Category Archives: Psoriasis

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Long-term data from Janssens Phase III DISCOVER-2a trial show that TREMFYA (guselkumab), a selective IL-23 inhibitor, lead to skin clearance and joint symptom relief for up to two years in patients with active psoriatic arthritis (PsA).

Janssens TREMFYA was approved for the treatment of adults with moderate to severe plaque psoriasis (PsO) in the U.S. back in July 2017 and then again in July 2020 for adults with active PsA. The latter approval was based on trial data from the DISCOVER-1 and DISCOVER-2, both of which showed that the treatment led to at least 20% improvement in joint symptoms (ACR 20) by 24 weeks.

TREMFYA is a selective inhibitor of IL-23, a key cytokine that fuels an inflammatory immune response associated with symptoms of PsO and PsA.

"PsA can be a chronically painful and debilitating disease, and many PsA patients are still searching for enduring relief of their symptoms," said study investigator Philip J. Mease, M.D., of the Swedish Medical Center/Providence St. Joseph Health and the University of Washington, Seattle, Washington. "These data, which show that the observed benefits of TREMFYA in PsA continue through two years, represent positive news for physicians and patients alike."

Findings from the new trial show that 56% and 55% of patients who took TREMFYA every four and every eight weeks, respectively, experienced at least a 50% improvement in the ACR score through 100 weeks. Approximately 62% of patients who took TREMFYA every 4 weeks and 55% of patients who took TREMFYA every eight weeks with clinically meaningfulbaseline PsO also achieved complete skin clearance by follow up.

Approximately 59% and 53% of those who had clinically meaningful baseline skin involvement who received TREMFYA every four weeks and eight weeks, respectively, experienced complete skin clearance by week 100. Additionally, 76% of patients treated with TREMFYA every four weeks and 74% treated every eight weeks had at least a 20% improvement in the ACR by the long-term follow-up period.

TREMFYA every four weeks also demonstrated significant inhibition of radiographic progression of joint structural damage at week 24. Rates of radiographic progression of joint damage observed from week 52 to 100 in patients who received the treatment every four and eight weeks were also numerically lower than those reported from baseline to week 52.

In terms of durability, the investigators of the DISCOVER-2a trial found that treatment with TREMFYA led to robust joint and skin response rates and improvements in outcome measures through the two-year follow-up period. Up to 90% of patients randomly assigned to TREMFYA also continued their assigned therapy through week 100. Overall, no new safety signals were observed through week 112.

"PsA is a chronic inflammatory disease of the skin, joints, and soft tissue and therefore, sustained control of this inflammation is important to physicians and patients," saidAlyssa Johnsen, M.D., Ph.D., Janssen Research & Developments Vice President and Rheumatology Disease Area Leader. "These long-term study results further bolster our confidence in the ability of TREMFYA to significantly improve the diverse manifestations of PsA over time."

Janssen said in a statement that the data from the DISCOVER-2a trial will soon be presented in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, held March 16 through 20, 2021.

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Janssen's Psoriatic Arthritis Drug Proves Long-Term Efficacy in Two-Year Trial - BioSpace

This article was originally published here

J Rheumatol. 2021 Mar 15:jrheum.201671. doi: 10.3899/jrheum.201671. Online ahead of print.

ABSTRACT

The coronavirus disease 2019 (COVID-19; caused by SARS-CoV-2) pandemic has affected the healthcare system on a global scale, and we utilized the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2020 annual meeting to examine how COVID-19 might affect patients with psoriatic disease (PsD) and the clinicians who care for them. Pressing issues and concerns identified included whether having psoriasis increased the risk of acquiring COVID-19, vaccine safety, and the acceptability of telehealth. The general message from rheumatologists, dermatologists, infectious disease specialists, and patient research partners was that data did not suggest that having PsD or its treatment significantly increased risk of infection or more severe disease course, and that the telehealth experience was a success overall.

PMID:33722951 | DOI:10.3899/jrheum.201671

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Psoriasis and Psoriatic Arthritis in the Context of the COVID-19 Pandemic: A Plenary Session From the GRAPPA 2020 Annual Meeting - DocWire News

WESTLAKE VILLAGE, Calif., March 17, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, will present safety, efficacy, and patient-reported outcomes from its Phase 2 open-label long-term safety study investigating roflumilast 0.3% cream in adult patients with mild-to-severe chronic plaque psoriasis at the Innovations in Dermatology: Virtual Spring Conference 2021.

