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A group of 297 young patients with Crohn's disease, who were starting treatment with infliximab or adalimumab, were randomly divided into two groups: one received methotrexate, while the other received a placebo. These patients were followed for a period of 12 to 36 months. The group that received a combination of methotrexate and adalimumab showed a twofold decrease in treatment failure compared to the group that only received the placebo (monotherapy). However, there was no significant difference in treatment failure between the methotrexate and placebo groups in the infliximab-initiator group. Although combination therapy resulted in more adverse effects, it also led to fewer serious side effects than monotherapy.
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