Original article—alimentary tractEfficacy and Safety of Tumor Necrosis Factor Antagonists in Crohn's Disease: Meta-Analysis of Placebo-Controlled Trials
Section snippets
Materials and Methods
See supplemental material “Web Materials and Methods” online at www.cghjournal.org.
Luminal Crohn's Disease
Fourteen studies involving 3955 patients were included (Table 1, Table 2). There were 2417 patients treated with anti-TNF agents (infliximab 308, adalimumab 713, certolizumab 830, CDP571 374, etanercept 23, onercept 169) and 1538 patients treated with placebo.
Safety Results
Twenty-one studies involving 5356 patients were included (Table 4 and web Tables 2–4; see supplemental material online at www.cghjournal.org). There were 3341 patients in the anti-TNF groups and 2015 patients in the control groups. The median follow-up was 24 weeks for the 21 trials included in safety analysis (range, 4–60 weeks).
Discussion
This is the first meta-analysis of anti-TNF therapy in luminal and fistulizing CD that includes all 6 agents evaluated in RCTs.
In luminal CD, anti-TNF therapy was more effective than placebo for induction of clinical remission at week 4, with a number needed to treat (NNT) of 9. By reanalyzing data from 14 trials, we were able to include 615 adult CD patients treated with certolizumab and 288 with adalimumab. Both drugs were effective with a NNT of 7 and 10 for adalimumab and certolizumab,
References (35)
- et al.
Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial
Lancet
(2002) - et al.
Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease
Gastroenterology
(1999) - et al.
Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial
Gastroenterology
(2007) - et al.
Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial
Gastroenterology
(2006) - et al.
A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease
Gastroenterology
(2005) - et al.
Onercept for moderate-to-severe Crohn's disease: a randomized, double-blind, placebo-controlled trial
Clin Gastroenterol Hepatol
(2006) - et al.
An engineered human antibody to TNF (CDP571) for active Crohn's disease: a randomized double-blind placebo-controlled trial
Gastroenterology
(2001) - et al.
Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial
Gastroenterology
(2001) - et al.
Randomised controlled trial of CDP571 antibody to tumour necrosis factor-alpha in Crohn's disease
Lancet
(1997) - et al.
Do anti-tumor necrosis factors induce response and remission in patients with acute refractory Crohn's disease?A systematic meta-analysis of controlled clinical trials
Biomed Pharmacother
(2007)
A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn's disease
Gastroenterology
Meta-analysis in clinical trials
Control Clin Trials
Infliximab plus azathioprine for steroid-dependent Crohn's disease patients: a randomized placebo-controlled trial
Gastroenterology
Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry
Clin Gastroenterol Hepatol
A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease: Crohn's Disease cA2 Study Group
N Engl J Med
Infliximab for the treatment of fistulas in patients with Crohn's disease
N Engl J Med
Infliximab maintenance therapy for fistulizing Crohn's disease
N Engl J Med
Cited by (0)
Drs Deltenre and de Suray contributed equally to this work.
Dr Sandborn has received research support from Centocor, Abbott Laboratories, UCB Pharma (formerly Celltech), Immunex (now Amgen), and Serono International; is a consultant to Centocor, Abbott Laboratories, UCB Pharma (formerly Celltech), Immunex (now Amgen), and Serono International; and has participated in continuing medical education events indirectly sponsored by Centocor, Schering-Plough, Abbott Laboratories, and UCB Pharma (formerly Celltech). Dr Colombel is a consultant to Centocor, Abbott Laboratories, and UCB Pharma (formerly Celltech) and has participated in continuing medical education events indirectly sponsored by Centocor, Schering-Plough, Abbott Laboratories, and UCB Pharma (formerly Celltech).