Intest Res.  2021 Oct;19(4):408-418. 10.5217/ir.2020.00025.

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study

• Hisamatsu T
• Suzuki Y
• Kobayashi M
• Hagiwara T
• Kawaberi T
• Ogata H
• Matsui T
• Watanabe M
• Hibi T

• KMID: 2521604
• DOI: http://doi.org/10.5217/ir.2020.00025

Abstract

Background/Aims
Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings.
Methods
This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI).
Results
The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks.
Conclusions
Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Keyword

Adalimumab; Crohn disease; Inflammatory bowel diseases; Japanese; Postmarketing surveillance

Figure

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  Fig. 1. (A) Patient disposition. (B) Kaplan-Meier curve for drug survival (safety analysis population). aThere could be more than 1 reason for exclusion of patients. CRF, case report form.

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  Fig. 2. (A) Clinical remission (Crohn’s Disease Activity Index <150). (B) Proportion of patients with extraintestinal manifestation (EIM). (C) Proportion of patients with mucosal healing on endoscopic evaluation. aNot limited to patients who underwent balloon endoscopic assessment; bOnly patients with data available on the same day for both the large and small intestines were included.

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  Fig. 3. Change in C-reactive protein (CRP) levels. SD, standard deviation.

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  Fig. 4. Work Productivity and Activity Impairment scores. aIncluded only patients who were employed.

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