Adalimumab effective in moderate to severe hidradenitis suppurativa: JAMA study

The study is published in the JAMA Network.

Surgery is a mainstay in the management of hidradenitis suppurativa (HS). Adalimumab is the first drug approved for hidradenitis suppurativa.

Falk G. Bechara and colleagues investigated the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing.

The Safety and Efficacy of Adalimumab for Hidradenitis Suppurativa Peri-Surgically (SHARPS) trial was a phase 4, randomized, double-blind, placebo-controlled study of adalimumab in conjunction with surgery.

Overall, 103 patients were randomized to adalimumab and 103 to matching placebo. Patients were enrolled and those eligible, aged 18-65 years had moderate to severe hidradenitis suppurativa that required radical surgery in an axillary or inguinal region and had 2 other anatomical regions affected, with 1 or more regions at Hurley stage II or III.

Patients were randomized 1:1 to receive continuous adalimumab, 40 mg, or placebo during presurgery (12 weeks), perioperative (2 weeks), and postoperative (10 weeks) periods. Analysis was thereafter conducted.

It was observed that among all patients, 51% (n = 106) were women, 94% (n = 193) were White, and the mean (SD) age was 37.6 (11.3) years. At week 12, significantly more patients receiving adalimumab (49 of 103 [48%]) vs placebo (35 of 103 [34%]; P = .049) achieved hidradenitis suppurativa clinical response across all body regions (treatment difference, 14% [95% CI, 0%-27%]).

Treatment-emergent adverse events were reported in 74 of 103 patients (72%) and 69 of 103 patients (67%) in the adalimumab and placebo groups, respectively. No increased risk of postoperative wound infection, complication, or hemorrhage was observed with adalimumab vs placebo. Two deaths occurred in the adalimumab group; neither was considered as having a reasonable possibility of relationship to study drug.

As a result, the authors concluded that adalimumab was efficacious in conjunction with wide-excision surgery followed by secondary intention healing, with no need to interrupt treatment prior to surgery.

Furthermore, these data support further investigation of adalimumab as an adjuvant therapy to surgery in patients with moderate to severe hidradenitis suppurativa.

For further reference log in to:

Bechara FG, Podda M, Prens EP, et al. Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: The SHARPS Randomized Clinical Trial. JAMA Surg. Published online August 18, 2021. doi:10.1001/jamasurg.2021.3655