Adalimumab Adds to Surgery Benefits for Hidradenitis Suppurativa

Adalimumab (Humira) in addition to surgery for moderate to severe hidradenitis suppurativa (HS) significantly increased the rate of complete response versus surgery alone, a first-ever randomized trial showed.

After 12 weeks of preoperative treatment, 48% of the adalimumab group met criteria for clinical response across all body sites compared with 34% of those who had surgery and placebo. Adverse event rates were similar for the two treatment groups, and the adalimumab and placebo arms had similar rates of postoperative wound infection, complication, and hemorrhage, reported Falk G. Bechara, MD, of St. Josef Hospital and Ruhr-University Bochum in Germany, and co-authors in JAMA Surgery.

“The results of this study demonstrate that adalimumab is an effective and safe adjunctive therapy to surgery when continued during the perioperative and postoperative periods, improving systemic inflammation in patients undergoing wide-excision surgery followed by secondary intention healing,” the authors wrote. “Importantly, no increased risk of postoperative wound infection or complication was reported with adalimumab.”

“Furthermore, 12-week adalimumab treatment was efficacious at decreasing the inflammatory load and reducing the number of HS inflammatory lesions across all body regions presurgery and clinically meaningful decreases in patients’ worst skin pain due to HS, reductions in overall HS symptoms and effect, and improvements in quality of life were observed throughout the study with adalimumab,” they added.

The results may provide guidance regarding the best approach to treatment for HS patients who are surgical candidates, they noted.

Most patients with moderate (Hurley II) or severe (Hurley III) HS require surgical treatment to address extensive sinus tract, fistula, and/or tunnel formation, anatomic destruction, and contracted painful scarring, Bechara and co-authors said. Postoperative rates of recurrence range as high as 70%, depending on the type of procedure performed. Wide-excision surgery reduces the risk of recurrence, but patients might have additional lesions that require simultaneous anti-inflammatory treatment.

In 2015, the FDA made adalimumab the first approved therapy for HS, specifically for adults with moderate or severe disease. Subsequent case series and observational studies suggested that the immunomodulatory effects of adalimumab may augment results with surgery, the authors continued. To provide placebo-controlled data on concomitant use of adalimumab with surgery, investigators at 45 worldwide sites enrolled patients in the randomized placebo-controlled SHARPS trial.

Patients with moderate or severe HS who were candidates for surgery were randomized to adalimumab or placebo and began treatment during the presurgical period (weeks 0 to 12). Randomized treatment continued through the perioperative period (weeks 13 and 14) and then postoperatively to week 23.

All patients underwent wide excision of one axillary or inguinal region that contained at least one active HS lesion. Non-surgical sites had at least three abscesses and/or inflammatory nodules (ANs). The primary endpoint was HS clinical response at week 12, defined as at least a 50% reduction in AN count with no increase in abscesses or draining fistulas across all body regions.

The intention-to-treat (ITT) analysis included all 206 randomized patients, 165 of whom completed the 24-week study. The primary analysis yielded a statistically significant 14% absolute difference in HS score for the adalimumab arm (P=0.049). A sensitivity analysis that excluded patients who did not meet key lesion criteria at enrollment showed significant differences favoring adalimumab beginning at week 2 (P=0.008) and continuing to week 12 (P=0.01).

A secondary ITT analysis of clinical response excluding the surgical site showed a nonsignificant 13% absolute difference favoring adalimumab at 12 weeks (P=0.07), increasing to 20% at week 24 (P=0.003). The sensitivity analysis yielded absolute differences of 18% at week 12 (P=0.02) and 26% at week 24 (P<0.001).

The most commonly reported adverse events were nasopharyngitis, worsening HS, procedural pain, headache, arthralgia, and diarrhea. Rates were similar between treatment arms, with the exception of procedural pain and arthralgia, which were more common in the adalimumab arm but considered unrelated to the biologic agent in most cases, the authors noted.