P957 Subcutaneous infliximab (CT-P13 SC) for ulcerative colitis: 2-year extension results of the LIBERTY-UC study

Abstract

Abstract Background Superiority of CT-P13 subcutaneous (SC) infliximab formulation over placebo in maintenance therapy was demonstrated in both ulcerative colitis1 and Crohn’s disease2. LIBERTY-UC study was continued up to Week 102 as an extension phase treatment. We now present the efficacy and safety results up to Week 102 of CT-P13 SC 120 mg group in the LIBERTY-UC study (NCT04205643). Methods Patients who completed the maintenance phase up to Week 54 and, in the opinion of the investigator, would benefit from continued treatment continued the open-label extension phase from Week 56 to Week 102. During extension phase, all patients received CT-P13 SC regardless of previous treatment group randomised at the start of maintenance phase. The patients who had received the adjusted dose of CT-P13 SC 240 mg during the maintenance phase continued receiving CT-P13 240 mg in the extension phase. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as not to achieve each endpoint. At Week 54 and 102, clinical remission, clinical response, endoscopic-histologic mucosal improvement and corticosteroid-free remission were assessed by among patients who entered and treated in extension phase (Figure 1A), and who entered and treated in extension phase and had valid efficacy results at the visit of interest (Figure 1B). Safety was evaluated throughout the extension phase. Results A total of 237 patients in CT-P13 SC 120 mg group entered into extension phase. Among them, 208 (87%) patients completed extension phase. Proportion of patients who achieved clinical remission, clinical response, endoscopic-histologic mucosal improvement and corticosteroid-free remission at Week 54 and Week 102 among patients who entered and treated in extension phase (i.e., patients who had missing or invalid data were considered as not to achieve each endpoint) are presented in Figure 1A. Among patients who entered and treated in extension phase based on the no imputation for missing or invalid data, each endpoints are generally well maintained or slightly higher in Week 102 compared to Week 54 (Figure 1B). During extension phase, no new safety signals were observed compared to maintenance phase1 (table 1). Conclusion The efficacy of CT-P13 SC 120 mg in UC patients was generally sustained through extension phase. No new safety concerns were found during the extension phase as well. These results indicate that long term use of CT-P13 SC can maintain clinical benefit as well as safety with the convenience of SC administration for patient with moderately to severely active UC. [1] Sands et al., Journal of Crohn's and Colitis, 2023.17(Supplement_1), i623-i624. [2] Colombel et al., Journal of Crohn's and Colitis, 2023.17.Supplement_1: i161-i162