New data show that switching patients with Crohn’s disease to CT-P13 from the reference infliximab led to comparable efficacy, safety, and tolerability between the 2 treatments over a 24-week period. The full 54-week results of the phase 3 study support the long-term effectiveness of treatment with CT-P13, the researchers say.
New data show that switching patients with Crohn’s disease (CD) to CT-P13 (Inflectra) from the reference infliximab (Remicade) led to comparable efficacy, safety, and tolerability between the 2 treatments over a 24-week period. The full 54-week results of the phase 3 study support the long-term effectiveness of treatment with CT-P13, the researchers say.
The data, presented at the 25th United European Gastroenterology Week in Barcelona, Spain, follow previously reported study data that demonstrated non-inferiority of the biosimilar to its reference in biologic-naïve patients with CD at 6 weeks. The randomized, double-blind, parallel-group study was conducted in 220 patients with active CD, and overall safety and efficacy between the biosimilar and the reference was determined by CD Activity Index-70 (CDAI-70) response rates.
From week 30 to week 54, patients receiving the reference infliximab were randomized to either continue their treatment with the reference or to switch to the biosimilar, while patients who were receiving the biosimilar were randomized to either continue treatment with the biosimilar or switch to the reference product. Final study results were collected at week 54. Comparable efficacy, as measured by the CDAI-70 response and by clinical remission after week 6, was observed. Response rates were maintained—and observed to be similar—in all study arms at week 54.
One-year data, including adverse events, serious adverse events, and infections, were also similar among all treatment groups. No clinically meaningful differences in immunogenicity were observed up to week 54.
“These data support previous findings which demonstrate the importance of CT-P13 as a treatment option for patients with [CD], providing healthcare professionals further confidence when stable patients switch to CT-P13 from [Remicade],” said Stephen B. Hanauer, MD, professor of medicine, gastroenterology and hepatology, at the Feinberg School of Medicine at Northwestern University.
Pfizer Essential Health’s senior vice president and CMO, Sam Azoulay, MD, added that “These new data add to the considerable body of evidence, including real-world studies and the NOR-SWITCH trial, for the switching of stable patients to [Inflectra].”
The announcement of these latest results follows other positive news for Pfizer and Celltrion’s biosimilar infliximab; earlier this month, a new study reported that biosimilar CT-P13 was as safe and effective in the treatment of pediatric inflammatory bowel disease as the reference product, and that CT-P13 was associated with significant cost savings.
However, a Dutch study, also published this month, reported a 24% discontinuation rate among patients with inflammatory diseases who had switched from originator infliximab to CT-P13. The researchers found that most patients had discontinued their therapy for what were considered “subjective” reasons, including a perceived lack of efficacy or adverse events.