at that hour anyway. I fell right back asleep, she said in her essay. I woke up that morning and I still couldnt pick up my phone. I was freaking out I couldnt even pick up a toothbrush, my hands hurt so badly.

At a certain press event, her pain level was so high that she couldnt even get dressed.

I couldnt even get my bra on that day, and I had to have someone dress me because the pain was so unbearable, she said. With the boots I was wearing, my ankles started to feel it in those joints. Thats when I knew it wasnt just an issue in my hands, it was a bone problem.

Kardashian finally sought help and went to the doctor, where she tested positive for rheumatoid arthritis and lupus, which turned out to be a false positive. But it did lead to her diagnosis of psoriatic arthritis.

Its similar to arthritis that can stem from psoriasis and it can come and go. Its still painful and scary, but I was happy to have a diagnosis, she shared.

Kim Kardashian/InstagramKardashian shared a candid photo of her skin condition in March.

These days, Kardashian maintains a plant-based diet and said that shes extremely comfortable with her skin condition.

No matter where it is on my body, sometimes I am fine with showing it off and other times I dont want it to be a distraction, so I cover it up withbody makeup, she said, before signing off with an encouraging message for anyone else struggling with psoriasis.

You cant let it ruin your life or get the best of you. You have to do what you can to make sure you are comfortable but not let it take over, Kardashian said.

Head to Poosh to read more of Kardashians piece.

REAL LIFE. REAL NEWS. REAL VOICES.

Help us tell more of the stories that matter from voices that too often remain unheard.

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Kim Kardashian Shares Pic Of 'Extremely Bad' Psoriasis On Her Face - HuffPost

Early Levels of Ustekinumab May Predict Longer-term Response in Patients With Psoriasis – AJMC.com Managed Markets Network

Measurement of drug levels early in treatment with ustekinumab for patients with psoriasis may be able to successfully predict patient response and, therefore, direct a treatment strategy.

The study included 491 British adults with psoriasis who were recruited from the multicenter Biomarkers of Systemic Treatment Outcomes in Psoriasis study as part of the British Association of Dermatologists Biologic and Immunomodulators Register. A total of 853 samples were obtained from the start of treatment.

The researchers measured disease activity using the Psoriasis Area and Severity Index (PASI) score. At least 1 PASI score was collected within the first year of treatment.

Early measured drug levels had a statistically significant association with 6-month response. Within 12 weeks after starting treatment, measured drug levels were associated with PASI75 (75% reduction in PASI score from baseline) 6 months after treatment started. The researchers reported that drug immunogenicity was low, with antidrug antibodies only detected in 17 (3.5%) of the patients.

This finding suggests that adequate drug exposure early in the treatment cycle may be particularly important in determining clinical outcome with ustekinumab, the authors wrote. They did suggest that additional research should focus on pharmacokinetic-pharmacodynamic modeling of the whole time course of response to ustekinumab.

In addition, they noted that further research is needed to confirm the use of therapeutic drug monitoring for ustekinumab.

In an accompanying editorial,2 Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, pointed out that although there are newer biologics available for psoriasis, there are a subset of patients who do well on older biologics and nonbiologic therapeutic options. The importance of this new study is that it helps identify which patients will respond to older and less expensive therapeutic options.

The results also bring us 1 step closer toward personalized medicine, an ideal type of future medical practice where all therapies would be chosen based on characteristics (eg, genetic, demographic, biologic) unique to a given individual patient, he wrote.Personalized medicine could assure that each chosen medication is tailored for a given patient, thus optimizing chances for therapeutic success.

References

1. Tsakok T, Wilson N, Dand N, et al. Association of serum ustekinumab levels with clinical response in psoriasis [published online September 18, 2019]. JAMA Dermatol. doi: 10.1001/jamadermatol.2019.1783.

2. Blauvelt A. Predicting clinical responses to ustekinumab: progress toward a future of personalized medicine [published online September 18, 2019]. JAMA Dermatol. doi: 10.1001/jamadermatol.2019.2587.

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Early Levels of Ustekinumab May Predict Longer-term Response in Patients With Psoriasis - AJMC.com Managed Markets Network

Kim Kardashian Published an 1000-Word Essay About Her Psoriasis for Poosh – Allure Magazine

Kim Kardashian has always been pretty open about living with psoriasis, but in a recent essay she penned for sister Kourtney's lifestyle site, Poosh, she got more real than ever about her journey with the condition.

In the 1000-word article, the 38-year-old mom of four detailed the highs and lows of living with the common skin condition, which she's had for 13 years now. She also shared never-before-seen photos of her psoriasis, including a flare-up on her face. Despite watching her mom, Kris Jenner, struggle with psoriasis growing up, she admitted that she ultimately had no idea what she was in for.

