CHARM (adalimumab every week)
Trial question
What is the role of adalimumab weekly in patients with Crohn's disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 518
518 patients (222 female, 296 male).
Inclusion criteria: adult patients with moderately to severely active crohn's disease.
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=257 adalimumab weekly (matching placebo 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
47%
17%
47.0 %
35.3 %
23.5 %
11.8 %
0.0 %
Adalimumab
weekly
Placebo
Significant
increase ▲
NNT = 3
Significant increase in week-4 induction therapy responders who achieved remission at week 26 (47% vs. 17%; AD 30%, 95% CI 12.2 to 47.8).
Secondary outcomes
Significant increase in week-4 induction therapy responders who achieved remission at week 56 (41% vs. 12%; AD 29%, 95% CI 11.79 to 46.21).
Significant increase in patients experiencing ≥ 70 points reduction in Crohn's disease activity index at week 56 (49% vs. 17.6%; AD 31.4%, 95% CI 12.77 to 50.03).
Significant increase in patients experiencing ≥ 100 points reduction in Crohn's disease activity index at week 56 (47.8% vs. 16.5%; AD 31.3%, 95% CI 12.73 to 49.87).
Safety outcomes
Significant differences in adverse events leading to study drug discontinuation (4.7% vs. 13.4%), serious adverse events (8.2% vs. 15.3%).
Conclusion
In adult patients with moderately to severely active crohn's disease, adalimumab weekly 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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