Clinical selection criteria in new clinical trials of hidradenitis suppurativa: External validity and implications on the daily clinical practice.

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.