title: Early non-response to certolizumab pegol in rheumatoid arthritis predicts treatment failure at one year. Data from a randomised phase III clinical trial.
abstract: To compare different early clinical criteria of non-response determined at three months as predictors of clinical failure at one year in patients with rheumatoid arthritis starting therapy with certolizumab pegol.
  
  
  
  Data were derived from a randomised Phase III clinical trial in patients with rheumatoid arthritis who failed to respond to methotrexate monotherapy. Patients included in this post-hoc analysis were treated with certolizumab pegol (400mg qd reduced to 200mg qd after one month) and with methotrexate. The study duration was twelve months. Response at three months was determined with the American College of Rheumatology-50, Disease Assessment Score-28 ESR, Health Assessment Questionnaire and the Clinical Disease Activity Index. The performance of these measures at predicting treatment failure at twelve months defined by the American College of Rheumatology-50 criteria was determined, using the positive predictive values as the principal evaluation criterion.
  
  
  
  Three hundred and eighty two patients were available for analysis and 225 completed the twelve-month follow-up. At Week 52, 149 (38.1%) patients met the American College of Rheumatology-50 response criterion. Positive predictive values ranged from 81% for a decrease in Health Assessment Questionnaire- Disability index score since baseline >0.22 to 95% for a decrease in Disease Assessment Score-28 score since baseline≥1.2. Sensitivity was≤70% in all cases. Performance of these measures was similar irrespective of the definition of treatment failure at 12months.
  
  
  
  Simple clinical measures of disease activity can predict future treatment failure reliably and are appropriate for implementing treat-to-target treatment strategies in everyday practice.
authors.affiliation: Inserm UMRS 938, Department of Rheumatology, Saint-Antoine Hospital, AP-HP, UPMC, Paris 6 University, Inflammation-Immunopathology-Biotherapy Department (DHU i2B), 184, rue du Faubourg-Saint-Antoine, 75012 Paris, France. Electronic address: Francis.berenbaum@sat.aphp.fr.
authors.forename: Francis
authors.initials: F
authors.lastname: Berenbaum
authors.affiliation: Rheumatology Department, Aix-Marseille University, 13284 Marseille, France; Rheumatology Department, Sainte-Marguerite Hospital, AP-HM, 13009 Marseille, France.
authors.forename: Thao
authors.initials: T
authors.lastname: Pham
authors.affiliation: Laboratoire d'Investigation Clinique (LIC) EA4393, Rheumatology Department, AP-HP, Henri-Mondor hospital, Paris Est Créteil University, 94010 Créteil, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Claudepierre
authors.affiliation: Market Access Department, UCB Pharma, 92700 Colombes, France.
authors.forename: Thibault
authors.initials: T
authors.lastname: de Chalus
authors.affiliation: Market Access Department, UCB Pharma, 92700 Colombes, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Joubert
authors.affiliation: Market Access Department, UCB Pharma, 92700 Colombes, France.
authors.forename: Carine
authors.initials: C
authors.lastname: Saadoun
authors.affiliation: Institut Phisquare, Fondation Transplantation, 75015 Paris, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Riou França
authors.affiliation: Rheumatology Department, Paris 6 University-GRC UPMC-08, AP-HP, 75005 Paris, France; Rheumatology Department, Groupe Hospitalier Pitié-Salpêtrière, 75013 Paris, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Fautrel
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D000068582:Certolizumab Pegol / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D017211:Treatment Failure
chemical_list: D018501:Antirheumatic Agents; D000068582:Certolizumab Pegol; D008727:Methotrexate
keywords: Anti-TNF; DMARDs (biologic); Disease activity; Rheumatoid arthritis