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Adalimumab for Moderately to Severely Active Ulcerative Colitis: A Systematic Review and Meta-Analysis

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Abstract

Background

Evidence-based studies are increasingly being focused on evaluating the efficacy and safety of adalimumab (ADA) for moderately to severely active ulcerative colitis (UC). However, the dosage pattern of ADA for UC management is still not clear.

Objective

A meta-analysis was conducted to evaluate the efficacy and safety of different ADA dosage regimens for moderately to severely active UC.

Methods

The Medline, EMBASE, ISI Web of Knowledge, and Cochrane databases were searched from their inception to January 2015. Randomized controlled trials (RCTs) comparing ADA with placebo were eligible for initial inclusion. The efficacy and side effects were evaluated for ADA 160/80 (ADA 160/80 mg at weeks 0/2 and then 40 mg at weeks 4 and 6), and ADA 80/40 (ADA 80/40 mg at weeks 0/2 and then 40 mg at weeks 4 and 6) induction therapy, with ADA 40 mg every other week (EOW) for maintenance therapy of 52 weeks. The pooled risk ratio (RR) and its 95 % confidence interval (CI) were calculated.

Results

Three RCTs were included. All of the studies were considered to have a low risk of bias. ADA 160/80 was more effective than placebo for induction of clinical remission (RR 1.62, 95 % CI 1.15–2.29), clinical response (RR 1.37, 95 % CI 1.19–1.59), mucosal healing (RR 1.27, 95 % CI 1.08–1.50), and inflammatory bowel disease questionnaire (IBDQ) response (RR 1.22, 95 % CI 1.05–1.43) and did not increase adverse events (RR 1.10, 95 % CI 0.95–1.27). Compared with placebo, ADA 80/40 did not show significant differences for induction of clinical remission and clinical response and did not increase adverse events. ADA 40 mg EOW was superior to placebo in maintaining clinical remission (RR 2.38, 95 % CI 1.57–3.59), clinical response (RR 1.69, 95 % CI 1.29–2.21), mucosal healing (RR 1.69, 95 % CI 1.26–2.28), and IBDQ response (RR 1.73, 95 % CI 1.28–2.34). Compared with placebo, ADA 40 mg EOW increased adverse events (RR 1.28, 95 % CI 1.06–1.54).

Conclusion

ADA 160/80 was a safe and effective treatment for induction management of moderately to severely active UC, but the benefits of ADA 80/40 application were limited. ADA 40 mg EOW was effective for maintenance management of UC. Additional well designed RCTs are needed to confirm these results.

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Author notes

    Authors and Affiliations

    1. School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China

      Xinlin Chen, Chuanwei Mo & Qian Xu

    2. The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China

      Jiangtao Hou, Bin Chen, Zhengkun Hou & Fengbin Liu

    3. The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China

      Yujie Yuan & Weiling He

    4. The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China

      Chaoyuan Huang & Haiwen Li

    5. Guangdong Province Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China

      Tianwen Liu

    Authors
    1. Xinlin Chen
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    2. Jiangtao Hou
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    3. Yujie Yuan
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    Corresponding authors

    Correspondence to Weiling He or Fengbin Liu.

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    Funding

    This study was funded by the National Natural Science Foundation of China (No: 81403296, 81373786), the Outstanding Youth Foundation of Guangdong Province colleges and universities (YQ2015041), the Young Talents Foundation of Guangzhou University of Chinese Medicine (QNYC20140101), and Science Program for Overseas Scholar of Guangzhou University of Chinese Medicine (Torch Program: XH20140105).

    Author contributions

    XC carried out the design, interpreted the results and wrote the manuscript. JH participated in the study design, extracted the data and wrote the manuscript. YY and TL modified the manuscript. CH contributed to the discussion. CM, HL and QX performed the statistical analyses and interpreted the results. BC and ZH assessed the risk of bias. WH and FL conceived the study and wrote the manuscript. All authors read and approved the final manuscript.

    Conflict of interest

    XC, JH, YY, CH, TL, CM, HL, BC, QX, ZH, WH and FL declare that they have no conflicts of interest.

    Additional information

    X. Chen and J. Hou contributed equally to this article.

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    Chen, X., Hou, J., Yuan, Y. et al. Adalimumab for Moderately to Severely Active Ulcerative Colitis: A Systematic Review and Meta-Analysis. BioDrugs 30, 207–217 (2016). https://doi.org/10.1007/s40259-016-0173-6

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