6/28/23, 12:07 AM CHARM (adalimumab-weekly) Pathway Feedback Search Clinical Topics Home Studies CHARM (adalimumab-weekly) CHARM (adalimumab-weekly) Disease Crohn's disease 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 62.0% female N = 518 38.0% male 518 patients (482 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 Percentage of week-4 induction therapy responders who achieved remission at week 26 47.0 % 47 35.3 % https://web.pathway.md/studies/recbsXdMDkgRmQNZZ 1/2 6/28/23, 12:07 AM 35 3 % CHARM (adalimumab-weekly) Pathway 23.5 % Significant increase 17 11.8 % NNT = 3 0.0 % Adalimumab weekly Placebo Significant increase in the percentage of 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 the percentage of 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 the percentage of 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 the percentage of 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 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/recbsXdMDkgRmQNZZ 2/2