NOVEL FORMULATION OF CT-P13 (INFLIXIMAB BIOSIMILAR) FOR SUBCUTANEOUS ADMINISTRATION: INITIAL RESULTS FROM A PHASE I OPEN-LABEL RANDOMIZED CONTROLLED TRIAL IN PATIENTS WITH ACTIVE CROHN'S DISEASE

Background: Intravenous (IV) CT-P13, an infliximab biosimilar, has shown comparable efficacy and safety to innovator infliximab in patients with active Crohn's disease (CD). 1 A novel subcutaneous (SC) formulation of CT-P13 is being developed to provide patients with opportunities for self-injection, which would lead to additional convenience and flexibility in treatment options.Objectives: The primary objective was to define the optimal dose of CT-P13 SC by pharmacokinetic (PK) comparability to IV dosing, supported by secondary evaluations of efficacy and overall safety over 30 weeks in patients with active CD.Methods: Patients with active CD (Crohn's Disease Activity Index [CDAI] score of 220 -450) were treated with CT-P13 IV (5 mg/kg) at Weeks 0 and 2. At Week 6, they were randomized into 4 cohorts (1:1:1:1 ratio).Cohort 1 was treated with CT-P13 IV (5 mg/kg, Weeks 6, 14, 22 and 30) and Cohorts 2, 3 and 4 were treated with CT-P13 SC 120 mg, 180 mg and 240 mg respectively, injected biweekly up to Week 30.Pharmacokinetic-pharmacodynamic (PK-PD) modeling was conducted to support dose finding and similarity.Results: In total, 44 patients were randomly assigned to 4 treatment cohorts.Overall, efficacy measures of CT-P13 SC were comparable to those of IV (change from baseline of CDAI, CDAI-70, CDAI-100 and clinical remission).Systemic safety profiles observed for CT-P13 SC after randomization were also comparable to those of IV.One patient each from Cohort 1 and 4 experienced hypersensitivity; only the patient from Cohort 1 was positive for anti-drug antibody (ADA).All injection site reactions were grade 1 or 2 in intensity.Proportion of patients with positive ADA was lower in the SC cohorts compared to the IV cohort (Table 1).PK-PD modeling based on the clinical results showed SC formulation bioavailability of 60% (95% CI, 52-66%).Dose linearity in 3 regimens was confirmed based on C max , C trough