Tajiri H, Arai K, Kagimoto S, et al. - In pediatric patients (aged 6–17 years) with moderate-to-severe ulcerative colitis (UC), researchers tested the safety, effectiveness, and pharmacokinetic profile of infliximab (IFX) and inadequate response to existing treatment. In total, 21 patients were treated in this open-label, uncontrolled, multicenter, Phase 3 trial. This trial was carried out at 17 centers in Japan between April 2012 and September 2014. Pediatric patients diagnosed with moderate-to-severe UC got a treatment protocol consisting of 5 mg/kg IFX at Weeks 0, 2, and 6, and Clinical Activity Index (CAI)-based responders at Week 8 also received treatment at 8-week intervals at Weeks 14 and 22, with a final assessment at Week 30. Investigators found that administration of IFX 5 mg/kg at Weeks 0, 2, and 6 rapidly improved clinical symptoms. This improvement has been sustained by administration at 8-week intervals throughout the maintenance treatment period from Week 14 to Week 30. The results also suggest that IFX treatment has been effective in reducing and withdrawing corticosteroids. Such findings support the use of IFX in treating patients with UC with insufficient response to current therapy. In 95.2 and 14.3% of patients, respectively, adverse events and serious adverse events were noted.