Featuring: Stephen B. Hanauer, MD
Subcutaneous maintenance therapy with an infliximab biosimilar after IV induction resulted in sustained clinical remission and greater endoscopic response vs. placebo in patients with moderate to severe Crohn’s disease.
“In the past several years, there have been a number of formulations of infliximab that have met criteria for what is known as biosimilarity,” says Stephen B. Hanauer, MD, the Clifford Joseph Barborka Professor of Medicine at Northwestern University Feinberg School of Medicine, told Healio. “One of those formulations is CT-P13.”
He continued, “CT-P13 has now been formulated as a subcutaneous form for administration and is considered a new drug. When you change the administration forms, it no longer meets the criteria for biosimilarity. The subcutaneous form of CT-P13 has been developed for treatment across indications and in this study, was used to maintain improvement after patients received the standard three intravenous doses of infliximab.”
To assess the performance of subcutaneous CT-P13 vs. placebo, Hanauer and colleagues enrolled 396 patients with moderate to severe CD in the LIBERTY-CD study and initiated treatment with IV CT-P13 (5 mg/kg at weeks 0, 2 and 6) as induction therapy.
At week 10, participants who responded were randomly assigned to receive subcutaneous CT-P13 120 mg (n = 231) or placebo (n = 112) every 2 weeks for 54 weeks.
Clinical remission and endoscopic response served as primary endpoints, while clinical response, endoscopic remission and corticosteroid-free remission were secondary endpoints. At week 54, researchers assessed safety.
According to results, which were presented at Digestive Disease Week, patients who received subcutaneous CT-P13 achieved greater clinical remission at week 54 compared with those who received placebo (62.3% vs. 32.1%; P < .0001). The endoscopic response rate also was greater in the subcutaneous CT-P13 group compared with placebo (51.1% vs. 17.9%; P < .0001).
According to Hanauer, one benefit of subcutaneous CT-P13 compared with IV CT-P13 is that is sustains “much longer and much better” trough levels. “Since we have not seen any dose-related risks for this, the higher trough levels probably account for the somewhat better long-term remission and endoscopic improvements we have seen with the subcutaneous formulation compared to intravenous maintenance infliximab,” he said.
Subcutaneous CT-P13 also demonstrated significantly higher efficacy on key secondary outcomes compared with placebo, including clinical response (65.8% vs. 38.4%), endoscopic remission (34.6% vs. 10.7%) and corticosteroid-free remission (39.8% vs. 22.7%).
Researchers noted similar safety profiles between groups, although one death was reported during the maintenance phase in the subcutaneous CT-P13 group.
“The world is moving toward subcutaneous maintenance therapy and away from intravenous therapy,” Hanauer said. “It is more convenient for the patients, but importantly, the drug levels are sustained better. The overall outcome is actually improved by subcutaneous administration compared to intravenous infusions and maintenance treatment.”
This article was originally published on healio.com on June 1, 2023.
Stephen B. Hanauer, MD, the Clifford Joseph Barborka Professor and Professor of Gastroenterology and Hepatology at Northwestern Medicine
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