Review Finds That Switching to Biosimilar Infliximab in Patients with IBD is Acceptable

The question of whether to switch patients from a reference biologic to an available biosimilar has been the subject of extensive debate, especially in patients with inflammatory bowel disease (IBD), an indication in which evidence on relevant clinical outcomes after switching is limited.

A newly published review sought to evaluate whether patients with IBD should be switched from the reference infliximab to CT-P13 (sold in the United States as Inflectra and in the European Union as Remsima). The researchers identified 24 studies, including 1326 patients with IBD, evaluating switches between the reference and the biosimilar.

Among these patients, disease control (defined as no evidence of disease worsening after a switch) was confirmed in 1163 patients (weighted mean [WM], 88%; 95% CI, 86%-89%). When only studies that included a follow-up from 4 to 8 months post-switch were included, the WM rose to 90% (95% CI, 89%-92%). When subanalyses were conducted in patients with Crohn disease (CD) and ulcerative colitis (UC), respectively, the WM were 86% (82%-89%) and 93% (89%-96%).

No unexpected adverse event (AEs) were reported in any of the included studies, and upon further evaluation, no differences in AEs were reported after switching versus before switching, and in the 1 randomized controlled trial included in the review (the NOR-SWITCH study), the frequencies of reported AEs were not different in patients who switched versus patients who did not switch.

Additionally, say the authors, no new safety or immunogenicity signals or changes in efficacy arose after a singled switch, though data on multiple switches are few. Because multiple switches could increase the likelihood of patients developing anti-drug antibodies, say the authors, repeated switching should be discouraged.

“The risks of switching to biosimilar products seem to be theoretical and not supported by the limited real world safety experience so far,” write the authors. They add that, in accordance with the European Crohn’s and Colitis Organisation’s position, a switch to the biosimilar from the reference infliximab is acceptable if a patients’ IBD disease is well controlled with the reference.

The decision to switch should be left in the hands of the treating physician, and physicians who do decide to switch a patient’s therapy must take an active role in educating the patient about the rationale for the change of therapy.

Reference

Gisbert JP, Chaparro M. Switching from an originator anti-TNF to a biosimilar in patients with inflammatory bowel disease: Can it be recommended? A systematic review. Gastroenterol Hepato. 2018:S0210-5705(18):30108-0. doi: 10.1016/j.gastrohep.2018.04.005.