Safety and efficacy of infliximab in the treatment of refractory uveoretinitis in Behçet’s disease: a large-scale, long-term postmarketing surveillance in Japan

Autor: Shigeaki Ohno, Itsuro Umebayashi, Miyuki Matsukawa, Takashi Goto, Toshiro Yano
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Arthritis Research & Therapy, Vol 21, Iss 1, Pp 1-12 (2019)
Druh dokumentu: article
ISSN: 1478-6362
DOI: 10.1186/s13075-018-1793-7
Popis: Abstract Background Infliximab, an anti-tumor necrosis factor-alpha antibody, has been reported to have excellent efficacy for refractory uveoretinitis in Behçet’s disease (RUBD), and was approved for this indication in Japan. However, the long-term safety profile and efficacy in real-world clinical settings in patients with RUBD have not been fully clarified. The BRIGHT study, a prospective, large-scale, long-term postmarketing surveillance (PMS) study, was conducted to investigate the long-term safety and efficacy of infliximab in Japanese patients with RUBD. Methods All patients with RUBD who started infliximab treatment between January 2007 and January 2010 were enrolled. Safety was evaluated every 6 months for up to 24 months after initiation of therapy in 656 patients, and efficacy was evaluated in 650 patients. Patient characteristics were compared using the chi-square or Fisher’s exact test. The frequency of ocular attacks before and after infliximab treatment was compared using the Wilcoxon signed-rank test. Independent associated factors for safety or efficacy were identified using multiple logistic regression analysis. A two-sided p value
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