Category Archives: Psoriasis

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If youre one of the roughly 7.5 million Americans living with psoriasis, you know it isnt exactly fun. While you may go for years without symptoms, when you have a psoriasis flare-up, it can be everything from uncomfortable to downright distressing. And part of what makes it such a difficult condition to deal with is because you never know when a flare-up might occur and what could cause it. One biggie thats thought to cause flare-ups is food.

Certain types of foods appear to trigger or worsen psoriasis symptoms, and others may actually help tame signs of psoriasis, but everyone is different and foods that trigger flare-ups for some may not affect others with psoriasis, so pay attention to what seems to personally affect you, says Annie Gonzalez, M.D., F.A.A.D, a board-certified dermatologist at Riverchase Dermatology in Miami, Florida.

To help, we rounded up the best foods to eat if you have psoriasis and ones you should try to avoid, if you can.

Psoriasis is a skin disease with an unclear cause whats known is that it happens when the immune system goes into overdrive, triggering inflammation and inflammatory skin symptoms due to that overactivity that speeds up skin cell growth. The most common type of psoriasis (80%-90% of people with psoriasis have this kind) is called plaque psoriasis, characterized by patches of thick, raised skin that may itch and be red or partially covered in silvery-white scales; these patches can develop anywhere but tend to appear on the elbows, knees, lower back and scalp. Other ways a psoriasis flare-up may manifest is as tiny, salmon-to-pink colored bumps; smooth, raw-looking red patches around skin creases like the armpits; red, swollen skin dotted with pus-filled bumps; and as nail issues like tiny dents, rough crumbling nails, discoloration or lifting of the nail.

Weather, stress, infections (such as strep throat), smoking or secondhand smoke and certain medications, like those to treat high blood pressure are some common psoriasis flare triggers. Food is also thought to play a role in prompting of psoriasis flares. Specifically, inflammatory foods (a.k.a. foods that cause inflammation in the body) are thought to be common culprits, but more research in this area needs to be done. My advice is, if you notice your skin gets worse after eating certain foods, avoid and stop eating them to see what happens, says Dr. Gonzalez.

In general, eat a well-balanced diet thats high in fruits and vegetables and healthy fats this mix ensures youre consuming an array of nutrients and antioxidants that help prevent and reduce inflammation that could trigger a psoriasis flare-up.

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Fruits and veggies may reduce inflammation because theyre high in antioxidants and vitamins, which have been also been related to lower levels of oxidative stress and inflammation, says Gonzalez. Aromatics like onions and garlic are also smart to incorporate; they contain quercetin, an anti-inflammatory antioxidant.

Load up on:

Heart-healthy fats and omega-3 fatty acids have anti-inflammatory properties that can help decrease inflammation to alleviate or prevent symptoms.

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Many of these flavor enhancers are also thought to play a role in taming inflammation.

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Foods to avoid if you have psoriasis:

Remember: Not every food on this list will definitely trigger a psoriasis flare-up, but if you do notice that your diet is affecting your skin, these inflammatory foods might be to blame, and cutting back or eliminating may help. Foods that have been known to trigger psoriasis include eggs, red and processed meat, canned produce, and packaged or processed foods, Gonzalez says.

These types of proteins tend to be high in saturated fat, an inflammation raiser and processed meats often contain preservatives, additives, and other flavor enhancers that may have a similar affect.

Avoid or limit:

These types of products often contain various inflammation triggers, such as added sugar, trans fat, preservatives, sodium and flavorings.

Avoid or limit:

Some research suggests that people with psoriasis may also be sensitive to gluten, a protein found in wheat, barley, and rye, possibly due to similar genetic and other inflammatory markers that affect people with Celiac disease.

Avoid or limit:

Everyone is different and different bodies will react differently to certain foods. Try jotting down which foods seem to impact your skin, so you can keep track and have that information on hand to consult with your doctor about your diet.

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Psoriasis Diet: What It Is, Best Foods to Eat and Food You Should Avoid - GoodHousekeeping.com

The main factors behind the vaccine hesitancy are the potential adverse effects post-vaccination and effect on their autoimmune conditions, as well as lack of trial data, an analysis shows.

Individuals with psoriasis are hesitant to get the COVID-19 vaccination, but there is no differential risk of respiratory tract infection (RTI) and serous infection (SI), the results of 2 new studies presented at the European Academy of Dermatology and Venereologys (EADV) 30th Congress show.

Our analysis reveals no differences in risk of respiratory tract infections between biologics, including the newer IL-17 and IL-23 inhibitors, in a prospective psoriasis patients cohort. In addition, our preliminary results suggest that biological treatments do not impact psoriasis patients susceptibility to COVID-19 infections, although this needs to be further investigated, Lara van der Schoot of the department of dermatology at Radboud University Medical Center in Nijmegen, Netherlands, said in a statement.

These findings provide key clinical value and will help to guide patient decisions with regard to psoriasis treatment options and choice, she said.

Results from the first study show that COVID-19 vaccine hesitancy was driven by safety concerns and worries about aggravation of the individuals underlying conditions, as well as a lack of trial data.

Additionally, investigators said that individuals had no information on the effect of the COVID-19 vaccine on biologic therapy in immunocompromised individuals.

