Novartis announced the results from two pivotal, Phase III studies, in which Cosentyx (secukinumab) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate-to-severe hidradenitis suppurativa (HS) with a favorable safety profile.
The data were presented as a late-breaking abstract at the 31st European Academy of Dermatology and Venereology (EADV) Congress.
HS is a chronic, inflammatory, debilitating skin condition with systemic comorbidities that has a profoundly negative effect on a patient’s quality of life and mental health. It is characterized by recurrent lumps or nodules under the skin that become inflamed and painful, breaking open to cause abscesses and sores. The chronic debilitating nature of HS makes it one of the most distressing dermatological conditions, with a considerable psychological burden on sufferers. Once considered a rare condition, it is now thought that as many as one in 100 people are affected by HS.
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.
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.
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.
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.
Since its initial approval in 2015, Cosentyx has helped more than 700,000 patients worldwide across five approved immune-mediated diseases, with the goal of preventing disease progression across even more immunological conditions in the future while demonstrating sustained treatment efficacy and safety.
