Efficacy and Safety of Biosimilar Infliximab in Bio-naïve Patients With Crohn’s Disease

The infliximab biosimilar CT-P13 was the first biosimilar drug targeting tumor necrosis factor-α. However, its efficacy and safety in real-world clinical situations have remained insufficient. Therefore, we aimed to verify the efficacy and safety of CT-P13 in bio-naïve patients with Crohn’s disease. This retrospective multicenter study compared the remission rate at week 54 between patients with Crohn’s disease treated with originator infliximab or CT-P13. Endoscopic and laboratory findings were assessed in both groups. A total of 184 (156 originator and 28 CT-P13) patients were analyzed. Of these, 138 originator users and 19 biosimilar users completed 54-week administration. The clinical remission rates in patients taking originator infliximab of CT-P13 at week 54 were 92.5% and 100%, respectively. The endoscopic scores of each group significantly decreased from baseline at week 54 in both groups, and the mucosal healing rate at week 54 was 53% and 64%, respectively. Laboratory data significantly improved from baseline to week 14 and 54 in both groups. Adverse events were observed more frequently in the CT-P13 group ( 25% vs. 4.5%, p = 0.0015). The efficacy of CT-P13 were comparable with those of originator infliximab in bio-naïve patients with Crohn’s disease evaluated by clinical, endoscopic, and laboratory findings.