Intest Res.  2021 Jul;19(3):301-312. 10.5217/ir.2020.00013.

Is adalimumab safe and effective in patients with intestinal Behcet’s disease in real-world practice?

• Suzuki Y
• Hagiwara T
• Kobayashi M
• Morita K
• Shimamoto T
• Hibi T

• KMID: 2518686
• DOI: http://doi.org/10.5217/ir.2020.00013

Abstract

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 Japanese 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 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 Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Keyword

Adalimumab; Behçet syndrome; Tumor necrosis factor-alpha

Figure

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  Fig. 1. Patient disposition. aSafety information was missing in the case report form (CRF); bGlobal improvement rating data not available.

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  Fig. 2. Treatment persistence rate (safety population). aOnly patients with an observation period of 156 weeks were included in this analysis.

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  Fig. 3. Incidence of adverse drug reactions (ADRs) by patient background factors (safety population). P-values determined using Fisher exact test. aNot related to Behçet’s disease.

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  Fig. 4. Percentage of patients achieving improvement in global gastrointestinal symptom score. P-value determined using Wilcoxon signed-rank test.

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  Fig. 5. Improvement in endoscopic findings.

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  Fig. 6. Mean change in serum C-reactive protein (CRP) levels. SD, standard deviation.

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