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( Yasuo Suzuki ),( Takashi Hagiwara ),( Mariko Kobayashi ),( Kazuo Morita ),( Tomoyo Shimamoto ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.3
Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japa nese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recom mended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) pa tients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P<0.0001), patients taking concomitant oral corticosteroids (P<0.0001), and those not self-administering adalimumab (P=0.0257). At study end, global improvement rating was “effective” (n=156, 40.7%) or “markedly effective” (n=168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n=324) to 0.58 at week 24 (n=208) and 0.25 at week 156 (n=37). Conclusions: This large real-world study confirmed the long-term safety and effective ness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registra tion number: NCT01960790) (Intest Res 2021;19:301-312)
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