Novartis announced January 15 that the FDA has approved secukinumab (Cosentyx, Novartis) for psoriatic arthritis (PsA) and active ankylosing spondylitis. The announcement comes a year after the FDA’s approval for secukinumab for treatment of adults with moderate to severe psoriasis. The drug is the only IL-17A antagonist approved for all three indications. learn more
Novartis announced January 15 that the FDA has approved secukinumab (Cosentyx, Novartis) for psoriatic arthritis (PsA) and active ankylosing spondylitis. The announcement comes a year after the FDA’s approval for secukinumab for treatment of adults with moderate to severe psoriasis. The drug is the only IL-17A antagonist approved for all three indications.
“[Secukinumab] is an outstanding treatment for patients with moderate-to-severe psoriasis; this new FDA approval now allows dermatologists and rheumatologists to treat their psoriasis patients with joint pain and inflammation with this same medication,” Andrew Blauvelt, M.D., M.B.A., president of the Oregon Medical Research Center, Portland, Ore., told Dermatology Times. Dr. Blauvelt is a consultant and Cosentyx clinical trial investigator for the psoriasis program at Novartis Pharmaceuticals Corporation.
The biologic was more effective than placebo in a phase 3 study of 606 adults with psoriatic arthritis. Researchers of the study randomly assigned subjects to receive intravenous secukinumab (at a dose of 10 mg per kilogram) at zero, two and four weeks, followed by subcutaneous secukinumab at a dose of either 150 mg or 75 mg every four weeks, or placebo.1
American College of Rheumatology 20 (ACR20) response rates at week 24 were 50% in the group receiving secukinumab at doses of 150 mg; 50.5% in the75 mg secukinumab group; and 17.3% in the placebo group. Those on the active drug also had significantly less joint structural damage than subjects on placebo.
Candida and other infections were more common in the secukinumab groups.
“Throughout the study (mean secukinumab exposure, 438.5 days; mean placebo exposure, 128.5 days), four patients in the secukinumab groups had a stroke … and two had a myocardial infarction …, as compared with no patients in the placebo group,” according to the study’s abstract. “The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use.”
In another study, funded by Novartis, researchers reported on a phase 3 double-blind, placebo-controlled study of patients with psoriatic arthritis at 76 centers around the world.2 In the study of nearly 400 adults, they found subcutaneous secukinumab 300 mg and 150 mg improved the signs and symptoms of psoriatic arthritis.
The FDA’s approvals for both psoriatic arthritis and active ankylosing spondylitis were based on the outcomes of four phase 3 studies, including more than 1,500 patients.
Steven R. Feldman, M.D., Ph.D.Dermatologist Steven R. Feldman, M.D., Ph.D., professor of dermatology, Wake Forest Baptist Medical Center, Winston-Salem, N.C., says that he treats psoriasis with secukinumab, and many of those patients also have psoriatic arthritis. Dr. Feldman hasn’t changed his approach since secukinumab was approved for psoriatic arthritis; rather, he’s continuing to do what he has for some time.
“There were published data showing [secukinumab] was effective for PsA long before the FDA approved the indication. I practice based on the evidence, not the indications listed in the package insert,” Dr. Feldman says.
While it may be too early to predict outcomes, Dr. Feldman says he is optimistic about secukinumab for patients with psoriasis and psoriatic arthritis.
“[Secukinumab] seems to be the most potent treatment we have for psoriasis,” Dr. Feldman says. “I hope that holds up over the long term. It also appears very safe so far; I hope that holds up over the long term, too.”
Colby Evans, M.D.Colby Evans, M.D., a dermatologist who practices in Austin, Texas, and is chair of the National Psoriasis Foundation Board of Directors, tells Dermatology Times that he has used secukinumab in patients with both psoriasis and PsA.
“I have definitely seen it help the joints, as well as the skin, so I was not surprised to hear that it has been approved for PsA,” Dr. Evans says.
But he says that the approval hasn’t changed his practice patterns much. Secukinumab is a useful tool for the treatment of psoriasis, according to Dr. Evans.
“When the patient has some arthritis, then I see if the biologic I have chosen helps it. If it does not help, or if I suspect ongoing joint damage, I would generally seek the help of a rheumatologist,” Dr. Evans says. “I do not think the new indication for PsA has much changed my practice, since I was already using [secukinumab] for patients with arthritis. It does increase my confidence in using it in that setting, and it may help with coverage now that is approved for both conditions.”
Dr. Evans says he hopes secukinumab helps dermatologists with the most severely affected patients and those who have failed traditional therapy and anti-TNF inhibitors.
“It is also my hope and my expectation that it will become more accessible on formularies as time passes,” Dr. Evans says.
Dr. Feldman has received research, teaching and consulting support from Novartis and from companies with products for psoriasis, including Janssen, Celgene, Abbvie, Pfizer, Amgen, Galderma, Mylan, National Biological Corporation, Psoriashield, Boehringer Ingelheim and Merck.
Dr. Evans speaks for Celgene and Abbvie, writes for About.com and has attended advisory boards for Janssen.
1. Mease PJ, Mcinnes IB, Kirkham B, et al. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015;373(14):1329-39.
2. Mcinnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386(9999):1137-46.