Efficacy and safety of on-demand versus daily rupatadine in chronic spontaneous urticaria: A randomized trial
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- dc.contributor.author Weller, Karsten
- dc.contributor.author Giménez Arnau, Anna Maria
- dc.contributor.author Baron, Jens
- dc.contributor.author Brehler, Randolf
- dc.contributor.author Ferrer, Marta
- dc.contributor.author Groffik, Adriane
- dc.contributor.author Grundmann, Sonja
- dc.contributor.author Jakob, Thilo
- dc.contributor.author Labrador-Horrillo, Moisés
- dc.contributor.author Müller, Sabine
- dc.contributor.author Staubach, Petra
- dc.contributor.author Wurpts, Gerda
- dc.contributor.author Metz, Martin
- dc.contributor.author Maurer, Marcus
- dc.date.accessioned 2024-04-24T06:48:21Z
- dc.date.available 2024-04-24T06:48:21Z
- dc.date.issued 2024
- dc.description.abstract Background: Non-sedating H1 -antihistamines (nsAH) are the most commonly used treatment for chronic spontaneous urticaria (CSU). Many patients use them as on-demand (OD) therapy rather than a maintenance treatment. Here, we compared OD versus daily maintenance treatment with the nsAH rupatadine, assessed the efficacy of rupatadine updosing, and investigated potential long-term disease-modifying effects. 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: 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: 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.
- dc.format.mimetype application/pdf
- dc.identifier.citation Weller K, Gimenez-Arnau AM, Baron J, Brehler R, Ferrer M, Groffik A, et al. Efficacy and safety of on-demand versus daily rupatadine in chronic spontaneous urticaria: A randomized trial. Allergy. 2024 Jan;79(1):93-103. DOI: 10.1111/all.15854
- dc.identifier.doi http://dx.doi.org/10.1111/all.15854
- dc.identifier.issn 0105-4538
- dc.identifier.uri http://hdl.handle.net/10230/59882
- dc.language.iso eng
- dc.publisher Wiley
- dc.relation.ispartof Allergy. 2024 Jan;79(1):93-103
- dc.rights © 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
- dc.subject.keyword Chronic spontaneous urticaria
- dc.subject.keyword Disease activity
- dc.subject.keyword On-demand
- dc.subject.keyword Rupatadine
- dc.subject.keyword Updosing
- dc.title Efficacy and safety of on-demand versus daily rupatadine in chronic spontaneous urticaria: A randomized trial
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion