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Cosentyx may help patients with psoriatic arthritis
Patients with psoriatic arthritis had improvements in skin and joint symptoms after treatment with Cosentyx, according to the results of a phase 3 study.
Researchers studied 606 patients with psoriatic arthritis, randomly assigned 1:1:1 to intravenous 10 mg/kg Cosentyx (secukinumab, Novartis) or placebo at weeks 0, 2 and 4, followed by either 75-mg or 150-mg secukinumab every 4 weeks or placebo. Depending on response, patients who received placebo were randomized to either 75-mg or 150-mg secukinumab at 16 or 24 weeks.
Patients were excluded in the presence of prior biologic drug therapy other than an anti-tumor necrosis factor-alpha (anti-TNF) agent, more than three previous attempts of treatments with anti-TNF agents, additional inflammatory diseases or active infection 2 weeks prior to randomization.
Patients met the Classification Criteria for Psoriatic Arthritis (CASPAR) and 53.6% had psoriasis on over 3% of body surface area, 53.5% had dactylitis and 61.4% had enthesitis. No prior treatment with anti-TNF agents occurred in 70.6% of patients, and 60.7% continued concurrent methotrexate therapy.
The proportion of patients with an American College of Rheumatology 20% response rate (ACR20) was greater in the 75-mg and 150-mg secukinumab groups compared to placebo. The Psoriasis Area and-Severity Index (PASI) 75 and 90 scores and the change in baseline Disease Activity Score in 28 Joints (DAS28) and the van der Heijde-modified total Sharp score (mTSS) were improved in two treatment groups compared to placebo.
An ACR20 response was reported by 54.5% of patients who had no history of anti-TNF treatment who received 150-mg secukinumab and in 55.6% of patients who received a 75-mg dose, compared to 17.5% of patients who received placebo. Among patients who had previous, inadequate response to anti-TNF treatment, 39% of patients who received 150 mg and 38.3% of patients who received 75 mg met an ACR20 response compared to 16.9% of patients who received placebo.
Adverse events through 16 weeks included nasopharyngitis, headache and upper respiratory tract infection and were more frequent among the treatment groups compared to placebo; one patient had a stroke. An additional three patients in the treatment group experienced a stroke after week 16 and one patient in the treatment group experienced myocardial infarction. Four of the six patients continued treatment with secukinumab. – by Shirley Pulawski
Disclosure: Mease reports the receipt of grants and personal fees from AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma. Please see the full study for a list of all other authors’ relevant financial disclosures.