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Category Archives: Psoriasis

Patient Comorbidities and Severity of Psoriasis Correlate With Choice of Systemic Therapy – Dermatology Advisor

Posted: October 27, 2019 at 2:41 pm

Several factors influence the choice of prescription systemic therapies for plaque psoriasis, with comorbidities and disease severity playing primary roles in clinical decision making, study findings published in the Journal of European Academy of Dermatology and Venereology suggest.

The Swiss Dermatology Network for Targeted Therapies registry in Switzerland was retrospectively reviewed for baseline data from patients with chronic plaque psoriasis who were included in the registry between March 2011 and December 2017. Only patients who had started a new systemic therapy for psoriasis were included in the analysis (n=549; mean age, 46.714.7 years). An a priori list of baseline variables and their associations with prescribed systemic therapies was assessed.

Patient variables associated with prescribing retinoids and methotrexate included having no prior history of systemic therapies, a moderate quality of life (QoL) at the onset of therapy, and age 60 years, according to a semantic connectivity map created by the investigators. Individuals with mild psoriasis (psoriasis area severity index [PASI] <10) and disease duration lasting 20 years were more likely to receive fumaric acid derivatives.

Severe chronic plaque psoriasis, characterized by impaired QoL, hospitalization, and inability to work, was associated with the use of cyclosporine and psoralen and ultraviolet A/ultraviolet light B (PUVA/UVB) therapies. Psoriatic arthritis, severe disease, and the presence of chronic liver or kidney diseases were associated with the use of both infliximab and adalimumab. Patients with a complex history of prior systemic treatments for psoriasis (2 therapies), moderate disease (PASI, 10 to 20), and patients who were overweight and had a university education were associated with the use of etanercept, ustekinumab, and secukinumab.

Study limitations include its exploratory and retrospective nature.

Some important comorbidities like psoriatic arthritis, chronic liver disease, and chronic kidney disease were found in the center of the map and in association with biological therapies, the researchers wrote, indicating that they may influence the choice of these treatments.

Disclosure: This clinical trial was supported by AbbVie, Celgene, Janssen, Lilly, Novartis and Pfizer. 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

Cazzaniga S, Anzengruber F, Augustin M, et al. Linkage between patients characteristics and prescribed systemic treatments for psoriasis: a semantic connectivity map analysis of the Swiss SDNTT registry [published online September 28, 2019]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.15983

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Over 125m people worldwide affected with psoriasis – The News International

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Over 125m people worldwide affected with psoriasis

Islamabad:Psoriasis drastically affects the everyday lives of patients as it victimizes more than 125 million people worldwide.

The Pakistan Psoriasis Foundation report states that in an analysis of survey data from 5,000 psoriasis patients, 20% of women said psoriasis was a massive problem in their everyday lives, compared to only 12 % of men. In addition, approximately 60 % of women said psoriasis interferes with their ability to enjoy life, as compared to only 52 per cent of men. Overall, women have greater difficulty dealing with the psychological and social issues brought about by having psoriasis.

Psoriasis is a chronic, inflammatory skin disease clinically evident as raised inflamed scaly red skin lesions that crack and itch. International Psoriasis Day is observed globally on October 29 to increase awareness of one of the most important skin problems. Psoriasis sufferers feel that people in general, including doctors, underestimate the overall impact the disease has on their lives. It is evident that the disease burden of psoriasis extends beyond the physical symptoms experienced by the patient.

Health professional and the general public should not minimize its impact as skin disorders are often chronic but not life threatening but they severely affect the mental well-being of patients. Psychologists who know the impact of the mental anxiety should come forward to help patients, opined Dr. Koukab Gulzar, Consultant Dermatologist at KRL Hospital.

Psoriasis can also cause inflammation of the joints, which is known as psoriatic arthritis. One-third of psoriatic patients have psoriatic arthritis. The risk for diabetes mellitus rises substantially in patients with psoriasis, with a 62% increase in risk noted in patients with severe psoriasis. Psoriasis appears to have a greater impact on womens lives and early cardiovascular deaths have been reported in psoriatic patients. Skin problems are generally the most common diseases seen in primary care settings all over the globe and its prevalence ranges from 20-50% in developing countries.

Psoriasis has a bimodal age of disease onset. The first peak is around 20 and the second peak is around 60. Around one-third of patients are under the age of 18 years. It is said that psoriasis has a genetic basis, as 23.4% to 71% of children will have a family history of psoriasis.

