Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial

Baili Chen, Xiang Gao, Jie Zhong, Jianlin Ren, Xuan Zhu, Zhanju Liu, Kaichun Wu, Jasmina Kalabic, Zhuqing Yu, Bidan Huang, Nisha Kwatra, Thao Doan, Anne M Robinson, Min-Hu Chen, Baili Chen, Xiang Gao, Jie Zhong, Jianlin Ren, Xuan Zhu, Zhanju Liu, Kaichun Wu, Jasmina Kalabic, Zhuqing Yu, Bidan Huang, Nisha Kwatra, Thao Doan, Anne M Robinson, Min-Hu Chen

Abstract

Background and aims: Efficacy of adalimumab in Crohn's disease (CD) has not been shown in China. The aim of this study was to evaluate the efficacy and safety of adalimumab in Chinese patients with CD.

Methods: This 26-week, multicenter, phase III study evaluated patients with moderately to severely active CD and elevated high-sensitivity C-reactive protein (⩾3 mg/l) who were naïve to anti-tumor necrosis factor therapy. Patients were randomized to double-blind adalimumab 160/80 mg at weeks 0/2 and 40 mg at weeks 4/6 or placebo at weeks 0/2 followed by blinded adalimumab 160/80 mg at weeks 4/6. At week 8, all patients received open-label 40 mg adalimumab every other week through week 26. The primary endpoint was clinical remission [CD activity index (CDAI) <150] at week 4. Clinical remission at week 26 was assessed in week-8 responders (decrease in CDAI ⩾70 points at week 8 from baseline) and compared with a clinically meaningful threshold of 30%. Adverse events (AEs) were recorded throughout the study.

Results: At baseline, 205 patients were enrolled, with mean [standard deviation (SD)] age of 32.9 (9.9) years and CD duration of 2.7 (3.0) years. At week 4, 38/102 patients (37%) receiving adalimumab and 7/103 (7%) receiving placebo (p < 0.001) achieved clinical remission. Among week-8 responders, 93/144 (65%) achieved clinical remission at week 26 (p < 0.001). No unexpected AEs and no malignancies, active tuberculosis, or deaths were reported.

Conclusions: Adalimumab induced and maintained remission in Chinese patients with CD. Safety results were consistent with the known safety profile of adalimumab.

Clinicaltrialsgov identifier: NCT02499783.

Keywords: Chinese; Crohn’s disease; adalimumab.

Conflict of interest statement

Conflict of interest statement: B. Chen, X. Gao, J. Zhong, J. Ren, X. Zhu, Z. Liu, K. Wu, and M. H. Chen have nothing to disclose. J. Kalabic, Z. Yu, B. Huang, N. Kwatra, T. Doan, and A. M. Robinson are AbbVie employees and may own AbbVie stock and/or options.

© The Author(s), 2020.

Figures

Figure 1.
Figure 1.
Study design. At week 4, patients receiving systemic corticosteroids had their corticosteroid dose tapered. At or after week 12, patients who experienced an inadequate response could increase their dosage to 80 mg EOW. DB, double blind; EOW, every other week.
Figure 2.
Figure 2.
Patient disposition.
Figure 3.
Figure 3.
Clinical remission at weeks 4 and 26, intent-to-treat population. Patients with response (decrease in CDAI ⩾70 from baseline; NRI) at week 8 were compared at week 26 with a prespecified, clinically relevant threshold of 30%. ADA, adalimumab; CDAI, Crohn’s disease activity index; NRI, non-responder imputation; PBO, placebo.
Figure 4.
Figure 4.
Mean change from baseline in (A) CDAI (LOCF), (B) hs-CRP (LOCF), and (C) FC (LOCF). For the ADA and PBO treatment groups, change from baseline at weeks 2 and 4 was analyzed for the intent-to-treat population. For the any-adalimumab set (any ADA), baseline and visits were relative to the first dose of ADA. FC was collected at baseline and weeks 4, 8, and 26. ADA, adalimumab; CDAI, Crohn’s disease activity index; FC, fecal calprotectin; hs-CRP, high-sensitivity C-reactive protein; LOCF, last observation carried forward; PBO, placebo.

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Source: PubMed

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