Publication:

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.