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Adalimumab may be effective for children with Crohn's disease
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.