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

Abstract

Chronic spontaneous urticaria; On-demand; Rupatadine

Urticaria crónica espontánea; Bajo demanda; Rupatadina

Urticària crònica espontània; Sota demanda; Rupatadina

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.

This study was funded in part by URIACH, and the analysis was funded by Charité—Universitätsmedizin Berlin as part of the “CU-LATER” study. Other features of the study were supported by intramural funding. In addition, this study benefited from the network of Urticaria Centers of Reference and Excellence (UCAREs; https://ga2len-ucare.com) of GA2LEN, the Global Allergy and Asthma European Network.