A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study

Abstract

ObjectivesTo compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment.MethodsPhase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5–25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity.ResultsAt week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI −6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28–CRP, ACR–EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively.ConclusionsCT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX.ClinicalTrials.gov IdentifierNCT01217086

The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis

“…1): screening, treatment period 1 (weeks 0-12), treatment period 2 (weeks [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] and an extension phase (weeks 31-52). In treatment period 1, patients were randomized 1 : 1 to self-administer 50 mg GP2015 or 50 mg ETN (Enbrel â ; Amgen Inc., Thousand Oaks, CA, U.S.A.; European Union authorized) twice weekly, subcutaneously.…”

Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea

“…CT-P13 (Remsima Ò , Inflectra Ò ) is a biosimilar of the infliximab reference medicinal product (RMP; Remicade Ò ) that was approved in Europe for all indications relevant for the RMP based on extensive comparability studies in vitro and in healthy human subjects and patients with RA and AS [11][12][13][14]. It is noteworthy that, following their guidelines on the evidence required for such a process, European regulators extrapolated comparability data observed between CT-P13 and RMP in rheumatic diseases to approve use in CD and UC [15].…”

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…46,75,76 The approval of CT-P13 was based on a full comparison exercise with originator infliximab, which included head-to-head clinical trials in patients with ankylosing spondylitis and RA. 77,78 Authorization of CT-P13 in Brazil represented the first approval of a mAb biosimilar via ANVISA’s comparative pathway. 79 Since that time, ANVISA has approved an etanercept biosimilar (SB4; Brenzys™) and a trastuzumab biosimilar (MYL-1401O; Zedora).…”

“…129–132 As mentioned, the submission package for the first of these, CT-P13, included data from initial comparative trials in RA and ankylosing spondylitis, 77,78 and in most cases regulatory authorities allowed extrapolation to other eligible indications, including Crohn’s disease and ulcerative colitis. 133 There was much debate on the issue of approval for extrapolated IBD indications.…”