Infliximab Biosimilar CT-P13 Provides Consistent Safety, Efficacy Across 4 Diseases

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A review of Japan post-marketing data support the biosimilar in use for psoriasis, rheumatoid arthritis, Crohn's disease and ulcerative colitis.

Infliximab biosimilar CT-P13 was associated with no new safety signals at long-term use—as well as notable efficacy in the treatment of patients naïve to biologics or switching from originator infliximab or other biologics for a litany of rheumatic or gastric conditions for which the agent is used, according to new analyses.

New data from an integrated analysis of 3 post-marketing studies of CT-P13, a biosimilar to originator infliximab marketed in the European Union and Japan, showed the biosimilar was associated with consistent measures of efficacy across patients receiving the agent for Crohn’s disease, psoriasis, ulcerative colitis, or rheumatoid arthritis. The analysis additionally showed varied adverse drug reaction rates based on patients’ history with biologic use—albeit no new signs of concern associated with CT-P13.

The team of Japan-based investigators concluded CT-P13 may provide notable benefit for treating immune-mediated diseases in patients naïve to, or switching from, biologic therapy.

Led by Tsutomu Takeuchi, MD, PhD, of the division of rheumatology at Keio University School of Medicine, investigators sought to address potential clinical pertinent to biosimilar use yet to be addressed trials involving CT-P13. Namely, the tram wanted to determine the biosimilar’s long-term safety profile; its association and risk factors for frequent adverse drug reactions; its efficacy in treating inflammatory diseases beyond rheumatoid arthritis; and the safety and efficacy of CT-P13 in patients who switched from originator infliximab or another biologic.

“All indications for the originator infliximab were granted for the intravenous formulation based on limited data from clinical trials conducted in a small number of patients with rheumatoid arthritis,” investigators wrote. “Therefore, post-approval studies of intravenous CT-P13 are needed to confirm a similar safety profile to that of the originator infliximab in real-world settings and therapeutic efficacy in patients with various types of disease."

Takeuchi and colleagues collected patient data from a trio of post-marketing studies of CT-P13:

  • An analysis of patients with rheumatoid arthritis who received a first intravenous administration of CT-P13 between January 2015 – November 2020 and were monitored for 1 year.
  • An analysis of patients with Crohn’s disease and ulcerative colitis who initiated CT-P13 between January 2015 – April 2017 and were followed for 2 years.
  • An analysis of patients with psoriasis who were enrolled from May 2015 – January 2020 and were followed for 1 year.

Patients were stratified by their biologic use prior to the study enrollment: those naïve to biologics, those who had been treated with originator infliximab then switched to CT-P13 for non-medical reasons, and those who had received other biologics and were switched to CT-P13 for medical reasons.

The total analysis included 1816 patients assessed for safety outcomes; 987 had rheumatoid arthritis; 342 had Crohn’s disease; 322 had ulcerative colitis; and 165 had psoriasis. Another 1150 patients with available disease parameter outcome data were included in the efficacy assessment.

Investigators observed adverse drug reactions in one-fourth (24.1%) of all treated patients. Patients switched from other biologics were most likely to report a reaction (33.5%), followed by biologic-naïve patients (30.5%), then patients switched from originator infliximab (17.0%).

The most common drug reaction was infusion reactions (8.2%)—at a rate significantly higher among patients with ulcerative colitis and a history of allergy. Another 6.1% of patients reported an infection; but only 4 patients (0.2%) reported tuberculosis. Risk of infection was particularly lower among patients with Crohn’s disease and psoriasis.

Another 16 patients (0.9%) reported interstitial lung disease (ILD)—predominately those with rheumatoid arthritis (n = 11).

Regarding efficacy, investigators observed similar decreases in disease activity outcomes across all 4 patient populations—however, discontinuation rates due to inefficacy were variable over a long period of use. Particularly, patients naïve to biologics reported a generally “rapid” decrease in disease parameters, and the proportion of such patients in disease remission increased.

Patients who switched from originator infliximab maintained the efficacy observed from their pre-switch status, and patients who switched from other biologics generally reported decreased disease parameters—but this latter group additionally reported trends of long-term inefficacy discontinuation.

The team concluded the incidence and severity of adverse drug reactions remained comparable between CT-P13 and originator infliximab, with no newly observed safety concerns. Efficacy ranged from maintained as from originator infliximab, to significant improved in biologic-naïve patients.

“Even in patients who relapsed on other biologics, CT-P13 also showed primary efficacy, although drug persistence was relatively low,” they wrote. ‘In conclusion, as a cost-effective biosimilar, CT-P13 could be useful for the treatment of immune-mediate inflammatory diseases in biologic-naïve patients and switched patients from biologics.”


Takeuchi T, Nishikawa K, Yamada F, et al. Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies [published online ahead of print, 2023 Sep 12]. Drug Saf. 2023;10.1007/s40264-023-01340-1. doi:10.1007/s40264-023-01340-1