Results of 2 phase 3 clinical trials demonstrate better response rate beyond the primary endpoint analysis at week 16 to more than 55 at week 55.
Long-term data from the pivotal SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) clinical trials, which evaluated secukinumab (Cosentyx) from Novartis in individuals with moderate-to-severe hidradenitis suppurativa (HS) were positive, and results were published in The Lancet.
Secukinumab is the first fully human biologic that inhibits interleukin-17A, associated with inflammation of psoriatic arthritis, moderate to severe plaque psoriasis, and more inflammatory diseases.
“HS is complex, painful, hard to treat and impacts patients’ quality of life at very high levels,” Alexa Kimball, MD, MPH, an investigator at Beth Israel Deaconess Medical Center in Massachusetts, said in a statement. “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.”
In the trials, the treatment response rates continued to improve beyond the primary endpoint analysis at week 16 to more than 55% of individuals achieving a HS Clinical Response (HiSCR) measure at week 52. Further, more than 60% of individuals at week 52 were free of flares.
More than 50% experienced a meaningful reduction in pain, which has been identified by individuals as the most burdensome symptom.
The safety results of the study were consistent with the well-established profile and no new signals were observed. Additionally, the long-term efficacy and safety results were seen among individuals who previously did not respond to biologic therapies.
The 2 trials were the largest phase 3 program in HS, with a combined enrollment of more than 1000 individuals in 40 countries. They were identical, multicenter, placebo-controlled, randomized trials that evaluated the short term, which was 16 weeks, and long term, which was 52 weeks, efficacy, safety, and tolerability of 2 dose regimens of secukinumab.
The results at week 16 demonstrated that a significantly higher proportion of individuals achieved a HiSCR when treated with secukinumab, in the 300-mg dosage, every 2 weeks after the loading doses compared with the placebo in the SUNSHINE trial at 45% and 33.7%, respectively, and the SUNRISE trials at 42.3% and 31.2%, respectively.
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.
At week 16, the study arm receiving secukinumab 300 mg, every 4 weeks after the loading doses, was superior to the placebo in achieving HiSCR in the SUNRISE study at 46.1% and 31.2%, respectively, though the same arm did not meet statistically significance in the SUNSHINE study at 41.8% and 33.7%.
“[Individuals] living with HS currently only have 1 approved treatment option for this disfiguring disease,” Angelika Jahreis, MD, PhD, FAAD, global head of Development Unit Immunology and Clinical Development Excellence at Novartis, said in the statement. “These data show that [secukinumab] could provide meaningful and long-lasting improvement of HS symptoms.”
The findings were submitted to regulatory authorities in Europe and the United States with decisions expected in 2023.
If approved, secukinumab would be the first interleukin-17 inhibitor for the treatment of moderate-to-severe HS.
Patients with hidradenitis suppurativa experienced sustained efficacy and symptom improvement at one year when treated with Novartis Cosentyx. Novartis. News release. February 4, 2023. Accessed February 8, 2023. https://www.novartis.com/news/media-releases/patients-hidradenitis-suppurativa-experienced-sustained-efficacy-and-symptom-improvement-one-year-when-treated-novartis-cosentyx