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Efficacy and safety of adalimumab for the Crohn’s disease: a systematic review and meta-analysis of published randomized placebo-controlled trials

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Abstract

Purpose

The aim of this study was to evaluate the efficacy and safety of adalimumab (ADA) for Crohn’s disease.

Methods

Electronic databases, including PubMed, Embase, the Cochrane Library, and the Science Citation Index, were searched to retrieve relevant trials. We estimated pooled estimates of the odds ratio (OR) and relevant 95 % confidence interval (CI) using fixed effects model or random effects model as appropriate.

Results

Six randomized placebo-controlled studies met the selection criteria. Short-term clinical response/remission and long-term remission were better in the ADA groups than in the control groups (P < 0.05), both in anti-TNF-naive patients and in subjects who lost their response and/or became intolerant to infliximab (IFX). And ADA was also effective for patients who were previously treated with IFX, and its efficacy in infliximab-exposed patients was probably less than in infliximab-naive patients. In patients with active Crohn’s disease (CD), ADA therapy was more effective than placebo for obtaining complete fistula closure. In comparison with placebo, ADA does not increase the risk of serious adverse events.

Conclusions

ADA appears to be effective in achieving short-term clinical response/remission, long-term remission, and complete fistula healing in CD, including patients not manageable with IFX, and appears to have a favorable safety profile. A longer duration of follow-up and a larger number of patients are required to better assess the safety profile of ADA in CD.

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Conflict of interest

The authors declare that they have no conflict of interest.

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Correspondence to Zhan-Jun Lu.

Supplemental material

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Fig. 1

The forest plot of short-term clinical remission owing to ADA for the treatment of CD (GIF 26 kb)

High resolution image (TIFF 573 kb)

Fig. 2

The effect of ADA compared with placebo on complete fistula closure (GIF 22 kb)

High resolution image (TIFF 483 kb)

Fig. 3

The forest plot of long-term efficacy of ADA in patients previously treated with IFX compared with placebo (GIF 21 kb)

High resolution image (TIFF 469 kb)

Fig. 4

The forest plot of adverse reactions with regard to the use of ADA for the treatment of CD (GIF 27 kb)

High resolution image (TIFF 736 kb)

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Song, YN., Zheng, P., Xiao, JH. et al. Efficacy and safety of adalimumab for the Crohn’s disease: a systematic review and meta-analysis of published randomized placebo-controlled trials. Eur J Clin Pharmacol 70, 907–914 (2014). https://doi.org/10.1007/s00228-014-1702-1

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  • DOI: https://doi.org/10.1007/s00228-014-1702-1

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