1. External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort.
- Author
-
van Straalen, Kelsey R., Tzellos, Thrasyvoulos, Alavi, Afsaneh, Benhadou, Farida, Cuenca-Barrales, Carlos, Daxhelet, Mathilde, Daoud, Mathieu, Efthymiou, Ourania, Giamarellos-Bourboulis, Evangelos J., Guillem, Philippe, Gulliver, Wayne, Jemec, Gregor B.E., Katoulis, Alexander, Koenig, Anke, Lazaridou, Elizabeth, Lowes, Michelle A., Marzano, Angelo V., Matusiak, Lukasz, Molina-Leyva, Alejandro, and Moltrasio, Chiara
- Subjects
HIDRADENITIS suppurativa ,QUALITY of life ,ODDS ratio ,CLINICAL trials ,TREATMENT effectiveness - Abstract
Background: Previously, a new dichotomous outcome was developed, calculated as 55% reduction in the International Hidradenitis Suppurativa 4 (IHS4-55) score. It was validated in datasets of adalimumab and placebo-treated HS patients. External validation is an important aspect of clinical outcomes. Objectives: We aimed to externally validate the novel dichotomous IHS4-55 in a non-biologic treated dataset of HS patients. Methods: Data from a previously published European-wide prospective clinical study of antibiotic treatment of HS patients were used to assess the association of IHS4-55 achievement with individual reduction in inflammatory nodules, abscesses, and draining tunnels. Moreover, the associations between IHS4-55 positivity and achievement of the minimal clinically important differences (MCIDs) for Dermatology Life Quality Index (DLQI), Numerical Rating Scale (NRS) Pain, and NRS Pruritus were analyzed. Results: Data were obtained from 283 individual patients, of which 36.4% (103/283) were treated with clindamycin and rifampicin and 63.6% (180/283) with tetracyclines for 12 weeks. Achievers of the IHS4-55 demonstrated a significant reduction the counts of inflammatory nodules, abscesses, and draining tunnels (all p < 0.001). Additionally, IHS4-55 achievers had an odds ratio for achieving the MCID of DLQI, NRS Pain, and NRS Pruritus of 2.16 (95% CI 1.28–3.65, p < 0.01), 1.79 (95% CI 1.10–2.91, p < 0.05), and 1.95 (95% CI 1.18–3.22, p < 0.01), respectively. Conclusions: This study shows the external validity of the novel IHS4-55 by demonstrating a significant association between IHS4-55 achievement and a reduction in inflammatory lesion counts as well as achievement of MCIDs for DLQI, NRS Pain, and NRS Pruritus in an antibiotic-treated cohort. These findings support the use of the IHS4-55 as a novel primary outcome measure in clinical trials. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF