Cosentyx meets primary endpoint in psoriatic arthritis phase 3 trial
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Novartis announced that Cosentyx met its primary endpoint in a phase 3 trial of patients with psoriatic arthritis, according to a company press release.
In the study, the results of which were published in The Lancet, Cosentyx (secukinumab, Novartis), an interleukin-17A (IL-17A) inhibitor, was administered subcutaneously to 100 patients with psoriatic arthritis (PsA) at 300 mg, 100 patients at 150 mg and 99 patients at 75 mg. Additionally, 98 patients received a placebo.
In patients who received 150 mg or 300 mg secukinumab during 1 year of treatment, 64% met the American College of Rheumatology (ACR) 20 response criteria, and 44% of patients who received 300 mg and 39% of patients who received 150 mg met ACR50 criteria. The primary endpoint, ACR20 at week 24, was met in 54% of patients who received 300 mg and in 51% of patients who received 150 mg compared with 15% of patients who received placebo, indicating a significant difference, according to the researchers.
“Secukinumab is the first IL-17A inhibitor to show consistent efficacy through 1 year in psoriatic arthritis, psoriasis, and ankylosing spondylitis,” Vasant Narasimhan, MD, MPP, global head of development at Novartis Pharmaceuticals, said in the release. “Novartis has recently filed global regulatory submissions for secukinumab in both psoriatic arthritis and ankylosing spondylitis and will continue to work to bring this important advance to patients with these debilitating diseases.”
In the release, Novartis reported that the safety profile was similar to results seen in a larger cohort of patients with psoriasis, and the most common adverse events were upper-respiratory tract infections and the common cold.
References: www.novartis.com.
MicInnes IB, et al. Lancet. 2015; doi:10.1016/S0140-6736(15)61134-5.
Disclosure: The researchers report the study was funded by Novartis.