Improvement in Hidradenitis Suppurativa and quality of life in patients treated with adalimumab: Real‐world results from the HARMONY Study

Background Hidradenitis suppurativa (HS), a chronic, recurrent, debilitating skin disease, is characterized by painful, inflammatory, subcutaneous lesions of the axilla, inguinal and anogenital regions. Overall prevalence of HS is ˜1%, and the impact of disease on patient quality of life (QoL) and healthcare resource utilization (HRU) is high. Objectives To estimate the real‐world effectiveness of adalimumab (Humira®) treatment in patients with moderate‐to‐severe HS on disease severity, pain, QoL, work productivity and HRU. Methods HARMONY (Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients – a Multi‐cOuNtry studY in Real Life Setting) is a multicentre, postmarketing observational study in adult patients with moderate‐to‐severe HS. Disease severity and QoL parameters were evaluated using validated measures at 12‐week intervals over 52 weeks of treatment. The primary endpoint was the proportion of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR: ≥50% reduction in abscess and inflammatory nodule count, with no increase in abscess and draining fistula counts relative to baseline) at 12 weeks. Secondary endpoints were HiSCR at 24, 36 and 52 weeks and changes in QoL parameters and work productivity assessments. Analyses were conducted using as‐observed data. Results The proportion of patients reaching the primary HiSCR endpoint was 70.2% (n = 132/188 enrolled) and remained ≥70% until study completion. There were statistically significant (P