Gabhane M
India Medical Affairs, Sun Pharma, Mumbai, India
Title: Efficacy and safety of oral desloratadine (10mg once daily) in patients with chronic spontaneous urticaria
Biography
Biography: Gabhane M
Abstract
Purpose: Chronic spontaneous/idiopathic urticaria (CSU/CIU) impairs quality of life and affects performance at work/school. Second-generation H1-antihistamines are recommended as first-line treatment for CSU. Updosing (upto 4 times) is recommended in patients unresponsive to the standard dose. This study evaluated efficacy and safety of desloratadine 10mg in the treatment of CSU. Methodology: A multi-centric, open-label, single-arm, phase 3 study was conducted in India in adult patients with moderate-to-severe CSU, active CSU ≥3 weeks, wheals present for ≥3 days/week and not responding to ≥2 weeks of desloratadine 5mg . Desloratadine 10mg was administered orally once daily for 4 weeks. Study assessments included weekly Urticaria Activity Score (UAS7) and Chronic Urticaria Quality-of-Life Questionnaire (CU-Q2oL). Results: Total 256 patients (mean age: 35.3 years) were enrolled in the study. Desloratadine 10mg led to a significant improvement as early as at week 2. Significant improvement by 42.32% (p<0.0001) was seen in mean UAS7 at week 4 (18.17) compared to baseline (31.90). The mean CU-Q2oL score improved by 38.48% from baseline (59.81) to week 4 (35.36) (p<0.0001). By week 4, 21% of patients improved to mild urticaria (UAS7=7-15) and 10% of patients were either well controlled or urticaria free (UAS7=0-6). Adverse events reported in 5.5% of patients were mostly mild (80%), non-serious and did not lead to discontinuation. Two events (0.8%) of dry mouth were reported. Somnolence/ drowsiness was not reported in this study. Conclusion: Desloratadine 10mg once daily was efficacious and well tolerated in patients with moderate-to-severe CSU nonresponsive to standard dose desloratadine. (Study registration number: CTRI/2017/10/010146)