CHARM (adalimumab every other week)
Trial question
What is the role of adalimumab, every other week in patients with Crohn's disease?
Study design
Multi-center
Double blinded
RCT
Population
521 patients
Inclusion criteria: adult patients with moderately to severely active Crohn's disease who were responders of adalimumab induction therapy through week 0 and week 2
Key exclusion criteria: ulcerative colitis; symptomatic obstructive disease; bowel resection within the past 6 months; ostomy; extensive small bowel resection; short bowel syndrome; history of cancer
Interventions
N=260 adalimumab-eow (a dose of 40 mg every other week through week 56 plus induction therapy)
N=261 placebo (matching placebo through week 56 plus induction therapy)
Primary outcome
Week-4 induction therapy responders who achieved remission at week 26
40
17
40.0 %
30.0 %
20.0 %
10.0 %
0.0 %
Adalimumab-eow
Placebo
Significant
increase ▲
NNT = 4
Significant increase in week-4 induction therapy responders who achieved remission at week 26 (40% vs. 17%; AD 23%, 95% CI 9.35 to 36.65)
Secondary outcomes
Significant increase in week-4 responders who achieved remission at week 56 (36% vs. 12%; AD 24%, 95% CI 9.76 to 38.24)
Significant increase in patients experiencing ≥ 70 points reduction in Crohn's disease activity index at week 56 (43% vs. 17.6%; AD 25.4%, 95% CI 10.33 to 40.47)
Significant increase in patients experiencing ≥ 100 points reduction in Crohn's disease activity index at week 56 (41.3% vs. 16.5%; AD 24.8%, 95% CI 10.08 to 39.52)
Safety outcomes
Significant differences in adverse events leading to study drug discontinuation (6.9% vs. 13.4%), serious adverse events (9.2% vs. 15.3%).
Conclusion
In adult patients with moderately to severely active Crohn's disease who were responders of adalimumab induction therapy through week 0 and week 2, adalimumab-eow was superior to placebo with respect to a week-4 induction therapy responders who achieved remission at week 26.
Reference
Jean-Frédéric Colombel, William J Sandborn, Paul Rutgeerts et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65.
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