Medical Research: What is the background for this study? What are the main findings?
Dr. Blauvelt: A2303E1 is a multicenter, double-blind, randomized withdrawal extension to the FIXTURE and ERASURE pivotal phase III studies. The purpose of this extension study was to collect additional long term efficacy, safety, and tolerability data on secukinumab (i.e., Cosentyx) in patients who demonstrated a PASI 75 response to Cosentyx at Week 52 of these core studies in moderate-to-severe plaque psoriasis.
In the extension phase, 995 patients who achieved Psoriasis Area Severity Index (PASI) 75 responses after 52 weeks of therapy received either Cosentyx 300 mg, Cosentyx 150 mg, or placebo for an additional year (Week 104). After two full years of therapy in patients treated with Cosentyx 300 mg, almost 9 out of 10 (88.2%) patients maintained their PASI 75 response, 7 out of 10 (70.6%) had clear or almost clear skin (PASI 90), and 4 out of 10 (43.9) had clear skin (PASI 100) at Week 104. For patients treated with Cosentyx 150 mg, 75.5% maintained their PASI 75 response, 44.6% had clear or almost clear skin (PASI 90), and 23.5% had clear skin (PASI 100) at Week 104. In addition, 94.8% of patients who initially received placebo (at the start of the extension), and were switched to receive Cosentyx 300 mg after relapse, were able to achieve PASI 75 and 70.3% achieved PASI 90 within 12 weeks of re-starting Cosentyx.
Medical Research: What should clinicians and patients take away from your report?
Dr. Blauvelt: The two-year extension data shows that 7 out of 10 psoriasis patients who were PASI 75 responders at 52 weeks, achieved clear to almost clear skin (PASI 90) after two years of Cosentyx 300 mg treatment. After two full years of therapy with Cosentyx 300 mg, almost 9 out of 10 psoriasis patients sustained their PASI 75 response.
Psoriasis is a chronic condition causing itching, scaling, and pain; patients need therapies that provide relief and clear skin over a long period of time. The two-year data is significant because it represents results from the longest continuous phase III study to date evaluating an IL-17A antagonist in the treatment of psoriasis. The study not only strengthens our understanding of the efficacy and safety of Cosentyx, but it shows that Cosentyx responses are durable over time for individuals suffering from moderate-to-severe plaque psoriasis.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Blauvelt: The data on IL-17A inhibitors presented at the AAD annual meeting continue to demonstrate the benefits of blocking this new target in psoriasis. As with any new therapy, additional long-term safety studies are needed, as we still don’t know whether long-term use of Cosentyx, as well as other biologics, will have a positive benefit on cardiovascular function over time. I believe this will likely be the case, however, given that long-term biologic therapy for patients with rheumatoid arthritis has been associated with decreased risk of cardiovascular disease in these patients. The dermatology community looks forward to additional safety and efficacy findings with long-term therapy.
2015 American Academy of Dermatology Meeting abstract:
Secukinumab treatment maintains efficacy in moderate to severe plaque psoriasis through second year of treatment: A randomized extension of the ERASURE
MedicalResearch.com Interview with: Andrew Blauvelt, M.D., M.B. (2015). Psoriasis: Effective Two Year Response to IL-17A Antagonist Cosentyx