Treatments for psoriasis are often associated with an increase in infections, so in the second study, investigators examined the effect of biological therapies on the risk for RTI and SI, including COVID-19.

Investigators found that there was no differential risk of RTI among included biologics adalimumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab, and no association with serious infections.

In the first unique study, investigators collected real-world data from social media to minimize limitations from traditional hospital surveys.

Investigators gathered 10,922 social media posts between January and March 2021. They included individuals in France, Germany, Spain, the United States, and the United Kingdom, using pre-defined words, which were narrowed down to 625 posts that were manually analyzed.

The second study included 714 individuals with psoriasis, with 1325 treatment episodes from the BioCAPTURE registry, 2224 with RTI and 63 with SI.

Just 1.3% of RITs were reported to be serious.

Reference

Safety analysis of biologics and highlighting vaccine hesitancy: real-world data shines a light on the impact of COVID-19 on psoriasis patients. EurekAlert. News release. September 30, 2021. October 1, 2021. https://www.eurekalert.org/news-releases/929887

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Individuals With Psoriasis Are Hesitant to Get Vaccinated for COVID-19 - Pharmacy Times

Treatment with tapinarof 1%, a nonsteroidal topical cream in clinical development, was associated with durable control of plaque psoriasis in a 52-week phase 3 trial presented as a latebreaker at the European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting.

The drug has several unique features with meaningful clinical differences from other topical psoriasis therapies, according to Linda Stein Gold, MD, director of dermatology clinical research, Henry Ford Health System, Detroit, Michigan.

"The currently available nonsteroidal topical therapies are typically associated with significant irritation. We did not see that with tapinarof," said Gold. This is one of several reasons she believes this drug will be a valuable addition if it receives regulatory approval.

Tapinarof is a small-molecule aryl hydrocarbon receptor (AhR) modulating agent. AhR is widely expressed in immune cells, including macrophages, mast cells, and antigen-presenting cells. It is believed that modulation of AhR signaling by tapinarof reverses immune dysregulation that is involved in the formation of psoriatic lesions.

The newly presented PSOARING 3 data with tapinarof 1% build on the data from the 12-week PSOARING 1 and PSOARING 2 trials, which were released in August 2020 but have yet to be published.

The primary endpoint in both of the 12-week trials, each of which enrolled about 500 patients with plaque psoriasis, was a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear). Relative to a placebo response rate of about 6% in both trials, the proportion of patients who achieved scores of 0/1 with tapinarof 1% was 35.4% and 40.2% in the PSOARING 1 and PSOARING 2 trials, respectively (P < .0001 vs placebo in both studies).

For the key secondary endpoint of 75% improvement in the Psoriasis Area and Severity Index (PASI75), the relative advantage for tapinarof over placebo was similar. The results were highly statistically significant (P < .0001) in both of the 12-week trials.

More than 90% of the patients who participated in PSOARING 1 and PSOARING 2 and were eligible for the open-label PSOARING 3 extension trial, according to Gold.

For the 79 patients with a score of 0 at the time of enrollment, tapinarof 1% was reapplied only if the PGA score reached 2 during the course of the study. For the 680 patients who entered with a PGA score of 1, once-daily applications of tapinarof 1% cream were maintained until a PGA score of 0 was achieved.

In the outcome analysis, response was defined as the proportion of patients with an initial PGA score of 2 who achieved PGA 0. A remittive effect was defined as duration of a PGA score of 0 or 1 while off therapy after achieving a PGA score of 0. Durability of response was defined as the proportion of patients who achieved a PGA sore of 0 or 1 at least once during the study while on therapy. This last outcome provided a test of tachyphylaxis.

"Overall, 40.9% of patients achieved complete disease clearance at least once during the trial, and 58.2% who entered the study with a PGA score of 2 or higher achieved a PGA score of 0 or 1," Gold reported.

For the 79 patients who entered PSOARING 3 with a PGA score of 0 and were off treatment, the median duration of a remittive effect was 115 days. For the patients who entered the trial with a higher PGA score but who achieved a score of 0 during the study (312 patients), the mean remittive effect after discontinuing therapy was 130 days.

There was no evidence of tachyphylaxis. Rather, "there was no loss of effect despite intermittent therapy observed over the course of the trial," Gold reported.

The most common treatment-emergent adverse events in PSOARING 3, as in the previous PSOARING studies, were folliculitis, which was observed in 24.0% of patients; contact dermatitis, which occurred in 5.9% of patients; and headache, which was reported in 2%. Rates of study drug discontinuations for folliculitis and contact dermatitis were 1.2% and 1.4%, respectively. Headache did not lead to any study discontinuations.

Calling tapinarof a "first-in-class nonsteroidal," Gold suggested that this is likely to be a useful adjunctive therapy for psoriasis control. It avoids the adverse events associated with long-term topical steroid use, and its tolerability might be particularly attractive for use in sensitive areas.

"This is likely to be very useful in patients who are looking for a topical therapy for skin folds or the face, where there is a need for well-tolerated topical treatments," Gold said.

