Gut Liver.  2016 Mar;10(2):262-274. 10.5009/gnl15042.

Efficacy and Safety of Adalimumab in Moderately to Severely Active Cases of Ulcerative Colitis: A Meta-Analysis of Published Placebo-Controlled Trials

• Zhang ZM
• Li W
• Jiang XL

• KMID: 2363972
• DOI: http://doi.org/10.5009/gnl15042

Abstract

BACKGROUND/AIMS
To evaluate the efficacy and safety of adalimumab (ADA) in moderately to severely active ulcerative colitis (UC) patients who are unresponsive to traditional therapy.
METHODS
Electronic databases, including the PubMed, Embase, and Cochrane databases, were searched to April 20, 2014. UC-related randomized controlled trials (RCTs) that compared ADA with placebo were eligible. Review Manager 5.1 was used for data analysis.
RESULTS
This meta-analysis included three RCTs. ADA was considerably more effective compared with a placebo, and it increased the ratio of patients with clinical remission, clinical responses, mucosal healing and inflammatory bowel disease questionnaire responses in the induction and maintenance phases (p<0.05), as well as patients with steroid-free remission (p<0.05) during the maintenance phase. Clinical remission was achieved in a greater number of UC cases in the ADA 160/80/40 mg groups (0/2/4 week, every other week) compared with the placebo group at week 8 (p=0.006) and week 52 (p=0.0002), whereas the week 8 clinical remission rate was equivalent between the ADA 80/40 mg groups and the placebo group. Among the patients who received immunomodulators (IMM) at baseline, ADA was superior to the placebo in terms of inducing clinical remission (p=0.01). Between-group differences were not observed in terms of serious adverse events (p=0.61).
CONCLUSIONS
ADA, particularly at doses of 160/80/40 mg (0/2/4 week, every other week), is effective and safe in patients with moderate-to-severe UC who are unresponsive to traditional treatment. Concomitant IMM therapy may improve the short-term therapeutic efficacy of ADA.

Keyword

Adalimumab; Efficacy and safety; Meta-analysis; Randomized controlled trials; Colitis; ulcerative

MeSH Terms

Adalimumab/*therapeutic use
Adult
Anti-Inflammatory Agents/*therapeutic use
Colitis, Ulcerative/*drug therapy/pathology
Female
Humans
Male
Middle Aged
Randomized Controlled Trials as Topic
Remission Induction/methods
Severity of Illness Index
Adalimumab
Anti-Inflammatory Agents