title: Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.
abstract: BACKGROUND
  CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs).
  
  
  METHODS
  This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) 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. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed.
  
  
  RESULTS
  Of 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events, infections and infusion-related reactions.
  
  
  CONCLUSIONS
  CT-P13 and RP have highly comparable efficacy (including PROs) and PK up to week 54. Over a 1-year period, CT-P13 was well tolerated and displayed a safety profile comparable to RP; no differences in immunogenicity were observed.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01220518 . Registered 4 October 2010.
authors.affiliation: Inha University Hospital, Incheon, Republic of Korea. parkwon@inha.ac.kr.
authors.forename: Won
authors.initials: W
authors.lastname: Park
authors.affiliation: Hanyang University Hospital, Seoul, Republic of Korea. dhyoo@hanyang.ac.kr.
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yoo
authors.affiliation: Linea Corporis, Warszawa, Poland. januszjaworski@ymail.com.
authors.forename: Janusz
authors.initials: J
authors.lastname: Jaworski
authors.affiliation: Wojewodzki Szpital Zespolony w Elblagu, Elblag, Poland. janisb@poczta.onet.pl.
authors.forename: Jan
authors.initials: J
authors.lastname: Brzezicki
authors.affiliation: Institute of Urgent and Recovery Surgery, Donetsk, Ukraine. andrewgm@ya.ru.
authors.forename: Andriy
authors.initials: A
authors.lastname: Gnylorybov
authors.affiliation: University Hospital St. Marina, Varna, Bulgaria. vladimirkadinov@yahoo.com.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Kadinov
authors.affiliation: Prosalud y Cia Ltda, Santiago, Chile. agoecke@med.uchile.cl.
authors.forename: Irmgadt Goecke
authors.initials: IG
authors.lastname: Sariego
authors.affiliation: Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí, Mexico. c_abud@hotmail.com.
authors.forename: Carlos
authors.initials: C
authors.lastname: Abud-Mendoza
authors.affiliation: Servimed Empresa Unipersonal, Bucaramanga, Colombia. wiotero@gmail.com.
authors.forename: William Jose Otero
authors.initials: WJ
authors.lastname: Escalante
authors.affiliation: Chungnam National University Hospital, Daejeon, Republic of Korea. kangsw@cnuh.co.kr.
authors.forename: Seong Wook
authors.initials: SW
authors.lastname: Kang
authors.affiliation: P. Stradina Clinical University Hospital, Riga, Latvia. daina.andersone@stradini.lv.
authors.forename: Daina
authors.initials: D
authors.lastname: Andersone
authors.affiliation: Hospital Universitario a Coruña, A Coruña, Spain. francisco.blanco.garcia@sergas.es.
authors.forename: Francisco
authors.initials: F
authors.lastname: Blanco
authors.affiliation: CELLTRION, Incheon, Republic of Korea. SeungSuh.Hong@celltrion.com.
authors.forename: Seung Suh
authors.initials: SS
authors.lastname: Hong
authors.affiliation: CELLTRION, Incheon, Republic of Korea. SunHee.Lee@celltrion.com.
authors.forename: Sun Hee
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Rheumazentrum Ruhrgebiet, Herne, Germany. juergen.braun@elisabethgruppe.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D038622:Internationality; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D057566:Self Report / Q000592:standards; D013167:Spondylitis, Ankylosing / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab