Efficacy and safety of bilastine vs. levocetirizine for the treatment of chronic idiopathic urticaria: A multicenter, double-blind, double-dummy, phase III, non-inferiority, randomized clinical trial
Abstract
To the Editor: Chronic urticaria, prevalent globally and increasing in China, predominantly affects young and middle-aged women, impacting their quality of life (QoL).[1] Standard treatment involves second-generation H1 antihistamines, with bilastine showing promise due to its selective action and minimal side effects. However, direct comparative studies are scarce, particularly in the Chinese population. We aimed to evaluate the efficacy and safety of bilastine compared to levocetirizine in Chinese patients. This multicenter, double-blind, double-dummy, non-inferiority, phase III trial conducted at 18 centers (CTR20181967, www.chinadrugtrials.org.cn; ChiCTR2300072867, www.chictr.org.cn) was approved by the Medical Ethics Committee of Peking University People’s Hospital (No. 2018PHA062-002) [Supplementary Table 1, https://links.lww.com/CM9/B953]. All patients provided written informed consent. Participants with chronic idiopathic urticaria who met the eligible criteria [Supplementary Table 2, https://links.lww.com/CM9/B953] were randomized to 1:1 to 28-day treatment with bilastine 20 mg or levocetirizine 5 mg daily, alongside matching placebos, using a centralized system to ensure blinding. The primary endpoint was the Total Symptom Score (TSS) for itching, wheals number, and size. Secondary endpoints encompassed detailed TSS analysis, Urticaria Composite Score (UCS), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS), and Global Clinical Impression (GCI).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 288 participants or records.
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