There are a lot of reasons to be positive about a new, well-tolerated topical agent for psoriasis, particularly as an alternative to topical steroids, agreed Adam Friedman, MD, director of translational research and professor and chair of the Department of Dermatology at George Washington School of Medicine and Health Sciences, Washington, DC. He considers the data with tapinarof promising in general, but he also likes any new, effective topical psoriasis therapy.

"Patients and physicians are always hungry for new options, especially psoriasis patients, given many have 'been there and done that' with topical steroids," Friedman said.

"Topical steroids are not irritating, but long-term use beyond recommended dosing can lead to skin thinning, lightening, tachyphylaxis, and, if really abused, HPA [hypothalamic-pituitary-adrenal]axis suppression and adrenal insufficiency," he observed.

A topical therapy with a durable effect is particularly intriguing.

"The other issue with topical steroids is that psoriatic plaques return rather easily after stopping. The data I have seen with tapinarof show more sustainability after cessation, owing to its mechanism of action," Friedman said. Rather than its potential for application to sensitive areas, such as the face, the durability "to me is more interesting," he said.

He suspects that, owing to "the incurable steroid phobia that haunts many of our patients," an effective nonsteroidal topical option is also likely to lead to better compliance with topical treatment over time.

"A well-tolerated nonsteroidal topical drug will probably find an important place in the future management of chronic inflammatory diseases," Marius-Anton Ionescu, MD, PhD, a dermatologist at the Hpital Saint Louis, Paris, France, said in an interview. He referred to the positive effects of treatment with tapinarof in clinical trials in adults with atopic dermatitis, in addition to psoriasis.

Tapinarof 1% is also being investigated in a phase 3 study involving patients with moderate to severe atopic dermatitis. In that study, patients are as young as age 2 years. The drug is under review at the US Food and Drug Administration for the plaque psoriasis indication in adults.

Gold has financial relationships with Arcutis, Amgen, Bristol-Myers Squibb, Eli Lilly, Leo Pharma Ortho Dermatologic, UCB, and Dermavant Sciences, which is developing tapinarof and is provided funding for the PSOARING 3 trial. Friedman reports financial relationships with Amgen, Biogen, Encore, Galderma, GlaxoSmithKline, IntraDerm, Johnson & Johnson, Nerium, Novartis, Oculus, Onset, Pfizer, Sanova, and Valeant Pharmaceuticals. Ionescu has been a speaker or investigator (honoraria) for Celgene, Novartis, Lilly, and Uriage Cosmetics.

European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting: Abstract 2860. Presented September 30, 2021.

Ted Bosworth is a medical journalist based in New York City.

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Novel Topical Found Effective for Psoriasis in 52-Week Study - Medscape

WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.(Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis.

Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, would enable chronic use across the body, without many of the local tolerability issues associated with alternative treatments.

Today is a critical milestone for Arcutis in our efforts to bring innovative treatments to dermatologists and their patients, and is a reflection of our deep dermatology expertise, said Frank Watanabe, President and CEO of Arcutis. Individuals with plaque psoriasis currently do not have topical treatment options that offer a combination of good tolerability and the ability to be used for long periods of time, and that can be used on all parts of the body. If approved, roflumilast cream will be the first and only topical PDE4 inhibitor approved for psoriasis and an important non-steroidal treatment option for the millions of individuals struggling with plaque psoriasis. I want to thank the Arcutis team, as well as the clinical investigators, patients, and partners, for helping us reach this important milestone.

Psoriasis is a common, non-contagious, immune-mediated skin disease that affects more than 3% of the U.S. population. The majority of patients develop plaques, or raised, red areas of skin covered with a silver or white layer of dead skin cells. Psoriatic plaques are often itchy and sometimes painful, and can appear on any area of the body. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and areas where two skin areas may touch or rub together.

Topical treatments are the mainstay of therapy for the vast majority of psoriasis patients, particularly those with mild-to-moderate disease, as well as many moderate-to-severe patients who use topicals in combination with other treatments. However, existing topical treatments often force physicians and patients to make difficult trade-offs between tolerability and long-term use, requiring the use of multiple products or complicated treatment schedules. Roflumilast cream has been designed to address the challenges posed to dermatologists and patients by existing topical therapies and aims to simplify the overall management of plaque psoriasis.

Arcutis submission is supported by positive data from Arcutis pivotal Phase 3 program. The DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition withRoflumilast for theManagement of plaque PsoriasIS One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy ofroflumilast cream 0.3%. Roflumilast met its primary endpoint and had an IGA Success rate of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). In trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.

About 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. 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 or the systemic treatment of plaque psoriasis.

About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions, with one NDA submission now under review with the FDA and three Phase 3 clinical data readouts anticipated by the end of 2022. The companys lead program, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visitwww.arcutis.comor follow Arcutis on LinkedIn and Twitter.

Forward-Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to be approved for the treatment of adults and adolescents with plaque psoriasis, the potential to use roflumilast cream over a long period of time, or chronically, and 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.

Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com

InvestorsEric McIntyre, Head of Investor Relationsemcintyre@arcutis.com

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Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis -...

MoonLake Immunotherapeutics will soon have $230 million to bankroll trials ofan investigational drug that signaled it could outperformed Novartis' Cosentyx in a midstage study last year.

