title: Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: the HIKARI randomized, placebo-controlled trial.
abstract: OBJECTIVE
  This 24-week, placebo-controlled, double-blind, randomized study (NCT00791921) investigated efficacy and safety of certolizumab pegol (CZP) in Japanese rheumatoid arthritis (RA) patients in whom methotrexate (MTX) cannot be administered.
  
  
  METHODS
  A total of 230 patients were randomized to subcutaneous CZP 200 mg (induction dosing: 400 mg at Weeks 0, 2 and 4) or placebo every 2 weeks.
  
  
  RESULTS
  ACR20 responses with CZP were rapid and significant versus placebo at Week 1, sustained to Week 12 (67.2% vs. 14.9%) and Week 24 (63.8% vs. 11.4%). Week 24-modified Total Sharp Score (mTSS) change from baseline (CFB) was 0.48 (CZP) versus 2.45 (placebo). CZP treatment was associated with higher Week 12 ACR20 responses versus placebo (with non-MTX disease modifying antirheumatic drugs [DMARDs], 74.2% vs. 20.0%; without [monotherapy], 59.3% vs. 8.2%) and inhibition of radiographic progression at Week 24 (mTSS CFB; with non-MTX DMARDs, 0.24 vs. 1.61; monotherapy, 0.68 vs. 3.65). Incidences of serious adverse events were 11.2% (CZP) and 2.6% (placebo); one CZP patient died of dissecting aortic aneurysm.
  
  
  CONCLUSIONS
  CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX cannot be administered resulted in rapid, sustained reductions in RA signs and symptoms. Notably, CZP monotherapy showed significant inhibition of radiographic progression.
authors: Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo , Tokyo , Japan.
authors: Kazuhiko
authors: K
authors: Yamamoto
authors: Tsutomu
authors: T
authors: Takeuchi
authors: Hisashi
authors: H
authors: Yamanaka
authors: Naoki
authors: N
authors: Ishiguro
authors: Yoshiya
authors: Y
authors: Tanaka
authors: Katsumi
authors: K
authors: Eguchi
authors: Akira
authors: A
authors: Watanabe
authors: Hideki
authors: H
authors: Origasa
authors: Koichi
authors: K
authors: Iwai
authors: Yoshiharu
authors: Y
authors: Sakamaki
authors: Désirée
authors: D
authors: van der Heijde
authors: Nobuyuki
authors: N
authors: Miyasaka
authors: Takao
authors: T
authors: Koike
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D000068582:Certolizumab Pegol; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol; D008727:Methotrexate
keywords: Certolizumab pegol; Monotherapy; Randomized controlled trial; Rheumatoid arthritis; Tumor necrosis factor-alpha inhibitor