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Health Board: Upcoming conferences, talks, campaigns and events – The Irish Times

Posted: at 2:41 pm

1) As part of Brain Tumour Awareness Week 2019, Brain Tumour Ireland, in partnership with The Royal College of Surgeons in Ireland and Trinity College Dublin, are hosting a public lecture on Finding New Ways in the Lab to Tackle Glioblastoma with Dr Kate Connor PhD, RCSI Dept of Physiology and Medical Physics followed by two GLIOTrain Project PhD students who will give an update on their research and Brain Tumours and Epilepsy: Vital Links Provide Valuable Clues? with Prof Mark Cunningham PhD FTCD, Discipline of Physiology, School of Medicine, Trinity College. The event takes place on Wednesday, October 30th at Trinity Biomedical Sciences Institute, Pearse Street, Dublin 2 from 6.30pm to 8pm. It is a free event, but register your attendance by emailing info@braintumourireland.com or at eventbrite.ie

2) The UCD Centre for Arthritis Research second annual Collaborative Approach to Arthritis Research conference will take place on Friday, November 1st in St Andrews Resource Centre, Dublin 2. The theme this year is Transitions; from before to after diagnosis, from child to adult patient, from work to retirement. Attendance is free but registration is required. See eventbrite.ie

3) Returning for a fourth year to Dundrum Town Centre in Dublin, the Psoriasis Shout Out will see consultant dermatologists, dermatology nurses and patient advocates offer free, one-to-one medical advice and support for people living with psoriasis. With waiting lists to see a dermatologist in Ireland in excess of 18 months, the Shout Out is an opportunity to have an initial chat, get some advice and speak to a dermatologist. The free event takes place on Saturday, November 2nd from 9.30am to 4.30pm on the 3rd floor (beside Tesco) in the centre.

4) As Halloween approaches, people are being warned that novelty contact lenses are dangerous and pose a risk to those who wear them. The warning was issued by CORU, Irelands multi-profession health regulator. Novelty contact lenses may look like harmless fun, but the reality can be far more serious, said Ginny Hanrahan, CEO of CORU. Common problems associated with unsupervised use of contact lenses can include red, sore or dry eyes. Poor quality lenses or poor hygiene practises can also lead to far more serious complications including severe infections that in a worst case scenario could cause permanent blindness. We are strongly advising anyone considering novelty contact lenses as part of a Halloween costume not to wear them.

5) Researchers from the School of Psychology at NUI Galway are currently recruiting participants from ages 16-35 in the Galway area to participate in a new psychology therapy study being trialed for individuals who are in the first five years of a diagnosis of psychosis. Early psychosis, which refers to a range of mental health difficulties often associated with experiences of hallucinations or delusions, can result in significant difficulties with social and occupational functioning. The CReST-R study (Cognitive Remediation and Social Recovery in Early Psychosis Study) focuses on helping to improve everyday functioning in young people living with psychosis. The study will involve weekly one-to-one therapy sessions over the course of 10 weeks, with an assessment before and after completion of therapy. This trial is part of a Health Research Board funded programme entitled YOULEAD (Youth Mental Health Research Leadership) as part of a collaboration between mental health researchers at NUI Galway, UCD and RCSI, and health service providers, including the HSE and Jigsaw. To participate in the study and for more information contact Emma Frawley, crestr@nuigalway.ie, 086 8527199. For more information about YOULEAD, see nuigalway.ie/youlead

6) The Irish Hospice Foundation (IHF) is hosting its annual evening of remembrance on Thursday, November 7th. This is a free public information event allowing people to hear about aspects of loss and bereavement which may help them understand aspects of their own loss. Guest speaker, writer Emma Hayes will talk about Living with Loss following the death of her mother Karen. Emma wrote about her personal experience of grief in The Irish Times. The event takes place at the Alex Hotel, on Dublins Fenian Street from 5.30pm to 8pm. All are welcome to attend.

7) Dublin Rape Crisis Centre (DRCC) will host a one-day conference discussing Sexual Violence in Ireland: Past, Present and Future on Thursday, November 7th (9am-4.30pm) in the Royal College of Surgeons to mark their 40th anniversary. The conference will reflect on the origin and role of the centre. Tickets (10-25) are available via eventbrite.ie

8) Diabetes Ireland is hosting a free Health & Wellbeing Event for people living with, and at risk of, developing diabetes. The event will include exhibitors, workshops, diabetes products, the latest technology and free testing, and takes place at Limerick Strand Hotel from noon-5pm on Sunday, November 10th. Registration is not required.

9) As darkness sweeps around the globe on Wednesday, November 13th, 25,000 people in 50 cities worldwide will put on their running shoes to complete a 5k or 10k Run in the Dark - the principal fundraising event for the Mark Pollock Trust. Run in the Dark will take place in locations across Ireland - from Dingle to Dublin abd Wexford to Galway For more information go to runinthedark.org/ireland

10) A social singing event called Heres a health to the company: Social singing, health and well-being will take place at the Irish World Academy of Music and Dance, University of Limerick on Friday, November 15th. The special event is focused on the health and well-being benefits of social singing, from the perspectives of music therapy, community music, voice studies, traditional song, social justice and more. November 15th is World Music Therapy Day. To register see eventbrite.ie

11) Fighting Blindness Retina 2019 Public Engagement Day takes place during Science Week Ireland on Saturday, November 16th. The event offers people with sight loss an opportunity to quiz leading eye experts about their conditions, and to hear about the latest advances being made to improve and ultimately cure various types of sight loss. The conference will feature research-focussed breakout sessions on more than 20 rare conditions such as retinitis pigmentosa, diabetic retinopathy, age-related macular degeneration, cataracts, glaucoma and many more. Retina 2019 takes place in the Radisson Blu Hotel, Golden Lane, Dublin 8. For information on registration, visit retina.ie

12) The All Ireland Paediatric Diabetes Health Professional Conference 2019 takes place at Carlton Hotel, Dublin Airport from November 28th-29th. For more details, contact info@diabetes.ie, (01) 842 8118.