Turns out, her experience has been quite different than Jenner's. "She had it in her scalp and all over her body, and Id see it all the time and remember her going to the tanning salon to try and ease it for me, however, that remedy would burn the areas and cause them to itch, so I always felt helpless," she wrote. "I am the only child my mom passed down her autoimmune issue to. Lucky me, lol," she added.

Kardashian was 25 when she experienced her first psoriasis flare-up, but at the time, she had it treated with a shot of cortisone and it went away for roughly five years. When it came back in her early 30s, it did so with vengeance, and despite trying myriad remedies (i.e. celery juice, countless creams, changing her diet), she said she now just deals with the largely unpredictable flare-ups. "I have learned to live with this spot (on my leg) without using any creams or medication I just deal. Sometimes I cover it up and sometimes I dont. It doesnt really bother me," the Keeping Up With the Kardashian's star wrote.

What's more, she revealed that both times she was pregnant, it went away completely, though it was short-lived. "That was amazing, but then it came back again," she said. "Earlier this year is when it got extremely bad it covered my whole face and a majority of my entire body."

The KKW Beauty founder also shared several photos of her psoriasis in different stages, including what it looks like when it's fully flaring, as well as how it presents when it's healing. No matter what stage it's in, though, Kardashian has come to terms with it: "Ive become extremely comfortable with my psoriasis. No matter where it is on my body, sometimes I am fine with showing it off and other times I dont want it to be a distraction, so I cover it up with body makeup," she explained.

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Kim Kardashian Published an 1000-Word Essay About Her Psoriasis for Poosh - Allure Magazine

Kim Kardashian details her struggle with psoriasis – Page Six

Kim Kardashians troubles are more than just skin-deep.

The reality TV star turned business mogul has written a heartfelt essay for Poosh.com in which she expands on her struggle with psoriasis and psoriatic arthritis.

Even though I always grew up with my mom having psoriasis and hearing her talk about her struggle, I really had no idea what my life would be like dealing with an autoimmune disease myself, she begins, explaining that its been 13 years since she first experienced a psoriasis flare-up. I am the only child my mom passed down her autoimmune issue to, she adds. Lucky me, lol.

According to the National Psoriasis Foundation, more than 8 million Americans suffer from the condition.

Kardashian, 38, treated her first psoriasis flare-up with a cortisone shot, conveniently delivered by her then-neighbor, a dermatologist, after which it went away for five years, only to return in her early 30s.

For the past eight years, although the spots are unpredictable, I can always count on my main spot on my right lower leg, which consistently stays flared up, she details, before adding that when I got pregnant both times, it fully went away.

Kardashian described her initial experience with the arthritis side of the disease as first occurring when she was unable to pick up her phone or use a toothbrush. At first she assumed that shed simply overdone a workout, but as the day wore on, I got a bit more movement in my hands, but they really hurt from the inside I felt it in my bones.

I immediately started to cry and felt so lost, Kardashian added, noting soon after she was diagnosed with rheumatoid arthritis and lupus. Her doctor, however, explained that it was possible shed had a false positive, so she came back three days later to discover this was indeed true, and that her pain stemmed from psoriatic arthritis.

Kardashian also outlined about four months before the arthritis diagnosis where she tried everything natural every ointment, cream, serum, and foam you can possibly imagine and everything from the dermatologist, including celery juice and herbal tea.

Today, however, she has become extremely comfortable with my psoriasis.

If you have psoriasis, you cant let it ruin your life or get the best of you. You have to do what you can to make sure you are comfortable but not let it take over I hope my story can help anyone else with an autoimmune disease feel confident that there is light at the end of the tunnel.

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Kim Kardashian details her struggle with psoriasis - Page Six

Womans psoriasis is worst docs have seen as scaly plaques cover 90% of her body – New York Post

A young mom has been forced to give up work due to the unbearable pain caused by her psoriasis.

Sabrina Speaks, 23, has scaly plaques covering 90 per cent of her body, after developing the same skin condition as Kim Kardashian.

And now Speaks is opening up about her battle with psoriasis in a bid to raise awareness of the crippling autoimmune condition.

In particular, the mother-of-two, from North Carolina, has admitted that her family and motherhood has saved her from complete depression.

Psoriasis has affected my entire life. It is an autoimmune disorder. I want to make more people aware of that, she said.

Basically, it doesnt allow my immune system to work in a way that it should.

I produce skin cells way too quickly and I also have psoriatic arthritis which is an arthritis that ties in with psoriasis in the most severe cases.

