Switch From Remicade to Celltrion’s Biosimilar CT-P13 Safe in IBD, Clinical Trial Concludes

Switch From Remicade to Celltrion’s Biosimilar CT-P13 Safe in IBD, Clinical Trial Concludes

Patients with inflammatory bowel disease (IBD) may safely switch from Remicade (infliximab) to its biosimilar version CT-P13 — sold as Remsima and Inflectra — according to recently published clinical trial results.

Since many healthcare systems advocate switching to biosimilars because they’re cheaper, these findings should go a long way in assuring patients and their physicians contemplating the switch.

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,” appeared in The Lancet. Although its findings can be viewed as a victory for biosimilars, researchers stressed that the study pertains only to CT-P13, made by South Korea’s Celltrion Healthcare.

“The publication of the NOR-SWITCH data in The Lancet marks another important milestone on the path to increasing physician confidence in using biosimilar infliximab when looking to switch their patients,” a Celltron official said in a press release.

Since no two antibodies are identical — even if they target the same structure — copies of biological drugs are called biosimilars. As biosimilar versions of biological drugs usually come with a cheaper price tag, it is common practice for healthcare systems to promote their use. But patients, stable on the original drug — and their physicians — might be reluctant to switch.

Although biosimilars must go through clinical trials showing that they are, in fact, similar, data is lacking about the safety of switching from the original to a biosimilar version of a drug.

The NOR-SWITCH study (NCT02148640), funded by the Norwegian government, involved 482 patients, 241 of whom continued treatment with Remicade and 241 of whom switched to CT-P13. Of the total, 32 percent had Crohn’s disease and 19 percent had ulcerative colitis; the remaining 49 percent had other inflammatory conditions.

Among those who stayed on Remicade, 26 percent saw their IBD get worse, while 30 percent in the biosimilar group experienced worsening symptoms. The adjusted difference was calculated to 4.4 percent — not enough to be considered significant. According to the pre-specified protocol, the difference would need to exceed 15 percent to be relevant.

The time to disease worsening was similar in both groups, as was the average time for discontinuation among patients who stopped taking their respective drug. In both groups, 61 percent achieved remission. Adverse events also occurred to a similar extent in the two groups; 70 percent of patients taking Remicade and 68 percent of patients on the biosimilar CT-P13 reported at least one adverse event.

Serious adverse events were reported in 10 percent of Remicade and 9 percent of CT-P13 treated patients. Measurements of anti-drug antibodies — which might prevent a biological drug from working optimally — were similar as well.

“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,” said Dr. Tore K. Kvien, a rheumatology professor at Norway’s Diakonhjemmet Hospital and the study’s senior author. “As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.”

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