1. Adalimumab was efficacious when used simultaneously with wide-excision surgery for treatment of moderate to severe hidradenitis suppurativa (HS).
Evidence Rating Level: 1 (Excellent)
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that affects the hair follicles, and is characterized by painful nodules, abscesses, scarring, and tissue destruction. It usually occurs in the anogenital, axillary, and inguinal areas. Wide-excision surgery is the preferred treatment for this condition, due to its low recurrence rate. However, surgery is often done on the most serious lesions, whereas anti-inflammatory treatments may be used to treat other lesions on the body. The drug adalimumab is indicated for moderate to severe HS, and observational studies have demonstrated that using adalimumab simultaneously with surgery may lead to improved outcomes. The purpose of this phase 4, multi-centre randomized controlled trial is to further explore the efficacy and safety of adalimumab when used alongside surgery for HS. 206 patients were randomized evenly to receive either adalimumab or a placebo, starting from 12 weeks pre-surgery until 10 weeks post-surgery (beginning with 160 mg at week 0, decreasing to 80 mg at week 2, and finally 40 mg from then on). The primary outcome (assessed at 12 weeks post-surgery) was the number of patients achieving an HS clinical response (HiSCR), which is a 50% or greater reduction in total abscess and inflammatory nodule (AN) count, and no increase in abscess and draining fistula count, for all areas of the body. The results showed that the proportion of patients attaining an HiSCR was significantly higher in the adalimumab group than the placebo (treatment difference 14%, 95% CI 0-27%, p = 0.49). Additionally, the proportion of patients achieving an HiSCR other than at the surgical site was not significantly higher, at 12 weeks (treatment difference 13%, 95% CI -1 to 26%, p = 0.07), but was significantly higher at 24 weeks (treatment difference 20%, 95% CI 7-34%, p = 0.003). As well, the percentage of treatment-emergent and serious adverse effects was similar between both groups. Overall, adalimumab was shown to be an efficacious and safe drug to be used in conjunction with surgical treatment for moderate to severe HS cases.
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