Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials.- Novartis

The data were presented as a late-breaking abstract at the 31st European Academy of Dermatology and Venereology (EADV) Congress.

“Hidradenitis suppurativa can cause intense pain, disability and anxiety, impacting many aspects of daily living. However, there are only limited treatment options available that can make a difference to people living with this debilitating disease,” said Dr. Alexa B. Kimball, lead investigator of the trials, investigator at Beth Israel Deaconess Medical Center, and Professor of Dermatology, Harvard Medical School. “These efficacy and safety findings are promising for people living with HS, who are in urgent need of new treatment options.”

These Phase III data have been submitted to regulatory authorities in Europe and will be submitted to regulatory authorities in the United States this year, with the goal of bringing Cosentyx as a new treatment option to patients living with HS as soon as possible.

Novartis also plans to share the long-term results from the trials in 2023. Available data support the sustained efficacy over continuous treatment up to 52 weeks in patients with HS.

The trials assessed two Cosentyx dose regimens across 16-week (vs placebo) and 52-week treatment periods ,. Results showed a significantly higher proportion of patients achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) when treated with Cosentyx 300 mg, dosed every two weeks (after standard weekly loading doses), compared with placebo at Week 16 in both the SUNSHINE and SUNRISE trials (45.0% vs 33.7% [P=.0070] and 42.3% vs 31.2% [P=0.0149], respectively). Cosentyx 300 mg dosed every four weeks (after standard weekly loading doses) was superior to placebo for achieving HiSCR in the SUNRISE study (46.1% vs 31.2% [P=0.0022]), though did not meet statistical significance in the SUNSHINE study (41.8% vs 33.7% [P=0.0418]). HiSCR is defined as at least a 50% decrease in abscess and inflammatory nodule count with no increase in the number of abscesses and/or draining tunnels. The safety profile was consistent with that of Cosentyx in existing indications, and no new safety signals were observed in either dosing group.

A key secondary endpoint was skin pain , as measured by the patient’s global assessment of skin pain Numeric Rating Scale (NRS30). In data pooled from the two studies, the 300 mg dose of Cosentyx given every two weeks proved statistically superior to placebo in reducing skin pain, the most bothersome symptom of HS.