Study Finds Biosimilar Infliximab CT-P13 Effective, Safe in IBD Patients

A recent Spanish study published in Digestive Diseases and Sciences concludes that CT-P13 (Remsima, Inflectra), a biosimilar of reference infliximab (Remicade) that has been approved in Korea, the European Union, and the United States, is efficacious and well tolerated in patients with moderate to severe Crohn’s disease (CD) or ulcerative colitis (UC).

Federico Argüelles-Arias, MD, PhD, and colleagues conducted a preliminary observational trial in patients in Spain with inflammatory bowel disease who were either naïve to anti-tumor necrosis factor (anti-TNF) treatment or who were switched from reference infliximab to CT-P13. Efficacy and safety were assessed at months 3 and 6 of therapy in both the treatment-naïve patients and in switched patients who were in remission at the time of the switch. All patients received intravenous corticosteroids and antihistamines as premedication prior to the infusion treatment.

A total of 80 CD patients and 40 UC patients were included in the study. Among the CD patients, 13 (16.25%) were naïve to anti-TNF and 67 (83.75%) were switched from reference infliximab to CT-P13. At the time of the switch, 56 of the 67 patients (83.5%) were in remission. Median duration of ongoing reference infliximab treatment at the start of the study was 297 weeks.

Over the course of the study, 6 participants were excluded (1 did not attend follow-ups, 3 had adverse events, 1 had no response to treatment, and 1 was referred to surgery).

Of the 40 UC patients, 9 (22.5%) were naïve to anti-TNF (6 of these 9 patients had treatment with steroids), and 31 (77.5%) were switched from reference infliximab to CT-P13. A total of 25 out of 31 of the UC switched patients were in remission at the time of the switch.

The researchers found that 87.5% of switched patients with CD who were previously in remission remained so, and 66.7% and 50% of treatment-naïve patients with CD reached remission at months 3 and 6, respectively.

In switched patients with UC, 92% and 91.3% of patients in remission at the time of the switch maintained remission at 3 and 6 months, respectively. In treatment-naïve patients with UC, the remission rates were 44.4% and 66.7% at months 3 and 6, respectively.

The researchers report that there were serious adverse events (AEs) in 9 patients (7.5%), 6 of whom discontinued treatment due to AEs, which included the following:

• Skin reaction (1)
• Abdominal pain (1)
• Headaches (2)
• Paresthesias during infusion treatment (2)
• Sweet’s Syndrome (1)
• Polyarthralgia (2)

The researchers concluded that CT-P13 was efficacious and well tolerated in patients with CD or UC. “Response was maintained in 84% of switched CD and in 91.3% of switched UC patients, and clinical remission was reached in 50% of naïve CD and 70% of naïve UC patients,” they said, demonstrating the effectiveness and safety of CT-P13 at 3 and 6 months. However, continuing assessment of response in these patients over a longer period is necessary.