title: Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study.
abstract: OBJECTIVE
  To investigate the efficacy and safety of certolizumab pegol (CZP) in a broad population of patients with active RA.
  
  
  METHODS
  In this 12-week, double-blind period of the phase IIIb trial, RA patients with inadequate response to at least one DMARD were randomized 4:1 to CZP (400 mg at weeks 0, 2 and 4, followed by 200 mg every 2 weeks) or placebo (every 2 weeks) plus current therapy stratified by previous TNF inhibitor use, concomitant methotrexate use and disease duration (<2 vs ≥2 years). The primary outcome was ACR20 response rate at week 12.
  
  
  RESULTS
  Of 1063 patients (CZP = 851; placebo = 212), 37.6% had previous TNF inhibitor use. Baseline mean HAQ Disability Index (HAQ-DI) and DAS 28-joint assessment-ESR [DAS28(ESR)] values were 1.5 and 6.4 in the CZP group, and 1.6 and 6.4 in the placebo group, respectively. The primary endpoint was significant (week 12 ACR20, CZP vs placebo: 51.1 vs 25.9%; P < 0.001); differences were noted at week 2 (31.8 vs 8.5%; P < 0.001). HAQ-DI and DAS28(ESR) change from baseline and ACR50 were significant from week 2. Week 12 ACR20 responses were similar across CZP patient subgroups regardless of concomitant DMARD use at baseline. Adverse and serious adverse events were comparable between CZP and placebo, with no new safety signals.
  
  
  CONCLUSIONS
  CZP was associated with rapid and consistent clinical responses and improved physical function in a diverse group of RA patients, irrespective of concomitant or previous therapy.
  
  
  BACKGROUND
  ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00717236.
authors.affiliation: Harvard Medical School, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA. mweinblatt@partners.org
authors.forename: Michael E
authors.initials: ME
authors.lastname: Weinblatt
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.forename: Tom W J
authors.initials: TW
authors.lastname: Huizinga
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.forename: Janet
authors.initials: J
authors.lastname: Pope
authors.forename: Elena M
authors.initials: EM
authors.lastname: Massarotti
authors.forename: Ronald F
authors.initials: RF
authors.lastname: van Vollenhoven
authors.forename: Jürgen
authors.initials: J
authors.lastname: Wollenhaupt
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.forename: Ben
authors.initials: B
authors.lastname: Duncan
authors.forename: Niti
authors.initials: N
authors.lastname: Goel
authors.forename: Owen R
authors.initials: OR
authors.lastname: Davies
authors.forename: Maxime
authors.initials: M
authors.lastname: Dougados
mesh_terms: 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; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol