Cosentyx sustains hidradenitis suppurativa improvement up to 1 year
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In two phase 3 trials, patients with moderate to severe hidradenitis suppurativa taking Cosentyx continued to improve beyond the primary endpoint analysis and up to 52 weeks, Novartis announced in a press release.
Published in The Lancet, SUNSHINE and SUNRISE comprise the largest phase 3 program in hidradenitis suppurativa (HS) with a combined total of 1,000 patients and 40 countries, according to the release.
Both multicenter, double-blind, placebo-controlled, randomized, parallel-group studies evaluated Cosentyx (secukinumab), the first and only human biologic that directly inhibits interleukin-17A for the treatment of moderate to severe HS.
“HS is complex, painful, hard to treat and impacts patients’ quality of life at very high levels,” Alexa B. Kimball, MD, MPH, lead investigator of the trials, investigator at Beth Israel Deaconess Medical Center and professor of dermatology at Harvard Medical School, said in the release. “These results build on the positive findings shared last year, providing additional promising data about the long-term efficacy and safety of Cosentyx in HS.”
Results showed that those treated with secukinumab 300 mg, dosed every 2 weeks, achieved a significantly higher HS clinical response by week 16 compared with placebo-treated patients in both SUNSHINE (45% vs. 33.7%; P = .007) and SUNRISE trials (42.3% vs. 31.2%; P = 0.0149). By week 52, more than 55% of patients treated with the study drug achieved HS clinical response, surpassing the program’s primary endpoints. Overall, more than 60% of patients were free of HS flares and more than 50% experienced a reduction in pain by week 52.
In addition, safety data was consistent with the study drug’s “well established” profile with no new signals presented, according to the release.
Having submitted these results to the regulatory authorities in Europe and the United States, Novartis anticipates a decision in 2023.
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