The integrated analysis of 1816 patients treated with biosimilar CT-P13 showed a similar safety profile to the originator infliximab and no additional safety concerns. Risk factors for infusion reactions and infections were identified by a multivariable analysis.

The primary efficacy of CT-P13, accessed by changes in disease activity parameters, was confirmed across four immune-mediated inflammatory diseases. Long-term efficacy, accessed by drug discontinuation because of inefficacy, differed by disease.

In biologic-naïve patients, CT-P13 exhibited a sufficient effect. In patients who switched from infliximab, the reduced disease activity was maintained, adverse reactions were infrequent, and drug persistence was high. Even in patients who relapsed on other biologics, CT-P13 also showed good primary efficacy, although drug persistence was relatively low.