RA Sufferers Can Safely Exchange Remicade with A lot Cheaper CT-P13 Remedy, Examine Concludes
Rheumatoid arthritis (RA) sufferers taking Remicade (infliximab) can safely change to CT-P13 (developed by Celltrion) — a less expensive biosimilar of Remicade — in line with a Norwegian examine revealed in The Lancet.
The examine, “Switching from originator infliximab to biosimilar CT-P13 in contrast with maintained remedy with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial,” was funded by Norway’s Ministry of Well being; it concerned 19 gastroenterology , 16 rheumatology and 5 dermatology departments from 25 hospitals all through the nation.
Therapy of RA and different inflammatory illnesses consists of infliximab, an inhibitor of the inflammatory pathway TNF-alpha. Nonetheless, the drug’s excessive value led researchers to analyze whether or not switching to the same however cheaper CT-P13 made sense.
“In 2014, CT-P13 was advisable by Norwegian well being authorities for sufferers beginning remedy with [Remicade],” wrote researchers, noting that CT-P13 was 39 p.c cheaper than Remicade in 2014, and 69 p.c cheaper in 2015, when the European patent for Remicade expired. “Thus, the introduction of biosimilar medicine may scale back monetary burdens on healthcare budgets. Moreover, biosimilars may enhance general and earlier entry to those medicine in lots of nations with prescription restrictions based mostly on their excessive value.”
The Part 4 NOR-SWITCH examine (NCT02148640) enrolled 482 sufferers with inflammatory illnesses being handled with Remicade. They have been then assigned to proceed their remedy with this drug or change to CT-P13 (241 sufferers in every group). Of the sufferers — all of whom have been adopted for 52 weeks — 32 p.c had Crohn’s illness, 19 p.c ulcerative colitis, 19 p.c spondyloarthritis, 16 p.c RA, 7 p.c persistent plaque psoriasis and 6 p.c psoriatic arthritis.
The trial aimed to check the 2 medicine’ efficacy, security and skill to manage the immune system. Its main endpoint was illness worsening throughout follow-up. Within the group assigned to obtain Remicade remedy, 53 sufferers (26 p.c) noticed their illness worsen, a consequence seen by 61 sufferers (30 p.c) within the CT-P13 group. This proved that the 2 therapies led to related outcomes.
Remicade and CT-P13 additionally had related security profiles, with severe antagonistic occasions reported in 24 p.c and 21 p.c of sufferers. 9 sufferers (4 p.c) within the Remicade group discontinued remedy as a result of antagonistic occasions, in comparison with eight affected person (3 p.c) within the CT-P13 group.
“Findings from the NOR-SWITCH trial confirmed that switching from [Remicade] … to CT-P13 was not inferior to continued remedy with [Remicade],” researchers wrote. “There was no suggestion of variations in security or immunogenicity between the 2 remedy teams. Consequently, the examine outcomes help that sufferers may be switched from originator to biosimilar [Remicade].”
