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Improvement in Hidradenitis Suppurativa and quality of life in patients treated with adalimumab: Real-world results from the HARMONY Study.
Hafner, A; Ghislain, P D; Kovács, R; Batchelor, R; Katoulis, A C; Kirby, B; Banayan, H; Schonbrun, M.
Afiliación
  • Hafner A; Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
  • Ghislain PD; UCL St Luc, Brussels, Belgium.
  • Kovács R; Department of Dermatology and Allergology, University of Szeged, Szeged, Hungary.
  • Batchelor R; Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
  • Katoulis AC; Second Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, 'Attikon' General University Hospital, Athens, Greece.
  • Kirby B; Department of Dermatology, St Vincent's University Hospital and University College, Dublin, Ireland.
  • Banayan H; AbbVie Biopharmaceuticals Ltd, Hod Hasharon, Israel.
  • Schonbrun M; AbbVie Biopharmaceuticals Ltd, Hod Hasharon, Israel.
J Eur Acad Dermatol Venereol ; 35(11): 2277-2284, 2021 Nov.
Article en En | MEDLINE | ID: mdl-34320249
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 < 0.0001) reductions in worst and average skin pain. All of the QoL measures evaluated improved significantly (P < 0.0001) by 12 weeks of adalimumab treatment, as did work productivity assessments (P < 0.05), and there was a ˜50% decrease in HRU between baseline and week 52. Adalimumab was well tolerated. CONCLUSIONS: In this real-world setting, adalimumab treatment of moderate-to-severe HS resulted in decreased disease severity and improvements in QoL and productivity. Response to adalimumab was rapid (within 12 weeks) and sustained (52 weeks). No unexpected safety signals were reported.
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Calidad de Vida / Hidradenitis Supurativa Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Adult / Humans Idioma: En Revista: J Eur Acad Dermatol Venereol Asunto de la revista: DERMATOLOGIA / DOENCAS SEXUALMENTE TRANSMISSIVEIS Año: 2021 Tipo del documento: Article País de afiliación: Israel

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Calidad de Vida / Hidradenitis Supurativa Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Adult / Humans Idioma: En Revista: J Eur Acad Dermatol Venereol Asunto de la revista: DERMATOLOGIA / DOENCAS SEXUALMENTE TRANSMISSIVEIS Año: 2021 Tipo del documento: Article País de afiliación: Israel