Intest Res.  2021 Oct;19(4):419-429. 10.5217/ir.2020.00033.

Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study

• Ogata H
• Hagiwara T
• Kawaberi T
• Kobayashi M
• Hibi T

• KMID: 2521605
• DOI: http://doi.org/10.5217/ir.2020.00033

Abstract

Background/Aims
Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.
Methods
In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.
Results
Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.
Conclusions
This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.

Keyword

Adalimumab; Japanese; Postmarketing surveillance; Real-world study; Ulcerative colitis

Figure

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  Fig. 1. Patient disposition. aReasons for exclusion were overlapped when data were aggregated. CRF, case report form.

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  Fig. 2. (A) Rates of clinical remission per partial Mayo score in the effectiveness analysis population (observed cases). Clinical remission was defined by a partial Mayo score ≤2 points with no individual subscore >1 point. (B) Rates of corticosteroid-free remission in patients initiating adalimumab with concomitant corticosteroid therapy (observed cases). (C) Rates of mucosal healing in the effectiveness analysis population (observed cases); mucosal healing was defined as a Mayo endoscopic subscore ≤1.

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