Psoriasis can significantly impact all aspects of a patients life, including adverse physical, emotional, and social effects, said Dr. Linda Stein Gold, MD, Henry Ford Health System and Chair, Innovations in Dermatology. Current topical treatments for plaque psoriasis are often ineffective for long-term treatment, are not well tolerated, or are ill-suited for use in some areas of the body. We are excited to present data demonstrating that roflumilast addresses these limitations with the added benefit of a favorable long-term safety and efficacy profile.

A poster presentation will feature new long-term efficacy and safety data on topical roflumilast 0.3% cream at 52- to 64-weeks (Dr. Linda Stein Gold). Additionally, two poster presentations will feature analyses of improved burden of signs and symptoms and improved itch severity (Dr. Leon Kircik), and itch-related sleep loss in adults with chronic plaque psoriasis (Dr. Linda Stein Gold) from the original Phase 2b study of roflumilast cream over a 12-week treatment period.

Arcutis also recently released positive topline data from the pivotal Phase 3 studies of roflumilast cream in plaque psoriasis, and plans to present the full results of those studies in the near future, as well as submit a New Drug Application later this year.

In addition to the plaque psoriasis presentations, Dr. Melinda Gooderham will present the results from the Phase 2 study of roflumilast cream 0.15% and 0.05% in patients with mild-to-moderate atopic dermatitis.

Existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability, said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis Chief Medical Officer. These data reinforce our conviction that topical roflumilast, if approved by the FDA, has the potential to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions by reducing the need to make such trade-offs.

Arcutis is investigating roflumilast as a once-daily, nonsteroidal treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4). Based on results from the pivotal Phase 3 studies, topical roflumilast potentially delivers efficacy comparable to the results of published clinical studies of high-potency steroid/calcipotriene or high-potency steroid/tazarotene combination products, but with safety and tolerability that supports chronic use in all areas of the body, and little or none of the local tolerability issues associated with many competitive agents.

For more information, visit the Innovations in Dermatology Spring Conference virtually and https://www.arcutis.com or follow the company on LinkedIn and Twitter.

About Plaque PsoriasisPsoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

About Atopic DermatitisAtopic dermatitis (AD) is the most common type of eczema, occurring in approximately 6% of the U.S. population. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms and legs, and the rash can cover significant areas of the body, in some cases half of the body or more. Disease onset is most common by 5 years of age, and the Company estimates that approximately 60% of patients suffering from AD are pediatric patients. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Given that most of the patients are pediatric, the safety and tolerability of AD therapies is paramount.

About Topical Roflumilast CreamRoflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The companys lead product candidate, topical roflumilast, has the potential to revitalize the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investor and Media ContactHeather Rowe Armstrongharmstrong@arcutis.com 805-418-5006 ext. 740

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Arcutis Biotherapeutics to Showcase Long-term Safety, Efficacy, and Patient-Reported Outcomes of Roflumilast Cream for Chronic Plaque Psoriasis at...

You may not have a choice about needing a mobility aid, but how you feel about it is completely up to you.

If someone had told me at 25 that I would be walking with a cane by age 30, I wouldnt have believed them.

In my case, the cause wasnt injury or accident, but psoriatic arthritis (PsA) a chronic, autoimmune disease that causes inflammation, joint pain, fatigue, and mobility limitations in 30 percent of people with psoriasis.

During the first arthritis flare-up that landed me in the hospital, I literally could not stand on my own feet.

Over the next several years, as doctors prescribed one medication regimen after another, I faced a daunting new reality: I could no longer walk without assistance.

How could I find the right mobility device to suit my needs and how could I get used to moving through the world with it?

Here are a few things I learned in my search to restore my mobility and maximize my quality of life with PsA.

Several weeks after the onset of PsA, I found I was still unable to walk, so I bought the cheapest manual wheelchair I could find. I chose a wheelchair partly because it was a familiar cultural icon, and I didnt know much about my other options.

Once I delved more deeply into the world of mobility devices, I realized just how many options there are.

Broadly speaking, people with mobility issues have a choice between walking aids and seated mobility devices.

Walking aids include:

Seated mobility devices include:

Since physical activity has been shown to improve both PsA symptoms and overall health, most users will want to choose the device that allows them to be as active as possible while also staving off pain and fatigue.

My manual wheelchair served me well in the short term, before I was able to find the right combination of medications to manage my symptoms. However, I soon realized that I wanted to be more active even if it meant dealing with more physical pain.