That financing is thanks to a blank-check tie-up the Swiss biotech inkedMonday with Helix Acquisition. The special purpose acquisition company, sponsored by Cormorant, will take MoonLake to Wall Street to fund multiple phase 2 studies of the tri-specific nanobody, dubbed sonelokimab.

MoonLake debuted with the drug in May after licensing it from Merck KGaA. The treatment's former owner took it through a phase 2b study in more than 300 patients with moderate to severe psoriasis and compared it to placebo and Novartis' Cosentyx.

The drug beat placebo on multiple measures after 12 weeks and was able to outperform Cosentyx but not enough to be statistically significant, Merck KGaA said last October. The treatment has shifted hands multiple times, with Merck KGaA originally snagging the license from Ablynx in 2013.

RELATED:MoonLake debuts with Cosentyx challenger from Merck KGaA

As a public company, MoonLake plans to take sonelokimab into midstage studies in patients with psoriatic arthritis (PsA), ankylosing spondylitis (AS) or radiographic axial spondyloarthritis (RaxSpA) and hidradenitis suppurativa (HS).

MoonLake will attempt to go up against a drug that has already received the green light in multiple skin and joint diseases. Novartis' Cosentyx is already approved in moderate-to-severe plaque psoriasis, PsA, AS as well as nonradiographic axSpA and in June received the go-ahead to treat children and adolescents with plaque psoriasis. The drug is also in a phase 3 HS study.

MoonLake's treatment is derived from nanobodies, compared to Cosentyx, which is based on conventional antibodies. Nanobodies are found naturally in llamas and other camelids and need only a single variable to its domain to recognize its target.

RELATED:Lilly scraps IL-23 psoriasis program despite phase 3 success, focuses on IBD race against AbbVie, J&J

Nanobodies such as sonelokimab are an exciting emerging therapeutic modality and sonelokimab has been engineered to have properties that may underpin potential for differentiated clinical activity in deep tissue and joint settings where IL-17A and IL-17F biology is emerging as central to disease," said Andy Phillips, Helix's chief financial officer and a managing director at Cormorant, in a statement.

The deal is slated to close later this quarter or in early 2022. MoonLake will list on the Nasdaq under the symbol "MLTX."

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MoonLake over the moon with $230M SPAC deal for llama antibodies to challenge Novartis' Cosentyx - FierceBiotech

LUGANO, 30 September, 2021 Real-world data looking at biologic treatment and vaccine hesitancy in psoriasis patients is being presented today at EADVs 30th Congress. The findings of two studies are helping to advance understanding of the safety of biological therapies for psoriasis and reasons for COVID-19 vaccine hesitancy in psoriasis patients.

Researchers in Spain have studied sentiment towards COVID-19 vaccination in biologic-treated patients with psoriasis and/or psoriatic arthritis.1 The real-world data was collected via social media to minimise the limitations of traditional hospital surveys, which only capture data from motivated patients that could be impacted by the presence of a doctor.

10,922 social media posts were identified between January and March 2021 from patients in the USA, UK, France, Germany and Spain using pre-defined keywords, which were then filtered down to 624 posts to be manually analysed to derive insights.

Important findings suggest that COVID-19 vaccine hesitancy in patients was driven by safety concerns and concerns about aggravation of their underlying condition (n=344). Main factors driving this perception were potential side effects post-vaccination, effect on their autoimmune conditions and lack of trial data. Moreover, patients had no information on the interaction of the COVID-19 vaccine with biologic therapy and did not know what effect it had in immuno-compromised patients.

lvaro Gonzlez-Cantero of the Department of Dermatology Hospital Universitario Ramon Y Cajal, Madrid, Spain said: Looking forward, we know that we have to take these findings on board and educate patients on the importance, safety and effectiveness of the COVID-19 vaccine. Were hoping to be able to collaborate with an Academy like the EADV to help us tackle vaccine hesitancy through education.

Biologic treatments for psoriasis - a chronic inflammatory skin disease - are often associated with increased risk of infection. In a second real-word study, researchers in The Netherlands examined the differential effect of biological therapies on risk of respiratory tract infections (RTI) and serious infections (SI), including COVID-19, to help determine if any associations exist.2 A daily practice cohort of 714 psoriasis patients with 1325 treatment episodes from the BioCAPTURE registry was analysed, with 2224 RTI and 63 SI reported but only 1.3% of RTI reported as serious.

Analysis found no differential risk of RTI between included biologics adalimumab, etanercept, infliximab, ustekinumab, secukinumab, ixekizumab, and guselkumab, and no association was revealed for serious infections. Regarding SARS-CoV-2 infections, the crude incidence rate was 3.8 (95% CI: 2.2-6.1) per 100 PY during 2020, in a single BioCAPTURE centre.

Our analysis reveals no differences in risk of respiratory tract infections between biologics, including the newer IL-17 and IL-23 inhibitors, in a prospective psoriasis patients cohort. In addition, our preliminary results suggest that biological treatments do not impact psoriasis patients susceptibility to COVID-19 infections, although this needs to be further investigated, says Lara van der Schoot of the Department of Dermatology at Radboud University Medical Center, Nijmegen, The Netherlands, and Lead Author of the study. These findings provide key clinical value and will help to guide patient decisions with regard to psoriasis treatment options and choice.

