News & Trends
FDA Approves Inclusion of New Evidence for Secukinumab
The FDA has approved the inclusion of new evidence showing that the biologic secukinumab (Cosentyx) significantly reduces the progression of joint structural damage among patients with active psoriatic arthritis (PsA). The data will be added to drug’s prescribing information.
The update is based on data from the phase 3 study, FUTURE 5, which included 996 participants with PsA. Patients who received secukinumab experienced significant reductions in progression of joint structural damage at week 24 compared with placebo.
Secukinumab is approved to treat PsA, active ankylosing spondylitis, and moderate to severe plaque psoriasis.
Psoriasis Registry Hits Milestone Enrollment
More than 5000 patients have enrolled in the Corrona Psoriasis Registry, a collaborative effort between the National Psoriasis Foundation (NPF) and Corrona, LLC, the leading sponsor of registries in autoimmune and immune-mediated diseases. The registry, which was created to help researchers compare the safety and effectiveness of approved psoriasis therapies, is the largest, independent North American registry of psoriasis patients from 175 sites across the United States and Canada.
Since launching 3 years ago, more than 328 participating dermatology health care providers have contributed data to the registry. Additionally, data from the registry has contributed to 33 research posters presented at international medical conferences analyzing disease severity, concurrent medical conditions, treatment effectiveness, and patient-reported outcomes.
“The Corrona Psoriasis Registry is an asset to the entire psoriasis community,” said Randy Beranek, president and chief executive officer of NPF. “By participating in this registry, researchers and patients contribute substantial data that can help millions of psoriasis patients receive safe and effective therapies to treat their disease.”
In a paradigm shift from the traditional model where individual pharmaceutical companies sponsor their own phase 4 clinical study to investigate the post-approval safety of its drug, the Corrona Psoriasis Registry uses a collaborative model that integrates the post-approval safety study (PASS) commitments of multiple companies into a single, large-scale registry with multiple drug treatment cohorts. This model offers numerous advantages, including efficient enrollment of many patients, a streamlined workflow for investigators and patients into a single protocol and set of questionnaires, and high quality, standardized data collection. The Corrona collaborative model supports FDA post-approval safety commitments for the 3 approved IL-17 inhibitor biologics for psoriasis.
“As an independent registry, the Corrona Registry can provide meaningful safety and effectiveness research on newly approved therapies which will inform the treatment of psoriasis,” said Mark Lebwohl, MD, professor and chairman, Kimberly and Eric J. Waldman department of dermatology, Icahn School of Medicine at Mount Sinai, chairman emeritus of the NPF Medical Board, and scientific co-director of the registry.
To learn more about the Corrona Psoriasis Registry, visit https://www.corrona.org/registries/psoriasis.
NPF Releases Guidelines on Dietary Interventions for Psoriatic Diseases
The National Psoriasis Foundation’s (NPF) Medical Board recently released guidelines on the use of dietary interventions among patients with psoriatic diseases.
“There is a critical lack of evidence on the relationship between psoriatic diseases and diet,” the authors said. “This literature gap speaks to the need for evidence-based dietary recommendations that are accessible to clinicians and patients.”
The NPF’s recommendations were based on data from 55 studies that evaluated diet interventions among 4534 participants with psoriasis. The quality of the studies was assessed to determine the strength of the recommendations.
Among the recommendations:
- Dietary weight reduction with a hypocaloric diet is strongly recommended for patients who are overweight or obese.
- A gluten-free diet is recommended for patients who have tested positive for serologic markers of gluten sensitivity; however, this recommendation is weak.
- Vitamin D supplementation and dietary weight reduction with a hypocaloric diet is weakly recommended for patients with psoriatic arthritis (PsA) who are overweight or obese.
In addition, the guidelines include recommendations on the Mediterranean diet, fish oil, and other supplements, including Vitamin B12.
“Adults with psoriasis and/or PsA can supplement their standard medical therapies with dietary interventions to reduce disease severity,” the authors concluded. “These dietary recommendations from NPF Medical Board will help guide clinicians regarding the utility of dietary interventions in adults with psoriatic diseases.”
Ford AR, Siegel M, Bagel, J, et al. Dietary recommendations for adults with psoriasis or psoriatic arthritis from the Medical Board of the National Psoriasis Foundation: a systematic review [published online June 20, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2018.1412