Subcutaneous Remsima non-inferior to IV formulation
The intravenous and subcutaneous formulations of Remsima had comparable efficacy, safety and immunogenicity profiles in patients with inflammatory bowel disease, according to study results.
Byong Duk Ye, MD, PhD, from the department of gastroenterology and IBD center at University of Ulsan College of Medicine in South Korea, and colleagues wrote that the IV formulation of Remsima (CT-P13 IV, Celltrion) has an established role in the treatment of IBD, but a subcutaneous version (CT-P13 SC) has several potential benefits.
“Subcutaneous biologics may benefit IBD patients, including through improved ease of use increasing convenience, and reduced requirement for medical visits and associated travel,” they wrote. “SC biologics also offer potential benefits for health care systems, by optimizing medical resources and reducing associated costs.”
Researchers conducted a randomized, open-label, parallel-group study in patients with ulcerative colitis or Crohn’s disease naive to anti-TNF treatment. After providing CR-P13 IV at induction, investigators randomly assigned patients to receive CT-P13 SC every 2 weeks from week 6 to week 54 (n = 66) or CT-P13 IV every 8 weeks from week 6 to week 22 (n = 65).
At week 30, all patients who initially received the IV formulation switched to CT-P13 SC every 2 weeks until week 54.
The primary outcome of the study was non-inferiority of CT-P13 SC to IV for observed pre-dose drug concentration at week 22.
Ye and colleagues found that CT-P13 SC treatment exceeded their predefined non-inferiority margin. Drug trough levels that were achieved with subcutaneous treatment were consistently maintained above the target therapeutic concentration regardless of which formulation patients received after induction.
“Furthermore, efficacy and safety profiles were comparable between patients who had received CT-P13 SC throughout and those who had switched from CT-P13 IV to CT-P13 SC treatment at week 30,” Ye and colleagues wrote. “These findings support the novel CT-P13 SC formulation as a suitable therapeutic agent to expand and improve treatment options for patients with IBD.”