P902 Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: 2 years results of the LIBERTY-CD study

Abstract

Background: CT-P13 subcutaneous (SC) infliximab formulation showed superiority over placebo as maintenance therapy at Week 54 in Crohn's disease (CD)1 and ulcerative colitis2. The LIBERTY-CD study1 included an extension phase up to Week 102, the results, of which, are reported. Method(s): Patients who completed the maintenance phase up to Week 54 and, in the opinion of the investigator, would benefit from continued treatment could continue the open-label extension phase from Week 56 to Week 102 and received CT P13 SC 120 mg regardless of the previous assigned arm of maintenance phase. Patients who had received the adjusted dose of CT-P13 SC 240 mg during the maintenance phase continued receiving the same doses in the extension phase. At Week 54 and Week 102, clinical remission, clinical response, endoscopic remission, endoscopic response, clinical remission (alternative definition) and corticosteroid-free remission were assessed for patients who were treated CT-P13 SC during the extension phase (Figure 1.A) or who were treated CT-P13 SC during the extension phase and had valid efficacy results at the visit of interest (Figure 1.B). Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter/non-responder. Safety was evaluated through the extension phase. Result(s): A total of 180 patients in the CT-P13 SC arm (assigned arm at the maintenance phase) entered into the extension phase. Overall, 85.6% (154/180) completed extension phase. Compared to the Week 54 results, efficacy results in the CT-P13 SC arm based on the non-responder imputation for missing or invalid data (i.e., patients who had missing or invalid data were considered as non-remitter/non-responder) were generally maintained in clinical remission, clinical response, endoscopic remission, endoscopic response, clinical remission (alternative definition), and corticosteroid-free remission at Week 102 (Figure 1.A). The efficacy results based on the no imputation for missing or invalid data (i.e., observed data) at Week 54 and Week 102 were similar (Figure 1.B). There was no new safety issue reported during the extension phase (Table 1). No death was reported during the extension phase. Conclusion(s): Efficacy of CT-P13 SC was maintained through the extension phase. No new safety concerns were observed during the extension phase. These results show that CT-P13 SC provides both a long-term clinical benefit and safety with the convenience of SC administration for moderately to severely active CD patients. (Figure Presented).