Over the course of the next several years, as biologic drugs began to suppress some of my disease activity, I transitioned to using a rollator, then forearm crutches, and then finally, a cane.

All this experimentation was expensive. I wish I had known that many device companies allow prospective users to rent or try out different mobility aids and determine which one best suits their needs.

I also wish I had consulted with a doctor, occupational therapist, or physical therapist to learn how to use these devices correctly, since improper usage cannot only decrease the helpfulness of your mobility aid, but may even have a negative impact on your posture or cause you greater discomfort.

When choosing your own mobility device(s), be open to multiple possibilities and dont be shy about asking for information on device usage from those in the know.

Even when I first got diagnosed with PsA, the last thing I wanted was to feel like a sick person.

I soon realized that I could keep my life as active and vibrant as possible by taking an open-minded, strategic approach to mobility aids.

Its true that certain activities like skiing, hiking, and climbing are no longer feasible for me, but Im lucky to be mobile enough that there are many things I can still do, if I have the right mobility aid on hand.

For instance, my arm crutches are ideal for nature walks, since they stabilize and support both sides of my body while leaving me flexible to maneuver.

When going to a museum or other accessible indoor attraction, I opt for a wheelchair, which lets me move through the space smoothly and view exhibits without pain or fatigue.

Now that my symptoms are mostly well-controlled, thanks to medication, I can often get by with a folding cane. It provides minimal support when I get tired, and it also serves as a signaling device to alert people that I may move slowly or need to sit down from time to time.

When choosing the mobility aid thats right for you, think about what you want or need to get done on a particular day. Ask yourself what accessibility challenges you might encounter, and which device would help you face them with comfort and confidence.

Prior to my PsA diagnosis, I assumed that disability was a stable, fixed category or, at least, a linear progression from wellness to illness.

One of the most surprising aspects of living with a chronic disease is how much my symptoms can fluctuate from one day or week to the next. Even in a single day, I often have periods in the morning and at night when my joints feel stiff and my range of motion is limited.

Once you know to expect these fluctuations, you become better able to plan your day even if that means expecting a bit of unpredictability.

These emotional and logistical aspects of living with PsA require both flexibility and resilience.

It can be discouraging to lapse into an arthritis flare-up and find oneself back in a wheelchair after weeks of walking around with a less intensive mobility aid.

It can also be frustrating to find that certain devices may not work well for you at times when particular joints are giving you trouble. For instance, forearm crutches can be terrific for taking pressure off of weak knees or ankles, but they put a significant strain on a users shoulders and wrists.

As you pick a mobility aid, check in with yourself to figure out which body parts need extra support, and be prepared for the prospect that your mobility needs might shift depending on factors like the time of day or the weather.

The changeable nature of PsA symptoms can be hard for nondisabled onlookers to understand.

I have had friends ask me excitedly if I was cured when they saw me using a cane on a good day, instead of my usual rollator.

Conversely, Ive encountered nosiness and skepticism from colleagues who had only met me at a meeting, seated, and later ran into me on the street and demanded, Whats with the cane?

Try not to get thrown off by these moments, and try not to feel like youre pretending or being dramatic by making use of a mobility aid. Only you are inside your body only you know what you need.

For me, the adjustment to this new world of mobility aids was emotionally fraught, since it meant reconciling myself to the fact of my disability. After all, those of us with PsA dont use our mobility aids in the way someone with a broken leg might use crutches.

We know that our symptoms are treatable with medication, but that PsA cant be cured. As a result, we may feel the need to integrate mobility devices into our sense of identity.

This can be difficult, especially if one doesnt use the same device every day. No matter what, it takes time to get used to how it feels to use a mobility aid.

Accepting that these tools are extensions of your body tools that accompany you through the world and help you live the life you want takes even longer.

Be patient with others, and with yourself, as you figure out which equipment works best for you.

You may not have a choice about how large a role mobility aids play in your daily routine, but how you feel about them is completely up to you.

Michael M. Weinstein has written about disability, illness, and gender for venues including The New Yorker, The Los Angeles Review of Books, and Michigan Quarterly Review. He holds a PhD in English from Harvard and an MFA from the University of Michigan, where hes currently a Zell Creative Writing Fellow. Hes currently at work on a book about the social and romantic lives of transgender Americans. You can find him on Twitter and Instagram.

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4 Tips for Navigating the World of Mobility Aids for PsA - Healthline

The joint and skin response rates of adults with active psoriatic arthritis observed with Tremfya (guselkumab) were maintained over two years.

