HealthDay News — For pediatric patients with moderate-to-severe Crohn’s disease (CD), for whom conventional treatment has been unsuccessful, adalimumab (Humira) induction and maintenance therapy is effective, and appears to be safe, according to a study published in the August issue of Gastroenterology.
Jeffrey S. Hyams, M.D., of the Connecticut Children’s Medical Center in Hartford, and colleagues conducted a study involving 192 pediatric patients with moderate-to-severe CD, for whom previous treatment had been unsuccessful, to evaluate the efficacy and safety of adalimumab maintenance therapy. All patients received adalimumab induction therapy at weeks zero and two. At week four, 188 patients were then randomized to receive high- or low-dose adalimumab every other week for 48 weeks. At 26 weeks, clinical remission was compared between the groups.
The researchers found that 80.9% of participants completed the entire study. At week 26, 33.5% had achieved clinical remission. Although more children in the high-dose group achieved clinical remission compared with the low-dose group, the between-group difference was not statistically significant (38.7 versus 28.4 percent; P = 0.075). No new safety concerns emerged.
“In children with moderately to severely active CD despite conventional treatment, adalimumab therapy in infliximab-naive patients resulted in rates of response and remission similar to those observed with infliximab treatment,” the authors write. “The finding that patients previously treated with infliximab had a lower response to adalimumab therapy in this population deserves further study.”
Several authors were employed by or disclosed financial ties to pharmaceutical companies.