NPF Board Recommends Dietary Changes to Lessen Severity of Psoriatic Disease
The National Psoriasis Foundation’s (NPF) Medical Board released guidelines on the use of dietary interventions among patients with psoriatic diseases. The guidelines, based on review of 55 studies evaluating 4,534 people with psoriasis, were published in JAMA Dermatology. Based on the literature review, the board made strong recommendations for dietary weight reduction with a hypocaloric diet in overweight and obese patients with psoriasis. They also weakly recommend a gluten-free diet—only in patients who test positive for serologic markers of gluten sensitivity. For patients with psoriatic arthritis, the group weakly recommends vitamin D supplementation and dietary weight reduction with a hypocaloric diet in overweight and obese patients. The board notes that dietary interventions should always be used in conjunction with standard medical therapies for psoriasis and psoriatic arthritis to reduce disease severity.
“These dietary recommendations from the National Psoriasis Foundation Medical Board will help guide clinicians regarding the utility of dietary interventions in adults with psoriatic diseases,” the authors conclude.
Novartis Clear About Psoriasis Survey Data Highlights Challenges Psoriasis Patients Face
Results of Novartis’ global Clear About Psoriasis survey, published in the Journal of the European Academy of Dermatology and Venereology, highlights that despite clear or almost clear skin being more achievable than ever before, patients may face a long journey to attain this reality.
The study of more than 8,300 people with moderate to severe psoriasis across 31 countries found that, on average, patients tried four different treatments and needed to see three different medical professionals before achieving clear skin. And, for nearly 30 percent of patients, this translated into a more than a half a decade-long wait to identify an efficacious treatment post-diagnosis. Of the 43 percent of respondents who confirmed they were able to achieve clear or almost clear skin, more than half had not previously believed this was a realistic and attainable treatment goal.
“Despite the availability of newer and better psoriasis treatments, these data tell us that many patients don’t seem to believe or know achieving clear skin is possible,” says Professor Richard B. Warren, Professor of Dermatology and Therapeutics at the Dermatology Centre Salford Royal Foundation Hospital, University of Manchester. “It’s critical we unite as a healthcare and patient community to raise awareness about these influential findings, in order to help people with psoriasis believe in and achieve the realistic treatment goal of clear skin.”
“The impact of psoriasis is more than skin deep and can have a profound effect on people’s physical and emotional wellbeing,” explains Shreeram Aradhye, Global Head Medical Affairs and Chief Medical Officer Novartis Pharmaceuticals. “People can feel trapped by the disabling symptoms of psoriasis and with the publication of this survey, we aim to inspire patients and support healthcare professionals in working together to achieve clearer skin sooner.”
Valeant: FDA Issues Complete Response Letter for Duobrii
The FDA issued a Complete Response Letter to Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc., regarding the company’s New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene; IDP-118) lotion in the treatment of plaque psoriasis.
“The CRL did not specify any deficiencies related to the clinical efficacy or safety of Duobrii and no issues with CMC processes. The CRL only noted questions regarding pharmacokinetic data,” says Joseph C. Papa, chairman and CEO, Valeant. “We are working to resolve this matter expeditiously and have already requested a meeting with the FDA. We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible.”
Luma Therapeutics Launches Novel illuvinate Phototherapy System
Luma Therapeutics has launched illuvinate as an innovative and modern twist on the Goeckerman regimen. By combining a narrowband UVB LED light with patented hydrogels containing coal tar micro-globules, illuvinate increases the skin’s hydration, decreases inflammation, and suppresses overactive immune cells.
Clinical trial data show that the system enables those suffering from chronic skin conditions, such as psoriasis, eczema or vitiligo, to experience clear skin after performing therapy in the comfort of their own homes in just minutes a day.
A digital therapeutic, the system is controlled by a smartphone app with a doctor’s prescription and Luma’s patented algorithm to modify the dose based on patient feedback. The illuvinate light module attaches magnetically to multi-day wear illuvinate hydrogels, freeing the user to relax during treatment sessions. In addition, users have the ability to share their progress with photographs taken on the app.
Backed by over $6 million in investments from groups such as the Mayo Clinic and Stanford-StartX, illuvinate offers a unique solution for those that don’t want to use messy topicals or pharmaceuticals with potentially harmful side effects.
Evan Anderson, founder and CEO of Luma Therapeutics, created the illuvinate system after he tried multiple options for treating his psoriasis. Mr. Anderson says, “I started Luma because I wasn’t happy with available treatments. Clinical trial patients have provided encouraging feedback and we’ve been granted multiple patents for our technology. Now I believe illuvinate is poised to make a meaningful impact on people suffering from inflammatory skin disease.”
illuvinate is currently available for purchase in California. A nationwide launch is planned for early 2019. Luma Therapeutics is a privately held medical device company.
FDA-Approved Label Update: Cosentyx Inhibits Progression of Joint Structural Damage in PsA
The FDA has approved a label update for Cosentyx (secukinumab) from Novartis, including data that show the treatment significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA). The data will be added to the drug’s prescribing information and is effective in the US immediately.
The update to the prescribing information is based on data from FUTURE 5, the largest Phase 3 study for a biologic done in PsA to date (996 patients). In the study, participants with active psoriatic arthritis (PsA) were randomized to receive Cosentyx 300mg with loading dose (LD), 150mg with LD, 150mg without LD, or placebo. All groups received Cosentyx or placebo at baseline, weeks 1, 2, 3, and 4, and then every four weeks. At week 16, placebo non-responders (patients with <20 percent improvement from baseline in tender or swollen joint counts) were switched to Cosentyx 300mg or 150mg; remaining placebo patients were switched at week 24. The primary endpoint was ACR20 at week 16, and the key secondary endpoint was radiographic structural progression, as measured by mTSS, assessed by two blinded readers, based on hand/wrist/foot X-rays obtained at baseline, week 16 (non-responders), and week 24.
Cosentyx is the only interleukin-17A (IL-17A) antagonist approved to treat active PsA, active ankylosing spondylitis, and moderate to severe plaque psoriasis in adults.
Xeljanz Receives EU Marketing Authorization for Adults with Active PsA
The European Commission (EC) has approved Xeljanz (tofacitinib citrate, Pfizer) 5mg twice daily in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
Xeljanz is the only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA. In 2017, Xeljanz in combination with MTX was approved in the EU for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to or who are intolerant to one or more DMARDs.
The EC approval was based on a submission package that included data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program in PsA, which consisted of two pivotal studies—OPAL Broaden and OPAL Beyond—as well as available data from an ongoing long-term extension trial, OPAL Balance.