TY - JOUR
T1 - External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort
AU - Van Straalen, Kelsey R.
AU - Tzellos, Thrasyvoulos
AU - Alavi, Afsaneh
AU - Benhadou, Farida
AU - Cuenca-Barrales, Carlos
AU - Daxhelet, Mathilde
AU - Daoud, Mathieu
AU - Efthymiou, Ourania
AU - Giamarellos-Bourboulis, Evangelos J.
AU - Guillem, Philippe
AU - Gulliver, Wayne
AU - Jemec, Gregor B.E.
AU - Katoulis, Alexander
AU - Koenig, Anke
AU - Lazaridou, Elizabeth
AU - Lowes, Michelle A.
AU - Marzano, Angelo V.
AU - Matusiak, Lukasz
AU - Molina-Leyva, Alejandro
AU - Moltrasio, Chiara
AU - Pinter, Andreas
AU - Potenza, Concetta
AU - Prens, Errol P.
AU - Romaní, Jorge
AU - Saunte, Ditte M.
AU - Sayed, Christopher
AU - Skroza, Nevena
AU - Stergianou, Dimitra
AU - Szepietowski, Jacek C.
AU - Trigoni, Anastasia
AU - Vilarrasa, Eva
AU - Kyrgidis, Athanassios
AU - Zouboulis, Christos C.
AU - Van Der Zee, Hessel H.
N1 - Publisher Copyright:
© 2023 Authors. All rights reserved.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - Clinicalrial
KW - Endpoint
KW - Hidradenitissuppurativa
KW - International Hidradenitis Suppurativa 4
KW - Outcome
KW - Treatment
KW - Validation
U2 - 10.1159/000528968
DO - 10.1159/000528968
M3 - Journal article
C2 - 36630943
AN - SCOPUS:85163163300
VL - 239
SP - 362
EP - 367
JO - Dermatology
JF - Dermatology
SN - 1018-8665
IS - 3
ER -