Pooled Analysis Underscores Safety of Biosimilar Infliximab, CT-P13, in Patients With IBD

Biosimilar infliximab CT-P13 (Remsima, Inflectra) has become established in the treatment landscape for a number of inflammatory diseases since its approval in the European Union and in the United States, and real-world evidence on the safety of the biosimilar continue to accrue.

During the United European Gastroenterology Week 2019, held October 29-23 in Barcelona, Spain, researchers from Celltrion presented pooled data from 3 postmarketing studies of CT-P13 in patients with inflammatory bowel disease (IBD) that underscore the safety of the biosimilar.

The study relied on the Pfizer CONNECT-IBD study conducted in 13 European countries, the Celltrion CT-P13 4.3 registry in 5 European countries, and the Celltrion CT-P13 KOREA PMS study in the Republic of Korea. In total, 2813 patients were included in the safety analysis. Data from these studies were collected up to the cut-off date of December 27, 2017. Given that 76.0% of the patients were in the European Union, "the results of this analysis can be considered representative of real-world [CT-P13] safety data from the EU,” write the authors.

In total, 999 of the patients had ulcerative colitis (UC) and 1814 had Crohn disease (CD). Overall, 27.43% of patients with UC and 27.78% of those with CD experienced at least 1 treatment-emergent adverse event (AE), and 10.01% and 10.92%, respectively, experienced at least 1 serious AE. A total of 8.81% and 5.68% patients in the 2 respective groups discontinued treatment due to AEs.

In terms of AEs of special interest, there were 24 cases of serious infection, including tuberculosis (TB), in the UC group and 40 cases in the CD group. Two cases of active TB were reported in the UC group and 4 were reported in the CD group. One case of serum sickness was reported in the UC group.

Three deaths occurred among the patients with UC: 1 sudden heart death, 1 case of sepsis, and 1 death due to an unknown cause. In the CD group, 1 death, attributed to rupture of aneurysm of the abdominal aorta, was reported.

The authors conclude that, among these patients with IBD, the incidence of AEs of special interest was low, and was consistent with the known safety profile of infliximab. “The pooled safety analysis,” write the authors, “suggests a favorable benefit-risk balance and safety profile for IBD patients treated with CT-P13 in EU.”

Reference

Lee SJ, Baek KM, Lee YJ, et al. A large pooled safety analysis of 3 post-marketing studies conducted in inflammatory bowel disease patients treated with biosimilar infliximab (CT-P13). Presented at: Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.