13) St Patricks Mental Health Services annual Founders Day conference on Friday, December 6th - at St Patricks University Hospital, Dublin 8 will focus on the theme of anxiety. The plenary lecture comes from Prof David Clark of Oxford University, who will be discussing effective psychological treatments for anxiety and the Improving Access to Psychological Therapies (IAPT) Programme. Prof Mark Freeston of Newcastle University will present on the role of intolerance of uncertainty in understanding, formulating and treating anxiety in anxiety disorders and beyond, while Prof Helen Kennerley of the Oxford Cognitive Therapy Centre will explore anxiety and dissociation. For more information and to book a place, visit stpatricks.ie/media-centre/events

For inclusion in these listings, email health@irishtimes.com with Health Board in the subject line

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Health Board: Upcoming conferences, talks, campaigns and events - The Irish Times

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Clarify Medical Closes $18M Series A Round to Commercialize its Connected Home Phototherapy System in the U.S. – Business Wire

Posted: at 2:41 pm

SAN DIEGO--(BUSINESS WIRE)--Clarify Medical announced today that it has closed an $18M Series A financing round with participation from H.I.G. BioHealth Partners, 7wire Ventures, SV Health Investors, and Bluestem Capital. The proceeds of the round will be used for the commercialization and further development of the Clarify Home Light Therapy System for the treatment and monitoring of patients with chronic skin conditions.

Michael Wasserman, Managing Director of H.I.G. BioHealth Partners; Robert Garber, Partner at 7wire Ventures; and Paul LaViolette, Managing Partner and Chief Operating Officer of SV Health Investors, will join the companys board of directors, effective immediately.

Clarify Medical has attracted a strong syndicate of leading medical technology and digital health investors to fuel its commercialization efforts, said Dr. Wasserman. The significant technological advances of the Clarify System will enable patients with chronic skin diseases like psoriasis, vitiligo, and eczema to safely and effectively manage their conditions at home, while remaining connected to their physicians via Clarifys cloud connectivity. The approach has tremendous benefit for patients, physicians and healthcare providers.

The Clarify System, which has been cleared by the FDA, is indicated for localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, and leukoderma on all skin types (I-VI). It is the first and only connected phototherapy system that uses an app on the patients own smartphone (iOS or Android) to manage the dose, frequency, and duration of targeted narrowband UVB (NB-UVB) light therapy; the System helps to ensure that patients receive the proper doses recommended by the American Academy of Dermatology in its published Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis and The Vitiligo Working Group Recommendations for NarrowBand Ultraviolet B Light Phototherapy Treatment of Vitiligo.

The treatment regimen is prescribed by the patients physician but monitored and controlled by the Clarify System, enabling patients to administer treatment with clinical precision and achieve clinical efficacy in the convenience of their homes. The connected system monitors dosing, adherence, compliance, patient progress, and satisfaction.

There are 30 million people in the U.S. with psoriasis, vitiligo, and eczema and approximately 5,400 medical dermatologists who help these patients treat and manage their conditions.

We are very pleased to have such high-caliber investors join our board, said George Mahaffey, President & CEO of Clarify Medical. In the brief time the Clarify System has been commercially available, weve established Medicare coverage and have helped many patients self-manage their chronic skin conditions at home. With this funding, we are now poised to fully launch the System in the U.S. by improving market access and building awareness within the medical dermatology community that there is now a home phototherapy option that patients can use safely and effectively.

About Clarify Medical, Inc.

Clarify Medical is a private San Diego-based medical device company focused on developing innovative technology, products, and services that improve care for people with chronic skin conditions. Its Clarify Home Light Therapy System is now available nationally in the U.S. Learn more at http://www.clarifymed.com.

