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The results of two large phase 3 clinical trials suggest that the drug secukinumab (Novartis) is a remarkably effective treatment for moderate-to-severe plaque psoriasis.
The results of two large phase 3 clinical trials suggest that the drug secukinumab (Novartis) is a remarkably effective treatment for moderate-to-severe plaque psoriasis.
Secukinumab is a laboratory-engineered antibody that targets interleukin-17A, a pro-inflammatory protein linked to psoriasis.
In one trial, doctors randomly administered the injectable to two-thirds of the 738 psoriasis patients involved. They received a weekly dose of either 300 mg or 150 mg for five weeks, then every four weeks thereafter. The remaining third received a placebo.
Improvements of 75 percent on the Psoriasis Area and Severity Index (PASI 75) were seen at three months in 81.6 percent of the 300 mg patients, and in 71.6 percent of the 150 mg group. Only 4.5 percent of those randomized to placebo demonstrated that kind of improvement.
In the second study, doctors adminstered either 300 mg or 150 mg of secukinumab to half of a pool of 1,306 psoriasis patients, as in the first trial. Another quarter received etanercept (Enbrel, Amgen), one of the top treatments for psoriasis. The remaining quarter received a placebo. PASI 75 responses at three months were reported for 77.1 percent of the 300 mg group, 67 percent of the 150 mg patients, 44 percent of the etanercept group and 4.9 percent of the placebo patients.
Within 12 weeks, 80 percent of patients who received 300 mg of secukinumab experienced a 75 percent improvement in their psoriasis symptoms, compared with one of every 20 patients receiving placebo. About 59 percent of patients receiving the higher dose of secukinumab reported a 90 percent improvement in symptoms, and nearly 30 percent said their psoriasis cleared completely.
“This is great news for psoriasis patients,” co-author Mark Lebwohl, M.D., chairman of the department of dermatology at Mount Sinai’s Icahn School of Medicine in New York, tells Dermatology Times. “Secukinumab achieves levels of clearing not reported in the past - even in patients who failed other biologics and systemic therapies. It is a breakthrough in the treatment of psoriasis.”
The studies, published online July 9 in the New England Journal of Medicine, were funded by Novartis.