Secukinumab approved for psoriasis
The FDA has given its thumbs up to what dermatologists say is an exciting treatment option in psoriasis: secukinumab (Cosentyx, Novartis).
Dermatologists and a rheumatologist gathered for the Psoriasis 2015 panel presentation during the January MauiDerm meeting in Maui, Hawaii. Among the topics of discussion: how this newly approved medication fits into the dermatologists’ ever-growing toolbox aimed at clearing skin disease and restoring quality of life.
Self-injectable biologic therapy
Secukinumab is a first-in-class, novel biologic therapy for moderate-to-severe psoriasis in adults. The FDA approved Secukinumab in January 2015. Patients self-inject this systemic medication once weekly for the first five injections and once monthly thereafter.
“It works by blocking [interleukin] IL-17. In this regard, it is a brand new mechanism of action that will be employed by follow-on drugs in the coming years,” said Bruce Strober, M.D., Ph.D., who led the panel discussion and is associate professor and vice chair at the University of Connecticut School of Medicine. “Based on clinical trials data, secukinumab, to date, offers the highest level of clinical response when compared to other FDA-approved self-injectable biologic therapies.”
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Attention has shifted to targeting cytokines versus affecting T-cells directly. And the cytokine approach has been much more successful, according to Craig Leonardi, M.D., clinical professor of dermatology at St. Louis University, St. Louis, Mo., and a MauiDerm panel member.
Dr. Leonardi said that dermatologists can understand secukinumab’s mechanism of action by reading the results of two phase 3 trials published July 24 in the New England Journal of Medicine. The paper includes data on the 150mg and 300mg doses of secukinumab compared to the 50mg dose of etanercept. Among the findings: secukinumab patients respond in approximately three weeks versus etanercept patients in approximately seven weeks, according to Dr. Leonardi.
“I generally see my [psoriasis] patients back at one month. With a drug like [secukinumab], you’re likely to understand at that visit whether the drug is going to achieve results you expect,” Dr. Leonardi said.
Researchers found the proportion of patients who met the criterion for PASI 75 at week 12 was higher with each secukinumab dose than with placebo or etanercept. In one study, the rates were 81.6% with 300mg of secukinumab, 71.6% with 150mg of secukinumab, and 4.5% with placebo.
The second study showed 77.1% with 300mg of secukinumab, 67.0% with 150mg of secukinumab, 44.0% with etanercept and 4.9% with placebo, according to the study’s abstract.
Researchers also found that the proportion of patients with a response of 0 or 1 (“clear or almost clear”) on the modified investigator's global assessment at week 12 was higher with each secukinumab dose than with placebo or etanercept. In the study comparing the two psoriasis drugs, rates were 62.5% with 300mg of secukinumab, 51.1% with 150mg of secukinumab, 27.2% with etanercept, and 2.8% with placebo. Infection rates were similar between secukinumab and etanercept, and higher than with placebo.