Cosentyx shows clinically meaningful symptom improvements in patients with painful skin condition in pivotal Phase III trials: Novartis
Hidradenitis Suppurativa 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.
Basel: Novartis has announced the results from two pivotal, Phase III studies (SUNSHINE and SUNRISE), in which Cosentyx (secukinumab) has 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.
"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."
"We are excited to share these promising results showing the benefit of Cosentyx as a treatment that provides relief from common signs and symptoms, pain and flares for people living with HS, with a favorable safety profile. We hope to offer Cosentyx as a potential new treatment option as soon as possible to support this underserved patient community, as part of our ambition to expand Cosentyx to 10 indications," said Todd Fox, Global Head of Medical Affairs Immunology, Novartis. "Beyond Cosentyx, we are also committed to advancing research in HS and are currently exploring a number of treatments with various mechanisms of action with hopes to further address the ongoing unmet needs of people living with this disease."
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.
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.