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Clarify Medical Closes $18M Series A Round to Commercialize its Connected Home Phototherapy System in the U.S. - Business Wire

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Durect Corporation: DUR-928 Data In Severe Alcoholic Hepatitis To Be Showcased At Upcoming AASLD Meeting – Seeking Alpha

Posted: at 2:41 pm

DURECT Corporation (DRRX) has a drug, DUR-928, that is being studied in alcoholic hepatitis (AH), non-alcoholic steatohepatitis (NASH) and psoriasis. There will be two presentations on DUR-928, including one oral late breaker, at November's AASLD meeting on AH, which is an important cause of liver-related morbidity leading to the need for a liver transplant and has no approved therapy. Current pharmacological therapies include corticosteroids (for which a significant percentage are contraindicated due to infection or acute kidney injury) and pentoxyphylline, but these have not been shown to be very effective. A 2015 study published in the Journal of Clinical Gastroentrology concluded that there are 325,000 alcoholic hepatitis-related hospitalizations in the US annually, with 65,000 representing a primary diagnosis. The study further suggested that, as it relates to the primary AH hospitalization, the cost was $46,000 and the in-hospital mortality rate was 5.8%. The study also noted that the thirty day mortality rate for severe alcoholic hepatitis has historically been in the 30-50% range. Liver transplant is indicated for patients who are steroid failures, but its cost can approach $600,000.

The Phase 2a data on DUR-928, as discussed in the abstracts, showed that the drug was safe at all IV doses. Treatment responders, defined by a Lille score of less than 0.45 were 89%, and among the severe AH patients it was 87%. It was noted that these response rates were significantly better than comparative published historic data. A larger Phase 2b trial is being planned for 2020.

NASH has become a leading cause of liver disease and liver transplant paralleling the obesity epidemic. It is estimated that 10-20 million Americans have the disease, though this could increase given that, according to the OECD, the adult obesity rate in the US is forecast to increase from 38% in 2014 to 47% in 2030. There are currently no approved medications, and it has been shown that a 10% weight loss can reduce the disease severity. The first drug, Ocaliva, should be on the market in mid-2020, but its benefit as monotherapy was seen in only about 23% of patients. I have long maintained that, given the complexity of the disease, pharmacologic treatment is likely to involve a polydrug regimen, and I expect Novo's (NYSE:NVO) oral semaglutide, Rybelsus, to be a cornerstone. DUR-928, in an oral formulation, would be very complimentary, given the beneficial effects it has shown in animal studies on fibrosis and ballooning, and on inflammation, bilirubin and liver injury in a Phase 1 human study. A larger 28 day, Phase 1b study is currrently ongoing, and it will assess safety, pharmacokinetics and some efficacy parameters, while laying the groundwork for a future Phase 2b study. The US NASH market is expected to exceed $10 billion annually, and, in my opinion, the most advanced drugs will represent "first generation" treatments, much like PEG-Intron for Hepatitis C.

DUR-928 is also being studied in a topical formulation for mild to moderate psoriasis. A multi-center Phase 2a trial is slated to have topline data by year end.

Over the next year, DURECT will be advancing DUR-928 in AH, NASH and psoriasis. Data on AH will be provided at November's AASLD, and topline data on NASH and psoriasis will follow soon thereafter. DUR-928 acts via several mechanisms to regulate inflammation, improve cell survival, improve insulin sensitivity, decrease lipid biosynthesis and reduce fibrosis. There is no approved drug for AH, and this market should exceed $1 billion in the US. Although several drugs should be on the market to treat NASH over the next three years, none seem likely to serve the majority of patients as monotherapy. It needs to be understood that NASH progresses from fibrosis stage one to four over a period exceeding a decade, and patients with stage one and two are more likely to die of cardiovascular disease, given the association with hypertension, obesity and Type 2 diabetes. Ultimately, the NASH drug market will be extremely large, with a combination of therapies directed at weight loss, insulin sensitivity and fibrosis required.

As I look at DURECT's stock, I find it similar to other small caps that I have designated as being priced for "non-success". Its lead drug is being advanced in three indications, and it has recently formed a partnership with a leading biopharmaceutical company relating to its legacy drug delivery technology that has brought in $35 million and could bring in additional milestone payments and royalties. Furthermore, the unique characteristics of DUR-928 make it a very attractive candidate for the indications being pursued.

Disclosure: I am/we are long DRRX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Navigating the Therapy Maze in Psoriasis – MedPage Today

Posted: October 24, 2019 at 10:53 am

LAS VEGAS -- As the number of effective biologic therapies for psoriasis continues to increase, optimizing treatment requires careful consideration of drug and patient characteristics, as well as patient preferences, two psoriasis specialists said here.

Adverse effects, impact on psoriatic arthritis, and activity against nail psoriasis represent some of the drug-specific considerations, whereas pregnancy, breastfeeding, and safety in pediatric patients are some of the patient considerations. If onset of action, dosing convenience, time to response, or complete disease clearance is a key issue in drug choice, clinicians need to be aware of differences among drugs, particularly data from head-to-head clinical trials, Boni E. Elewski, MD, said at the Fall Clinical Dermatology Conference.

"We have 11 FDA-approved biologics ... and several oral medications. How do we begin approaching a patient with psoriasis?" said Elewski, of the University of Alabama at Birmingham. "The first thing I like to do is look at the nails. The nails can tell you whether a patient is likely to get psoriatic arthritis or whether the patient might have psoriatic arthritis. They're correlated. The more severe the nail psoriasis, the more likely you are to have psoriatic arthritis."

