Therapeutic Research

Abstract

Objective：This drug use‒results survey was conducted to evaluate the safety and effectiveness of fexofenadine, Allegra® 5％ Dry Syrup（ALE DS）, for young children with allergic rhinitis and skin disorders in the real‒world setting of Japanese clinical practice. Methods：This observational study was conducted in accordance with Japan GPSP regulations. In this nationwide prospective product registry, children（aged 6 months to 7 years）who had been prescribed ALE DS were eligible for enrollment. According to the package insert, ALE DS is indicated for the treatment allergic rhinitis, urticaria, or pruritus associated with cutaneous disease（eczema cutaneous pruritus, atopic dermatitis）. Per‒label, children aged 6 months to 2 years and 2 to 7 years are to receive fexofenadine hydrochloride 15 mg（as 0.3 g ALE DS）and 30 mg（as 0.6 g ALE DS）twice daily, respectively. Safety was assessed through the occurrence of adverse events（AE, evaluated in number of patient‒cases and events）, adverse drug reaction（ADR）, their severity and outcomes. In particular, the incidence of predefined neurological adverse events was assessed as an outcome of particular interest. Subgroup analyses based on body weight and age（under 2 years）were also conducted. The primary endpoint for effectiveness was the physician‒rated global improvement scale（GIS）at 4‒week treatment after ALE DS initiation and at the end of the observation period. The secondary objective was to assess the clinical course of the disease conditions. Results：Of the 413 patients enrolled, 271 and 254 patients were analyzed for safety and effectiveness, respectively. The mean（SD）treatment duration with ALE DS was 46.9 （31.8）days. Overall, 13 events（ADRs）were reported in 8 patients（2.95％）. No serious ADRs was reported. Neurological ADRs were reported in 2 cases （drowsiness and headache）. There was no between‒group difference in the occurrence of ADRs among the prespecified age and weight subgroups. Improvement rate（improved or markedly improved）as determined by GIS was 70.6％ and 77.5％ at 4‒week treatment after ALE DS initiation and at the end of the observation period, respectively. Conclusions：In this observational study, the use of ALE DS in pediatric patients was associated with an improvement in symptoms of allergic rhinitis, urticaria, and pruritus with a good safety profile.