A RANDOMISED, DOUBLE-BLIND, PARALLEL-GROUP, PHASE 1 STUDY COMPARING THE PHARMACOKINETICS, SAFETY AND EFFICACY OF CT-P13 AND INFLIXIMAB IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: 54 WEEK RESULTS FROM THE PLANETAS 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 assess the PK, efficacy and safety of CT-P13 in patients with active AS up to week 54 and to compare this with INX, also in relation to the formation of anti-drug antibodies (ADAs).Methods Patients with active AS (1984 modified NY criteria) were randomised (1:1) to receive either CT-P13 (5mg/kg) or INX (5mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54.Results Of 250 patients randomised at baseline, 213 patients were treated up to week 54. Cmax of CT-P13 and INX were shown to be equivalent, since 90% CIs for the ratio of geometric means were within 80?125% at all doses (CT-P13, 128.1μg/mL?172.2μg/mL; INX, 123.0μg/mL?176.7μg/mL). At week 54, the proportion of patients testing positive for ADAs was comparable between CT-P13 and INX (22.9% [25/109] vs 26.7% [28/105]). ADAs had similar effects on PKs in both groups. Patients with negative ADA results had higher Cmax values (CT-P13, 134.5μg/mL?177.2μg/mL; INX, 131.9μg/mL?177.4μg/mL) compared with patients with positive results (CT-P13, 101.8μg/mL?160.4μg/mL; INX, 104.0μg/mL?175.2μg/mL). At week 54, ASAS40 and ASAS partial remission were comparable between groups (CT-P13, 54.7% and 19.8%; INX, 49.1% and 17.6%, respectively). More patients with negative ADA results achieved ASAS40 responses (CT-P13, 61.0%; IFX, 54.7%) compared with patients with positive results (CT-P13, 37.9%; IFX, 36.4%). The safety profiles of CT-P13 and INX were also comparable (table). Active tuberculosis (TB) was reported in 3 patients (CT-P13, 2; INX, 1) and there were no malignancies.