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P598 Safety and effectiveness of adalimumab treatment in 1523 patients with ulcerative colitis: Results from a prospective, multi-centre, observational study

H. Ogata*1, T. Hagiwara2, Y. Ito2, T. Kawaberi2, M. Kobayashi2, T. Hibi3

1Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan, 2AbbVie GK, Tokyo, Japan, 3Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan

Background

In a Phase 2/3 trial and its 4-year extension, adalimumab (ADA) induced early clinical remission that was maintained with no new safety signals in Japanese patients (patients) with moderate-to-severe active ulcerative colitis (UC). We conducted an observational study to evaluate the real-world safety and effectiveness of ADA in UC.

Methods

This prospective, multi-centre, post-marketing, 52-week study was conducted between 2013 and 2018 in Japan (NCT01947816). Pts with moderate-to-severe UC who were prescribed ADA were included in the study. Subcutaneous ADA was administered at an initial dose of 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. The primary endpoint was the incidence of adverse drug reactions (ADRs). Effectiveness endpoints included assessments of clinical remission based on partial Mayo scores (pMS), mucosal healing, steroid-free remission, and change in C-reactive protein (CRP) levels from baseline.

Results

Of 1593 registered patients, 1523 (male, 57.6%; mean age, 41.8 years) and 1241 were included in the safety (Table 1) and effectiveness population, respectively.

Table 1. Patient demographics and baseline characteristics

The period of ADA administration was 266.9 ± 135.5 days (mean ± standard deviation [SD]) in the safety population. ADRs and serious ADRs were reported in 18.1% (276/1523) and 4.9% (74/1523) of patients, respectively (Table 2).

Table 2. Summary of ADRs.

Infection was reported in 6.0% (92/1523) of patients and tuberculosis was reported in 0.2% (3/1523) of patients. No cases of de novo or reactivation of hepatitis B were reported. Clinical remission was achieved in 49.7% (531/1068) of patients at Week 4 and increased to 74.4% (539/724) at Week 52. In patients who used steroid at baseline, steroid-free remission rates gradually increased over time, from 10.4% (51/489) at Week 4 to 32.9% (124/377) at Week 24 and 53.1% (171/322) at Week 52. More than 60% of patients showed mucosal healing at Weeks 24 (Mayo endoscopic sub-score [MES] 0, 29.5%; MES1, 34.4%) and 52 (MES0, 34.3%; MES1, 33.3%). The CRP levels decreased from baseline (1.2 ± 2.4 mg/dl, n = 1058) to Weeks 4 (0.6 ± 1.7 mg/dl, n = 882) and 52 (0.3 ± 0.9 mg/dl, n = 597).

Conclusion

ADA treatment was efficacious and well tolerated in patients with UC in real-world settings, without any new safety signals.