P492 Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for ulcerative colitis: A Phase 3, randomized, placebo-controlled study: Results of the LIBERTY-UC study
Sands, B.E.(1)*;Hanauer, S.B.(2);Colombel, J.F.(3);Sandborn, W.(4);Schreiber, S.(5);Danese, S.(6);Klopocka, M.(7);Kulynych, R.(8);Kierkus, J.(9);Soltysiak, A.(10);Smolinski, P.(11);Gonciarz, M.(12);Sreckovic, S.(13);Valuyskikh, E.(14);Horynski, M.(15);Gasbarrini, A.(16);Kim, S.(17);Bae, Y.(17);Lee, S.(17);Lee, J.H.(17);Lee, J.(17);Lee, S.J.(18);Lee, S.G.(18);Kim, J.M.(18);
(1)Icahn School of Medicine at Mount Sinai, Dr. Henry D. Janowitz Division of Gastroenterology, New York, United States;(2)Northwestern University/ Feinberg School of Medicine, Gastroenterology and Hepatology, Chicago- IL, United States;(3)Icahn School of Medicine at Mount Sinai, Gastroenterology, New York, United States;(4)University of California San Diego, Gastroenterology, La Jolla, United States;(5)University Hospital Schleswig Holstein, Medicine I, Kiel, Germany;(6)IRCCS San Raffaele Hospital, Gastroenterology, Milan, Italy;(7)Nicolaus Copernicus University- Collegium Medicum in Bydgoszcz, Gastroenterology and Nutrition Disorders, Bydgoszcz, Poland;(8)Zaporizhzhia regional clinical hospital, Gastroenterology and Endoscopy, Zaporizhzhia, Ukraine;(9)The Children Memorial Health Institute, Gastroenterology- Hepatology- Feeding Disorders and Pediatrics, Warsaw, Poland;(10)Centrum Medyczne Lukamed Joanna Łuka, Centrum Medyczne Lukamed Joanna Łuka, Chojnice, Poland;(11)EuroMediCare Szpital Specjalistyczny, Gastroenterology Clinical Trials, Wroclaw, Poland;(12)Military Institute of Medicine - National Research Institute, Gastroenterology and Internal Diseases, Warsaw, Poland;(13)Clinical university hospital Zvezdara, Gastroenterology and hepatology, Belgrade, Serbia;(14)LLC Novosibirskiy Gastrocenter, Clinical Research, Novosibirsk, Russian Federation;(15)Endoskopia sp. Z o.o, Gastroentrology, Sopot, Poland;(16)Dipartimento Medicina e Chirurgia Traslazionale, Dipartimento Medicina e Chirurgia Traslazionale, Roma, Italy;(17)Celltrion- Inc., Medical Science Division, Incheon, Korea- Republic Of;(18)Celltrion- Inc., Data Science Institute, Incheon, Korea- Republic Of; CT-P13
Background
CT-P13 subcutaneous (SC) infliximab formulation was developed to provide patients with a convenient option for treatment. Previous studies have shown efficacy and safety of CT-P13 SC comparable to CT-P13 intravenous (IV) in inflammatory bowel disease (IBD)1 and rheumatoid arthritis2. This study aimed to demonstrate superiority of CT-P13 SC over placebo in maintenance therapy after induction therapy of CT-P13 IV in patients with ulcerative colitis (UC).
Methods
Patients with moderately to severely active UC (modified Mayo score 5 to 9 with endoscopic subscore of ≥ 2 points) were enrolled LIBERTY-UC (NCT04205643) and treated with open label CT-P13 IV 5 mg/kg at Weeks 0, 2 and 6 as induction therapy. At Week 10, patients who had a clinical response, defined as decrease in modified Mayo score from baseline of at least 2 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1 point, were randomised in a 2:1 ratio to receive either CT-P13 SC 120 mg (CT-P13 SC) or placebo SC arms every 2 weeks up to Week 54. The primary endpoint was clinical remission at Week 54. The key secondary endpoints of clinical response, endoscopic-histologic mucosal improvement, and corticosteroid-free remission were assessed at Week 54. Safety was evaluated up to Week 54.
Results
A total of 548 patients were enrolled. Among them, 438 patients (79.9%) responded to CT-P13 IV induction dosing and were randomised (294 in CT-P13 SC arm and 144 in placebo arm, respectively) at Week 10. The rate of clinical remission at Week 54 was significantly greater in CT P13 SC (43.2%) compared to placebo (20.8%) (P<0.0001). Clinical response, endoscopic-histologic mucosal improvement and corticosteroid-free remission also showed statistically greater improvement with CT-P13 SC treatment group, compared to placebo treatment group (Table 1).
The safety profile during maintenance phase was generally comparable between CT-P13 SC and placebo arms (table 2). No deaths were reported.
Conclusion
CT-P13 SC was more effective than placebo for clinical remission, clinical response, endoscopic histologic mucosal improvement, and corticosteroid-free remission at Week 54 in patients with moderately to severely active UC. No new safety concerns were identified. These results demonstrate that the CT-P13 SC provides both a robust clinical benefit and the convenience of SC administration to patient with moderately to severely active UC.
1 Schreiber et al., 2021. Gastroenterology 2021;160:2340–23
2 Westhovens et al., 2020. Rheumatology 2020;00:1