Adalimumab GAINs more CHARM in Crohn's disease

Adalimumab [Humira] induces clinical remission in patients with difficult-to-treat Crohn's disease who lost response to, or were intolerant of, infliximab [Remicade], according to results of the GAIN* study presented at the 14th United European Gastroenterology Week (UEGW) [Berlin, Germany, October, 2006]. Conducted in more than 300 patients with moderately to severely active Crohn's disease, the phase III study showed that a significantly higher proportion of patients treated with adalimumab than placebo achieved clinical remission at week 4. Two new analyses of the CHARM** study were also presented. The first analysis evaluated the efficacy of adalimumab in providing corticosteroid-free clinical remission in patients with Crohn's disease; among patients who were in clinical remission at weeks 26 and 56, a significantly greater proportion of patients treated with adalimumab than placebo remained corticosteroid-free for 90 days or more. The second analysis investigated the effects of baseline C-reactive protein (CRP) level on adalimumab's ability to maintain clinical remission over one year, and showed that adalimumab induced and maintained clinical remission at weeks 26 and 56, independent of baseline CRP levels.