No Disease Activity Changes After Children With IBD Switched to Infliximab Biosimilar

A real world study in an adolescent and young adult inflammatory bowel disease (IBD) population found no significant differences in key laboratory markers or disease activity in patients who remained on the originator (Remicade) compared with those who switched to the biosimilar CT-P13 (Inflectra; infliximab-dyyb). Dosing regimens and the development of antidrug antibodies were also similar between groups over 1 year.

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Prior to this study there was limited data on switching from the reference infliximab to biosimilars in pediatric patients with IBD, according to the authors. They wrote, “patients and families should be reassured of the safety of switching to a biosimilar.”

Tumor necrosis factor (TNF)-α inhibitors are indicated for treatment of adults and children with inflammatory bowel disease (IBD). Infliximab was first approved for pediatric use in 2006. The first biosimilar, CT-P13 was approved by the European Medicines Agency in 2013 and FDA in 2016. Many children with IBD have been switched from the reference product to the biosimilar due to payer mandates. Although there is “ample” evidence in adults with IBD demonstrating equivalent effectiveness and safety of CT-P13 to the originator, the authors said, pediatric and adolescent data “remain limited.”

Since patients and families may be reluctant to switch when IBD has been controlled well on the originator, the authors conducted a real-world study in a large pediatric, adolescent, and young adult population with IBD undergoing a switch from the reference product to CT-P13. Patients aged 6 to 26 years with IBD treated at Connecticut Children Hospital, who had been treated with the reference product for at least 1 year, and had low disease activity or were in clinical remission were included in the retrospective case-control study. A total of 279 patients, most of whom (n = 243) had Crohn disease (CD), were included; 93 patients switched to CT-P13 and 186 remained on the reference product. In both groups the mean time since diagnosis was more than 6 years, and mean anti-TNF use duration more than 5 years.

At 6-month and 12-month time points, there were no significant changes in disease activity or laboratory markers including hemoglobin, albumin, C‐reactive protein, or erythrocyte sedimentation rate in either group. Differences between groups were not statistically significant. Rates of hospitalization, approximately 2%, were similar in the 2 groups.

Dosing changes were observed in both groups. Among the switched group, 4% of patients required a decrease in dose, 30% required an increase, and 66% did not require a change. In the reference product group, 17% required a decrease in dose, 34% required an increase, and 49% did not require a change. Antidrug antibodies were detected in “a small number of patients,” the authors said, 11.7% in the biosimilar group and 16.9% in the reference product group.

The authors noted their results are consistent with those of a previous, but a very small study (n = 12 participants), that found pediatric patients with IBD did not experience a change in disease activity following a switch to an infliximab biosimilar. To the authors’ knowledge, “this is the largest single‐center comparison of pediatric/adolescent and young adult patients who underwent a switch” from the reference product to CT-P13 or remained on the reference product.

The authors concluded there were “no changes in clinical course” following a switch from the infliximab reference product to CT-P13. They also called for future studies to include fecal markers of inflammation and endoscopic evaluation when appropriate, as well as studies spanning multiple centers.

The authors concluded, “It is imperative that providers anticipate patient and family concerns about therapy switches,” they wrote, adding “our data should be reassuring to providers, patients, and their families.”

Reference

Solomon V, Kuzoian S, Michel G, Brimacombe M, Hyams JS. Change from originator infliximab to biosimilar does not affect 1-year outcome in children with inflammatory bowel disease. JPGN Rep. 2024;5(4):442-446. doi:10.1002/jpr3.12134