Evaluation of efficacy and safety of bilastine 20 mg tablets in adult patients with allergic rhinitis

Background: Bilastine is a nonsedating, H1-antihistamine used for symptomatic treatment of allergic rhinitis; However, data on its efficacy and safety in Indian patients with allergic rhinitis are lacking.Methods: In this multicenter, single-arm, investigator-initiated study, 90 patients with allergic rhinitis received bilastine 20 mg tablets once daily for 4 weeks. The primary endpoint was change in total symptom score (TSS=nasal symptom score [NSS] + non-nasal symptom score [NNSS]) at day 28 from baseline. Severity of individual nasal and non-nasal symptoms was assessed at baseline, day 7, and day 28 by rating each symptom on a scale of 0-3. Key secondary endpoints were incidence of treatment-emergent adverse events (TEAEs), changes in NSS, NNSS, and rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and from baseline to days 7 and 28, and change in Stanford sleepiness scale (SSS) score from baseline to 2 hours post-first dose.Results: The mean allergic rhinitis symptom scores TSS, NSS and NNSS showed a significant decrease (p˂0.0001) at each visit compared with baseline. A statistically significant decline (p˂0.0001) in the mean RQLQ score was observed at days 7 and 28 versus baseline. Median SSS score was 1.0 (range: 1.0-7.0) before and after the 1st dose of bilastine, indicating that it did not cause sedation. No TEAEs were reported during the study.Conclusions: Bilastine 20 mg once daily was efficacious in reducing nasal and non-nasal allergic symptoms, was well tolerated, and had a good safety profile in patients with allergic rhinitis