The Janssen Pharmaceutical Companies of Johnson & Johnson have released long-term data from the Phase III DISCOVER-2 study showing that the skin clearance, joint symptom relief and safety of Tremfya(guselkumab) previously demonstrated through 24 weeks and one year (week 52) in adults with active psoriatic arthritis (PsA) continued through two years (week 112).

Tremfya is currently the only IL-23 inhibitor therapy approved in the US to treat both adults with active PsA and adults with moderate to severe plaque psoriasis (PsO). The PsA approval was based on results from DISCOVER-1 and DISCOVER-2 previously published inThe Lancet.

At week 100, 59 percent of patients receiving Tremfya every four weeks (q4w) and 53 percent of those receiving Tremfya every eight weeks (q8w) achieved complete skin clearance (assessed using the Psoriasis Area Severity Index [PASI]). Among patients who had clinically meaningful PsO at baseline, 62 percent of Tremfya q4w patients and 55 percent of Tremfya q8w patients achieved complete skin clearance as measured by the Investigator Global Assessment (IGA) score of 0.

Additionally, 76 percent of the patients receiving Tremfya q4w and 74 percent of those receiving Tremfya q8w achieved at least 20 percent improvement in joint pain (assessed using the American College of Rheumatology [ACR 20] response criteria). Moreover, 56 percent of Tremfya q4w patients and 55 percent of Tremfya q8w patients achieved at least 50 percent improvement in ACR score.

The study also assessed radiographic progression. At 24 weeks, Tremfya q4w demonstrated statistically significant inhibition of radiographic progression of joint structural damage (measured by PsA-modified van der Heijde-Sharp [vdH-S scores]). Tremfya q8w afforded numerically, but not statistically significant, less radiographic progression compared with placebo. From week 52-100, low rates of radiographic progression of joint damage were observed in patients receiving TREMFYA q4w (0.75) and Tremfya q8w (0.46), which were both further numerically reduced from the results observed during weeks 0-52 (1.06, q4w; 0.99, q8w).

In the group of patients who crossed over from placebo to Tremfya q4w at week 24, mean changes in vdH-S scores were 1.12 from week 0-24 while receiving placebo and 0.34 from week 24-52 and 0.13 from week 52-100 while receiving Tremfya q4w, indicating that further numerical improvements were also made through year two in this group.

According to Janssen, approximately 90 percent of patients randomised to Tremfya q4w or q8w continued treatment with Tremfya through Week 100.

No new safety signals were observed in the safety analysis conducted through week 112.

PsA is a chronic inflammatory disease of the skin, joints, and soft tissue and therefore, sustained control of this inflammation is important to physicians and patients, said Dr Alyssa Johnsen, Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. These long-term study results further bolster our confidence in the ability of Tremfya to significantly improve the diverse manifestations of PsA over time.

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Data shows long-term efficacy of Tremfya in active psoriatic arthritis - European Pharmaceutical Review

NORTH CHICAGO, Ill., March 17, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplementalNew Drug Application (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. The updated Prescription Drug User Fee Act (PDUFA) action date has been extended three months to late Q2 2021.

AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.

Separately, AbbVie received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.

"We remain confident in the sNDA and are committed to working with the FDA to bring upadacitinib to patients living with psoriatic arthritis and other immune-mediated diseases," saidMichael Severino, M.D., vice chairman and president, AbbVie.

About Upadacitinib (RINVOQ)

Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases.It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.InAugust 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is also approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs and active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 15 mg. Phase 3 trials of RINVOQ in ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis and giant cell arteritis are ongoing.

Important Safety Information about RINVOQ (upadacitinib)

RINVOQ U.S. Use and Important Safety InformationRINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

What is the most important information I should know about RINVOQ?RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

What should I tell my HCP BEFORE starting RINVOQ?Tell your HCP if you:

Tell your HCP about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

What should I tell my HCP AFTER starting RINVOQ?Tell your HCP right away if you:

What are the common side effects of RINVOQ?These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.You are encouraged to report negative side effects of prescription drugs to the FDA. Visithttp://www.fda.gov/medwatchor call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. VisitAbbVie.com/myAbbVieAssistto learn more.

Please click here for theFull Prescribing InformationandMedication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com/. Follow @abbvie on Twitter, Facebook, Instagram, YouTubeand LinkedIn.

Forward-Looking StatementsSome 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, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. 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 2020 Annual Report on Form 10-K, which has been filed with theSecurities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.

SOURCE AbbVie

abbvie.com

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AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis...

