6/28/23, 12:06 AM CHARM (adalimumab-eow) Pathway Feedback Search Clinical Topics Home Studies CHARM (adalimumab-eow) CHARM (adalimumab-eow) Disease Crohn's disease 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 Percentage of week-4 induction therapy responders who achieved remission at week 26 40.0 % 40 30.0 % 20.0 % 17 Significant increase 10.0 % NNT = 4 0.0 % https://web.pathway.md/studies/recx5morH6R5z4bfm 1/2 6/28/23, 12:06 AM CHARM (adalimumab-eow) Pathway 0 0 % Adalimumab-eow Placebo Significant increase in the percentage of 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 the percentage of week-4 responders who achieved remission at week 56 (36% vs. 12%; AD 24%, 95% CI 9.76 to 38.24) Significant increase in the percentage of 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 the percentage of 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 the percentage of week-4 induction therapy responders who achieved remission at week 26. Reference Jean-Fr d ric 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. Open reference URL https://web.pathway.md/studies/recx5morH6R5z4bfm 2/2