The main side effects of my condition are fatigue, pain, swelling, itching, burning, depression and anxiety.

I cant work because of the pain it causes and also the reactions that I get from people seeing it.

While psoriasis isnt a rare condition, the severity of Speaks psoriasis is extreme with docs saying she is one of the worst cases they have seen.

A lot of people have it. It can be brought on by many things. Stress or even a simple cold can start your symptoms straight away, she said.

But a lot of people do not have it as severe as I do, where a lot of treatments dont work.

Heath Franklin / Barcroft Media

Heath Franklin / Barcroft Media

Barcroft Media

Barcroft Media

Barcroft Media

Heath Franklin / Barcroft Media

I am 90 percent or more covered in plaques. Im clearing up a bit now Im taking my injections, but prior to this, I was way more covered from head to toe.

According to my doctor, I am one of the worst cases theyve ever seen.

The hardest part about living with it is how it affects me as a person, how it changes me.

Im unable to be the person I want to be. I want to be running around with my children and doing things in the world without getting stared at, or without feeling pain.

Unfortunately, I just cant.

There is currently no cure for psoriasis, but Sabrina is having injections on a treatment plan to try and ease the pain and the number of plaques she has.

It all started out as just one spot on the back of her head a spot that suddenly turned really itchy and into a crusty patch.

It kept getting worse and worse. At first doctors said it was ringworm, but eventually, we found out it was psoriasis, Speaks added.

In my teenage years, making friends was really hard. A lot of people were like whos that girl that has all that stuff on her skin and why is she always tired? Just so many questions. I endured way too much bullying as a child and teenager.

And as well as the physical pain, Sabrina has a tricky time when out in public and tries her best to cope with the stares and pointing.

Adults are definitely more harsh than children. Children will come up and ask me about it. Whereas adults will just whisper, point, give you dirty looks and stares, she said.

They dont bother to just ask. Its really hurtful. I hope that with certain people reading and watching my story, they wont be that person in the future. To not just me, but to anyone living with a disease or illness.

Despite her crippling pain, Speaks has managed to find happiness in the shape of her husband and two daughters, Sophia and Madison.

My babies are my life, she said.

If Im anything in this world, Im a mother. Thats what I am first and what Ive always wanted to be.

On a daily basis, they drive me bonkers. But they have also improved my condition.

They make me happier, they take a lot of stress away too.

The turning point in my life was definitely having my first daughter, Sophia. The moment I saw her, I knew I had to be more confident for her sake.

Whether that meant me suffering or not.

And Speaks husband, Daniel, 28, added: I would describe Sabrina as a beautiful, loving mother and wife that would do anything for anybody.

Shes got a heart of gold.

When we first met, she told me about her condition. I was just like youre a really nice person and I want to get to you know you better I didnt mind it. We clicked right away.

I try to take good care of her when shes sick. She struggles a lot sometimes, I so want to make sure Im there for her.

Speaks is now focusing her attention on raising more awareness for psoriasis and those who live with similar conditions.

Its so important to raise awareness for this because theres just not enough information out there, she added.

Were tired, were exhausted, were in pain its a lot to handle. I am proud of everything I am trying to do in my life now, despite my condition. I have a loving husband and two wonderful children, so what more could I want?

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Womans psoriasis is worst docs have seen as scaly plaques cover 90% of her body - New York Post

Kim Kardashian Was Diagnosed With Psoriatic Arthritis After Her Lupus Scare On ‘KUWTK’ – Women’s Health

Axelle/Bauer-GriffinGetty Images

Kim Kardashian's health woes have been a major plot line for the new season of Keeping Up With The Kardashians. On last week's episode, Kim underwent testing for lupus and rheumatoid arthritis antibodies after she said she'd been experiencing numbness in her hands and other symptoms, and tested positive.

Ive been feeling so tired, so nauseous and my hands are really getting swollen, she said. I feel like I literally am falling apart. My hands are numb. Lately, my wrists are starting to hurt again but its definitely a different feeling, she said. I feel this in my bones. Its starting to really worry me. I really have to look into this. Based on the symptoms, it looks like I have rheumatoid arthritis. Its so scary. So I have to go to the doctor and see whats going on because I cant live like this.

But she still didn't have exact answers for what was going on. On last night's episode of KUWTK, Kim finally learned what was causing her pain.

In the episode, she went to a doctor and had an ultrasound done on her hands to determine whether or not she was suffering from lupus or rheumatoid arthritis. And it turns out, she was diagnosed with psoriatic arthritis.