The COVID-19 pandemic has posed an unprecedented challenge to patients with immune-mediated inflammatory diseases like psoriasis, shares Dee-Dee Murrell, EADV Board Member and Professor of Dermatology at the University of NSW, in Australia, However, the research presented here provides actionable insights that can help to educate and support psoriasis patients with regards to the impact of biological treatments on infection, and on the need for COVID-19 vaccinations.

END

Notes to Editors

A reference to the EADV 30th Congress or EADV Congress 2021 must be included when communicating any information within this press release.

Contact:

For further information or to arrange an expert interview, please contact:

Boryana Kermenova EADV Press Officer

bkermenova@saycomms.co.uk

+44 (0) 20 8971 6429

Catriona Martin EADV Press Officer

cmartin@saycomms.co.uk

+44 (0) 20 8971 6412

About Psoriasis and Psoriatic Arthritis

Psoriasis

Psoriasis is a chronic, systemic immune-mediated inflammatory disease that causes raised plaques and scales on the skins surface.3 It can range in severity from a few scattered red, scaly plaques, to the involvement of almost the entire body surface it may also wax and wane in its severity over time.4 There are many different kinds of psoriasis, but the most common is plaque psoriasis which is found in 80% of people with the condition.5 Psoriasis affects between 2-3% of the worlds adult population, and <1% of children.6,7,8

Psoriatic arthritis

Psoriatic arthritis is a type of arthritis that affects some people with psoriasis. It typically causes affected joints to become swollen, stiff and painful.9 Arthritis is a common condition that causes pain and inflammation in a joint.10 Like psoriasis, psoriatic arthritis is a long-term condition that can get progressively worse. The severity can vary considerably however, if severe, there is a risk of the joints becoming permanently damaged or deformed.9 It usually develops between the ages of 30 and 50 and affects approximately 24 in 10,000 people. Between 5-10% of people with psoriasis develop psoriatic arthritis.11

About EADV

Founded in 1987, EADV is a leading European Dermato-Venereology Society with the important aims of improving the quality of patient care, furthering knowledge and education of dermatologists and venereologists and advocating on behalf of the speciality and patients. It is a non-profit organisation with nearly 7,000 members across 116 different countries in the world, providing a valuable service for every type of dermato-venereologist professional. To find out more visit https://www.eadv.org/.

About EADV 30th Congress 2021

The EADV's 30th Congress Anniversary Edition is a special celebration of three decades of science and innovation in the Dermatology and Venereology field. The 4-day Scientific Programme packed full with new findings and scientific breakthroughs and provides a unique opportunity to hear the latest in Dermato-Venereology and connect with leading experts. To find out more visit https://www.eadvcongress2021.org/.

References:

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Safety analysis of biologics and highlighting vaccine hesitancy: real-world data shines a light on the impact of COVID-19 on psoriasis patients -...

Ah, scalp care, the buzziest hair practice of 2021. Were not sure what finally dawned on the world, but our hair grows from the roots, not the ends, so naturally, we should always tend to this part of our strands. That said, because the added step in our haircare routine is still super new to some, not everyone knows the results of scalp care to expect, or when to expect them.

Rest assured, we reached out to Dr. Simmy Kaur, resident GP/MD atMONPURE.MONPURE is a luxury haircare brand based in London that was one of the first to go full-throttle with a scalp care collection. Weve been using their products for a few months and have seen noticeable results, including dissipation of dandruff. Keep reading for everything Kaur has to say about the results of scalp care, and when you should start noticing them.

Scalp care should be considered in terms of skincarewe all need it!

The whole purpose of scalp care is to treat the skin on the head exactly as you would the skin on the face, Kaur tells Mane Addicts. If we spend time with and nurture the skin on our faces we see positive change. In the same way, having a good scalp care regime will help your hair to grow and flourish. For those people with scalp issues such as dry or greasy scalp, the benefits may be even more apparent.

As with anything, its important to note that timing on scalp care results will differ from person to person and depend on what products you use.

That said, Generally speaking, you would see an almost instant soothing effect with an irritated scalp, if you use a scalp mask or hydrating serum, Kaur explains.If the aim is to stimulate hair follicles or prevent hair loss, the time it takes to see results will be longer. Typically, most people can see some improvement by 4-6 weeks. As with skincare, if you persevere, its likely that youll see a significant improvement by three months.

Kaur points out that any time you upgrade your hair routine (quality of products, healthier practices, etc), you should always expect results. But there are specific benefits scalp care will bring to especially troubled strands.

For those with particular hair problems such as dry scalp, itchy scalp, greasy scalp, dandruff, recurrent fungal infections and scalp psoriasis, good scalp care can work wonders! Kaur says.

Because MONPURE has a product for essentially every scalp concern and hair type, Kaur broke down just how to get maximized use from each.

For a particularly greasy scalp or for help with getting rid of flaky skin and alleviating symptoms of dandruff and even psoriasis,MONPUREsClarifying Scalp Scrubis a noteworthy, much-loved classic, Kaur suggests. In the same way that exfoliating the skin on the face and body can be really beneficial, the same principle can be applied to the scalp skin.

