title: Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study.
abstract: OBJECTIVE
  To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.
  
  
  METHODS
  This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20% (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group).
  
  
  RESULTS
  Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7% vs 71.8% for ACR20, 48.0% vs 51.4% for ACR50 and 24.3% vs 26.1% for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3% vs 44.8%, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5% and 53.8%, respectively).
  
  
  CONCLUSIONS
  Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years.
  
  
  BACKGROUND
  NCT01571219; Results.
authors.affiliation: Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yoo
authors.affiliation: Clinical Center Banja Luka, Banja Luka, Bosnia.
authors.forename: Nenad
authors.initials: N
authors.lastname: Prodanovic
authors.affiliation: Reumatika Centrum Reumatologi, Warszawa, Poland.
authors.forename: Janusz
authors.initials: J
authors.lastname: Jaworski
authors.affiliation: Universidad de Chile and Centro de Estudios Reumatologicos, Santiago de Chile, Chile.
authors.forename: Pedro
authors.initials: P
authors.lastname: Miranda
authors.affiliation: Brokenshire Memorial Hospital, Davao City, Philippines.
authors.forename: Edgar
authors.initials: E
authors.lastname: Ramiterre
authors.affiliation: Mary Mediatrix Medical Center, Batangas, Philippines.
authors.forename: Allan
authors.initials: A
authors.lastname: Lanzon
authors.affiliation: Lithuanian University of Health Sciences, Kaunas, Lithuania.
authors.forename: Asta
authors.initials: A
authors.lastname: Baranauskaite
authors.affiliation: Medical University of Wroclaw, Wroclaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Wiland
authors.affiliation: Hospital Central and Faculty of Medicine, Universidad Autónoma de San Luis Potosí, San Luis Potosí, Mexico.
authors.forename: Carlos
authors.initials: C
authors.lastname: Abud-Mendoza
authors.affiliation: Military Medical Academy, Sofia, Bulgaria.
authors.forename: Boycho
authors.initials: B
authors.lastname: Oparanov
authors.affiliation: I.Ya. Horbachevsky Ternopil State Medical University, Municipal Institution of Ternopil Regional Council "Ternopil University Hospital", Ternopil, Ukraine.
authors.forename: Svitlana
authors.initials: S
authors.lastname: Smiyan
authors.affiliation: CELLTRION, Incheon, Republic of Korea.
authors.forename: HoUng
authors.initials: H
authors.lastname: Kim
authors.affiliation: CELLTRION, Incheon, Republic of Korea.
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: CELLTRION, Incheon, Republic of Korea.
authors.forename: SuYeon
authors.initials: S
authors.lastname: Kim
authors.affiliation: IN-HA University, School of Medicine, Medicine/Rheumatology, Incheon, Republic of Korea.
authors.forename: Won
authors.initials: W
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000906:Antibodies / Q000276:immunology; D000911:Antibodies, Monoclonal / Q000276:immunology / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000276:immunology / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D059451:Biosimilar Pharmaceuticals; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000276:immunology / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab; D008727:Methotrexate
keywords: Anti-TNF; DMARDs (biologic); Rheumatoid Arthritis; Treatment