Dermatologic therapy · 2020
Clinical selection criteria in new clinical trials of hidradenitis suppurativa: External validity and implications on the daily clinical practice.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Montero-Vilchez Trinidad, Salvador-Rodriguez Luis, Sanchez-Diaz Manuel, Cuenca-Barrales Carlos, Martinez-Lopez Antonio, Arias-Santiago Salvador, Molina-Leyva Alejandro
Аннотация
INTRODUCTION: There are an increasing number of biologic drugs in the pipeline for treating hidradenitis suppurativa (HS). Clinical trials for these drugs usually share the same clinical selection criteria.
OBJECTIVES: (a) To describe the clinical profile of HS patients receiving first-line biologic treatment in an HS clinic setting, (b) to assess how this population would meet clinical criteria to participate in a clinical trial, and (c) to assess treatment effectiveness at week 16 in eligible vs non-eligible patients.
METHODS: Prospective observational study. Patients were grouped according to their eligibility for clinical trials. The effectiveness of adalimumab was assessed by HiSCR, IHS4-category-change and a-50%-reduction on IHS4 at week 16.
RESULTS: Thirty-eight patients were included in the study: eight (21.05%) were eligible for clinical trials and 30 (78.95%) were not. The main reason for non-eligibility was not having an AN count ≥5. Both groups presented similar number of draining tunnels. Effectiveness at week 16 was lower in non-eligible than eligible patients when evaluated by HiSCR-response but similar if evaluated by the IHS4-category-change or the 50%-reduction in IHS4.
CONCLUSION: In our population, the external validity of current eligibility criteria for clinical trials is low. Most patients receiving adalimumab in real-life setting would not be eligible for clinical trials.
OBJECTIVES: (a) To describe the clinical profile of HS patients receiving first-line biologic treatment in an HS clinic setting, (b) to assess how this population would meet clinical criteria to participate in a clinical trial, and (c) to assess treatment effectiveness at week 16 in eligible vs non-eligible patients.
METHODS: Prospective observational study. Patients were grouped according to their eligibility for clinical trials. The effectiveness of adalimumab was assessed by HiSCR, IHS4-category-change and a-50%-reduction on IHS4 at week 16.
RESULTS: Thirty-eight patients were included in the study: eight (21.05%) were eligible for clinical trials and 30 (78.95%) were not. The main reason for non-eligibility was not having an AN count ≥5. Both groups presented similar number of draining tunnels. Effectiveness at week 16 was lower in non-eligible than eligible patients when evaluated by HiSCR-response but similar if evaluated by the IHS4-category-change or the 50%-reduction in IHS4.
CONCLUSION: In our population, the external validity of current eligibility criteria for clinical trials is low. Most patients receiving adalimumab in real-life setting would not be eligible for clinical trials.