External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Standard

External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort. / 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; Pinter, Andreas; Potenza, Concetta; Prens, Errol P.; Romaní, Jorge; Saunte, Ditte M.; Sayed, Christopher; Skroza, Nevena; Stergianou, Dimitra; Szepietowski, Jacek C.; Trigoni, Anastasia; Vilarrasa, Eva; Kyrgidis, Athanassios; Zouboulis, Christos C.; Van Der Zee, Hessel H.

I: Dermatology, Bind 239, Nr. 3, 2023, s. 362-367.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Van Straalen, KR, Tzellos, T, Alavi, A, Benhadou, F, Cuenca-Barrales, C, Daxhelet, M, Daoud, M, Efthymiou, O, Giamarellos-Bourboulis, EJ, Guillem, P, Gulliver, W, Jemec, GBE, Katoulis, A, Koenig, A, Lazaridou, E, Lowes, MA, Marzano, AV, Matusiak, L, Molina-Leyva, A, Moltrasio, C, Pinter, A, Potenza, C, Prens, EP, Romaní, J, Saunte, DM, Sayed, C, Skroza, N, Stergianou, D, Szepietowski, JC, Trigoni, A, Vilarrasa, E, Kyrgidis, A, Zouboulis, CC & Van Der Zee, HH 2023, 'External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort', Dermatology, bind 239, nr. 3, s. 362-367. https://doi.org/10.1159/000528968

APA

Van Straalen, K. R., Tzellos, T., Alavi, A., Benhadou, F., Cuenca-Barrales, C., Daxhelet, M., Daoud, M., Efthymiou, O., Giamarellos-Bourboulis, E. J., Guillem, P., Gulliver, W., Jemec, G. B. E., Katoulis, A., Koenig, A., Lazaridou, E., Lowes, M. A., Marzano, A. V., Matusiak, L., Molina-Leyva, A., ... Van Der Zee, H. H. (2023). External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort. Dermatology, 239(3), 362-367. https://doi.org/10.1159/000528968

Vancouver

Van Straalen KR, Tzellos T, Alavi A, Benhadou F, Cuenca-Barrales C, Daxhelet M o.a. External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort. Dermatology. 2023;239(3):362-367. https://doi.org/10.1159/000528968

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 ; Moltrasio, Chiara ; Pinter, Andreas ; Potenza, Concetta ; Prens, Errol P. ; Romaní, Jorge ; Saunte, Ditte M. ; Sayed, Christopher ; Skroza, Nevena ; Stergianou, Dimitra ; Szepietowski, Jacek C. ; Trigoni, Anastasia ; Vilarrasa, Eva ; Kyrgidis, Athanassios ; Zouboulis, Christos C. ; Van Der Zee, Hessel H. / External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort. I: Dermatology. 2023 ; Bind 239, Nr. 3. s. 362-367.

Bibtex

@article{780d985ecb2d414093494bb05dfd19a3,
title = "External Validation of the IHS4-55 in a European Antibiotic-Treated Hidradenitis Suppurativa Cohort",
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. ",
keywords = "Clinicalrial, Endpoint, Hidradenitissuppurativa, International Hidradenitis Suppurativa 4, Outcome, Treatment, Validation",
author = "{Van Straalen}, {Kelsey R.} and Thrasyvoulos Tzellos and Afsaneh Alavi and Farida Benhadou and Carlos Cuenca-Barrales and Mathilde Daxhelet and Mathieu Daoud and Ourania Efthymiou and Giamarellos-Bourboulis, {Evangelos J.} and Philippe Guillem and Wayne Gulliver and Jemec, {Gregor B.E.} and Alexander Katoulis and Anke Koenig and Elizabeth Lazaridou and Lowes, {Michelle A.} and Marzano, {Angelo V.} and Lukasz Matusiak and Alejandro Molina-Leyva and Chiara Moltrasio and Andreas Pinter and Concetta Potenza and Prens, {Errol P.} and Jorge Roman{\'i} and Saunte, {Ditte M.} and Christopher Sayed and Nevena Skroza and Dimitra Stergianou and Szepietowski, {Jacek C.} and Anastasia Trigoni and Eva Vilarrasa and Athanassios Kyrgidis and Zouboulis, {Christos C.} and {Van Der Zee}, {Hessel H.}",
note = "Publisher Copyright: {\textcopyright} 2023 Authors. All rights reserved.",
year = "2023",
doi = "10.1159/000528968",
language = "English",
volume = "239",
pages = "362--367",
journal = "Dermatology",
issn = "1018-8665",
publisher = "S Karger AG",
number = "3",

}

RIS

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 -

ID: 365661737