Introduction

Psoriasis is a chronic, inflammatory, recurrent, and noninfectious skin disease affecting 24% of the global population. It can occur in both sexes at any age, and the development of the disease is stimulated by various genetic, immunological and environmental factors, which could be interrelated to some degree. Psoriasis is manifested by increased proliferation of the epidermis, which, along with inflammation, leads to skin lesions of varying severity.1,2 Nowadays, patients with moderate-to-severe psoriasis are treated with conventional immunosuppressants or with new biological agents, with milder cases being most often treated topically. Phototherapy is the first-line treatment for patients for whom topical therapy is insufficient.3

Various types of phototherapy have been developed. Among them broadband ultraviolet (UV) B light (UVB, range: 290315 nm) was the first to be used. However, it was later replaced by more effective narrowband (NB)-UVB (311313 nm) phototherapy. Nowadays, NB-UVB treatment is still extensively used for plaque psoriasis.4,5 Moreover, NB-UVB is a highly economical and safe treatment that could avoid or delay starting more expensive third-line treatments for psoriasis.6

Although numerous studies have been carried out, it is difficult to predict the outcome of phototherapy in individual patients. There are numerous suggestions that machine learning models developed in recent years could estimate the outcome of treatment without predetermining medical pathways for psoriasis. Random forest (RF) methodology and the related free access RF software appear very promising when searching for complex heterogeneous and high dimensionless data when a link between input and output variables could not be revealed due to unrecognized relationships among the models predictors and their complicated influences on output variables.7,8 RF could deal with a large number of input parameters, even larger than the number of output samples, without the need for deleting some input variables to reduce dimensionality. RF models have been used to solve various biological/medical problems and have also found applications in dermatology.912

The objectives of this study are prediction of outcome of the phototherapy in terms of good (or bad) response to NB-UVB phototherapy, short (or long) duration of remission, and identifying patients who will resign from further follow-up visits and possible treatments after completing the first phototherapy course. These objectives are important for making clinical decisions based on output of the RF classifier.

Eighty-two adult patients with plaque-type psoriasis, for whom the NB-UVB phototherapy was recommended, were recruited for the study. There were 42 men and 40 women with a mean age of 55 years and seven months (range: 2476 years). Patients with a moderate-to-severe psoriasis, ie having Psoriasis Area and Severity Index (PASI) >10 and awaiting NB UVB therapy, were selected for the study. The patients voluntarily agreed to take part in additional blood tests. All the participants were advised not to apply active topical treatment during the phototherapy sessions, not to use sunbeds, and to avoid sunbathing. The study was conducted in accordance with the Declaration of Helsinki. Data acquisition and analysis were performed in compliance with protocols approved by the Ethical Committee at the Medical University of d (MUL), ethical approval number RNN/219/18/KE. Written informed consent was obtained from all participants prior to the study.

Outcomes of psoriatic patients treated with NB-UVB phototherapy at the Department of Dermatology MUL were examined. Fluorescent tubes (Phillips TL01) were used to expose patients in a medical cabinet. All patients underwent the same standard phototherapy procedure with 20 treatments.

The mean initial dose was ~0.15 Jul cm2 (depending on the patients phototype) at the start of phototherapy and was gradually increased by approximately 10% with each subsequent treatment to avoid the development of erythema depending on the patients skin reaction. The maximum dose reached ~1.5 Jul cm2. NB-UVB phototherapy was administrated three times weekly, typically for six to eight weeks.

The MUL phototherapy cabinet needed to be calibrated due to the expected aging of the discharge tubes. It was done twice a year by the outer calibration campaigns. Independent occasional measurements by the handheld radiometer ILT 1400, Quantum Design, confirmed the accuracy of the calibration procedure.

The database includes all psoriatic patients (n=82) attending NB-UVB phototherapy. It consists of three parts: the firstanswers to a questionnaire, the secondresults of medical tests carried out before and after each round of the cabinet exposures, the thirdvalues of Psoriatic Severity Measures (PSM): PASI, body surface area (BSA), and Physician Global Assessment (PGA), obtained before and after each course of the exposures. Data can be shared with other users upon request.

The first part of the database (n=82) contains the answers from the questionnaire grouped into following categories:

The second part of database (n=71) contains numerical values obtained from various medical blood tests collected during the study. These were as follows:

The third part of the database contains PSM scores and their changes due to the therapy. The following values are stored:

The effectiveness of NB-UVB phototherapy is determined from changes of PASI, BSA, and PGA, after the first (n=71) and second (n=21) course of the NB-UVB treatment. For all these metrics, the percentage change relative to the baseline value at the start of new course of the 20 exposures is calculated (denoted as PASI, BSA, and PGA). The phototherapy outcome is compared after each course of the exposures and separately for two sub-groups: present in both successive courses or only in the first course.

