HS Treatment Response Rates Continue to Improve with Secukinumab at Week 52

Newly released safety and efficacy data on Novartis’ secukinumab for hidradenitis suppurativa is published in The Lancet.

In two of the largest phase III clinical trials (SUNSHINE and SUNRISE) conducted in hidradenitis suppurativa (HS), secukinumab (Cosentyx; Novartis) treatment response rates continued to improve beyond the initial HS Clinical Response (HiSCR) analysis at week 16 to more than 55% at week 52, according to recent data published in The Lancet.1

The recent long-term data from the SUNSHINE2 (NCT03713619) and SUNRISE3 (NCT03713632) trials detailed more than 60% of patients were free of HS flares at week 52. More than 50% of patients also experienced a meaningful reduction in pain, which has been noted by patients as the most burdensome symptom of HS. Safety findings were consistent with the well-established safety profile of secukinumab, with no new signals. According to the data, long-term efficacy and safety results were also seen among patients who previously did not respond to biologic therapies. More than 1000 patients across 40 countries are enrolled between both trials.

"Hidradenitis suppurativa is one of the most challenging chronic, inflammatory conditions we treat as dermatologists. Much of this challenge comes from an immense patient burden consisting of severe and unpredictable disease flares, along with limited efficacious, targeted therapies. These data show that secukinumab treatment is associated with long-term disease control in a majority of subjects with moderate-to-severe HS after one year - a major real-world goal for HS patients - and they further suggest that secukinumab has the potential to be the first anti-IL-17 biologic therapy approved for this disease," said Raj Chovatiya, MD, PhD, assistant professor of dermatology and director of the Center for Eczema and Itch at the Northwestern University Feinberg School of Medicine in Chicago, Illinois, and a Dermatology Times® editorial advisory board member.

SUNSHINE and SUNRISE are identical, global phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies that evaluated the short-term (16 weeks) and long-term (up to 52 weeks) efficacy, safety, and tolerability of two dose regimens of secukinumab in adults with moderate-to-severe HS. Both SUNSHINE and SUNRISE achieved their initial primary endpoints of HiSCR defined as at least a 50% decrease in abscess and inflammatory nodule count with no increase in the number of abscesses and/or in the number of draining fistulae at week 16.

Secukinumab is the first and only fully human biologic that directly inhibits interleukin (IL)-17A, an important cytokine involved in the inflammation of psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. If approved by the US Food and Drug Administration (FDA), secukinumab will be the first and only IL-17 inhibitor approved for the treatment of moderate-to-severe HS.

Alexa B. Kimball, MD, MPH, lead investigator of the trials, investigator at Beth Israel Deaconess Medical Center Massachusetts, and professor of dermatology at Harvard Medical School noted that the newly published results demonstrate promising data for the long-term efficacy and safety of secukinumab for treating HS, and that patients desperately need a new treatment option that reduces symptoms, disability, pain, and flares.

Currently, adalimumab (Humira; AbbVie) is the only FDA-approved treatment for moderate-to-severe HS.

References

1. Patients with hidradenitis suppurativa experienced sustained efficacy and symptom improvement at one year when treated with Novartis Cosentyx. Novartis. Published February 3, 2023. Accessed February 3, 2023.

2. A study of efficacy and safety of two secukinumab dose regimens in subjects with moderate to severe hidradenitis suppurativa (HS)(SUNSHINE). Clinicaltrials.gov identifier: NCT03713619. Updated January 19, 2023. Accessed February 3, 2023. https://clinicaltrials.gov/ct2/show/NCT03713619?term=SUNSHINE&cond=Hidradenitis+Suppurativa&draw=2&rank=1

3. A study of efficacy and safety of two secukinumab dose regimens in subjects with moderate to severe hidradenitis suppurativa (HS) (SUNRISE). ClinicalTrials.gov Identifier: NCT03713632. Updated October 5, 2022. Accessed February 3, 2023. https://clinicaltrials.gov/ct2/show/NCT03713632?term=SUNRISE&cond=Hidradenitis+Suppurativa&draw=2&rank=1

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