title: Continued inhibition of structural damage over 2 years in patients with rheumatoid arthritis treated with rituximab in combination with methotrexate.
abstract: BACKGROUND
  Rituximab inhibited structural damage at 1 year in patients with rheumatoid arthritis (RA) who had had a previous inadequate response to tumour necrosis factor (TNF) inhibitors.
  
  
  OBJECTIVE
  To assess structural damage progression through 2 years.
  
  
  METHODS
  Intention-to-treat patients with one post-baseline radiograph (rituximab n=281; placebo n=187) received background methotrexate (MTX) and were randomised to rituximab (2 x 1000 mg infusions, 2 weeks apart) or placebo; patients were eligible for rituximab re-treatment every 6 months. By week 104, 82% of the placebo population had received > or = 1 dose of rituximab. Radiographic end points included the change in total Sharp score (TSS), erosion and joint space narrowing scores at week 104.
  
  
  RESULTS
  At week 104, significantly lower changes in TSS (1.14 vs 2.81; p<0.0001), erosion score (0.72 vs 1.80; p<0.0001) and joint space narrowing scores (0.42 vs 1.00; p<0.0009) were observed with rituximab plus MTX vs placebo plus MTX. Within the rituximab group, 87% who had no progression of joint damage at 1 year remained non-progressive at 2 years.
  
  
  CONCLUSIONS
  Rituximab plus MTX demonstrated significant and sustained effects on joint damage progression in patients with RA and a previously inadequate response to TNF inhibitors.
authors.affiliation: Metroplex Clinical Research Center, Dallas, Texas, USA. scohen@arthdocs.com
authors.forename: Stanley B
authors.initials: SB
authors.lastname: Cohen
authors.forename: Edward
authors.initials: E
authors.lastname: Keystone
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
authors.forename: Charles
authors.initials: C
authors.lastname: Peterfy
authors.forename: Paul Peter
authors.initials: PP
authors.lastname: Tak
authors.forename: Matt
authors.initials: M
authors.lastname: Cravets
authors.forename: Tim
authors.initials: T
authors.lastname: Shaw
authors.forename: David
authors.initials: D
authors.lastname: Hagerty
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D011859:Radiography; D000069283:Rituximab; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D000069283:Rituximab; D008727:Methotrexate