A prospective open-label clinical trial of efficacy of the every week administration of adalimumab in the treatment of hidradenitis suppurativa

Abstract

Background: Hidradenitis suppurativa (HS) is a debilitating disease refractory to treatment. As its impact on patients' quality of life is strong, it requires effective treatment.

Objectives: To evaluate the efficacy and safety of adalimumab using a higher dosage regimen for HS treatment and establish the recurrence-free interval after treatment discontinuation.

Material and methods: Patients with moderate to severe HS were treated with 80 mg adalimumab at baseline, followed by 40 mg every week for 24 weeks. Subsequently, patients entered an observational period for another 24 weeks. Clinical evaluation took place every 4 weeks during the study period. Sartorius scoring system was used as assessment tool regarding disease activity. At the same time points patients evaluated disease activity by Visual Analogue Scale (VAS). They completed a Dermatology Life Quality Index (DLQI) questionnaire at baseline and at weeks 24 and 48.

Results: Fifteen patients completed the study. Significant reduction in Sartorius score was obtained by week 24 with a marked improvement during the first month. Mean time to relapse was 11 weeks after treatment cessation, but even at the final visit Sartorius score was significantly lower than at baseline. VAS score and DLQI showed a significant decrease at week 24. There was significant worsening at week 48, however both scores remained significantly lower than baseline levels.

Conclusions: Our study data demonstrate the significant efficacy of the once weekly regimen, as well as its benefit regarding time to recurrence. However, the question if benefit outweighs the risk of a long-term anti-TNF-α antagonist's administration needs still to be answered.