Levocetirizine versus Bilastine as Monotherapy in the Management of Chronic Spontaneous Urticaria: A Randomised Controlled Trial

Abstract

Introduction: Chronic urticaria is defined as the almost daily occurrence of wheals and pruritus for a minimum of six weeks, adversely affecting the quality of life and necessitating management with a drug with better efficacy and a high safety profile. This study was designed to determine how monotherapy with newer antihistamines benefits chronic spontaneous urticaria by producing earlier and longer periods of remission. Additionally, the study aimed to assess the adverse effects associated with the drugs. Aim: To compare the efficacy of Levocetirizine and Bilastine in chronic spontaneous urticaria. Materials and Methods: The study was a single-blinded randomised controlled trial conducted in the Department of Dermatology at Madras Medical College, Chennai, Tamil Nadu, India over 24 months from January 2020 to December 2021. A total of 163 patients with chronic urticaria were randomly divided into two groups: Group A with 82 patients and group B with 81 patients. The patients were treated with tablet Levocetirizine 5 mg and tablet Bilastine 20 mg for six months (with up-dosing to four-fold maximum) in Group A and Group B, respectively. The treatment response was assessed using the Urticaria Activity Score (UAS) at each follow-up. Patients were followed-up for an additional six months to observe the time of recurrence. Total 15 patients were lost to follow-up and were consequently excluded from the statistical analysis. Results: At the end of six months, the improvement observed in UAS was statistically similar in both groups (p-value=0.513). The time taken for remission was shorter with Levocetirizine (11.19±5.31 weeks) compared to Bilastine (14.59±5.02 weeks). Recurrence occurred earlier with Bilastine compared to Levocetirizine. Conclusion: Levocetirizine and Bilastine are equally effective in controlling urticaria at the end of six months of treatment. Patients on Levocetirizine experienced earlier remission as well as late recurrence compared to those on Bilastine.