Regardless of the initial approach to disease assessment, the patient's wishes and preferences should figure prominently in treatment decisions, even if the information has to be coaxed out, said David M. Pariser, MD, of Pariser Dermatology Specialists and Eastern Virginia Medical School in Norfolk.

"As providers we often don't have the time or want to take the time to work up a new patient," said Pariser. "Patients often don't offer what is bothering them. Patients think that the psoriasis speaks for itself, that if they show me the psoriasis, I know what is bothering them. They think I should know by looking, but I don't. I don't think we really take the time to ask, 'What is it that really bothers you about your psoriasis?'"

Where to Start

Regarding the association between nail psoriasis and psoriatic arthritis, inhibitors of tumor necrosis factor (TNF) and interleukin (IL)-17 have demonstrated activity in psoriatic arthritis. In fact, drugs in both classes may help "prevent" the development of psoriatic arthritis in patients with psoriatic skin disease, said Elewski.

Inherently, safety is a principal consideration in pediatric patients with psoriasis. Both etanercept (Enbrel) and ustekinumab (Stelara) have FDA approval for use in children, said Elewski. Pediatric trials of ixekizumab (Taltz) and apremilast (Otezla) are under way.

TNF blockers are considered safe in pregnancy and for men attempting conception and not harmful to lactation. Preclinical studies of IL-17 inhibitors showed no harm to developing fetuses, although a higher neonatal mortality was seen in a study involving ixekizumab, said Elewski. The safety of IL-23 inhibitors in pregnancy remains unknown, and no studies have assessed human breast milk for the presence of the drugs.

A recent longitudinal population-based cohort study involving 6,200 women and 8,600 pregnancies showed that use of biologic therapies did not increase the risk of infection in infants.

"Most biologics are pregnancy category B (safe for routine use), but collaboration with an ob/gyn is essential," said Elewski. "Data on pregnancy outcomes are available for all of the approved agents."

Lifestyle considerations may come into play for some patients, such as dosing convenience for maintenance therapy. Frequency of administration ranges from weekly with etanercept to every 12 weeks with ustekinumab and tildrakizumab (Ilumya). Speed of disease improvement (based on 75% clearance, or Psoriasis Area and Severity Index [PASI] 75, at 4 weeks) ranges from 8% with etanercept to 60% for both ixekizumab and brodalumab (Siliq).

If 100% clearance (PASI 100) is the principal goal, rates range from 13% at 16 weeks with certolizumab pegol (Cimzia) to 40% or more at 12-16 weeks with ixekizumab, brodalumab, and guselkumab (Tremfya). Data from multiple head-to-head studies have shown that most newer biologics lead to better short-term efficacy as compared with etanercept, the oldest of the biologic agents. In other trials, secukinumab, ixekizumab, and brodalumab demonstrated superiority over ustekinumab; guselkumab over adalimumab (Humira) and secukinumab; and ixekizumab over guselkumab.

Comorbidities also can influence treatment choice. TNF inhibitors and methotrexate, for example, confer a higher risk of nonmelanoma skin cancer as compared with other biologics. Data are mixed with regard to the risk of tuberculosis reactivation with biological treatment, said Elewski. Authors of a National Psoriasis Foundation consensus statement recommended that patients with a history of TB receive a full course of TB prophylaxis prior to beginning biologic therapy.

Patients with HIV infection warrant special consideration any time immunosuppressive therapy is being considered. A recent review found limited data on HIV and use of biologics to treat psoriasis, but the authors concluded that the evidence suggested that "biologic therapies may be effective for cases of psoriasis recalcitrant to other systemic agents and may have a positive effect on CD4 and viral counts when used in combination with highly active antiretroviral therapy (HAART); however, further studies are needed."

Similarly, limited evidence exists to guide the use of biologic agents in patients with hepatitis B or C infection, said Elewski. Interdisciplinary patient management is essential, but selected patients might be eligible for biologic therapy after successful hepatitis treatment.

Involve the Patient

In deciding what is important to patients, Pariser said clinicians need to be upfront in inquiring about psoriasis' impact on daily life, including symptoms of anxiety and depression.

"Ask the patient, 'What about your psoriasis bothers you the most?'" Pariser said. "Tell me what your day today would be like without psoriasis."

Patient expectations frequently do not match up with those of the clinician, Pariser continued. Clinicians rely on objective measures, such as body surface area and PASI score, whereas patients' often have completely different expectations about the outcomes of treatment.

One study showed that patients and physicians had discordant expectations almost a third of the time. Another study showed that almost half of patients with psoriasis had not seen a provider in the past year, and 20% of them said they thought no one could help them.

Discordance between provider and patient expectations is a consequence of poor communication, which often leads to undertreatment.

"Patients don't communicate what their goals of therapy are, and providers don't ask," said Pariser. "Providers assess the severity of psoriasis and their evaluation of success differently from patients."