If you need a little extra hydration or have an irritated or uncomfortable scalp, a scalp mask with a little massage can be of huge benefit.MONPUREsNourish and Stimulate Scalp Maskis great for this, Kaur says.

In addition to this, Using regular treatment serums can also be of great benefit, Kaur explains.MONPUREsHydrate and Soothe Scalp Serumis famed for its healing properties. It can calm irritation, it promotes skin cell renewal and is especially good for sensitive skin. It contains pro vitamin B5, which is great if your scalp is dry and flaky. It works like a sponge, rapidly absorbing moisture and locking it in. It also contains witch hazel, which is a natural toner and anti-inflammatory.

Lastly, Kaur explains why MONPUREsFollicle Boost Hair Density Serummay be up your alley.

It can help feed the hair follicles with the essential vitamins and nutrients that they need to flourish and grow to their optimum, Kaur says. It contains ingredients such as pumpkin seed extract which can help to prevent hair loss, and AHAs and retinol, which help exfoliate and resurface the scalp skin to help speed up cell rejuvenation. These ingredients have been used for a long time in conventional beauty products for the face, so its really great that we can now use these ingredients in formulations especially designed for the scalp.

And as a final recap on the results of scalp care, Kaur insists: Remember to use a hair mask when required for that extra boost; exfoliate at least once a week; cleanse, condition and finish off with a good hair serum!

For more scalp care pointers, HEREs why you may want to try Embodys new eczema-fighting gummies!

Continued here:
This Is How Long It Should Take for You to See Scalp Care Resultsand What to Look Out For - Mane Addicts

BRUSSELS and ATLANTA, Sept. 29, 2021 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced new interim results from the BE BRIGHT open-label extension (OLE) study evaluating the long-term safety, tolerability and efficacy of bimekizumab through to two years in adult patients with moderate to severe plaque psoriasis who completed one of the three Phase 3 pivotal studies. These data, together with additional findings from the Phase 3/3b clinical program for bimekizumab in psoriasis, were presented today across nine UCB-supported abstracts at the 30th European Academy of Dermatology and Venereology (EADV) Congress.

"Following the recent approval of bimekizumab in Europe, we are pleased to share new two-year data at EADV supporting the clinical value of bimekizumab in the treatment of moderate to severe psoriasis. The range of longer-term efficacy and safety data presented offer important new insights for the dermatology community and reflect our commitment to improving the standard of care for people with psoriasis," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

Interim data from the BE BRIGHT study presented at EADV showed that patients treated with bimekizumab achieved sustained levels of skin clearance (PASI 90 and PASI 100) through to two years with continuous maintenance dosing, and that bimekizumab was generally well tolerated, with no new safety signals identified.1,2,3 Switching to bimekizumab following 24 weeks of adalimumab treatment (BE SURE) resulted in a sustained increase in PASI 90 and PASI 100 responder rates up to two years.1,4 In addition, switching to bimekizumab following 52 weeks of ustekinumab treatment (BE VIVID) resulted in a sustained increase in PASI 100 responder rates up to week 100.2,5 Patients switching to bimekizumab after an inadequate response to ustekinumab at week 52 also showed sustained improvements in levels of skin clearance (PASI 90 and PASI 100).2

"In clinical practice, patients with moderate to severe plaque psoriasis may need to transition between biologics to optimally control their disease. Longer-term results from the BE SURE study and the BE BRIGHT open-label extension study shared at EADV 2021 demonstrated that switching from adalimumab to bimekizumab helped more patients with moderate to severe psoriasis to achieve and maintain completely clear skin, as measured by PASI 100, through two years of treatment," said Professor Diamant Thai, Institute and Comprehensive Center for Inflammation Medicine, University Hospital of Lbeck, Lbeck, Germany.

Longer-term results from BE SURE and BE BRIGHT open-label extension trial After completing the Phase 3 BE SURE trial, patients could enroll in the OLE study.1,4 In bimekizumab-randomized patients (320 mg every four weeks [Q4W] through two years), PASI 90 response rates were 91.2 percent at both weeks 16 and 104.1,4,5 PASI 100 response rates in this group were 61.6 percent at week 16 and 72.3 percent at week 104.1,4 In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] through two years), the percentage of patients reaching PASI 90 was 89.4 percent at week 16 and 89.7 percent at week 104.1,4 Levels of PASI 100 response in this group were 62.8 percent at week 16 and 68.1 percent at week 104.1,4

Switching from adalimumab to bimekizumab 320 mg Q4W resulted in sustained response rates (PASI 90 and PASI 100) through to two years (week 104), which were comparable to the response rates seen in patients receiving continuous bimekizumab treatment.1 Bimekizumab was well tolerated over two years, with no new safety signals.1

Bimekizumab data up to two years in patients switching from ustekinumab This analysis included adult patients from BE VIVID who were initially randomized to ustekinumab 45 mg / 90 mg (by weight) at weeks 0 / four, then every 12 weeks, or bimekizumab 320 mg Q4W through week 52.2,5 Based on the PASI 90 response at week 52, patients entering the OLE were re-randomized to bimekizumab 320 mg Q4W or Q8W.2

