August 02, 2012
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Adalimumab may be effective for children with Crohn's disease

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Children with moderate to severe Crohn’s disease can benefit from treatment with adalimumab, particularly those patients who have not been treated previously with infliximab, according to recent results.

In a phase 3, multicenter trial, researchers evaluated 192 children aged 6 to 17 years with moderate-to-severe Crohn’s disease who were unresponsive to previous treatment. Patients initially received induction therapy with subcutaneous adalimumab at weeks 0 and 2. After 4 weeks, 188 participants were grouped according to clinical response and prior infliximab exposure, and randomly received maintenance therapy at high (n=93) or low doses (n=95) according to body weight every 2 weeks for 48 weeks.

At 26 weeks, no significant difference was observed between remission rates (38.7% for high-dose and 28.4% for low-dose; P=.075) or response rates (59.1% for high-dose and 48.4% for low-dose; P=.073) of the two groups. Among patients who had not received previous infliximab treatment, remission rates were higher for high-dose recipients than low-dose recipients (56.9% vs. 35.2%; P=.026). Within the high-dose group specifically, remission and response rates were higher among infliximab-naive patients than in those with previous infliximab treatment (P<.001 for remission rates; P=.04 for response), while only response rates were significantly higher among infliximab-naive patients in the low-dose group (P<.001).

At 52 weeks, remission rates were 33.3% for high-dose and 23.2% for low-dose patients (P=.1) and response rates were 41.9% for high-dose and 28.4% for low-dose patients (P=.038). Response rates among infliximab-naive patients were significantly higher in the high-dose group than the low-dose group (54.9% vs. 33.3%; P=.026), while remission rates were not significantly higher (45.1% vs. 27.8%; P=.065). Infliximab-naive patients had higher response and remission rates than patients with previous infliximab treatment in the high-dose group (P=.005 for response and P=.008 for remission), but not the low-dose group (P=.223 for response and P=.221 for remission).

“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 researchers wrote. “The finding that patients previously treated with infliximab had a lower response to adalimumab therapy in this population deserves further study.”

Disclosure: See the study for a full list of relevant disclosures.