CT-P13 Shows Similar Effectiveness, Safety in Biologic-Naive Patients With Crohn Disease

Celltrion’s infliximab biosimilar CT-P13 demonstrated similar effectiveness and safety to the originator in biologic-naïve patients with Crohn disease (CD) in a retrospective, real-world study in Japan.

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Biologic therapies, including the tumor necrosis factor (TNF)-α monoclonal antibody infliximab, have contributed to improved treatment outcomes for patients with inflammatory bowel disease, according to the investigators. CT-P13 was the first available infliximab biosimilar, approved by the European Medicines Agency and FDA in 2013 and 2016. The approval of CT-P13 was based on clinical trials in rheumatoid arthritis and ankylosing spondylitis, and the use of CT-P13 in inflammatory bowel disease (CD and ulcerative colitis) was approved based on extrapolation.

The authors noted that the first randomized controlled trial comparing CT-P13 to the reference product in biologic-naïve patients with CD was published in 2019 and suggested non-inferiority of the biosimilar to the reference product. However, they said, although nearly 30% of the participants in this trial were Asian, “validation of the efficacy and safety of CT-P13 for CD patients in real-world clinical situations required more extensive evaluation in Asian patients with CD because of the rising prevalence of CD in the Asian population.” They aimed to evaluate effectiveness and safety of CT-P13 compared to the originator in biologic-naïve patients with CD in multiple centers in Japan.

Remission rates, endoscopic findings, laboratory values, and adverse events were compared between 138 patients treated with the reference product and 19 with CT-P13 who completed 54 weeks of treatment.

At baseline, the median Harvey Bradshaw index (HBI) was significantly higher in the reference product group compared to the biosimilar group. Other demographic and disease characteristics were similar between groups, according to the investigators. Clinical remission rates, based on HBI less than 5, were 79.5% and 71.5% in the reference product and biosimilar groups at week 54, with no significant difference between groups. The authors added that logistic regression analysis confirmed that differences in baseline characteristics between groups did not have any impact on remission rates at week 54.

Median SES-CD (simple endoscopic score for Crohn disease) significantly decreased from baseline to 54 weeks in both groups, from 10 to 3 in the originator group and from 12.5 to 3.0 in the CT-P13 group. Mucosal healing rates based on endoscopic findings were 53% and 64% in the reference product and CT-P13 groups. The authors commented that mucosal healing “has been recently recognized as an important therapeutic target for CD,” and that similar mucosal healing rates between patients treated with CT-P13 and the reference product have been previously reported. Serum C-reactive protein, albumin, and hemoglobin also improved significantly from baseline to week 14 and baseline to week 54 in both groups.

There were no significant differences in rates of severe adverse events (AEs) between groups. The authors noted that previous studies have reported severe AE rates of 0% to 2% for CT-P13 treatment, similar to their findings. Severe AEs with grade 3 or higher occurred in 3 patients (1.9%) in the reference product group and 1 patient (3.5%) in the CT-P13 group. However, overall, AEs occurred more frequently in the CT-P13 group (n = 7 patients; 25%) than in the originator group (n = 7 patients; 4.5%).

The authors concluded that effectiveness and safety of CT-P13 were “comparable” with the reference product in biologic-naïve patients with CD. They commented that “CT-P13 has not yet gained popularity in Japan largely due to the generous support for medical expenses by universal insurance.” Accordingly, their study included only a small number of patients using CT-P13 compared to the reference product, which they noted as a limitation. They said their study “establishes the needed groundwork for the development of a strategy for treatment with biologics in patients with Crohn’s disease.”

Reference

Oike T, Akizue N, Ohta Y, et al. Efficacy and safety of biosimilar infliximab in bio-naïve patients with Crohn's disease. Arab J Gastroenterol. 2024:S1687-1979(24)00036-4. doi:10.1016/j.ajg.2024.03.006