title: Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of 2-year administration of certolizumab pegol (CZP) + MTX in patients with active RA.
  
  
  METHODS
  Patients completing 52 weeks in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 1 trial (52-week completers), or withdrawing at week 16 due to lack of ACR20 response were eligible for open-label treatment (CZP 400 mg every other week + MTX). After 2 years' treatment, HAQ-Disability Index response, ACR20/50/70 responses, DAS-28 and radiographic progression were assessed in 52-week completers. ACR20/50/70 and DAS-28 were also calculated for the intent-to-treat (ITT) population. Adverse events were assessed in patients who received one or more CZP doses during the study.
  
  
  RESULTS
  At week 100, 88.9% (n = 216) of 52-week completers who originally received CZP 200 mg + MTX and open-label treatment remained in the study. In this group, ACR20/50/70 at week 100 were 68.2, 55.2 and 35.6%, respectively. HAQ-DI and DAS-28 improvements were sustained throughout the open-label extension (mean change -0.79 and -3.5 at week 100, respectively). A total of 46.7% (n = 113) of CZP 200 mg + MTX 52-week completers achieved low disease activity by week 100. Inhibition of radiographic progression was maintained. Similar findings were observed in 52-week completers who originally received CZP 400 mg + MTX and in the ITT population. Rates of serious infection or malignancies did not increase over time and no new safety signals were observed.
  
  
  CONCLUSIONS
  CZP + MTX provided sustained, 2-year inhibition of radiographic progression and sustained improvements in RA clinical signs and symptoms, with no new safety signals observed in patients who completed 2 years of treatment.
  
  
  BACKGROUND
  clinicaltrials.gov, http://www.clinicaltrials.gov, NCT00175877.
authors.affiliation: Mount Sinai Hospital, 60 Murray Street, Toronto, ON, Canada. edkeystone@mtsinai.on.ca
authors.forename: Edward C
authors.initials: EC
authors.lastname: Keystone
authors.forename: Bernard
authors.initials: B
authors.lastname: Combe
authors.forename: Josef
authors.initials: J
authors.lastname: Smolen
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.forename: Niti
authors.initials: N
authors.lastname: Goel
authors.forename: Ronald
authors.initials: R
authors.lastname: van Vollenhoven
authors.forename: Philip
authors.initials: P
authors.lastname: Mease
authors.forename: Robert
authors.initials: R
authors.lastname: Landewé
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.forename: Kristel
authors.initials: K
authors.lastname: Luijtens
authors.forename: Désirée
authors.initials: D
authors.lastname: van der Heijde
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D001175:Arthrography; D000068582:Certolizumab Pegol; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006304:Health Status; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D007596:Joints / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D020127:Recovery of Function; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol; D008727:Methotrexate