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


CONCLUSIONS
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.
School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.
Xinlin
X
Chen
The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Jiangtao
J
Hou
The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
Yujie
Y
Yuan
The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Chaoyuan
C
Huang
Guangdong Province Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.
Tianwen
T
Liu
School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.
Chuanwei
C
Mo
The First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Haiwen
H
Li
The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Bin
B
Chen
School of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.
Qian
Q
Xu
The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Zhengkun
Z
Hou
The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China. 106382803@qq.com.
Weiling
W
He
The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. liufb21@21cn.com.
Fengbin
F
Liu
D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D006801:Humans; D016032:Randomized Controlled Trials as Topic
D000893:Anti-Inflammatory Agents; D000068879:Adalimumab