title: Effect of the early use of the anti-tumor necrosis factor adalimumab on the prevention of job loss in patients with early rheumatoid arthritis.
abstract: OBJECTIVE
  To compare work disability and job loss in early rheumatoid arthritis (RA) patients receiving adalimumab plus methotrexate (adalimumab + MTX) versus MTX alone.
  
  
  METHODS
  In this multicenter, randomized, controlled trial, patients with RA for <2 years who had never taken MTX and who self-reported work impairment were randomized to adalimumab + MTX or placebo + MTX for 56 weeks. Primary outcome was job loss of any cause and/or imminent job loss at or after week 16. Secondary outcomes included disease activity, function (Health Assessment Questionnaire [HAQ] score), and RA quality of life (RAQoL) questionnaire score. Work was evaluated with work diaries and the RA Work Instability Scale.
  
  
  RESULTS
  Although job loss during the 56-week study was significantly lower with adalimumab + MTX (14 of 75 patients) compared with MTX alone (29 of 73 patients; P=0.005), the primary end point was not met (12 of 75 versus 20 of 73 patients; P=0.092), likely owing to early drop out in the MTX group. There were significant improvements in American College of Rheumatology 20% response criteria, 28-joint Disease Activity Score, DeltaHAQ, DeltaRAQoL, and working time lost in the adalimumab + MTX group. Twenty-four serious adverse events were reported in 17 participants, with no differences between groups.
  
  
  CONCLUSIONS
  Adalimumab + MTX reduced job loss and improved productivity in early RA when compared with MTX alone, which supports the early use of anti-tumor necrosis factor therapy and suggests its cost efficacy.
authors.affiliation: University of Leeds, Leeds, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Bejarano
authors.forename: Mark
authors.initials: M
authors.lastname: Quinn
authors.forename: Philip G
authors.initials: PG
authors.lastname: Conaghan
authors.forename: Richard
authors.initials: R
authors.lastname: Reece
authors.forename: Anne-Maree
authors.initials: AM
authors.lastname: Keenan
authors.forename: David
authors.initials: D
authors.lastname: Walker
authors.forename: Andrew
authors.initials: A
authors.lastname: Gough
authors.forename: Michael
authors.initials: M
authors.lastname: Green
authors.forename: Dennis
authors.initials: D
authors.lastname: McGonagle
authors.forename: Ade
authors.initials: A
authors.lastname: Adebajo
authors.forename: Stephen
authors.initials: S
authors.lastname: Jarrett
authors.forename: Sheelagh
authors.initials: S
authors.lastname: Doherty
authors.forename: Lesley
authors.initials: L
authors.lastname: Hordon
authors.forename: Richard
authors.initials: R
authors.lastname: Melsom
authors.forename: Kristina
authors.initials: K
authors.lastname: Unnebrink
authors.forename: Hartmut
authors.initials: H
authors.lastname: Kupper
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology*; D004359:Drug Therapy, Combination; D042241:Early Diagnosis; D004651:Employment; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab; D008727:Methotrexate