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First IL-17A inhibitor approved in Japan for psoriasis, psoriatic arthritis

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Novartis announced the first approval of secukinumab for the treatment of psoriasis and psoriatic arthritis in Japan.

Secukinumab (Cosentyx, Novartis) is the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval for either indication in Japan, according to company press release. About 50% to 54% of the psoriatic arthritis patients enrolled in two phase 3 trials, FUTURE 1 and FUTURE 2, achieved a 20% reductions in symptoms based on the American College of Rheumatology (ACR) criteria. About 70% of study participants with psoriasis achieved clear or almost clear skin by week 16 of the study with 300 mg of secukinumab.

At the ACR meeting in November, researchers presented data from the two studies, which included 606 adults with moderate to severe psoriatic arthritis who were randomized to graduated, intravenous doses of secukinumab or placebo. Doses were given at baseline, week 2 and week 4, then every 4 weeks from week 8 through week 52. Sustained improvement in symptoms and inhibition of joint damage was reported, and the researchers said the drug was well tolerated through week 52.

The drug also underwent a random, double-blind, placebo-controlled study with 219 patients with ankylosing spondylitis. A 20% improvement in symptoms was achieved in 61.1% of patients compared to 27% of patients in the placebo group. Serious adverse events were reported in 5.5% of patients given 75 mg of secukinumab vs. 5.6% receiving 150 mg, compared to 4.1% in the placebo group.

References:

http://www.novartis.com/newsroom/media-releases/en/2014/1883568.shtml

Baeten DL. Paper #819. Presented at: American College of Rheumatology Annual Meeting; Nov. 14-19, 2014; Boston.

Mease PJ. Paper #953. Presented at: American College of Rheumatology Annual Meeting; Nov. 14-19, 2014; Boston.

Sieper J. Paper #536. Presented at: American College of Rheumatology Annual Meeting; Nov. 14-19, 2014; Boston.

Disclosure: See the study abstracts for a full list of all authors’ relevant financial disclosures.