Standard statistical parameters (mean value, standard deviation, median, and the minimum-maximum range) are calculated to find out the metrics differences between two successive rounds of NB-UVB exposure. Moreover, the statistical significance of the differences between the outcomes are calculated using:

Descriptive statistics and testing are from analytic software package, Statistica, TIBCO Software Inc. (https://www.tibco.com/products/data-science).

Answers to the questionnaire prior to the first course of phototherapy and results of various medical tests at the beginning and end of each course of NB-UVB treatments provide a set of potential predictors to be used by the RF classifier. PASI is the best rating scale for assessing the psoriasis severity and it is well correlated with other scales.13 Thus, for the purpose of the RF classification of the NB-UVB phototherapy outcome, only the PASI scores are considered.

All PASI values after the first exposure round and duration of remission were ordered (from the poorest to the best outcome). The ordered PASI data (n=71) were divided into two groups below (n=25) and above (n=46) the threshold of PASI=50%. For examination of the duration of remission, the threshold was set as the median value (eight weeks), so there were two sub-groups with short (below the median with the median inclusive) and long duration of remission (above the median). Some patients missed the second course of the NB-UVB exposures after completing the first course. Two sub-groups thus emerged, absent (n=44) and present (n=27) in the second course of the therapy. RF classifier is used to predict in advance (before phototherapy) which patients belong to the above mentioned sub-groups.

The RF classification was optimized by examining different sets of the initial setup parameters. We decided to use the model with the greatest accuracy and with the smallest possible number of the explanatory variables. The classification of the psoriatic patients is carried out implementing RF source programs available on public web page: https://www.stat.berkeley.edu/~breiman/RandomForests/cc_software.htm

Figure 1 and Table 1 show results of statistical analyses of relative changes (in % of values at the beginning of phototherapy) of PASI, BSA, and PGA, due to the phototherapy. Improvement in psoriasis could be seen in all considered indices. The mean values of the relative changes are: ~60% (PASI), ~4050% (BSA and PGA).

Figure 1 Box and whisker plot for the relative change in psoriatic severity measure (as a percentage of the value at the start of phototherapy), after the first and second rounds of 20 narrowband UVB exposures.

Abbreviations: BSA, body surface area; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment.

Table 1 Statistical Characteristics of the Phototherapy After the First and Second Courses of NB-UVB Phototherapy for Various Groups of Patients

The statistical tests confirm the hypothesis that there is no change of the statistical distribution for each PSM when comparing outputs of the first and the second rounds of the NB-UVB exposures (see Table 1 for all probability values >0.05).

The patients, who attended only the first course of phototherapy, had almost a similar outcome of phototherapy (for all psoriatic severity measures) when compared to patients continuing phototherapy after relapse. There was no significant difference in therapy outcomes after the first and second courses.

The mean duration of remission was about two months. The first patient returns for the next round of phototherapy after two weeks, but the last one after eight months. It is unlikely that duration of remission was longer than the project duration of three years.

Two versions of the RF model, ie with all possible and limited number of the predictors (excluding the cytokine data), are considered. The latter model is a low-cost option for the classification as only standard blood tests are examined. Its performance (Table 2) is shown for the following groups: the bad (PASI 50) or good (PASI >50) effectiveness of the therapy, short (8 weeks) or long duration (>8 weeks) of remission, and presence or absence in the second course of phototherapy. Statistics used to quantify the results of the RF model are in line with the 22 contingency table analysis standard, including: sensitivity, specificity, predictive values, likelihood ratios, and overall accuracy.14

Table 2 Statistical Characteristics of the RF Classification, without Cytokine Input, for Various Sub-Groups of the Psoriatic Patients

RF classifier appears as a useful tool for identifying in advance the patients sub-groups. Its sensitivity is over 84%, and accuracy is of 75% (for good and bad outcome), 85% (short and long remission), and 79% (absence and presence in the second course). Positive and negative likelihood ratios are significantly larger and lower than one, respectively. If a value of 1.0 is within the 95%CI, the prediction is no better than a coin toss. Moreover, for all cases, positive prediction value (PPV) is of ~80% and the 95%CI is over the 50% level of random forecast. This confirms the usefulness of the prediction of the positive effect by RF classifier. In only one case, ie prediction of a bad result of the phototherapy, the 95%CI of negative predictive value (NPV) contains 50%, ie the prediction can be like a coin toss. Positive effects are better predicted then negative ones in terms of smaller range of 95%CI and larger sensitivity (>84%) compared to specificity (~5570%). Using a larger number of possible predictors (ie blood tests including cytokine data) at the start of the RF classification surprisingly did not improve its accuracy.

