title: Assessment of anti-TNF-alpha efficacy in rheumatoid arthritis: is 3 months sufficient?
abstract: OBJECTIVE
  The optimal therapeutic trial duration of anti-TNF-alpha therapy is currently unknown. The British Society for Rheumatology (BSR) guidance states that non-response at 3 months warrants re-evaluation of treatment and recommends not to persist beyond 6 months. The National Institute for Health and Clinical Excellence (NICE) specifies treatment continuation if response is achieved by 6 months, yet the European League against Rheumatism (EULAR) and the American College of Rheumatology (ACR) maintain a 3 month cut-off. No evidence exists to support a 6 month therapeutic trial over 3 months. Thus, we undertook a study to evaluate the proportion of patients who failed to meet NICE response criteria at 3 months but obtained this by 6 months, and to identify predictive factors for this.
  
  
  METHODS
  Patients who commenced anti-TNF-alpha therapy for RA were studied, counting those who switched to a second or third agent separately for each instigation of therapy (n = 244). Response at 3 and 6 months was defined according to NICE criteria as a >or=1.2 reduction in Disease Activity Score (DAS28).
  
  
  RESULTS
  Of the 189 patients with available 3 month DAS28 responses, 149 fulfilled response criteria. Of the 40 who failed, 27 continued treatment, of whom 21 were available for follow-up at 6 months. Out of the 21 patients, 12 (57%; 95% CI 36, 78) achieved a response at this time. This data set was too small to investigate predictors of response at 6 months.
  
  
  CONCLUSIONS
  A substantial proportion of patients who fail NICE response criteria at 3 months and continue on treatment to 6 months achieve a response. These results support a 6 month therapeutic trial over 3 months.
authors.affiliation: Department of Rheumatology, Addenbrooke's Hospital, Cambridge CB2 2QQ, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Pocock
authors.forename: J C
authors.initials: JC
authors.lastname: Vasconcelos
authors.forename: A J K
authors.initials: AJ
authors.lastname: Ostör
mesh_terms: D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004334:Drug Administration Schedule; D006801:Humans; D017410:Practice Guidelines as Topic; D011379:Prognosis; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha