Subcutaneous infliximab could ‘transform’ how patients with IBD navigate care
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Subcutaneous infliximab achieved greater clinical remission and endoscopic response rates compared with placebo in patients with inflammatory bowel disease and has potential to become a more convenient, “patient-centric” treatment option.
“Infliximab has been used in clinical practice for more than 20 years, and it is known to be one of the most effective IBD treatments,” Nam Lee, PhD, medical director in the department of medical affairs at Celltrion Healthcare, told Healio. “However, given the inconvenience of intravenous route of administration of infliximab, a subcutaneous formulation could significantly increase convenience for patients with autoimmune conditions who require long-term treatment.”
Lee added: “A subcutaneous route of administration can be an alternative option for patients as it offers flexibility and removes the need to regularly travel to treatment centers, leading to increased autonomy and improved quality of life.”
At the ECCO ’23 Congress, results were presented from LIBERTY-UC and LIBERTY-CD, two randomized, placebo-controlled phase 3 trials that evaluated subcutaneous infliximab (Celltrion Healthcare, CT-P13 SC) as maintenance therapy for ulcerative colitis and Crohn’s disease, respectively. Researchers also assessed safety in both trials.
In LIBERTY-CD, 396 patients with moderate to severe CD were enrolled, of whom 343 achieved clinical response at 10 weeks to CT-P13 IV (5 mg/kg at weeks 0, 2 and 6) and were randomly assigned to receive CT-P13 SC 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 54 weeks, researchers reported that more patients achieved clinical remission in the CT-P13 SC group compared with the placebo group (62.3% vs. 32.1%, P < .0001), in addition to endoscopic response (51.1% vs. 17.9%, P < .0001). Safety profiles were similar between CT-P13 SC and placebo; however, one death was reported in the CT-P13 SC group during maintenance.
Similarly, in the LIBERTY-UC trial, 548 patients with moderate to severe UC were enrolled, of whom 438 responded to CT-P13 IV induction dosing (5 mg/kg at weeks 0, 2 and 6) and were randomized at 10 weeks to CT-P13 SC (n = 294) or placebo (n = 144). Clinical remission at week 54 served as the primary endpoint, while other endpoints included clinical response, endoscopic-histologic mucosal improvement and corticosteroid-free remission.
The rate of clinical remission at week 54 was greater in the CT-P13 SC group compared with placebo (43.2% vs. 20.8%, P < .0001), and statistically greater improvements in secondary endpoints were also noted with CT-P13 SC vs. placebo. Safety profiles were similar between the two treatment groups, with no deaths reported.
“Based on the results of LIBERTY studies, we anticipate that CT-P13 SC can be considered as a more patient-centric alternative treatment option given its clinical benefit and advantages such as convenience,” Lee said. “We believe that CT-P13 SC can transform how American patients navigate their care and manage chronic conditions, such as inflammatory bowel disease.”
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Sands BE, et al. Poster P492. Presented at: European Crohn’s and Colitis Organization; March 1-4, 2023; Copenhagen.
Colombel JF, et al. Presentation DOP86. Presented at: European Crohn’s and Colitis Organization; March 1-4, 2023; Copenhagen.
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