title: A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.
abstract: OBJECTIVE
  To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS).
  
  
  METHODS
  Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed.
  
  
  RESULTS
  Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively.
  
  
  CONCLUSIONS
  The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, Republic of Korea. parkwon@inha.ac.kr
authors.forename: Won
authors.initials: W
authors.lastname: Park
authors.forename: Pawel
authors.initials: P
authors.lastname: Hrycaj
authors.forename: Slawomir
authors.initials: S
authors.lastname: Jeka
authors.forename: Volodymyr
authors.initials: V
authors.lastname: Kovalenko
authors.forename: Grygorii
authors.initials: G
authors.lastname: Lysenko
authors.forename: Pedro
authors.initials: P
authors.lastname: Miranda
authors.forename: Helena
authors.initials: H
authors.lastname: Mikazane
authors.forename: Sergio
authors.initials: S
authors.lastname: Gutierrez-Ureña
authors.forename: MieJin
authors.initials: M
authors.lastname: Lim
authors.forename: Yeon-Ah
authors.initials: YA
authors.lastname: Lee
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Lee
authors.forename: HoUng
authors.initials: H
authors.lastname: Kim
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yoo
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000097:blood* / Q000276:immunology / Q000627:therapeutic use; D000917:Antibody Formation; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000097:blood* / Q000276:immunology / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000097:blood* / Q000276:immunology / Q000627:therapeutic use; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000097:blood* / Q000188:drug therapy / Q000276:immunology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C000591237:CT-P13; D007074:Immunoglobulin G; D000069285:Infliximab