Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa

Abstract

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 PARTICIPANTSThe 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 MEASURESThe 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 RELEVANCEAdalimumab 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.

Biologics and small molecule inhibitors for hidradenitis suppurativa

“…A Phase 4 trial, the Safety and Efficacy of Adalimumab for Hidradenitis Suppurativa Peri-Surgically (SHARPS) trial, included 206 patients and found that adalimumab was efficacious in conjunction with wide-excision surgery, and there was no increased risk of adverse events or postoperative complications. 6 This study supports that there is no need to interrupt adalimumab treatment before or post HS surgery.…”

Surgical management of hidradenitis suppurativa: A review of techniques, data, and future directions

“…There was no increased rate of postoperative wound infection, surgical complication, or hemorrhage between the two groups. This study, the most robust of its kind, supports that adalimumab use in the perioperative setting may indeed be safe and efficacious, thus supporting that no cessation of adalimumab is necessary before surgery 27 …”

“…This study, the most robust of its kind, supports that adalimumab use in the perioperative setting may indeed be safe and efficacious, thus supporting that no cessation of adalimumab is necessary before surgery. 27 Further investigation with similar studies is still required for other biologics to determine the appropriate timing of holding the medications, or if this is necessary at all. Very few studies report what, if any, perioperative medication changes have been made and more importantly, the timing of these changes.…”

Real‐world safety and effectiveness of adalimumab in patients with hidradenitis suppurativa: 12‐week interim analysis of post‐marketing surveillance in Japan

“…Pharmacological treatment includes topical treatment (clindamycin), systemic antibiotics (tetracycline, clindamycin‐rifampicin), anti‐inflammatory agents (corticosteroids), and biologics (anti‐TNF, ustekinumab). Combination therapy with a biologic, including adalimumab, and surgery has been shown to be effective 40–45 . The majority of patients (84.3%) in this study had received pharmacological treatment for HS prior to adalimumab administration.…”

“…Combination therapy with a biologic, including adalimumab, and surgery has been shown to be effective. [40][41][42][43][44][45] The majority of patients (84.3%) in this study had received pharmacological treat-…”