Viewpoint on the evaluation of severity and treatment effects in mild hidradenitis suppurativa: the cumulative IHS4 (IHS4-C).

Hidradenitis suppurativa (HS) is a chronic, recurrent and debilitating inflammatory skin disease, characterized by painful inflamed nodules, abscesses and tunnels in the skin folds. Up to 66% of HS patients can be classified as having mild disease. However, currently, most clinical trials are focusing on patients with moderate to severe disease, resulting in more available treatment options for this smaller group of patients. This difference in treatment options and lack of clinical trials for patients with mild HS has been noticed and additional focus on milder HS cases is requested. However, an important hurdle to overcome studying treatment efficacy in mild HS is an adequate treatment outcome. Patients with mild HS sometimes have no lesions due to waxing and waning of the disease. Furthermore, the difference in aim of a clinical trial for patients with mild disease should be taken into consideration. Where treatment of moderate to severe patients focusses on lowering the number of draining tunnels, abscesses and inflammatory nodules, in patient with mild disease, we focus on prevention of new lesions and progression to moderate and severe disease. This clinical characteristic of mild HS and difference in aim of clinical trials are the key challenges for efficacy measurement in mild HS. To overcome these challenges, we propose to measure the continuous international hidradenitis suppurativa severity score (IHS4) monthly and use the cumulative IHS4 score (IHS4-C) over all these visits as a primary outcome in clinical trials in patients with mild HS, to increase the probability to detect the inflammatory lesions with a temporary nature. We argue that this novel application of the IHS4, has the potential to better facilitate assessment of treatments or interventions in patients with mild HS and should be tested in future studies.

Adalimumab in conjunction with surgery compared with adalimumab monotherapy for hidradenitis suppurativa: A Randomized Controlled Trial in a real-world setting.

BACKGROUND: Adalimumab, the only biologic registered for hidradenitis suppurativa, shows clinical response in up to 60% of patients, leaving many patients in need for other treatment options such as surgery. OBJECTIVE: To compare the clinical effectiveness of adalimumab combined with surgery vs adalimumab monotherapy in patients with moderate to severe hidradenitis suppurativa. METHODS: A pragmatic Randomized Controlled Trial was performed from August 2018 to July 2022. Primary outcome was the difference in mean International Hidradenitis Suppurativa Severity Score System reduction after 12 months of treatment with the difference in mean Dermatology Life Quality Index reduction as a key secondary outcome. RESULTS: Thirty-one patients were included per arm. The mean International Hidradenitis Suppurativa Severity Score System at baseline was 23.9 ± 10.7 in the surgery group and 20.9 ± 16.4, in the monotherapy group. After 12 months of treatment the surgery group had a significantly greater reduction in International Hidradenitis Suppurativa Severity Score System compared with the monotherapy group (-19.1 ± 11.3 vs -7.8 ± 11.8, P < .001). Moreover, the surgery group showed a greater reduction in Dermatology Life Quality Index after treatment compared with the monotherapy group (-8.2 ± 6.2 vs -4 ± 7.7, P = .02). LIMITATIONS: The study follow-up was too short to assess surgical recurrence rates. DISCUSSION: Combining adalimumab with surgery resulted in greater clinical effectiveness and improved quality of life after 12 months in patients with moderate to severe hidradenitis suppurativa.

Validity and Reliability of Two Digital Wound Measurement Tools after Surgery in Patients with Hidradenitis Suppurativa.

BACKGROUND: After excision surgery in patients with hidradenitis suppurativa (HS), wounds are usually left open for secondary intention healing. To evaluate wound healing, reliable wound measurement is important. However, digital wound measurement tools for measuring the surface area are validated for small wounds located on flat or mildly convex body surfaces in studies, often powered inadequately. Up until now, a validated digital measurement tool to accurately measure wounds on all body surfaces, including the intertriginous areas, was not available. OBJECTIVES: The aim of this study was to validate two digital wound measurement tools for the measurement of the surface area of larger and concave wounds, using surgical wounds in patients with HS. METHODS: This prospective observational validation study included consecutive patients with HS undergoing excision surgery in the Department of Dermatology of the Erasmus University Medical Center, Rotterdam. Wound measurements using a ruler, the tracing method, the inSight® 3-dimensional (3D) device, and the ImitoWound app were performed by three investigators. The intraclass correlation coefficients (ICCs) for concurrent validity and the intra- and inter-rater reliability were analyzed. The standard error of measurement (SEm) and minimal detectable change were calculated, and Bland-Altman plots were constructed to determine the limits of agreement. RESULTS: Twenty patients with a total of 52 wounds were included. The wounds had a mean surface of 18.7 cm2. The inSight® 3D device showed an ICC of 0.987 for concurrent validity, 0.998 for intra-rater reliability, and 0.997 for inter-rater reliability. The ICCs from the ImitoWound application were 0.974, 0.978, and 0.964 for concurrent validity, intra-rater reliability, and inter-rater reliability, respectively. The SEms for intra- and inter-rater reliability were 0.95 cm2 and 1.11 cm2 for the inSight® 3D device and 3.33 cm2 and 3.51 cm2 for the ImitoWound app, respectively. CONCLUSION: Both the inSight® 3D device and the ImitoWound app demonstrated excellent concurrent validity and reliability for the surface measurements of concave wound, enabling these tools to be used reliably in clinical research and daily practice. Furthermore, it paves the way for broader application, such as telemonitoring of wound care at home.