Desloratadine has a rapid and enduring impact on signs & symptoms in chronic idiopathic urticaria☆

Abstract Rationale We studied the effect of desloratadine (DL), a potent, once-daily, nonsedating antihistamine, on signs/symptoms of chronic idiopathic urticaria (CIU) in a new multicenter trial. Methods Patients (≥18yr) with a CIU history for ≥6wks and active disease at enrollment (pruritus score ≥2 (screening); AM/PM pruritus sum score (days −3 to 1) ≥14; global CIU severity ≥2 (screening/randomization)) were randomized to receive DL 5mg or placebo OD for 6wks. CIU signs/symptoms (pruritus, wheal number, largest wheal size, global severity) were rated twice-daily (AM (pre-dosing)/PM) using a 4-point scale. The therapeutic response was rated on a 5-point scale at day 42. The primary endpoint was change from baseline in mean reflective pruritus score at day 14. Secondary criteria included therapeutic response, and changes in individual CIU signs/symptoms scores. Adverse events were rated according to severity/relation to treatment. Results The DL (n=65) and placebo (n=72) groups were balanced at baseline for pruritus. The mean decrease from baseline in pruritus at day 14 was greater with DL than placebo (p=0.001). Day 1 instantaneous pruritus scores were lower with DL than placebo (p=0.016). Mean reflective pruritus scores decreased by more with DL versus placebo at days 7, 42 (p≤0.005). Significant decreases in wheal size (days 1, 7, 14, 42 (p≤0.009)) and wheal number (days 14, 42 (p≤0.016)) occurred with DL versus placebo. More patients experienced a therapeutic response with DL (69%) versus placebo (37%; p≤0.001). The safety profiles of DL and placebo were similar. Conclusions DL was effective from the first dose and throughout 6weeks in CIU.