Efficacy and safety of on-demand versus daily rupatadine in chronic spontaneous urticaria: A randomized trial.

chronic spontaneous urticaria disease activity on-demand rupatadine updosing

Journal

Allergy
ISSN: 1398-9995
Titre abrégé: Allergy
Pays: Denmark
ID NLM: 7804028

Informations de publication

Date de publication:
19 Aug 2023
Historique:
revised: 25 05 2023
received: 11 04 2023
accepted: 16 06 2023
medline: 19 8 2023
pubmed: 19 8 2023
entrez: 19 8 2023
Statut: aheadofprint

Résumé

Non-sedating H This multicenter, randomized study consisted of 2 weeks of screening, 8 weeks of double-blind treatment, and 6 weeks of treatment-free follow-up (OD allowed). Adult patients were randomized to 10 mg rupatadine OD or 10 mg rupatadine daily. At Week 4, if patients did not have a complete response, they switched from 10 to 20 mg rupatadine daily or underwent sham updosing (patients on 10 mg rupatadine OD). The primary aim was to compare CSU disease activity at the end of follow-up between daily versus OD. Additionally, we assessed the efficacy of rupatadine updosing. Major outcomes were disease activity, CSU-related quality of life (QoL), and disease control. At Week 4, disease activity and QoL significantly improved in daily versus OD-treated patients. Updosing of rupatadine did not improve the mean disease activity, but the number of complete responders increased during updosing from 5% to 22%. At the end of follow-up, the disease activity of patients treated OD versus daily was not significantly different. Daily rupatadine treatment significantly improved CSU disease activity and QoL during treatment versus OD treatment but not after discontinuation of rupatadine, indicating the benefits of a daily maintenance nsAH schedule.

Sections du résumé

BACKGROUND BACKGROUND
Non-sedating H
METHODS METHODS
This multicenter, randomized study consisted of 2 weeks of screening, 8 weeks of double-blind treatment, and 6 weeks of treatment-free follow-up (OD allowed). Adult patients were randomized to 10 mg rupatadine OD or 10 mg rupatadine daily. At Week 4, if patients did not have a complete response, they switched from 10 to 20 mg rupatadine daily or underwent sham updosing (patients on 10 mg rupatadine OD). The primary aim was to compare CSU disease activity at the end of follow-up between daily versus OD. Additionally, we assessed the efficacy of rupatadine updosing. Major outcomes were disease activity, CSU-related quality of life (QoL), and disease control.
RESULTS RESULTS
At Week 4, disease activity and QoL significantly improved in daily versus OD-treated patients. Updosing of rupatadine did not improve the mean disease activity, but the number of complete responders increased during updosing from 5% to 22%. At the end of follow-up, the disease activity of patients treated OD versus daily was not significantly different.
CONCLUSIONS CONCLUSIONS
Daily rupatadine treatment significantly improved CSU disease activity and QoL during treatment versus OD treatment but not after discontinuation of rupatadine, indicating the benefits of a daily maintenance nsAH schedule.

Identifiants

pubmed: 37597162
doi: 10.1111/all.15854
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Charité - Universitätsmedizin Berlin
Organisme : Uriach

Informations de copyright

© 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

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Auteurs

Karsten Weller (K)

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany.
Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Ana Maria Gimenez-Arnau (AM)

Department of Dermatology, Hospital del Mar, IMIM, Universitat Pompeu Fabra, Barcelona, Spain.

Jens Baron (J)

Department of Dermatology and Allergy, University Hospital, RWTH Aachen, Aachen, Germany.

Randolf Brehler (R)

Department of Dermatology, University Hospital Muenster, Muenster, Germany.

Marta Ferrer (M)

Department of Allergy, Clinica Universidad de Navarra, Pamplona, Spain.
RICORS Red De Enfermedades Inflamatorias (REI)-RD21/0002/0028, Madrid, Spain.

Adriane Groffik (A)

Department of Dermatology, University Medical Center Mainz, Mainz, Germany.

Sonja Grundmann (S)

Hospital of Dermatology, Bad Rothenfelde, Germany.

Thilo Jakob (T)

Department of Dermatology and Allergy, University Medical Center, Justus Liebig University Gießen, Giessen, Germany.

Moisés Labrador-Horrillo (M)

Allergy Department, Hospital Universitario Vall d'Hebron, VHIR, Universitat Autònoma de Barcelona, Barcelona, Spain.

Sabine Müller (S)

Department of Dermatology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

Petra Staubach (P)

Department of Dermatology and Allergy, University Medical Center, Mainz, Germany.

Gerda Wurpts (G)

Clinic for Dermatology and Allergology, Aachen Comprehensive Allergy Center (ACAC), Uniklinik RWTH Aachen, Aachen, Germany.

Martin Metz (M)

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany.
Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Marcus Maurer (M)

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany.
Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Classifications MeSH