Switching from originator infliximab to a biosimilar, CT-P13 (Inflectra), does not result in any change in efficacy or safety in IBD patients up to 18 months, new results from the NOR-SWITCH extension trial show.
Presenting findings from a six-month open label follow up of the 52-week NOR-SWITCH trial, researchers from Norway told DDW 2018 there were no significant differences in the key outcomes of disease worsening or remission for patients with Crohn’s disease or ulcerative colitis.
The original study findings, published in 2017, showed no difference at 52 weeks between 482 patients randomised to infliximab or CT-P13. In the open label extension, the remaining patients taking infliximab were switched to CT-P13 and followed for a further 26 weeks.
In the Extension phase, disease worsening rates were not significantly different for the 63 Crohn’s disease patients who were maintained on CT-P13 (20.6%) and 61 who switched to CT-P13 from infliximab (13.1%). Likewise there was no difference in disease worsening rates for the 39 patients with ulcerative colitis on maintenance arm of CT-P13 (15.4%) and the 35 patients who switched from infliximab (2.9%).
For disease remission there were also no significant difference for patients with Crohn’s disease (65.1% vs & 75.4% for maintenance and switch respectively) or for ulcerative colitis (82.1% vs 85.7%). Subgroup analysis showed no difference in other markers of IBD such as faecal calprotectin levels.
Rates of adverse events were similar for the maintenance and switch groups (44% vs 40%), and there were serious adverse events reported for 7% and 4% of patients in each group, respectively.
Immunogenicity rates were also not significantly different between grips, with 6.6% of patients in the maintenance group and 5.5% in the switch group showing anti-drug antibodies after 26 week extension period.
Study lead investigator Dr Kristin Jorgensen of the Department of Gastroenterology, Akershus University Hospital, Norway, said the latest results from NOR-SWITCH confirm that switching from originator to biosimilar is safe.
“Short versus long term treatment with CT-P13 is comparable regarding efficacy, tolerability and immunogenicity,” she said.
“These results support switching from originator infliximab to CT-P13 but we recommend caution in generalising these trends to other biologic agents, and further studies are needed to investigate multiple switches between biologic agents,” she added.
The study was funded by the Norwegian Ministry of Health and Care Services and the co-investigators said they had received grants and fees from marketers of originator and biosimilar products.
In a DDW 2018 panel discussion on biosimilars, Dr Peter Lakatos, a gastroenterologist at McGill University, Montreal, said the mounting evidence combined with Europe experience with biosimilars supported the full interchangeability biologics in IBD.
He pointed out that in his home country of Hungary, mandatory (non-medical) multiple switching between infliximab and its biosimilar did not results in any change in efficacy or safety in IBD patients.
“Confidence and experience is growing for switching in terms of efficacy, mucosal healing, safety and therapeutic drug monitoring,”
“In Europe, we have seen biosimilars can help address patients access and healthcare affordability,” he concluded.
In Australia, Remicade is the originator infliximab brand, but biosimilar Renflexis and Inflectra have been approved for PBS listing with “uptake drivers” of streamlined authority to encourage their prescribing.