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

Abstract

Background 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. Objective 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. Methods 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). Results 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). Conclusion 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.

Real‐world effectiveness and safety of the LAight‐therapy in patients with hidradenitis suppurativa

“…A trusting, positive, and stable relationship with healthcare providers leads to better adherence to treatment and better control of disease symptoms 34 . This might be the reason for the observation that the DLQI response to treatment with LAight appeared to be more rapid than the scores for disease activity (IHS4 and pain).…”

Drivers of disease severity and burden of hidradenitis suppurativa: a cross‐sectional analysis on 553 German patients

“…For all variables, the effect size was given with an associated 95% CI. The study size resulted from the sample size calculation of the EsmAiL-study 7 ; no separate sample size calculation was performed. The data were analyzed by the Institute of Medical Epidemiology, Biometry and Informatics of the Medical Faculty of the Martin Luther University Halle-Wittenberg as an independent institution.…”

“…For the initial assessment, physicians of several specialties were qualified to be so-called "screeners" who were trained in the usage of the intended HS classifications and survey instruments. To participate in EsmAiL, interested patients had to register with the study team and afterward received an appointment with one of the 15 trained screeners who collected the baseline data independently (see the publication of the results of the RCT "EsmAiL" for more details 7 ).…”

Real‐World‐Effektivität und Sicherheit der LAight‐Therapie bei Patienten mit Hidradenitis suppurativa

“…6,19 Eine vertrauensvolle, positive und stabile Beziehung zum betreuenden Behandler führt zu einer besseren Therapietreue und damit zu einer besseren Kontrolle der Krankheitssymptome. 34 Dies könnte der Grund für die Beobachtung sein, dass der DLQI schneller auf die Behandlung mit LAight anzusprechen scheint als die Endpunkte der Krankheitsaktivität (IHS4 und Schmerz). Außerdem impliziert dies, dass Patienten schneller eine Verbesserung der Lebensqualität erreichen, als sich die Auswirkungen auf die Krankheitssymptome zeigen.…”