We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort.
- Authors
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; Moltrasio, Chiara
- 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.
- Subjects
HIDRADENITIS suppurativa; QUALITY of life; ODDS ratio; CLINICAL trials; TREATMENT effectiveness
- Publication
Dermatology (10188665), 2023, Vol 239, Issue 3, p362
- ISSN
1018-8665
- Publication type
Article
- DOI
10.1159/000528968