Improvement in psoriasis due to NB-UVB phototherapy was found. However, the vast majority of the patients (~70%) attending the first course of therapy did not return to the department for further appointments. The comparison of the psoriasis severity scores in patients who participated in two successive phototherapy courses with those completing only the first course of treatment showed that their worse outcome of phototherapy was not a reason to quit follow-up appointments.

The RF classifier is able, ie both PPV and NPV are significantly >50%, to identify in advance the patients who will attend phototherapy courses or quit after the first course. The classification by RF can also effectively identify those who will have a short or long duration of relapse. The RF classification only fails (ie 95%CI of NPV contains 50%) to identify patients with a bad outcome of the phototherapy. However, in this case, the RF tool helps to select the patients to be closely supervised during phototherapy as they may need a different form of therapy.

RF classifier selects the best set of predictors (Table 3) from initial large set of potential predictors and provides the ranking of the predictors (from the best to the worst). The accuracy of RF classifier using a limited number of starting predictors (without cytokine data) is even better than the RF classifier with more potential predictors (with cytokine data) at the start. Thus, it is enough to use a few standard medical tests and a questionnaire for building a limited database to serve as RF input. However, the model response to the selected single predictor cannot be quantified. This requires the use of other models (eg logistic regression for modelling binary outcome).

Table 3 Ranking of Explanatory Variables from Most Important to Least Important

The list of potential variables explaining outcome of the NB-UVB therapy is not fixed and could be extended and adapted to local circumstances and the patients profile (by entering additional medical tests and questions to the questionnaire). Therefore, before any psoriatic therapy, the artificial intelligence tool will be able to identify patients for whom NB-UVB phototherapy should be the first choice. This method requires further validation in a larger and a more diverse cohort but seems to be very promising. Despite the small number of patients enrolled in this study, the RF classifier shows that many predictions are much better than a coin toss.

We present the method that helps to identify psoriatic patients in whom phototherapy will significantly improve their skin, or those in whom other therapies should be recommended beforehand. For patients who may avoid subsequent follow-up visits, some preventive actions can be taken to change their attitude toward the treatment.

RF classification tool does not yet have practical applications in todays standard of the psoriasis treatment. The article presents preliminary results that individual patients data (from low-cost blood tests and patients questionnaire) can be transformed, using the RF tool, into valuable information-facilitating decision-making by doctors.

BMI, body mass index; BSA, body surface area; DLQI, dermatology life quality index; NB-UVB, narrow band ultraviolet B; NPV, negative predictive value; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PPV, positive prediction value; PSM, psoriatic severity measure; RF, random forest.

This research was funded by the Polish National Science Centre grant project no. UMO-2013/11/B/NZ5/00037. JN, AL, MS, and MN are supported by statutory activities no. 503/5-064-04/503-01. JK, PS, and BR are supported by statutory activities no. 3841/E-41/S/2019.

The authors report no conflicts of interest in this work.

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5. Zhang P, Wu MX. A clinical review of phototherapy for psoriasis. Lasers Med Sci. 2018;33(1):173180. doi:10.1007/s10103-017-2360-1

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[Full text] A Priori Estimation of the Narrow-Band UVB Phototherapy Outcome for Mo | CCID - Dove Medical Press

Guselkumab was a safe and effective treatment for biologic-nave patients with psoriatic arthritis (PsA), according to one-year data from a phase 3 study.

Guselkumab, a human monoclonal antibody specific to interleukin23p19, demonstrated efficacy and safety versus placebo through week 24 of the phase III DISCOVER2 trial in biologicnaive patients with PsA. Here we report 1year DISCOVER2 findings, the researchers explained.

The study included adult patients with PsA who had at least five swollen and five tender joints as well as Creactive protein level 0.6 mg/dl despite nonbiologic treatment. Patients were randomized to receive guselkumab 100 mg every four weeks; guselkumab 100 mg at week zero, week four, and every eight weeks thereafter; or placebo with crossover to guselkumab 100 mg every four weeks at week 24.

A total of 739 patients were randomized and treated, and 93% completed the study up to week 52. The proportions of patients who achieved at least a 20% improvement in American College of Rheumatology criteria (ACR20) was maintained after week 24; by week 52, in the treatment every four weeks group, it was 71%, and in the every eight weeks group, 75%. The proportions of patients who achieved ACR50, ACR70, skin responses, minimal or very low disease activity, and dactylitis or enthesitis resolution by week 24 also maintained through week 52. Continued treatment was associated with low levels of radiographic progression and improved physical function and health-related quality of life through week 52. The rates of serious infections through week 52 were low. There were no opportunistic infections or deaths reported.

The study was published in Arthritis & Rheumatology.

In conclusion, guselkumab 100 mg every 4 weeks or every 8 weeks effectively treated the diverse manifestations of active PsA in biologicnaive patients. The overall treatment effect observed during the 24week placebocontrolled period was well maintained, and the riskbenefit profile remained favorable for both guselkumab regimens, through week 52 of DISCOVER2, the researchers summarized in their conclusion.

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Guselkumab Safe, Effective in Biologic-nave Patients with Psoriatic Arthritis - DocWire News

A phase 3 clinical trial of mirikizumab in ulcerative colitis has met its primary endpoint, boosting Eli Lillys hopes of establishing the anti-IL-23p19 antibody in gastrointestinal disorders.

Lilly has ceded a head start to AbbVies anti-IL-23 antibody Skyrizi and Johnson & Johnsons Stelara, which hits IL-12 and IL-23, in plaque psoriasis. Faced with a competitive market, which also features Novartis IL-17 drug Cosentyx, Lilly embarked on a broad R&D program that positioned it to establish mirikizumab as a late entrant to the psoriasis space and an early mover in gastrointestinal disorders.

The top-line phase 3 results provide partial validation of Lillys big bet on mirikizumab. In LUCENT 1, Lilly set out to compare intravenous mirikizumab to placebo in patients with moderately to severely active ulcerative colitis who had been failed by conventional or biologic therapies.

After 12 weeks, the rate of clinical remission was significantly higher in the mirikizumab arm, causing the trial to hit its primary endpoint with a p-value of less than 0.0001. Subjects were classed as being in clinical remission when the control or resolution of colon inflammation led to the normalization, or near-normalization, of symptoms such as stool frequency and bleeding.

Mirikizumab also beat placebo against all key secondary endpoints including bowel urgency and endoscopic remission with highly statistically significant p-values, Lilly said. Symptoms stopped as early as four weeks after treatment. The responders to mirikizumab included patients failed by JAK inhibitors and biologic therapies.

The top-line readout suggests mirikizumab improves outcomes in ulcerative colitis patients who have exhausted existing treatment options. However, the lack of numbers in the Lilly release make it hard to gauge how big an impact mirikizumab could have on the market.

Lilly plans to disclose the full data in the future but for now is still working to gather evidence on the effects of mirikizumab in ulcerative colitis. A placebo-controlled maintenance study of mirikizumab in patients who have completed the 12-week LUCENT-1 induction is ongoing, as is a long-term efficacy and safety trial. The trials will give Lilly 52-week data on the effects of mirikizumab.

Full results from the studies are expected early next year. The timeline gives Lilly a shot at getting mirikizumab to market in ulcerative colitis before developers of other anti-IL-23 antibodies. AbbVie is running a phase 2/3 trial of Skyrizi in ulcerative colitis but last year delayed the estimated primary completion. ClinicalTrials.gov lists the new primary completion as September 2022. J&Js IL-23 drug Tremfya is in a phase 2/3 ulcerative colitis trial with a primary completion date of June 2022.

Stelara is cleared for use in ulcerative colitis but appears to be less effective than pure IL-23 inhibitors in psoriasis. If Lilly shows pure IL-23 inhibitors have a similar edge over Stelara in ulcerative colitis, it could carve out a piece of the market before facing competition from Skyrizi and Tremfya.

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Lilly's Skyrizi rival hits goal in ulcerative colitis phase 3, as it ups the ante against AbbVie - FierceBiotech

The Psoriasis Drug Market is expected to grow at a CAGR of 6.67% and is poised to reach US$XX Billion by 2027 as compared to US$XX Billion in 2020. The factors leading to this extraordinary growth is attributed various market dynamics discussed in the report. Our experts have examined the market from a 360 degree perspective thereby producing a report which is definitely going to impact your business decisions.

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