Adalimumab With Surgery in Moderate to Severe Hidradenitis Suppurativa JAMA Surgery

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• Patients with moderate or severe hidradenitis suppurativa (HS) requiring radical surgery in the axilla or inguinal area were randomized to receive adalimumab or placebo before and after surgery. HS clinical response at week 12 was more likely in those treated with adalimumab compared with placebo. Quality of life, symptoms, and skin pain were also improved with adalimumab versus placebo. The adverse events seen with adalimumab were similar to prior studies, with no new safety signals identified. Notably, there was no increased risk of postoperative infection or other complications seen in adalimumab-treated patients.

• Adalimumab is effective and safe to continue in the pre-, peri-, and postoperative period in patients with HS undergoing radical excisional surgery with secondary intention healing. Treatment interruption around the time of surgery is not necessary.

–  Caroline K. Crabtree, MD

Adalimumab With Surgery in Moderate to Severe Hidradenitis Suppurativa

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Importance

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

Objective

To investigate the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing.

Design, Setting, and Participants

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. Patients were enrolled in 45 sites across 20 countries from July 18, 2016, to February 2, 2019, with the last patient visit on October 16, 2019. Eligible patients (aged 18-65 years) had moderate to severe HS 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. Analysis was conducted in November 2019.

Interventions

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.

Main Outcomes and Measures

The primary end point was the proportion of patients achieving HS clinical response across all body regions at week 12.

Results

Overall, 103 patients were randomized to adalimumab and 103 to matching placebo. 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 HS 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.

Conclusions and Relevance

Adalimumab was efficacious in conjunction with wide-excision surgery followed by secondary intention healing, with no need to interrupt treatment prior to surgery. These data support further investigation of adalimumab as an adjuvant therapy to surgery in patients with moderate to severe HS.

Trial Registration

ClinicalTrials.gov Identifier: NCT02808975.

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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