Secukinumab Relieves HS Symptoms in Phase 3 Studies

Alexa B. Kimball, MD, MPH

Study results from 2 parallel trials—presented at the European Academy of Dermatology and Venerology (EADV) 2022 Congress—show symptom relief after treating hidradenitis suppurativa (HS) with secukinumab.

Secukinumab is an antibody that directly inhibits interleukin-17A, a cytokine known to affect psoriatic arthritis inflammation, plaque psoriasis, and several other disorders. The HS researchers in the phase 3 studies were led by Alexa B. Kimball, MD, MPH, professor of dermatology at Harvard Medical School and board member at Beth Israel Deaconess Medical Center.

“Hidradenitis suppurativa can cause intense pain, disability and anxiety, impacting many aspects of daily living,” Kimball said in a statement. “However, there are only limited treatment options available that can make a difference to people living with this debilitating disease.”

Research and Methods

The SUNSHINE and SUNRISE trials recruited 1048 total participants from 33 countries to evaluate the use of secukinumab over the course of 16 and 52 weeks, respectively. Kimball and colleagues used 2 dose regimens on 541 and 543 participants with moderate-to-severe HS in each respective trial.

Both phase 3 trials were parallel, randomized, double-blind, placebo-controlled studies, with 3 treatment arms:

• After 5 weekly loading doses, 300 mg of secukinumab after 2 weeks
• After 5 weekly loading doses, 300 mg taken every 4 weeks
• After 5 weekly doses of placebo, a placebo dose every 2 weeks

The investigators’ main endpoints in their research involved the identification of HS Clinical Response (HiSCR) following 16 weeks of secukinumab or placebo treatment. HiSCR was defined as a 50% decrease in abscess and inflammatory nodules (AN) count with no rise in the amount of abscesses or draining tunnels.

Their main secondary endpoints involved the number of participants with a flare up after 16 weeks of treatment, the number of participants with a rating of 30 in skin pain response by week 16, and identifying the percentage changes from baseline AN count.

Study Results

In both the SUNSHINE and SUNRISE studies, the investigators found that a larger proportion of participants with HS achieved HiSCR following 16 weeks of secukinumab treatment given every 2 weeks as opposed to those given the same timeframe in the placebo arm. The 2 trials saw 45.0% compared to 33.7% HiSCR (P = .0070) and 42.3% compared to 31.2% (P = .0149), respectively.

The investigators also found in their research that, in the data pooled from both trials, the secukinumab treatment dose provided every 2 weeks was demonstrated statistically superior to placebo in skin pain reduction.

In the SUNRISE trial, the secukinumab treatment every 4 weeks was identified as superior to the placebo regarding HiSCR, at 46.1% compared to 31.2% (P = .0022). However, they found that it did not achieve statistical significance in the SUNSHINE study, with 41.8% compared to 33.7% (P = .0418).

Looking to the future, the researchers “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,” said Todd Fox, the Global Head of Medical Affairs Immunology at Novartis.