Patient expectations often relate directly to personal goals: better interpersonal relationships, enjoyment of physical intimacy, less psychological discomfort about the disease, or simply to stop itching. Providers should consider patient goals and incorporate them to the extent possible into disease management.

"The patient needs to be a part of the selection process," said Pariser. "Be sure that the patient has realistic expectations and that you are addressing the patient's own treatment target. Give the treatment a chance, usually 3 months, but don't 'beat a dead horse' -- move on to something else if treatment isn't working."

"A follow-up visit for a well-controlled psoriasis patient is one of the most rewarding doctor-patient interactions," Pariser added.

Elewski disclosed relationships with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Incyte, LEO, Lilly, Merck, Novartis, Pfizer, Regeneron, Valeant (Ortho), and Sun.

Pariser disclosed relationships with Galderma, Abbott/AbbVie, Eli Lilly, Stiefel, Pfizer, LEO, Sun, Amgen, Centocor/Janssen Biotech, Celgene, Merck, Boehringer Ingelheim, and Bristol-Myers Squibb.

2019-10-22T14:15:00-0400

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The American Journal of Managed Care Launches ‘Understanding the Comorbidities: Psoriasis and Metabolic Syndrome’ Video Series – Business Wire

Posted: at 10:53 am

CRANBURY, N.J.--(BUSINESS WIRE)--The American Journal of Managed Care (AJMC), the leading multimedia peer-reviewed journal dedicated to issues in managed care, presents its most recent Peer Exchange panel discussion, Understanding the Comorbidities: Psoriasis and Metabolic Syndrome. The video series features experts in the field of dermatology discussing psoriasis and metabolic syndrome and dissecting a variety of treatment options.

Led by Dr. Peter L. Salgo, the panel of experts featured in this educational video series will provide an understanding of these comorbid conditions and discuss the causal relation between psoriasis and metabolic syndrome, said Mike Hennessy Jr., president and CEO of MJH Life Sciences, parent company of AJMC.

Here are the four distinguished experts on the panel:

The Peer Exchange begins with a conversation that defines both psoriasis and metabolic syndrome. The experts also discuss the burdens of psoriasis in addition to the role that genetics play in this chronic systemic inflammatory disease. Next the experts shift the conversation to discuss an understanding of the increased risk of developing metabolic syndrome for patients with psoriasis, highlighting their connectivity. The causal relation between the two conditions will be analyzed as the experts dive deeper into the biologics used to treat psoriasis and review their efficacy in patients who also present with metabolic syndrome.

For more information and to view the video series, click here.

AboutThe American Journal of Managed Care

The American Journal of Managed Care(AJMC) is a multimedia peer-reviewed, MEDLINE-indexed journal that keeps industry leaders on the forefront of health policy by sharing digital research relevant to industry decision-makers. Other brands in theAJMCfamily includeThe American Journal of Accountable Care,Evidence-Based Oncology andEvidence-Based Diabetes Management. These comprehensive multimedia brands bring together stakeholder views from payers, providers, policymakers and other industry leaders in managed care. AJMC is a brand of MJH Life Sciences, the largest privately held, independent, full-service medical media company in the U.S. dedicated to delivering trusted health care news across multiple channels.

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Arcutis Biotherapeutics Announces Positive End-of-Phase 2 Meeting with FDA and Planned Initiation of Phase 3 Program for ARQ-151 for Plaque Psoriasis…

Posted: at 10:53 am

Arcutis Also Announces Enrollment of Last Patient in 52-Week Long-term Safety Study of ARQ-151 Cream as a Potential Topical Treatment for Plaque Psoriasis

WESTLAKE VILLAGE, CA / ACCESSWIRE / October 24, 2019 / Arcutis Biotherapeutics, Inc. (Arcutis), a privately held clinical-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced plans to initiate its Phase 3 program of ARQ-151 as a potential topical treatment for plaque psoriasis following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Company anticipates initiating a Phase 3 clinical trial in the first half of 2020.

Frank Watanabe, Arcutis' President and Chief Executive Officer, commented: "We appreciate the collaborative interaction with the FDA to reach agreement on the key elements of our Phase 3 program that we intend to use to support the submission of a New Drug Application for ARQ-151 for plaque psoriasis. Based on our clinical data to date, we believe ARQ-151 has the potential to be both a best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis. We look forward to starting our Phase 3 program in the first half of next year."

The Company also announced that it has completed enrollment of a 52-week Phase 2 long-term safety study of ARQ-151 in plaque psoriasis. Topline results are expected in the first half of 2021. The Company expects this study to supply the 12-month safety data required for regulatory submissions. In the previous Phase 2b trial in plaque psoriasis, both tested doses of ARQ-151 were well tolerated and demonstrated rapid onset of effect with statistically significant superiority over vehicle. ARQ-151 is a topical cream formulation of roflumilast, a highly potent and selective Phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for once-a-day application to treat plaque psoriasis and atopic dermatitis.

