A PHASE 3 RANDOMISED CONTROLLED TRIAL TO COMPARE CT-P13 WITH INFLIXIMAB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS: 54 WEEK RESULTS FROM THE PLANETRA STUDY

Abstract

Background CT-P13 is a biosimilar product of infliximab (INX). Data up to week 30 has been reported at EULAR 2012.1Objectives To compare the efficacy and safety of CT-P13 and INX in active rheumatoid arthritis (RA) patients up to week 54.Methods Patients with active RA (1987 ACR criteria) and inadequate response to methotrexate (MTX) were randomised (1:1) to receive either CT-P13 (3mg/kg) or INX (3mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54 in combination with MTX (12.5?25mg/week).Results Of 606 patients randomised at baseline, 457 patients were treated up to week 54. At week 54, ACR20 was highly similar between groups (CT-P13, 57.0% [172/302]; INX, 52.0% [158/304]; 95% CI: -0.03?0.13). ACR50 and ACR70 scores were also comparable between groups (CT-P13, 33.1% and 16.2%; INX, 31.6% and 15.1%, respectively). In the CT-P13 and INX groups respectively, 26.4% and 27.8% of patients reached remission with DAS28-CRP; additionally, 14.3% and 14.8% reached low disease activity compared to approximately 80% high disease activity in both groups at baseline. The proportion of patients testing positive for anti-drug antibodies (ADAs) was comparable between CT-P13 (52.3%) and INX (49.5%). More patients with negative ADA results achieved ACR20 responses (CT-P13, 73.9%; INX, 67.2%) compared with patients with positive results (CT-P13, 53.2%; INX, 48.1%). Total Sharp scores at baseline and week 54 were comparable (CT-P13, 104.6 and 70.4; INX, 103.6 and 73.0). Cmax of CT-P13 or INX at all doses ranged from 66.1μg/mL?112.2μg/mL and 60.3μg/mL?104.5μg/mL, respectively. The safety profiles of CT-P13 and INX were also comparable (table).