Efficacy and Safety of Adalimumab in Moderately to Severely Active Cases of Ulcerative Colitis: A Meta-Analysis of Published Placebo-Controlled Trials
Gut and Liver
;
: 262-274, 2016.
Article
in English
| WPRIM
| ID: wpr-193419
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Severity of Illness Index
/
Remission Induction
/
Colitis, Ulcerative
/
Randomized Controlled Trials as Topic
/
Adalimumab
/
Anti-Inflammatory Agents
Type of study:
Controlled clinical trial
/
Systematic reviews
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
English
Journal:
Gut and Liver
Year:
2016
Type:
Article
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