A centre-based, ambulatory care concept for Hidradenitis suppurativa improves disease activity, burden, and patient satisfaction: results from the randomised controlled trial EsmAiL.

Abstract

Hidradenitis suppurativa is an inflammatory disease of the inverse skin regions that occurs particularly in young women and affects approximately 1% of the population. Outpatient care is often inadequate and usually cannot prevent progression. The aim of the EsmAiL trial was to evaluate whether an innovative care concept can decrease disease activity and burden, as well as improve patient satisfaction. EsmAiL was conducted as a two-arm, multicentre, prospective randomised controlled trial including 553 adults with HS. Inclusion criteria were a minimum of three inflammatory lesions and at least moderate impact of the disease on the quality of life. The control group (CG) remained in standard care, whereas the intervention group (IG) was treated according to a trial-specific, multimodal concept. Primary endpoint was the absolute change in the International Hidradenitis Suppurativa Severity Score System (IHS4). 279 patients were randomised to the IG and 274 to the CG. Of those, 377 attended final assessment after 12-month of intervention. Participants in the IG (n=203) achieved a mean improvement in the IHS4 of 9.3 points while the average decrease in the CG patients (n=174) amounted to 5.7 points (p=0.003). Patients receiving the new care concept also reported a significantly (p<0.001) higher decrease in pain, DLQI and HADS compared to changes in the CG. Patient satisfaction was also significantly higher in the IG than in the CG (p<0.001). The establishment of standardised treatment algorithms in so-called "acne inversa centres (AiZ)" in the ambulatory setting has a substantial, positive impact on the course of the disease and significantly improves patient satisfaction.