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

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 assessed the longer term potential disease‐modifying effects of rupatadine, evaluated the effects of updosing, and compared daily versus OD treatment in patients with CSU. Daily rupatadine treatment significantly improved CSU disease activity and QoL during treatment versus OD treatment but not after discontinuation of rupatadine. Updosing rupatadine from 10 to 20 mg increased the number of complete responders but did not improve the overall disease activity.Abbreviations: CSU, chronic spontaneous urticaria; OD, on‐demand; QoL, quality of life; vs., versus