At entry to the OLE study, 44.9 percent of ustekinumab-treated patients and 73.6 percent of bimekizumab-treated patients had achieved PASI 100.2, For all patients who switched from ustekinumab to bimekizumab the PASI 100 response increased to 65.4 percent at week 56, 78.7 percent at week 68 and 69.9 percent at week 100, which was comparable to the response rate seen in patients receiving continuous bimekizumab treatment at week 68 (75.4 percent) through week 100 (68.8 percent).2 For patients who switched to bimekizumab following an inadequate response to ustekinumab at week 52, high levels of response were achieved. At week 56, after one dose of bimekizumab, 77.3 percent of these patients achieved PASI 90 and 40.9 percent achieved PASI 100. These responses were sustained and further improved at week 100, with 84.1 percent and 54.5 percent of patients achieving PASI 90 and PASI 100, respectively. There were no unexpected safety findings in patients who switched from ustekinumab to bimekizumab during the OLE. 2

Pooled safety data from up to two years of treatment in Phase 2 and 3 clinical trialsAcross Phase 2 and 3 trials, the total bimekizumab exposure was 3,109.7 patient-years (N=1789).3Treatment emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 202.4 per 100 patient-years, serious TEAEs were seen at an EAIR of 5.9 new cases per 100 patient-years and TEAEs leading to discontinuation at 3.8 new cases per 100 patient-years.3The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nasopharyngitis (EAIR: 19.1 new cases per 100 patient-years), oral candidiasis (12.6 new cases per 100 patient-years) and upper respiratory tract infection (8.9 new cases per 100 patient-years).3 The EAIR for oral candidiasis showed a decrease compared with one year of bimekizumab treatment (12.6 new cases per 100 patient-years versus 16.4 new cases per 100 patient-years) and was lower with bimekizumab dosed Q8W (9.6 per 100 patient-years) compared with Q4W (16.4 per 100 patient-years).3 The majority of cases (98.5 percent of patients experiencing oral candidiasis) were mild or moderate and rarely led to study discontinuation.3

Modified non-responder imputation analyses

Non-responder imputation analyses

About BimekizumabBimekizumab is an investigational humanized IgG1 monoclonal antibody that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.4,5,7 Selective inhibition of IL-17F in addition to IL-17A has been shown to suppress inflammation to a greater extent than IL-17A inhibition alone.4,5,7

The efficacy and safety of bimekizumab have not been established. Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults.

About BE BRIGHT6BE BRIGHT (NCT03598790) is an ongoing, multicenter, open-label extension study assessing the long-term safety, tolerability and efficacy of bimekizumab in adult patients with moderate to severe plaque psoriasis. Patients who completed one of three bimekizumab Phase 3 studies, BE READY, BE VIVID and BE SURE, were eligible to enroll in the BE BRIGHT study. More details can be found at ClinicalTrials.gov.

About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements UCB This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

For further information, contact UCB:

Corporate Communications

Laurent Schots,

Media Relations, UCB

T +32.2.559.92.64

[emailprotected]

Investor Relations

Antje Witte,

Investor Relations, UCB

T +32.2.559.94.14 [emailprotected]

Brand Communications

Eimear O'Brien,

Brand Communications, UCB

T +32.2.559.92.71

[emailprotected]

U.S. Immunology Communications

Nicole Herga

U.S. Communications, UCBT 404.226.7591, [emailprotected]

References

1 Thai D, Vender R, de Rie M, et al. Safety and efficacy of bimekizumab through 2 years in patients with moderate to severe plaque psoriasis: Longer-term results from the BE SURE randomised controlled trial and the BE BRIGHT open-label extension trial. Presented at EADV 2021.2 Leonardi C, Sator PG, Morita A, et al. Bimekizumab efficacy and safety up to two years in patients with moderate to severe plaque psoriasis switching from ustekinumab: Interim results from the BE BRIGHT open-label extension trial. Presented at EADV 2021.3 Reich K, Sthle M, Okubo Y, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to two years of treatment in phase 2 and 3 clinical trials. Presented at EADV 2021. 4 Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.5 Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.6 ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790?term=NCT03598790&draw=2&rank=1. Last accessed September 20217 Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

SOURCE UCB, Inc.

http://www.ucb.com

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New Bimekizumab Two-Year Data in Moderate to Severe Plaque Psoriasis Presented at the 30th European Academy of Dermatology and Venereology Congress -...

LONG BEACH, Calif., & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced final results from the Phase 3 PSOARING 3 long-term extension study of its investigational product tapinarof, a 1% once daily, non-steroidal topical cream for the treatment of plaque psoriasis in adults. The study results demonstrated that tapinarof cream was well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3. In addition, in the study tapinarof demonstrated a high rate of complete disease clearance, a median remittive effect off-therapy for approximately four months for patients entering with a PGA score of 0, durability of response for up to 52 weeks, and consistent efficacy regardless of intermittent treatment based on PGA response during the study. The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

For the millions of people living with plaque psoriasis, the chronic nature of the condition has both physical and emotional impacts, leaving many looking for additional treatment options, said Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine, and lead investigator for the PSOARING 3 study. These consistent PSOARING 3 safety and efficacy results suggest that, subject to FDA approval, tapinarof could be an important new topical treatment option for this debilitating condition.

Eligible patients completing PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3, which comprised an additional 40 weeks of open-label treatment followed by a 4-week follow-up. Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks. PSOARING 3, which enrolled 763 patients, was designed to assess the safety and real-world use of tapinarof, and included prespecified analyses of duration of remittive effect off-therapy (defined as off-therapy maintenance of a PGA score of 0 or 1) and durability of response on-therapy. Outcomes were based on Physician Global Assessment (PGA) scores. Results from a planned interim analysis of data from PSOARING 3 were previously announced in February 2021.

Efficacy Data

With a high rate of complete disease clearance, a 4-month median remittive effect for patients entering with a PGA score of 0, and durable response with long-term use demonstrated in the PSOARING 3 study, the data for tapinarof continues to impress me over time, said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System, and PSOARING 3 study investigator. As a clinician, I am excited about these final results from PSOARING 3 and the potential for tapinarof to be a new therapy for patients suffering from plaque psoriasis.

Safety Data

Results from the interim analysis of PSOARING 3, along with results from the previously reported Phase 3 PSOARING 1 and PSOARING 2 trials, served as the basis for the New Drug Application that Dermavant submitted to the U.S. Food and Drug Administration (FDA) in May 2021. The FDA accepted the application and assigned a Prescription Drug User Fee Act target action date in Q2 2022.

We are excited to offer a more detailed picture at EADV of the long-term efficacy and safety profile of tapinarof in PSOARING 3, said Philip M. Brown, MD, J.D., Chief Medical Officer of Dermavant. We look forward to engaging with the FDA on our NDA in due course, as we work to bring tapinarof to plaque psoriasis patients as expeditiously as possible.

About Dermavants Phase 3 Program for Tapinarof in Psoriasis

Dermavants pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.

PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.

PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and completed PSOARING 3 received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavants focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The companys robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older. For more information, please visit http://www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

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Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress...

Psoriatic arthritis and mental health are deeply connected. Because the condition is so unpredictable, you may never know exactly how youre going to feel when you wake up in the morning, which can trigger really complicated feelings of anxiety, depression, and even guilt.

Psoriatic arthritis, a chronic inflammatory condition that affects about 30%1 of people with psoriasis, causes joint pain, stiffness, and swelling, as well as immense fatigue that can make the simplest tasks feel impossible, from brushing your teeth to chopping up vegetables for dinner. Especially in the midst of a flare, you might have to quickly change your plans to accommodate your condition or prioritize rest when your symptoms are hard to deal with.

Understandably, managing all of this can affect how you feel about your body and your life, and the weight of these emotions can be a lot to navigate on your own on top of already painful symptoms. In fact, about 33% of people with psoriatic arthritis reported being at least mildly anxious and 20% experienced mild depression, according to a 2020 review of studies involving more than 31,000 people with psoriatic arthritis published in the journal Clinical Rheumatology.2

So we asked people who have psoriatic arthritis (PsA) about how they take care of their mental well-being when day-to-day life starts to feel isolating, frustrating, or overwhelming. Here are some psoriatic arthritis strategies that make a true difference for them.

Jocelyn Hall, 35, who was diagnosed with psoriatic arthritis when she was 28, says her symptoms are well-managed and she is able to remain active thanks to medication. But she still feels anxious knowing there is a risk for unpredictable flare-ups. Plus, she sometimes feels judged by coworkers who dont understand why she has difficulty moving some days, like when she has trouble carrying heavy plates at her job in a restaurant.

To process her emotions, she finds it helpful to talk with a therapist, who encourages her to think about being kinder to herself during stressful times. She helps me maintain good expectations for myself, not ones that push me too far, Hall tells SELF.

For Meaghan Ingram, 28, who was diagnosed with psoriatic arthritis at 26, the symptoms go beyond physical pain. When Im in a flare and I cant move, the depression hits pretty hard and fast, Ingram tells SELF. She has worked with a therapist who incorporated cognitive behavioral therapy (CBT)which involves reframing unhelpful thoughts and changing thinking patterns3in their sessions.

Now Ingram practices acceptance and commitment therapy (ACT) strategies on her own, using The Happiness Trap book (Amazon, $8). This form of psychotherapy teaches her to observe and sit with her thoughts without trying to fix them. It's about accepting where Im at in that moment, and not trying to be anything else, she says.

Even though it can be helpful, finding a therapist is a tricky process for many people, and it may not be accessible for everyone. If you have insurance, you can contact your provider for mental health professionals in your area. Websites like Open Path, Inclusive Therapists, and Thero.org include directories of therapists who accept reduced-fee payments if you dont have insurance or dont want to use your insurance benefits. And finally, you can check the Association for Behavioral and Cognitive Therapies for a therapist that specifically practices CBT.

Psoriatic arthritis support groups can be invaluable, according to the people we talked to. The thing that's gotten me through this change in my life has been the community that I've found online, Ingram says. Theres just something so special about being able to really connect with people that understand my day-to-day, what I feel, and what Im going through.

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Psoriatic Arthritis and Mental Health Self-Care Tips - Self