First of all, if you have any evidence for lupus, we would have screened it, the doctor explained. You do not have lupus and rheumatoid arthritis. So, you can be reassured. You probably have psoriatic arthritis because psoriasis comes and goes. Theres nothing there right now.

Kim immediately let out a deep breath after hearing the news. Im so relieved that this is just psoriatic arthritis, Kim admitted. The pain is going to come and go sometimes, but I can manage it and this isnt going to stop me.

According to the American College of Rheumatology, psoriatic arthritis is a form of inflammatory arthritis that happens to people with psoriasis. Kim's been open about her struggles with the skin condition psoriasis in the past.

The main symptoms of psoriatic arthritis are painful, stiff and swollen joints. While the cause of psoriatic arthritis is not known, of those with psoriatic arthritis, 40 percent also have a family member with psoriasis or arthritis, according to the American College of Rheumatology.

It's not unusual for someone Kim's age to be diagnosed with psoriatic arthritispeople between 30 and 50 years old are the most likely to be diagnosed, per the American College of Rheumatology. And while there is no cure for psoriatic psoriasis, treatments usually involve over-the-counter anti-inflammatories or prescription anti-rheumatic drugs.

Here's hoping Kim finds a resolution to her symptoms soon.

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Kim Kardashian Was Diagnosed With Psoriatic Arthritis After Her Lupus Scare On 'KUWTK' - Women's Health

Psoriasis Drug Target Holds Potential for Bone Cancer – Technology Networks

Using a mouse model, researchers have discovered a potential therapeutic target for osteosarcoma one which is already used to treat psoriasis. These new findings are published in Cancer Discovery.

Not just "growing pains"

Osteosarcoma is a type of bone cancer, commonly diagnosed in young people; around half of new cases in the United States each year are in children and teenagers. As such, the signs and symptoms can often be mistaken for "growing pains", which can delay diagnosis. If, by this point, the cancer has spread outside the bone, five-year survival rates decrease from 77% to 65%.

Current treatment for osteosarcoma follows a standard pattern; surgery, chemotherapy and/or radiotherapy. Given the survival rate, there are efforts to develop treatments beyond this standard. One such treatment is immunotherapy, which is rapidly becoming the fifth pillar of cancer treatment.1

The role of the immune system

Researchers were led towards immune molecules by the results of genome-wide association studies (GWAS), which associated the gene GRM4 with susceptibility to osteosarcoma.2,3 It was through investigating this gene that they found an association between osteosarcoma and IL-23, a pro-inflammatory molecule within the immune system.

In a recent press release, lead author Maya Kansara says : "In a mouse model of osteosarcoma, we investigated the role of GRM4, as well as a number of immune molecules, the production of which is regulated by GRM4," she continues: "In our model, we discovered that the inflammatory molecule IL-23 was critical to osteosarcoma formation and progression."

The authors uncovered the role of IL-23 by removing it from mice, via a gene knock-out, finding that they were then protected from developing osteosarcomas. Blocking IL-23 in mice with existing osteosarcomas was also trialed the growth of these tumors was successfully suppressed.4From bench to bedside

The relationship between IL-23 and development of osteosarcoma suggests the former could be targeted in treatment of the latter. IL-23 is already a target in the treatment of some autoimmune diseases, including psoriasis.

"Drugs that block IL-23 are approved and well-tolerated, and on the market now for the treatment of psoriasis," says Professor David Thomas, co-author of the study. "We are now designing clinical trials to see whether they can provide much-needed improved health outcomes for osteosarcoma patients."

References

1.Oiseth, S.J., Aziz, M.S. (2017) Cancer immunotherapy: a brief review of the history, possibilities, and challenges ahead. Journal of Cancer Metastasis and Treatment. DOI: https://doi.org/10.20517/2394-4722.2017.41

2.Savage, S.A., et al. (2013) Genome-wide association study identifies two susceptibility loci for osteosarcoma. Nature Genetics. DOI: https://dx.doi.org/10.1038%2Fng.2645

3.Jiang, C., et al. (2014) GRM4 gene polymorphism is associated with susceptibility and prognosis of osteosarcoma in a Chinese Han population. Medical Oncology. DOI: https://doi.org/10.1007/s12032-014-0050-4

4.Kansara, M., et al. (2019) Infiltrating myeloid cells drive osteosarcoma progression via GRM4 regulation of IL23. Cancer Discovery. DOI: https://doi.org/10.1158/2159-8290.CD-19-0154

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Psoriasis Drug Target Holds Potential for Bone Cancer - Technology Networks

High blood pressure risk in psoriasis, psoriatic arthritis – Dermatology Times

Psoriasis and psoriatic arthritis are relatively common immune mediated diseases. The increase in cardiovascular disease associated with psoriatic disease is well established. Interestingly, some studies suggest a stronger link between psoriatic arthritis and cardiovascular disease.

