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Comparable Long-Term Efficacy, as Assessed by Patient-Reported Outcomes, Safety and Pharmacokinetics, of CT- P13 and Reference Infliximab
Arthritis Research & Therapy (01/20/2016) Vol. 18, No. 1, P. 25; Park, W.; Yoo, D.H.; Jaworski J.
Korean researchers sought to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK), and safety of CT-P13, a biosimilar of infliximab (Remicade) approved in Europe, with the reference product (RP) in patients with ankylosing spondylitis (AS). The multinational, double-blind, parallel-group study involved 250 patients with active AS. Participants were randomized to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. At 54 weeks, Assessment of Spondylo Arthritis international Society (ASAS) 20 response, ASAS40 response, and ASAS partial remission were comparable between treatment groups. Changes from baseline in patient-reported outcomes--such as mean Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, and Short Form Health Survey scores--were similar between treatment groups. The researchers report that 19.5 percent and 23 percent of patients receiving CT-P13 and RP, respectively, had anti-drug antibodies. According to the authors, CT-P13 and infliximab were found to have highly comparable efficacy and PK up to week 54, with no differences seen in immunogenicity.
Abstract News © 2016 INFORMATION, INC.
