Efficacy of increased dose of rupatadine up to 20 mg on itching in Japanese patients due to chronic spontaneous urticaria, dermatitis, or pruritus: A post hoc analysis of phase III clinical trial

Autor: Michihiro Hide, Takamasa Suzuki, Ayaka Tanaka, Hiroshi Aoki
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Journal of Cutaneous Immunology and Allergy, Vol 2, Iss 5, Pp 128-134 (2019)
Druh dokumentu: article
ISSN: 2574-4593
DOI: 10.1002/cia2.12072
Popis: Abstract Objectives The effect of rupatadine, a novel H1 antihistamine with platelet‐activating factor antagonist activity, had been demonstrated for itching in Japanese patients with chronic spontaneous urticaria, dermatitis, or pruritus in a 12‐month, open‐label clinical trial (JapicCTI‐152787). However, patients could have received an updose at various timings due to distinct reasons in the study; timing of updose was not evaluated. This study aimed to elucidate the relationship between performance of rupatadine and timing of updose. Methods For 206 enrolled patients was evaluated the total pruritus score (TPS) to Week 2 with 10 mg rupatadine. From Week 3 to Week 52, rupatadine was updosed to 20 mg accordingly. Subpopulation was categorized by absence/presence of updosing and timing of updose (Week 3 or ≥Week 5). Results Reduction of TPS from baseline to Week 2 in patients updosed at Week 3 was significantly lower than those given an updose at ≥Week 5 and fixed dose. However, significant improvement in the change in mean TPS from 1 week pre‐updose to the second week post‐updose was achieved regardless of updose timing, scoring −0.903 for Week 3 and −0.983 for ≥Week 5 (P
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