Novartis has reported data from two Phase III clinical trials where its Cosentyx (secukinumab) offered quick and lasting relief from moderate-to-severe hidradenitis suppurativa’s (HS) common clinical signs and symptoms.
Named SUNSHINE and SUNRISE, the multicentre, international, randomised, placebo-controlled, double-blind, parallel-group trials enrolled over 1,000 subjects with HS in 33 countries.
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They assessed the safety, efficacy, and tolerability of two dosing schedules of Cosentyx in adult patients for 16 weeks and up to 52 weeks.
Attaining HS Clinical Response (HiSCR) following 16 weeks of treatment was the primary endpoint for both of the trials.
According to the findings from the trials, a substantially increased proportion of subjects attained a HiSCR following treatment with 300mg Cosentyx given every two weeks, versus a placebo.
300mg Cosentyx given every four weeks was also found to be superior to a placebo in attaining HiSCR in the SUNRISE trial while it failed to meet statistical significance in the SUNSHINE trial.
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By GlobalDataCosentyx’s safety profile was in line with current indications and no new safety signals were reported in the trial.
Skin pain, as evaluated by the subject’s global assessment of the skin pain Numeric Rating Scale (NRS30), was the trials’ key secondary endpoint.
As per the pooled trial data, Cosentyx was found to be statistically superior compared to a placebo in lowering skin pain.
The company submitted these findings from the Phase III trials to the European regulatory agencies, with submission in the US planned for this year.
A fully human biologic, Cosentyx hinders interleukin-17A.
Novartis Medical Affairs Immunology global head Todd Fox said: “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 favourable 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 ten indications.”
In December last year, the company reported positive data from the Phase III KESTREL trial of Beovu (brolucizumab) in people with diabetic macular oedema-linked visual impairment.
