Patients taking Remicade (infliximab) can safely switch to treatment with biosimilar CT-P13, sold as Pfizer’s Inflectra and Celltrion Healthcare’s Remsima, according to recently published results of a clinical study.
Results of the clinical trial were published with the title “Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial” in the journal The Lancet.
Inflammatory diseases such as psoriasis, rheumatoid arthritis (RA), and inflammatory bowel disease (IBD) include treatment with Remicade, an inhibitor of the inflammatory pathway TNF-alpha. But Remicade can be expensive, leading researchers to investigate whether switching to the less expensive CT-P13, a biosimilar, could be a viable option.
“In 2014, CT-P13 was recommended by Norwegian Health Authorities for patients starting treatment with [Remicade],” researchers wrote. “The cost saving for CT-P13 was 39% in 2014 compared with originator [Remicade], and increased to 69% after the 2015 tender. Thus, the introduction of biosimilar drugs could reduce financial burdens on health-care budgets. Additionally, biosimilars could improve overall and earlier access to these drugs in many countries with prescription restrictions based on their high cost.”
The Phase 4 NOR-SWITCH study (NCT02148640) enrolled 482 patients with inflammatory diseases taking Remicade. They were assigned to continue their treatment with Remicade or switch to CT-P13 (241 patients in each arm). Patients were followed up for 52 weeks.
The objective of the trial was to compare the effectiveness, safety, and the ability to regulate the immune system of Remicade compared to CT-P13. The trial’s primary endpoint was disease worsening during follow-up.
In the study, 30 (6%) had psoriatic arthritis; 35 (7%) had chronic plaque psoriasis; 155 patients (32%) had Crohn’s disease; 93 (19%) had ulcerative colitis; 91 (19%) had spondyloarthritis; and 77 (16%) had RA.
In the Remicade group, 53 patients (26.2%) experienced disease worsening, compared to 61 patients (29.6%) in the CT-P13 group, showing that both treatments had similar responses. The difference was not considered significant.
Also, Remicade and CT-P13 had similar safety profiles. In the Remicade group, nine patients (4%) discontinued treatment due to adverse events, compared to eight (3%) in the CT-P13 group.
“NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13,” Tore Kvien, the trial’s lead researcher, said in a news release.
“As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.”