Study in Patients With IBD Finds Good Long-Term Efficacy of CT-P13

Biologic drugs can effectively treat inflammatory bowel disease (IBD), but the cost of these products can be prohibitive. Biosimilars such as CT-P13 (Remsima, Inflectra), an infliximab biosimilar referencing Remicade, have the potential to drive down treatment costs and enhance access to biologics for the patients who need them.

During the Asian Pacific Digestive Week 2018 meeting, held November 15-18 in Seoul, Republic of Korea, researchers presented on the long-term efficacy and safety of CT-P13 in treating patients with IBD.

The retrospective, multicenter study was performed for 368 patients with IBD who received at least 3 infusions of CT-P13 at 16 hospitals in Korea between 2012 and 2016.

In total, 267 of the patients were naïve to anti—tumor necrosis factor (anti-TNF) treatment when they began taking the biosimilar, while 101 patients were switched from the reference product. Retention rates at year 1, year 3, and year 5 were 86.1%, 68.5%, and 58.7%, respectively, in the anti-TNF–naïve group. In the switched patients, the respective retention rates were 69.7%, 46.0%, and 26.7%, respectively.

Among anti-TNF—naïve patients who had Crohn disease (CD), rates of clinical response and clinical remission were 94.3% and 78.6% at week 14, 92.7% and 82.4% at year 1, and 76.8% and 72.2% at year 3. Among the anti-TNF–naïve patients with ulcerative colitis (UC), the corresponding rates were 85.6% and 42.6% at week 14, 80.0% and 59.8% at year 1, and 55.2% and 44.2% at year 3, respectively.

In the patients who switched from the reference infliximab, the clinical efficacy of CT-P13 was maintained in 84.6% of patients with CD and 65.2% of patients with UC.

In total, adverse events related to CT-P13 were observed in 11.9% of patients with CD and 8.5% of patients with UC.

The researchers concluded that the biosimilar has good long-term efficacy and that it was, overall, well tolerated in patients with IBD. According to the study’s authors, the biosimilar is “a comparable alternative” to Remicade in treating patients with IBD.

Reference

Kim NH, Park DI, Kim YS, et al. Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. Presented at Asian Pacific Digestive Week 2018, November 15-18, 2018; Seoul, Republic of Korea. Abstract EE-0388 (PE-0543). onlinelibrary.wiley.com/doi/10.1111/jgh.14488.