Howard Welgus, Arcutis' Chief Medical Officer, commented: "Because psoriasis is a chronic disease, it is critical to understand the efficacy, safety and tolerability of any new psoriasis treatment over an extended period. Thus, this long-term safety study is important to our understanding of ARQ-151's potential to address the unmet needs in topical treatment of psoriasis. Furthermore, this strategic clinical development approach to generating long-term safety data allows our Phase 3 studies to be of shorter duration."

The ARQ-151-202 study is a Phase 2, multi-center, open label study of the long-term safety of ARQ-151 0.3% cream in adult subjects with chronic plaque psoriasis involving up to 25% total body surface area (BSA), evaluated in two cohorts: 231 patients who have completed the ARQ-151-201 Phase 2b, randomized, controlled trial; and 102 previously untreated subjects. The qualifying subjects will apply ARQ-151 0.3% cream once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression. The primary outcome measures of the study are the occurrence of treatment emergent adverse events and the occurrence of serious adverse events.

About ARQ-151

ARQ-151 is a topical cream formulation containing roflumilast, a PDE4 inhibitor, that Arcutis is developing to treat plaque psoriasis, including intertriginous psoriasis, and atopic dermatitis. PDE4 is an intracellular enzyme that regulates the production of pro-inflammatory and anti-inflammatory cytokines and cell proliferation. Roflumilast is a potent PDE4 inhibitor that was approved by the FDA for systemic treatment to reduce risk of exacerbation of chronic obstructive pulmonary disease (COPD) in 2011, and has shown greater potency based on IC50 values (a non-clinical measure of a drug's potency) than other PDE4 inhibitors.

About Psoriasis

Psoriasis is a common, non-contagious, immune disease that affects approximately 8.6 million patients in the United States. About 90% of psoriasis cases are plaque psoriasis, which is characterized by "plaques", or 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 the plaques 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.

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Arcutis Biotherapeutics Announces Positive End-of-Phase 2 Meeting with FDA and Planned Initiation of Phase 3 Program for ARQ-151 for Plaque Psoriasis...

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UCB psoriasis drug beats J&J’s second top-selling product in Phase III study – MedCity News

Posted: at 10:53 am

A drug made by Johnson & Johnson for psoriasis that is one of the biggest revenue generators in its portfolio could be under threat in the future following the success of a new competitor in a Phase III study.

Brussels-based UCB said Thursday that results of its BE VIVID study showed that its antibody, bimekizumab, was superior in its efficacy against J&Js Stelara (ustekinumab) in adult patients with moderate-to-severe chronic plaque psoriasis.

The company did not disclose the full results, which it said would be presented in due course, but stated that the trial met the primary endpoint of showing at least a 90 percent improvement in psoriasis area and severity index or PASI90 and an investigator global assessment score of clear or almost clear after 16 weeks. The safety profile was consistent with the Phase II BE ABLE studies.

BE VIVID randomizes patients to receive bimekizumab for one year, Stelara for one year with placebo at certain time points to maintain blinding or placebo for 16 weeks followed by bimekizumab for the remainder of the study period. Bimekizumab is an IgG1 antibody tat neutralizes IL-17A and IL-17F, two key cytokines that drive inflammation.

These encouraging first results provide strong evidence that bimekizumab has the potential to raise the bar for achieving skin clearance rates in patients, investigator Dr. Mark Lebwohl of New Yorks Icahn School of Medicine said in a statement. Achieving clear skin is of critical importance in positively impacting the lives of psoriasis patients.

Stelara, which was approved in 2009, was J&Js second largest product in 2018, accounting for about 6.3 percent of its total sales for the year, with global sales of about $5.2 billion, according to its 2018 annual report. U.S. patents for Stelara are expected to expire in 2023 due to a patent term extension, followed by expiration in Europe the following year. The companys top-selling product is the autoimmune disease drug Remicade (infliximab), which had sales of $5.3 billion and which already has biosimilar competitors.

In the Phase IIb BE ABLE 1 trial, which randomized patients to various dose levels of bimekizumab or placebo, patients treated with the drug showed a statistically significant dose-dependent response for PASI90, with 46.2-79.1 percent of patients achieving it, compared with 0 percent in the placebo arm. In addition, 27.9-60 percent of bimekizumab-treated patients achieved PASI100, also compared with 0 percent in the placebo arm. Treatment-emergent adverse events occurred among 126 of the 208 patients treated with bimekizumab, compared with 15 of 42 who received placebo.

Photo: juststock, Getty Images

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What Is Oregon Grape? Uses and Side Effects – Healthline

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Oregon grape (Mahonia aquifolium) is a flowering herb that has been used for centuries in traditional Chinese medicine to treat numerous conditions, including psoriasis, stomach issues, heartburn, and low mood.

As such, you may wonder whether these benefits are backed by scientific evidence, and whether the plant has any side effects.

This article examines Oregon grape, explaining everything you need to know about its uses and side effects.

Despite its name, Oregon grape does not produce grapes.

