Window of Opportunity and Predictors of Sustained Remission in Patients with Hidradenitis Suppurativa Treated with Adalimumab: A 540-Patient Cohort Study

Abstract

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease. Predicting responses of “prolonged disease-free remission” to biological therapy is essential for identifying a “window of opportunity” for disease modification. A retrospective multicenter cohort study (2015–2023) of 540 patients with HS treated with adalimumab (ADA) was performed. A super-response to ADA (ADA-SR; ADA super-responders) was defined as sustained complete remission (absence of nodules, abscesses, and inflamed or draining tunnels) for ≥ 12 months leading to drug discontinuation. Predictors were analyzed using multivariable Cox regression. Clinically interpretable thresholds were derived post hoc via maximally selected log-rank statistics. Of the 540 patients, 19 (3.5%) were identified as ADA-SR. Median [interquartile range (IQR)] overall ADA survival was 56.2 (51.15–80.25) months, while the median time to ADA discontinuation in ADA-SR was 18.6 (IQR 23.3–41) months. After discontinuation, six of the 19 ADA-SR patients (31.6%) experienced relapse during follow-up; only one required the reintroduction of biologic therapy. ADA-SR patients demonstrated distinct clinical, demographic, and therapeutic profiles. Independent predictors of sustained remission included lower body mass index (BMI < 29 kg/m2), shorter time from disease onset to biologic initiation (within 3 years), and lower baseline tunnel burden (< 3 tunnels). Lower BMI, early biologic intervention, and a limited baseline burden of tunnels are key predictors for achieving sustained remission off-drug, supporting a limited window of opportunity in HS. Graphical abstract available for this article. Hidradenitis suppurativa (HS) is a chronic skin condition that can be painful and difficult to treat. The biologic adalimumab (ADA) is an effective therapy for many patients, but only a few achieve complete and lasting remission that allows treatment to be stopped. This study focused on identifying which patients are most likely to reach this level of response, often called a “super-response,” and not on examining reasons for treatment failure. Real-world medical records from 540 adults with moderate-to-severe HS who were treated with ADA in Spain between 2015 and 2023 were reviewed. Patients were grouped based on whether they achieved complete remission and stopped ADA, continued treatment, or stopped due to lack of response. Patient characteristics, disease severity, body weight, and how early treatment was started were analyzed to identify factors linked to complete remission. Only 19 patients (3.5%) achieved complete and sustained remission that allowed ADA discontinuation. These patients generally had a lower body mass index, started biologic treatment earlier after disease onset, and had fewer inflammatory tunnels at the beginning of therapy. Early treatment, particularly within the first 3 years of disease, was strongly associated with better outcomes. Most patients who stopped ADA due to remission remained stable during follow-up. Defining the clinical characteristics of the “window of opportunity” is crucial in order to identify patients in whom early ADA intervention can reverse disease progression and prevent permanent scarring, addressing a significant gap in current HS management.