Hypertension is a major risk factor for the development of cardiovascular disease. It is therefore considered an important modifiable risk factor in the development of cardiovascular disease. Previous studies have shown that patients with psoriasis have an increased risk of poorly controlled hypertension. Furthermore, there appears to be an increased prevalence of hypertension in patients with psoriatic arthritis even after adjusting for traditional cardiovascular risk factors.

RELATED:Cardiovascular risk associated with psoriasis patients age, race

A group of collaborating physicians from Hospital Universitario Central de Asturias (HUCA), Spain, led by Dr. Ruben Queiro performed an observational cross-sectional study to analyze the comparative prevalence of hypertension in psoriatic disease.

The patient cohort was from a multidisciplinary (rheumatology/dermatology), single center clinic, in a university hospital in Spain. 290 patients with psoriatic arthritis and 310 patients with psoriasis (in the absence of psoriatic arthritis) were included. For the purpose of the study hypertension was defined as 140/90 on two separate days during a one month period or the chronic use of antihypertensive medication.

The study cohort was composed of 324 men and 276 women with a mean age of 5312 years. The study results showed the following: 144/600 patients had hypertension (24%). The mean age at onset of psoriasis and arthritis was significantly higher in the hypertension population (3917 in HBP vs. 2616 years in non-HBP, p<0.01, 4917 in HBP vs. 4114 years in non-HBP, p<0.01). The mean body weight and BMI were significantly higher in HBP patients (8316 in HBP vs. 7715 kg in non-HBP, p<0.01, 30.24.9 in HBP vs. 274.4 in non-HBP, p<0.01).

References:

Queiro R, Lorenzo A, Tejn P, Pardo E, Coto P. Hypertension is associated with increased age at the onset of psoriasis and a higher body mass index in psoriatic disease. Clin Rheumatol. 2019;38(8):2063-2068.

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High blood pressure risk in psoriasis, psoriatic arthritis - Dermatology Times

Psoriasis cant be cured, but new treatments can clear skin in many – Pocono Record

Plaque psoriasis is a common skin condition that causes raised red patches covered with a silvery white buildup of dead skin cells to form. Plaque psoriasis is the most common form of psoriasis about 80 to 90% of the 7 million to 8 million Americans who have psoriasis have plaque psoriasis, according to the National Psoriasis Foundation.

Plaque psoriasis is most commonly found on the scalp, elbows, knees and lower back, but it can affect anywhere on the body, says Dr. Alan Westheim, dermatologist at St. Lukes Medical Associates of Monroe County in East Stroudsburg. The plaques can be itchy and painful, he says.

Because psoriasis can be unsightly, many fear it is contagious, but it is not, Westheim says. It cant be spread by touch or by close contact, he says. We also know that psoriasis has a large effect on the patients quality of life.

Psoriasis is an autoimmune disease, Westheim explains. That means the body sees its own cells as foreign invaders and attacks them. The attacks cause the skin to grow more quickly, Westheim says. Normal skin replenishes every five to six weeks, Westheim says. When you have psoriasis, your skin replenishes every five to six days.

It isnt known why some people get psoriasis and others dont, Westheim says. Genetics is believed to play a role. About 10% of people are born with genes that make them prone to psoriasis, but only about 3% of people get psoriasis. Obesity also appears to play a role; the greater your weight, the greater likelihood of developing psoriasis, he says.

If both parents have psoriasis, their children are more likely to get psoriasis, too, Westheim says.

You can get psoriasis at any age, even as an infant, Westheim says. However, it is most common when people are in their late teens and early 20s and again after age 60.

Topical, systemic treatments available

There is no cure for psoriasis, but it can be treated, Westheim says. Some people are able to achieve clear skin with the newer treatments available. The newer treatments are designed to stop the immune process that leads to plaques.

When it comes to treatment, theres a ladder we climb, Westheim says. We try one treatment, and if that doesnt work, we go onto the next.

Depending on the severity of your psoriasis, your doctor may recommend topical treatments topical creams and steroids and vitamin D derivatives, he says. If you respond, great. If you dont, we might try UV light treatments. And if that doesnt work, we can talk about medications.

Methotrexate had been the mainstay for many years, but now there are a number of newer drugs on the market, Westheim says. The newer medicines are biologics and work wonderfully but are costly around $20,000 a year, he says.

Treatments are important to prevent disease progression and joint destruction, he says. It is important to look at psoriasis as a systemic disease as there is associated risk for heart disease and other systemic illnesses.

