title: 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: OBJECTIVE
  To 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.
  
  
  METHODS
  Phase 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.
  
  
  RESULTS
  At 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.
  
  
  CONCLUSIONS
  CT-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 IDENTIFIER: NCT01217086.
authors.affiliation: Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea. dhyoo@hanyang.ac.kr
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yoo
authors.forename: Pawel
authors.initials: P
authors.lastname: Hrycaj
authors.forename: Pedro
authors.initials: P
authors.lastname: Miranda
authors.forename: Edgar
authors.initials: E
authors.lastname: Ramiterre
authors.forename: Mariusz
authors.initials: M
authors.lastname: Piotrowski
authors.forename: Sergii
authors.initials: S
authors.lastname: Shevchuk
authors.forename: Volodymyr
authors.initials: V
authors.lastname: Kovalenko
authors.forename: Nenad
authors.initials: N
authors.lastname: Prodanovic
authors.forename: Mauricio
authors.initials: M
authors.lastname: Abello-Banfi
authors.forename: Sergio
authors.initials: S
authors.lastname: Gutierrez-Ureña
authors.forename: Luis
authors.initials: L
authors.lastname: Morales-Olazabal
authors.forename: Michael
authors.initials: M
authors.lastname: Tee
authors.forename: Renato
authors.initials: R
authors.lastname: Jimenez
authors.forename: Omid
authors.initials: O
authors.lastname: Zamani
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Lee
authors.forename: HoUng
authors.initials: H
authors.lastname: Kim
authors.forename: Won
authors.initials: W
authors.lastname: Park
authors.forename: Ulf
authors.initials: U
authors.lastname: Müller-Ladner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D000069285:Infliximab; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D000069285:Infliximab; D008727:Methotrexate