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
Background: Hidradenitis suppurativa (HS) is a chronic, recurrent, inflammatory skin disease with frequent comorbidities of painand depression. Adalimumab treatment for 16 weeks improved HS lesions significantly versus placebo (NCT00918255).Objective: The relationship between pain and depressive symptoms and the effects of adalimumab on each was examined in this post hoc analysis.Methods: Patients with moderate to severe HS (N=154) were randomized 1:1:1 to adalimumab 40 mg weekly (ew), adalimumab 40 mg every other week (eow), or placebo. Skin pain was assessed using a visual analog scale (VAS; 0–100 mm). Depressive symptoms were assessed using the 9-item Patient Health Questionnaire (PHQ-9; score ≥10 indicative of depression).Results: At baseline, overall mean±SD pain VAS was 54.3±26.5 mm and 41.8% of patients had PHQ-9 scores ≥10. At baseline, VAS pain scores (mean±SD) were significantly higher (P<0.001) for patients with PHQ-9 scores ≥10 (63.9±23.3) versus <10 (47.4±26.7). At Week 16, clinically relevant pain reduction 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 reach statistical significance. In patients with high baseline pain (≥median VAS score), adalimumab ew significantly decreased depressivesymptoms versus placebo (PHQ-9 scores, –34.03% vs +2.26%; P<0.01).Conclusion: Patients with moderate to severe HS had a high degree of pain and depressive symptoms at baseline. Adalimumabtherapy was associated with decreased pain and depressive symptoms compared to baseline.