About a third of people with psoriasis also develop psoriatic arthritis, which can cause joint pain and swelling, Westheim says.

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Psoriasis cant be cured, but new treatments can clear skin in many - Pocono Record

Anti-psoriasis compound could lead to new drug for malaria – Futurity: Research News

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Redesigning molecules originally developed to treat the skin disease psoriasis could lead to an effective new drug against malaria, according to new research.

Researchers modified a class of molecules called pantothenamides to increase their stability in humans. The new compounds stop the malaria parasite from replicating in infected humans and from being transmitted to mosquitoes. Theyre also effective against malaria parasites resistant to currently available drugs.

Malaria is a major global health concern, with around 216 million cases and 400,000 deaths annually. The deadliest form of the disease is caused by the parasite Plasmodium falciparum, which is transmitted to humans from the bite of an infected Anopheles mosquito. Because many Plasmodium parasites have developed resistance to the most common drugs used against them, there is a pressing need for effective new treatment options.

We have known for a long time that pantothenamides are extremely potent against the malaria parasite, but they become unstable within biological fluids because an enzyme clips them apart before they can act, says coauthor Manuel Llins, professor of biochemistry and molecular biology and of chemistry at Penn State. The researchers found that changing a chemical bond in a pantothenamide molecule prevents this clipping, making it viable for use as a new antimalarial drug, he says.

The team found that the modified pantothenamide molecules not only interfere with the development of the malaria parasite during its asexual growth phase in the blood but also prevent transmission of the sexual form of the parasite from human blood to mosquitoes.

By also preventing the transmission of malaria parasites from infected people into mosquitoes, these pantothenamides can reduce the chances that mosquitoes will be infectious to others, says Llins. It is currently widely accepted that next-generation antimalarial drugs must target the parasite at multiple stages to both cure the disease in an infected individual and prevent its spread to others.

Llins and Erik Allman, postdoctoral scholar at Penn State at the time of the research, investigated exactly how the four most potent molecules in the compound class kill the malaria parasite. Specifically, they examined how these compounds affect the parasites metabolism while growing in human blood.

The team discovered that, because the pantothenamide molecule closely resembles the essential vitamin B5, the parasite mistakenly takes it in and metabolizes it. This leads to the formation of molecular analogues, or antimetabolites, which decrease the parasites production of acetyl-CoA, a compound critical for its survival.

The molecule has a mechanism of action that hasnt been used before, says Koen Dechering, of TropIQ Health Sciences. This means that theres no resistance to the drug as yet, and it is effective against many forms of malaria. Because parasite resistance to malaria drugs is a major problem worldwide, we are very close to a breakthrough.

Pantothenamides have a simple chemistry, so they are easy and inexpensive to make, says Llins, And we now know their mode of action, which we dont always know before moving into drug development. This makes pantothenamides excellent candidates for further development and eventual clinical trials.

The research appears in the journal Science Translational Medicine.

Additional researchers from Penn State, Radboud University Medical Center in the Netherlands, St. Judes Childrens Research Hospital, Chiralix in the Netherlands, XenoGesis in the United Kingdom, the Swiss Tropical and Public Health Institute in Switzerland, the University of Basil in Switzerland, the Art of Discovery in Spain, Medicines for Malaria Venture in Switzerland, and Hermkens Pharma Consultancy in the Netherlands contributed to the work.

Source: Penn State

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Anti-psoriasis compound could lead to new drug for malaria - Futurity: Research News

Guselkumab Demonstrates Superiority to Secukinumab for Reducing Psoriasis Area and Severity – Dermatology Advisor

Guselkumab administered at 100 mg for 5 weeks and then every 8 weeks was superior to secukinumab at 300 mg for 5 weeks and then every 4 weeks in inducing a 90% reduction in the Psoriasis Area and Severity Index (PASI 90) response at 48-week follow-up, a phase 3 study in the Lancet suggests.

Patients aged 18 years who had moderate to severe plaque-type psoriasis were enrolled in the trial. The study was a comparator-controlled analysis conducted at 142 outpatient centers in nine countries. Only patients who were candidates for phototherapy or systemic therapy were eligible to participate. Study investigators randomly assigned patients to either 100 mg guselkumab at week 0 and week 4 and then every 8 weeks (n=534) or 300 mg secukinumab at weeks 0, 1, 2, 3, and 4, and then every 4 weeks (n=514).

