PMID- 21557525
OWN - NLM
STAT- MEDLINE
DCOM- 20110707
LR  - 20151119
IS  - 2151-4658 (Electronic)
IS  - 2151-464X (Linking)
VI  - 63
IP  - 5
DP  - 2011 May
TI  - Effect of rituximab on physical function and quality of life in patients with 
      rheumatoid arthritis previously untreated with methotrexate.
PG  - 711-20
LID - 10.1002/acr.20419 [doi]
AB  - 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.
CI  - Copyright (c) 2011 by the American College of Rheumatology.
FAU - Rigby, William
AU  - Rigby W
AD  - Dartmouth Medical School, Lebanon, New Hampshire, USA. 
      william.rigby@dartmouth.edu
FAU - Ferraccioli, Gianfranco
AU  - Ferraccioli G
FAU - Greenwald, Maria
AU  - Greenwald M
FAU - Zazueta-Montiel, Beatriz
AU  - Zazueta-Montiel B
FAU - Fleischmann, Roy
AU  - Fleischmann R
FAU - Wassenberg, Siegfried
AU  - Wassenberg S
FAU - Ogale, Sarika
AU  - Ogale S
FAU - Armstrong, Gillian
AU  - Armstrong G
FAU - Jahreis, Angelika
AU  - Jahreis A
FAU - Burke, Laura
AU  - Burke L
FAU - Mela, Christopher
AU  - Mela C
FAU - Chen, Annie
AU  - Chen A
LA  - eng
SI  - ClinicalTrials.gov/NCT00299104
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Arthritis Care Res (Hoboken)
JT  - Arthritis care & research
JID - 101518086
RN  - 0 (Antibodies, Monoclonal, Murine-Derived)
RN  - 0 (Antirheumatic Agents)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Murine-Derived/administration & dosage/*therapeutic use
MH  - Antirheumatic Agents/administration & dosage/*therapeutic use
MH  - Arthritis, Rheumatoid/diagnosis/*drug therapy/physiopathology/psychology
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Methotrexate/administration & dosage/*therapeutic use
MH  - Middle Aged
MH  - *Quality of Life
MH  - Recovery of Function
MH  - Rituximab
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2011/05/11 06:00
MHDA- 2011/07/08 06:00
CRDT- 2011/05/11 06:00
PHST- 2011/05/11 06:00 [entrez]
PHST- 2011/05/11 06:00 [pubmed]
PHST- 2011/07/08 06:00 [medline]
AID - 10.1002/acr.20419 [doi]
PST - ppublish
SO  - Arthritis Care Res (Hoboken). 2011 May;63(5):711-20. doi: 10.1002/acr.20419.