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KMID : 0988920210190030301
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Intestinal Research
2021 Volume.19 No. 3 p.301 ~ p.312
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Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behcet’s disease: results from a large real-world observational study
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Suzuki Yasuo
Hagiwara Takashi
Kobayashi Mariko
Morita Kazuo
Shimamoto Tomoyo
Hibi Toshifumi
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Abstract
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Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behcet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behcet’s disease.
Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behcet’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 recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, 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 effectiveness of adalimumab in patients with intestinal Behcet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)
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KEYWORD
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Adalimumab, Behcet syndrome, Tumor necrosis factor-alpha
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