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Switching from Remicade to biosimilar Inflectra safe, effective through 1 year in IBD
Patients with inflammatory bowel disease who switched from Remicade to Inflectra showed no differences in drug levels or disease activity through 1 year of follow-up, indicating that the biosimilar is safe and effective, according to new research published in Alimentary Pharmacology & Therapeutics.
However, investigators noted that 26% of patients stopped therapy during follow-up, but said the high rate of discontinuation was “mostly due to elective withdrawal or subjective disease worsening.”
“Switching to biosimilars and performing therapeutic drug monitoring as part of routine care can optimize infliximab therapy of inflammatory bowel disease efficiently and make it more cost-effective,” Luc Derijks, PharmD, PhD, of the Máxima Medical Center in the Netherlands, said in a press release.
To assess the long-term safety and efficacy of biosimilars in IBD, Derijks and colleagues prospectively evaluated 133 patients (64% with Crohn’s disease, 36% with ulcerative colitis) from two hospitals in the Netherlands who received Remicade (infliximab, Janssen) for a median of 52 months and then switched to Inflectra (CT-P13/infliximab-dyyb; Celltrion). Forty-eight percent were also receiving concomitant immunosuppressive therapy, mostly thiopurines.
Patients switched therapies in a controlled setting as part of routine care, and through 1 year of follow-up, investigators assessed their disease activity and took blood samples right before their first, second, fourth and seventh infusions to measure infliximab trough levels, antibodies to infliximab (ATI), C-reactive protein and erythrocyte sedimentation rate.
Before switching, 82% of patients with CD and 90% of patients with UC were in remission or had mild disease. Further, they showed “widely varying” levels of infliximab before they switched to the biosimilar, with 40% of patients with CD and 27% of patients with UC showing levels within the therapeutic range (median, 3.5 µg/mL). Finally, 6% of patients showed ATI before switching, and infliximab therapy was discontinued in those with very high ATI.
After switching to CT-P13, which was given at the same dose and frequency for the most part, patients showed no significant differences in drug levels, C-reactive protein or disease activity scores at all four evaluations throughout follow-up. During this 12 months, 26% of patients stopped therapy, primarily due to subjective disease worsening (9%) and adverse events (9.8%), the most common of which included general malaise or fatigue, arthralgia, skin problems and infusion reactions.
According to Derijks and colleagues, although the number of dropouts was higher than in similar studies — in the NOR-SWITCH study, they noted, 1.2% of patients stopped treatment due to lack of effectiveness and 3% due to adverse events within 1 year — “this is probably due to the nonblinded setup of our study and the fact that a real-life cohort was monitored rather than a well-defined and preselected population, which induces the nocebo effect.”
They concluded that CT-P13 is safe and effective given the lack of differences in drug levels and disease activity after switching. – by Adam Leitenberger
Disclosures: The authors report no relevant financial disclosures.