Instead, its root and stalk contain active plant compounds, which may combat bacterial and fungal infections, as well as inflammatory and skin conditions (1, 2).

One of these compounds, berberine, has both antimicrobial and anti-inflammatory properties, which may make it effective at treating many diseases (1).

Oregon grape is found in a variety of products intended for oral or topical use, including supplements, extracts, oils, creams, and tinctures. You can look for these products online or in various health stores.

Oregon grape contains berberine, a powerful plant compound that may relieve many health conditions. This herb is available in various supplements, oils, creams, and extracts.

Some evidence suggests that Oregon grape reduces the severity of symptoms associated with psoriasis and atopic dermatitis.

These common, inflammatory skin conditions can be chronic and occur anywhere on your body. Psoriasis is characterized by reddish, scaly patches of skin, whereas atopic dermatitis is a severe form of eczema that causes itchy, dry skin (1).

In a 6-month study in 32 people with psoriasis who applied an Oregon grape topical cream, 63% reported that the product was equal or superior to the standard pharmaceutical treatment (3).

Likewise, in a 12-week study, 39 people who used an Oregon grape cream experienced significantly improved psoriasis symptoms, which remained stable and didnt require any follow-up treatment for 1 month (3).

Furthermore, a 3-month study in 42 people with atopic dermatitis observed improvements in symptoms after having them apply a skin cream containing Oregon grape3 times daily (4).

Though these results are promising, more rigorous research is necessary to determine this herbs ability to treat these conditions.

Small-scale human studies indicate that Oregon grape may treat psoriasis and atopic dermatitis. All the same, more research is needed.

Oregon grape is a versatile plant with numerous other potential benefits.

Berberine, an active compound in Oregon grape, demonstrates strong antimicrobial activity (1, 5).

Its used mainly to treat diarrhea and parasitic infections caused by bacteria (5).

Moreover, a test-tube study revealed that Oregon grape extracts exhibit antimicrobial activity against certain harmful bacteria, fungi, and protozoa (6).

Multiple studies demonstrate similar results, indicating that berberine may combat MRSA and other bacterial infections, such as those caused by E. coli (7, 8, 9).

The berberine in Oregon grape may ease symptoms of irritable bowel syndrome (IBS), as well as other stomach issues like gut inflammation.

In an 8-week study in 196 people with IBS, those who received a berberine treatment experienced reductions in diarrhea frequency, abdominal pain, and overall IBS symptoms, compared with those on a placebo (10).

Animal studies using this compound have suggested improvements not only in IBS symptoms but also in other stomach conditions like gut inflammation (11, 12).

Still, human research on the effects of Oregon grape and gut inflammation is lacking.

Due to the anti-inflammatory effects of berberine, Oregon grape may help prevent heartburn and related damage to your esophagus (13).

Heartburn is a common symptom of acid reflux, which occurs when stomach acid rises into your esophagus. Heartburn triggers a painful, burning sensation in your throat or chest.

In a study in rats with acid reflux, those treated with berberine had less esophageal damage than those treated with omeprazole, a common pharmaceutical heartburn treatment (13).

Keep in mind that human research is needed.

Some evidence indicates that berberine, an active compound in Oregon grape, may alleviate symptoms of depression and chronic stress (14, 15, 16, 17).

In a 15-day study in mice, a berberine treatment increased levels of serotonin and dopamine by 19% and 52%, respectively (18).

These hormones are known to help regulate your mood.

Yet, human research is needed before Oregon grape can be recommended as a treatment for depression.

Berberine, a powerful plant compound in Oregon grape, may exert strong antimicrobial activity and help improve symptoms of IBS, heartburn, and low mood. However, further research is necessary.

Despite the potential benefits of Oregon grape, there are several concerns associated with its use.

Most studies on this herb have tested it as a topical cream for psoriasis treatment. While its widely recognized as safe in this form, insufficient information exists to determine whether Oregon grape is safe to ingest (1, 3).

Thus, you may want to practice caution or talk to your healthcare provider before taking supplements, tinctures, or other orally administered forms of this herb.

Whats more, children and women who are pregnant or breastfeeding should avoid all preparations of this product due to a lack of safety information.

Notably, berberine, an active compound in Oregon grape, can cross the placenta and cause contractions (19).

Oregon grape is generally safe to use on your skin, but you should practice caution with oral supplements. Children and women who are pregnant or breastfeeding should avoid it due to insufficient data regarding its safety.

Oregon grape is a flowering plant that has been used for centuries in traditional Chinese medicine.

Scientific research suggests it relieves symptoms of psoriasis and other skin conditions, but it may also boost your mood, offer antibacterial activity, and ease IBS and heartburn.

Though generally safe, Oregon grape should not be taken by children or pregnant or breastfeeding women.

If youre interested in trying this herb, it may be best to start by using a topical treatment containing it, such as a skin ointment, and consult a medical professional before taking supplements or other oral formulations.

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