The proportion of patients who achieved a 90% reduction in PASI 90 response at week 48 comprised the primary endpoint. Additional secondary endpoints included the proportion of patients who achieved a PASI 75 response at weeks 12 and 48, PASI 90 response at week 12, PASI 75 response at week 12, PASI 100 response at week 48, Investigators Global Assessment score of 0 (cleared) at 48 weeks, and Investigators Global Assessment score of 0 or 1 (minimal) at 48 weeks. In patients who received 1 dose of their assigned study drug from week 0 to week 56, safety was also assessed.

At 48 weeks, a higher proportion of patients who achieved a PASI 90 response was observed in the guselkumab group vs the secukinumab group (84% vs 70%, respectively; P <.0001). Guselkumab was noninferior to secukinumab in terms of the proportion of patients who achieved a PASI 75 response at both week 12 and week 48 (85% vs 80%, respectively; treatment difference, 4.3 percentage points; 95% CI, 0.2 to 8.9; P <.0001). The researchers were unable to establish superiority of guselkumab for PASI 75 at these time points (P =.0616). There was no difference between the groups with regard to the rate of adverse events, infections, or serious adverse events.

Limitations of the study were the lack of assessment of drug concentrations as well as the data projecting longer than 1 year.

The researchers added that blocking the regulatory capacity of the [interleukin]-23 pathway with guselkumab rather than directly targeting interleukin-17A with secukinumab might be useful for maintaining a durable response and preventing recurrence of disease in patients with psoriasis.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors disclosures.

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Reference

Reich K, Armstrong AW, Langley RG, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019;394(10201):831-839.

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Guselkumab Demonstrates Superiority to Secukinumab for Reducing Psoriasis Area and Severity - Dermatology Advisor

Patients With Psoriasis Have 2-Fold Higher Risk of Mortality – Dermatology Advisor

In the United States, patients with psoriasis have a 2-fold higher risk for mortality compared with individuals without psoriasis, a study in the Journal of the American Academy of Dermatology suggests. The risk for mortality in these patients appears to be partially mediated by the higher prevalence of infectious, cardiovascular, and neoplastic disorders that are frequently observed in patients with psoriasis.

The ongoing, cross-sectional National Health and Nutrition Examination Survey (NHANES) was used to identify patients aged >10 years with self-reported psoriasis (n=347) and control patients without psoriasis (n=12,684). Only individuals who participated in the NHANES between 2003 and 2006, as well as 2009 and 2010, were included in the retrospective study.

Medical history questionnaires were used to assess participants comorbidities, including history of cancer, cardiovascular disease, chronic kidney disease, and diabetes mellitus. Data linked from national databases were examined to identify associated mortality rates.

The presence of psoriasis was associated with a 1.99-fold higher risk for mortality during a 52.3-month follow-up period compared with nonpsoriatic control patients (hazard ratio, 1.99; 95% CI, 1.01-3.93; P =.047), according to the adjusted analysis. Female sex and income were associated with a lower mortality risk, whereas smoking and increasing age drove the higher risk for mortality. Comorbidities that partially mediated the increased risk for mortality in patients with psoriasis included cardiovascular disease (15.5%), chronic obstructive pulmonary disease (8.7%), cancer (11.7%), diabetes mellitus (5.9%), chronic kidney disease (4.2%), and stroke (4.7%).

Limitations of the analysis include its retrospective nature, as well as the self-reported nature of some of the data.

Considering the different guidelines and use of systemic therapies between countries, the researchers wrote, future population-based studies investigating the effect of systemic therapies on mortality risk are essential for understanding the long-term effects of these medications.

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Reference

Semenov YR, Herbosa CM, Rogers AT, et al. Psoriasis and mortality in the US: Data from the National Health and Nutrition Examination Survey [published online August 12, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.08.011

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Patients With Psoriasis Have 2-Fold Higher Risk of Mortality - Dermatology Advisor

J&J Files sBLA for Tremfya With FDA for Psoriatic Arthritis – Yahoo Finance

Johnson & Johnson JNJ submitted a supplemental biologics license application (sBLA)to the FDA, seeking approval to expand the label of itsIL-23 inhibitor Tremfya as a treatment for active psoriatic arthritis (PsA).

The sBLA filing was based on data from the phase III DISCOVER 1 and 2 studies, which evaluated the safety and efficacy of Tremfya compared to placebo for treating adult patients with PsA.

In June, J&Js subsidiary, Janssenhad announced top-line results from the studies, which evaluated Tremfya administered by subcutaneous injection. The studies met the primary endpoint of achieving American College of Rheumatology 20% improvement while the safety profile was consistent with the previous programs on Tremfya/guselkumab.

J&J expects to file a similar regulatory application with the European Medicines Agency by the end of this year.

J&Js stock has risen 0.4% this year so far against a decrease of 1.9% recorded by the industry.

