Patients with moderate to severe hidradenitis suppurativa (HS) treated with secukinumab demonstrate sustained efficacy and symptom improvement at one year, according to two new studies.
Published in The Lancet, long-term data from the SUNRISE and SUNSET Phase III trials show patients on the interleukin-17 inhibitor continued to improve beyond the primary endpoint analysis at Week 16 to Week 52, as evaluated by the HS Clinical Response (HiSCR) measure. The two identical, multicentre, randomized, placebo-controlled, double-blind studies evaluated more than 1,000 patients in 40 countries.
In both trials, patients aged 18 years and older were randomly assigned (1:1:1) to receive subcutaneous secukinumab 300 mg every 2 weeks, subcutaneous secukinumab 300 mg every 4 weeks, or subcutaneous placebo all via a 2 mL prefilled syringe in a double-dummy method. According to study parameters, the primary endpoint was defined as a decrease of 50% or more in abscess and inflammatory nodule count at week 16 with no increase in the number of abscesses or draining fistulae compared to baseline. Clinical response included evaluation of the number of abscesses, inflammatory nodules, draining fistulae, total fistulae, and other lesions in the hidradenitis suppurativa affected areas, the authors noted.
Analysis at Week 52 showed more than 60% of patients did not have any HS flares and more than 50% experienced a meaningful reduction in pain. The researchers reported no new safety signals.
“HS is complex, painful, hard to treat and impacts patients’ quality of life at very high levels,” said lead investigator Dr. Alexa B. Kimball in a press release. “These results build on the positive findings shared last year, providing additional promising data about the long-term efficacy and safety of [secukinumab] in HS. As a physician who frequently treats people living with HS, I see patients with tremendous need for new options that reduce symptoms, disability, pain, and flares.” Dr. Kimball is an investigator at Beth Israel Deaconess Medical Center in Boston and Professor of Dermatology at Harvard Medical School.