title: Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate.
abstract: OBJECTIVE
  To assess the effect of rituximab plus methotrexate (MTX) compared with MTX alone on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) in patients with active early rheumatoid arthritis (RA) previously untreated with MTX.
  
  
  METHODS
  Patients with active early RA were randomized to groups receiving placebo, rituximab 500 mg, or rituximab 1,000 mg. Rituximab was given by intravenous infusion on days 1 and 15. From week 24, patients with a Disease Activity Score in 28 joints-erythrocyte sedimentation rate of ≥2.6 were eligible for retreatment. Physical function was assessed by Health Assessment Questionnaire (HAQ) disability index (DI) and Short Form 36 (SF-36) scores. Patients achieving a minimal clinically important difference (MCID) for PROs were determined. Additional PROs, including fatigue and pain, were assessed.
  
  
  RESULTS
  A total of 748 patients were randomized and received the study drug. Patient characteristics were well balanced. At week 52, treatment with rituximab in both dose groups showed significant improvements in the HAQ DI compared to the MTX alone group (-0.905 and -0.916 in the rituximab 500 mg plus MTX and 1,000 mg plus MTX groups, respectively, versus -0.628 in the MTX alone group; P < 0.0001). Higher proportions of patients achieved MCID in the HAQ DI in the rituximab plus MTX groups compared to MTX alone. Treatment with rituximab plus MTX led to a significant reduction in the SF-36 physical component summary for both rituximab dose groups, but did not show statistically significant differences in the SF-36 mental component summary. Compared to the MTX alone group, both doses of rituximab plus MTX were associated with significant reductions in the patient global assessment of disease activity and pain, and a significantly higher improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores from baseline to 52 weeks.
  
  
  CONCLUSIONS
  Rituximab plus MTX was associated with significant improvement in physical function and HRQOL outcomes compared with MTX alone in patients previously untreated with MTX.
authors.affiliation: Dartmouth Medical School, Lebanon, New Hampshire, USA. william.rigby@dartmouth.edu
authors.forename: William
authors.initials: W
authors.lastname: Rigby
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferraccioli
authors.forename: Maria
authors.initials: M
authors.lastname: Greenwald
authors.forename: Beatriz
authors.initials: B
authors.lastname: Zazueta-Montiel
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.forename: Siegfried
authors.initials: S
authors.lastname: Wassenberg
authors.forename: Sarika
authors.initials: S
authors.lastname: Ogale
authors.forename: Gillian
authors.initials: G
authors.lastname: Armstrong
authors.forename: Angelika
authors.initials: A
authors.lastname: Jahreis
authors.forename: Laura
authors.initials: L
authors.lastname: Burke
authors.forename: Christopher
authors.initials: C
authors.lastname: Mela
authors.forename: Annie
authors.initials: A
authors.lastname: Chen
mesh_terms: D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004185:Disability Evaluation; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D020127:Recovery of Function; D000069283:Rituximab; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab; D008727:Methotrexate