Secukinumab Improves Moderate-to-Severe Hidradenitis Suppurativa Symptoms

Moderate-to-severe hidradenitis suppurativa signs and symptoms are rapidly and safely improved with secukinumab every 2 weeks up to 52 weeks, according to study findings published in The Lancet.

Researchers conducted identical randomized, double-blind, placebo-controlled, multicenter phase 3 trials, SUNSHINE (ClinicalTrials.gov Identifier: NCT03713619) and SUNRISE (ClinicalTrials.gov Identifier: NCT03713632) in 40 countries across 219 primary sites from February 2019 to June 2021. Study participants (78% White, 8% Black) were aged 18 years and older (32% aged under 30 years; <2% aged 65 years and older), had moderate-to-severe hidradenitis suppurativa for at least 1 year, and received daily topical over-the-counter antiseptics on affected areas.

Participants with at least 20 fistulae at baseline or ongoing active conditions requiring treatment with systemic biologic immunomodulating treatment, live vaccines, or other investigational treatments were excluded. The primary outcome was the proportion of participants with hidradenitis suppurativa clinical response.

Participants in both trials were randomly assigned in a 1:1:1 fashion to receive either subcutaneous secukinumab 300 mg every 2 weeks, subcutaneous secukinumab 300 mg every 4 weeks, or subcutaneous placebo. Hidradenitis suppurativa clinical response was calculated by counting draining fistulae, total fistulae, inflammatory nodules, abscesses, and lesions in the affected areas. The presence of adverse events and serious adverse events were used to evaluate safety. Use of antibiotics for increases in abscess and inflammatory nodule count or single lesion interventions, including intralesional steroid administration or incision and drainage, was permitted for the treatment of worsening disease severity.

A total of 24% of all participants had previously received biologic therapy.

There were 304 women (56%) and 237 men (44%) in the SUNSHINE trial (mean age, 36.1±11.7 years), of whom 181 (33%) were in the secukinumab every 2 weeks group, 180 (33%) were in the secukinumab every 4 weeks group, and 180 (33%) were in the placebo group.

More participants in the every 2 weeks group had a hidradenitis suppurativa clinical response vs the placebo group (rounded average number of patients with response in 100 imputations, 81.5 of 181 patients [45%] vs 60.7 of 180 patients [34%], respectively; odds ratio (OR), 1.8; 95% CI, 1.1-2.7; P =.007). There was no significant difference in hidradenitis suppurativa clinical response with participants in the secuhidradenitis suppurativakinumab every 4 weeks group (75.2 of 180 participants [42%]) vs those in the placebo group (OR, 1.5; 95% CI, 1.0-2.3; P =.042).

Percentage change from baseline in abscess and inflammatory nodule count at week 16 was better in the every 2 weeks group vs placebo group (-46.8% [standard error {SE}, 3.3] vs -24.3% [SE, 4.3], respectively). Abscess and inflammatory nodule count at week 16 was not significantly improved in the secukinumab every 4 weeks group vs placebo. In the every 2 week group, significantly fewer participants had flares vs placebo group across week 16.

There were 306 women (56%) and 237 men (44%) in the SUNRISE trial (mean age 36.3±11.4 years), of whom 180 (33%) were in the secukinumab every 2 weeks group, 180 (33%) in the secukinumab every 4 weeks group, and 183 (34%) in the placebo group. More participants in the every 2 weeks group had more severe disease than in the other groups.

Researchers found significantly more participants in the every 2 weeks group vs placebo group had a hidradenitis suppurativa clinical response (76.2 of 180 [42%] vs 57.1 of 183 [31%], respectively); OR, 1.6; 95% CI, 1.1-2.6; P =.015). They noted significantly more participants in the every 4 weeks group had a hidradenitis suppurativa clinical response (83.1 of 180 [46%]) vs placebo group (OR, 1.9; 95% CI, 1.2-3.0; P =.0022).

Percentage change from baseline in abscess and inflammatory nodule count at week 16 was better in the every 2 weeks group vs placebo group (-39.3% [SE, 4.4] vs -22.4% [SE, 4.8], respectively). Abscess and inflammatory nodule count at week 16 vs placebo was significantly improved in the secukinumab every 4 weeks group (-45.5% [SE, 4.1] vs -22.4% [SE, 4.8], respectively). In the every 2 week group, there was no significant difference in flares vs the placebo group.

Study limitations include imbalance of disease severity between treatment groups at baseline, high placebo response rates, and a low number of Black participants.

Researchers conclude, “The clinical efficacy at week 16 was superior to placebo in both the SUNSHINE and SUNRISE trials for secukinumab administered every 2 weeks and was superior to placebo only in the SUNRISE trial for secukinumab dosed every 4 weeks.”

Disclosure: This research was supported by Novartis Pharma. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.