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Remicade biosimilar Inflectra shows safety, efficacy through 1 year in IBD
Patients with inflammatory bowel disease who switched from Remicade to its biosimilar Inflectra — marketed as Remsima in the U.K. — or maintained therapy through 1 year, showed comparable safety, efficacy and tolerability, according to new research presented at UEG Week.
“The data announced today show that 24 weeks (6 months) after switching from Remicade [infliximab, Janssen] to the infliximab biosimilar CT-P13 [infliximab-dyyb; Celltrion/Pfizer], patients with Crohn’s disease continue to experience similar efficacy, safety and tolerability compared to staying on Remicade,” Stephen B. Hanauer, MD, professor of medicine in the division of gastroenterology and hepatology at Feinberg School of Medicine, Northwestern University, said in a press release from Pfizer. “These data support previous findings which demonstrate the importance of CT-P13 as a treatment option for patients with Crohn’s disease, providing healthcare professionals further confidence when stable patients switch to CT-P13 from Remicade.”
As Healio Gastroenterology and Liver Disease previously reported, investigators shared 6-week data from this phase 3 randomized controlled trial at ECCO 2017, which showed Inflectra was non-inferior to Remicade in Crohn’s disease.
At UEG Week, investigators presented updated 54-week data on the 220 patients with active Crohn’s disease whom they randomly assigned to maintain or switch treatments at week 30 in a double-blind fashion.
Overall, 166 patients completed the study, and all four groups maintained comparable Crohn’s Disease Activity Index (CDAI)-70 response and clinical remission rates, Short Inflammatory Bowel Disease Questionnaire scores, and safety (including adverse drug reactions, serious adverse events and infections), through 54 weeks.
For example, 78.6% of patients who stayed on Inflectra achieved CDAI-70 scores vs. 70.9% of those who switched to Remicade. Further, 70.4% of those who stayed on Remicade vs. 76.4% of those who switched to Inflectra achieved CDAI-70 scores.
There were also “no clinically meaningful differences in immunogenicity” between groups, according to the study abstract.
The press release noted that these data were not powered to draw definitive conclusions, but add to the body of evidence supporting use of and switching to Inflectra from Remicade for patients with Crohn’s disease. This includes more than 50 real-world studies in over 7,500 IBD patients.
Updated data from the NOR-SWITCH Extension trial were also presented at UEG Week, further demonstrating Inflectra was non-inferior to Remicade in both patients with Crohn’s disease and ulcerative colitis.
As Healio Gastroenterology and Liver Disease previously reported, Jørgen Jahnsen, MD, PhD, professor of gastroenterology at the University of Oslo, Norway, presented 52-week data from the NOR-SWITCH trial at last year’s UEG Week. This year, he shared results from an exploratory subgroup analysis from the 26-week open-label extension study, which again showed similar outcomes between patients who switched from Remicade to Inflectra at week 52 or stayed on Inflectra for the whole 78 weeks.
Of the 451 patients in the main trial, 380 entered the extension study, with 16.8% who stayed on Inflectra and 11.6% of those who switched to Inflectra experiencing worsening of their disease, with an adjusted difference of –5.9% (95% CI, –12.9 to 1.1), which fell within the pre-specified non-inferiority margin of 15%. Researchers observed similar results in separate analyses of ulcerative colitis and Crohn’s patients. Adverse events and the development of anti-drug antibodies were also comparable between maintenance and switching arms.
Jahnsen and colleagues concluded this extension trial showed no differences in efficacy, safety, or immunogenicity between patients with either Crohn’s disease or ulcerative colitis who stayed on Inflectra or switched from Remicade to Inflectra. – by Adam Leitenberger
References:
Kim Y, et al. Abstract LB04. Presented at: UEG Week; Oct. 28 to Nov. 1, 2017; Barcelona.
Jørgensen KK, et al. Abstract LB06. Presented at: UEG Week; Oct. 28 to Nov. 1, 2017; Barcelona.
Disclosures: Pfizer and Celltrion funded these trials. Jahnsen reports he has served as a speaker, a consultant or an advisory board member for MSD, Tillot, Ferring, AbbVie, Celltrion, Hospira, Orion Pharma, Takeda, Napp Pharm, Meda, AstroPharma, Hikma, Janssen, Shire, Sandoz, MundiPharma and Pfizer. Hanauer reports financial relationships with AbbVie, Actavis, Amgen, Arena, Astra Zeneca, Baxter, Boehringer Ingelheim, Bristol-Myers Squibb, Catabasis, Celltrion, Cubist, Ferring, Genentech, Entera Health, GlaxoSmithKline, Hospira, Janssen, Lilly, Novartis, Novo Nordisk and Pfizer.