Tremfya was first approved in the United States and the EU in 2017 for the treatment of moderate-to-severe plaque psoriasis and was off to a solid start after its launch.

The drug recorded sales of $452 million in the first half of 2019. If approved by the FDA for PsA, Tremfya will be the first IL-23 inhibitorto be approved to treat this complex inflammatory disease, which causes pain, stiffness and swelling in and around the joints. It will expand the drugs eligible patient population and should boost its sales.

Tremfya has proved its superiority over other drugs in the past. Last December, J&J announced results from a head-to-head phase III ECLIPSE study, which compared Tremfya with Novartis' NVS psoriasis drug, Cosentyx (secukinumab).

Data from the study showed that after a 48-week treatment, 84.5% of the patients treated with Tremfya achieved 90% improvement in disease symptoms as measured by the Psoriasis Area Severity Index in comparison to 70% achieved by Novartis' Cosentyx.

The drug is also being studied for various other indications including phase IIb/III studies in Crohns disease and ulcerative colitis and in a phase II study for hidradenitis suppurativa.

J&J currently has a Zacks Rank #3 (Hold). Some better-ranked large-cap pharma stocks include Roche Holding AG RHHBY and Merck MRK, both with a Zacks Rank #2 (Buy). You can see the complete list of todays Zacks #1 Rank (Strong Buy) stocks here.

Shares of Roche have gained 10.8% this year so far. Earnings estimates for 2019 have risen 0.8% while that for 2020 have increased 2% over the past 60 days.

Mercks stock is up 7.3% this year so far. Its earnings estimates have risen 3.6% for 2019 and 1.3% for 2020 over the past 60 days.

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J&J Files sBLA for Tremfya With FDA for Psoriatic Arthritis - Yahoo Finance

J&J’s Tremfya filed for approval in US for psoriatic arthritis – PMLiVE

Johnson & Johnson has submitted an application to the FDA for the approval of Tremfya in psoriatic arthritis, which could further congest an intensely competitive therapy area.

Tremfya (guselkumab) is Janssens follow-up to IL-23/IL-12 inhibitor blockbuster Stelara (ustekinumab), which has faced competition from rival new treatments across immunology indications.

This includes Novartis Consentyx (secukinumab), AbbVies Skyrizi (risankizumab), Eli Lillys Taltz (ixekizumab) and Pfizers Xeljanz (tofacitinib citrate) , which are all already approved in psoriatic arthritis.

The application to the FDA is based on thetop line results from the pivotal phase 3 trials of Tremfya, DISCOVER-1 and DISCOVER-2.

The drug hit its primary endpoint of ACR20 response at week 24, and multiple secondary endpoints including ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA) and quality of life (SF-36 PCS and MCS).

DISCOVER-2 also assessed the effect on structural damage using the van der Heide-Sharp score as a key endpoint. DISCOVER-1 studied Tremfya in 381 participants, including some who were previously treated with anti-TNF biologics, and the duration of the study was 52 weeks. DISCOVER-2 included 739 biologic-naive participants, and continued up to 100 weeks.

J&J will face tough competition from other psoriasis therapies, including Novartis Cosentyx. The two drugs both treat psoriasis by targeting interleukins involved in the inflammatory process, with Consentyx targeting IL-17 and Tremfya inhibiting IL-23, and they are among a crowd of new biologic therapies vying for market share in the psoriasis category.

Despite the competition, Tremfya is still a source of growth for J&J sales of Tremfya, which came to market in 2017, totalled $452m over the first half of 2019. With a successfulhead-to-head trial against Novartis Cosentyx in plaque psoriasis under its belt, J&Js drug has been established as a significant contender in the crowded field of psoriasis drugs.

However, J&J has been subject to another head-to-head trial Eli Lillys Taltzoutperformed Tremfya in a post-marketing trial in patients plaque psoriasis.

Taltz already has a large portion of the market share, having generated sales of $606m over the first half of 2019, which suggests full-year revenues will beat the $938m it brought in last year.

Lillys Taltz has also been proved to be superior to market leader Humira (adalimumab), in reducing psoriatic arthritis activity by half, and also completely cleared patients skin after 24 weeks. These factors could damage Tremfyas uptake in this indication, if approved, but its already established presence in the field could counteract this.

AbbVies Humira and J&Js Stelara have remained blockbuster drugs, partly due to their ability to rapidly clear up 75% of lesions in most patients.

J&J is also set to submit a marketing application to the European Medicines Agency for Tremfya in the same indication before the end of the year.

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J&J's Tremfya filed for approval in US for psoriatic arthritis - PMLiVE


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