The efficacy and safety of adalimumab in conjunction with wide-excision surgery for the treatment of moderate to severe hidradenitis suppurativa (HS) found support in study data published in JAMA Surgery.
The Safety and Efficacy of Adalimumab for Hidradenitis Suppurativa Peri-Surgically (SHARPS) trial was a randomized, placebo-controlled study that enrolled patients with HS from 45 sites in 20 countries from July 18, 2016 to February 2, 2019. Eligible patients were aged 18 65 years and had moderate to severe HS, defined by the following characteristics: requiring “radical surgery” in an axillary or inguinal region; affecting at least 2 other anatomical regions; and with 1 or more regions in Hurley stage II or III. Patients were randomized 1:1 to receive continuous treatment with either placebo or 40 mg adalimumab during the presurgery (12 weeks), perioperative (2 weeks), and postoperative (10 weeks) periods. The primary endpoint was the percentage of patients achieving HS clinical response in all body regions at week 12 during the presurgery period.
A total of 206 patients were enrolled in the SHARPS trial: 103 to the adalimumab arm and 103 to the placebo arm. Among all patients, mean age was 37.6 ± 11.3 years; 51% were women; and 94% were White. Overall, 80% completed the 24-week study period. At week 12, the percentage of patients achieving clinical response across all body regions was significantly higher with adalimumab vs placebo (48% vs 34%; P =.049). Clinical response at week 24 was also more common in the adalimumab arm (difference: +20%; P =.003). Other outcomes were comparable between groups, including the percentage of patients who required less extensive surgery than the surgical plan or no surgery at week 12 (P =.75). Treatment-emergent adverse events were reported by 72% of the adalimumab group and 67% of the placebo group. In all, 4 patients in each group discontinued study drug due to adverse events.
The most common adverse events were nausea, worsening of HS, procedural pain, headache, arthralgia, and diarrhea. Frequency of these events was similar between study arms, although arthralgia and procedural pain were slightly more common with adalimumab. It was reported that 2 deaths occurred in the adalimumab group, but neither were considered study drug related. No increased risk of postoperative wound infection, complication, or hemorrhage was observed with adalimumab compared with placebo.
Results from the SHARPS study demonstrate the safety and efficacy of adalimumab as a component of presurgery HS treatment, the investigators believe. Global improvement in HS was higher with adalimumab compared with placebo, although secondary outcomes occurred with similar frequencies across study arms. Adalimumab was well-tolerated by patients.
As study limitations, investigators cited the short study period: the role of adalimumab in postoperative healing remains unexplored. In addition, only wide-excision surgery was assessed; other options for wound closure require further investigation.
“Adalimumab treatment was efficacious in conjunction with wide-excision surgery (followed by secondary intention healing) for moderate to severe HS, indicating no need to interrupt adalimumab treatment prior to surgery,” investigators concluded.
Disclosure: This research was supported by AbbVie. Please see the original reference for a full list of disclosures
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. 2021 Aug 18:e213655. doi:10.1001/jamasurg.2021.3655