Reduction in pain scores and improvement in depressive symptoms in patients with hidradenitis suppurativa treated with adalimumab in a phase 2, randomized, placebo-controlled trial

Abstract

Hidradenitis suppurativa (HS) is a chronic, recurrent, inflammatory skin disease withfrequent comorbidities of painand depression. Adalimumab treatment for 16 weeks improved HS lesions significantly versus placebo(NCT00918255). The relationship between pain and depressive symptoms and the effects of adalimumab oneach was examined in this post hoc analysis. Patients with moderate to severe HS (N=154) were randomized 1:1:1 to adalimumab 40 mgweekly (ew), adalimumab 40 mg every other week (eow), or placebo. Skin pain was assessed using avisual analog scale (VAS; 0-100 mm). Depressive symptoms were assessed using the 9-item PatientHealth Questionnaire (PHQ-9; score ≥10 indicative of depression). At baseline, overall mean±SD pain VAS was 54.3±26.5 mm and 41.8% of patients had PHQ-9scores ≥10. At baseline, VAS pain scores (mean±SD) were significantly higher (P<0.001) for patientswith PHQ-9 scores ≥10 (63.9±23.3) versus <10 (47.4±26.7). At Week 16, clinically relevant painreduction was observed for ew-treated patients with baseline PHQ-9 score ≥10 (ew, 45.8%; eow,29.4%; placebo, 23.8%) and <10 (ew, 50.0%; eow, 37.9%; placebo, 29.6%), but did not reachstatistical significance. In patients with high baseline pain (≥median VAS score), adalimumab ewsignificantly decreased depressivesymptoms versus placebo (PHQ-9 scores, -34.03% vs +2.26%; P<0.01). Patients with moderate to severe HS had a high degree of pain and depressive symptomsat baseline. Adalimumabtherapy was associated with decreased pain and depressive symptoms compared to baseline.