title: Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients who could not receive methotrexate: 52-week results from an open-label extension of the HIKARI study.
abstract: OBJECTIVE
  To evaluate the long-term efficacy and safety of certolizumab pegol (CZP) treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients who could not receive methotrexate (MTX).
  
  
  METHODS
  HIKARI double-blind (DB) patients were entered into an open-label extension (OLE) study. Patients withdrawn at 16 weeks due to lack of efficacy and DB completers without a 24-week American College of Rheumatology (ACR)20 response received CZP 200 mg every 2 weeks (Q2W). DB completers with 24-week ACR20 responses were randomized to CZP 200 mg Q2W or CZP 400 mg every 4 weeks.
  
  
  RESULTS
  The ACR20/ACR50/ACR70 response rates of DB completers (n = 98) were 82.7%/56.1%/34.7% at OLE entry, and 83.7%/65.3%/48.0% at 52 weeks, respectively. Other clinical, functional, and radiographic outcomes were sustained during long-term administration of CZP, even without MTX. No new unexpected adverse events were observed during long-term CZP treatment. The efficacy and safety of CZP treatment were similar between the two dosing schedules.
  
  
  CONCLUSIONS
  Long-term CZP administration is efficacious and safe for RA patients. No obvious differences in clinical efficacy and safety were observed between the two dosing schedules. The choice between two maintenace regimens adds flexibility in administration schedules for RA patients and physicians.
authors.affiliation: First Department of Internal Medicine, University of Occupational and Environmental Health, Japan , Kitakyushu, Fukuoka , Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishiguro
authors.forename: Katsumi
authors.initials: K
authors.lastname: Eguchi
authors.forename: Akira
authors.initials: A
authors.lastname: Watanabe
authors.forename: Hideki
authors.initials: H
authors.lastname: Origasa
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Shoji
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Miyasaka
authors.forename: Takao
authors.initials: T
authors.lastname: Koike
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D001175:Arthrography; D000068582:Certolizumab Pegol; D018450:Disease Progression; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol
keywords: Certolizumab pegol; Monotherapy; Rheumatoid arthritis; TNF inhibitor; TNFα