Rheumatoid arthritis (RA) patients taking Remicade (infliximab) can safely switch to CT-P13 (developed by Celltrion) — a much cheaper biosimilar of Remicade — according to a Norwegian study published in The Lancet.
The study, “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,” was funded by Norway’s Ministry of Health; it involved 19 gastroenterology , 16 rheumatology and five dermatology departments from 25 hospitals throughout the country.
Treatment of RA and other inflammatory diseases includes infliximab, an inhibitor of the inflammatory pathway TNF-alpha. However, the drug’s high cost led researchers to investigate whether switching to the similar but less expensive CT-P13 made sense.
“In 2014, CT-P13 was recommended by Norwegian health authorities for patients starting treatment with [Remicade],” wrote researchers, noting that CT-P13 was 39 percent cheaper than Remicade in 2014, and 69 percent cheaper in 2015, when the European patent for Remicade expired. “Thus, the introduction of biosimilar drugs could reduce financial burdens on healthcare 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 being treated with Remicade. They were then assigned to continue their treatment with this drug or switch to CT-P13 (241 patients in each group). Of the patients — all of whom were followed for 52 weeks — 32 percent had Crohn’s disease, 19 percent ulcerative colitis, 19 percent spondyloarthritis, 16 percent RA, 7 percent chronic plaque psoriasis and 6 percent psoriatic arthritis.
The trial aimed to compare the two drugs’ efficacy, safety and ability to regulate the immune system. Its primary endpoint was disease worsening during follow-up. In the group assigned to receive Remicade treatment, 53 patients (26 percent) saw their disease get worse, a result seen by 61 patients (30 percent) in the CT-P13 group. This proved that the two treatments led to similar outcomes.
Remicade and CT-P13 also had similar safety profiles, with serious adverse events reported in 24 percent and 21 percent of patients. Nine patients (4 percent) in the Remicade group discontinued treatment due to adverse events, compared to eight patient (3 percent) in the CT-P13 group.
“Findings from the NOR-SWITCH trial showed that switching from [Remicade] … to CT-P13 was not inferior to continued treatment with [Remicade],” researchers wrote. “There was no suggestion of differences in safety or immunogenicity between the two treatment groups. Consequently, the study results support that patients can be switched from originator to biosimilar [Remicade].”