PMID- 18050385
OWN - NLM
STAT- MEDLINE
DCOM- 20080311
LR  - 20151119
IS  - 0315-162X (Print)
IS  - 0315-162X (Linking)
VI  - 35
IP  - 1
DP  - 2008 Jan
TI  - Improved health-related quality of life for patients with active rheumatoid 
      arthritis receiving rituximab: Results of the Dose-Ranging Assessment: 
      International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) 
      Trial.
PG  - 20-30
AB  - OBJECTIVE: To evaluate the effect of rituximab treatment on health-related 
      quality of life (HRQOL) in patients with active rheumatoid arthritis (RA), who 
      have had an inadequate response to disease-modifying antirheumatic drugs, 
      including biologic agents. METHODS: A randomized, multicenter, double-blind, 
      placebo-controlled clinical trial involving 367 rheumatoid factor-positive 
      patients was conducted. Patients received 2 infusions 2 weeks apart of placebo (n 
      = 122), rituximab 500 mg (n = 123), or rituximab 1000 mg (n = 122), with or 
      without glucocorticoids. All patients received stable doses of methotrexate (10 
      25 mg/wk). Measures included SF-36, assessed at baseline and at 24 weeks, as well 
      as the HAQ and FACIT-Fatigue scale assessed at baseline and monthly for 24 weeks. 
      Patients exceeding prespecified minimal clinically important differences (MCID) 
      were examined. Clinical efficacy measurements (ACR20/50/70 and EULAR responses) 
      were compared with HRQOL outcomes. RESULTS: At 24 weeks, the rituximab 500 mg and 
      1000 mg groups both reported statistically significantly greater improvements on 
      the SF-36 physical component summary (4.37 and 4.89 points higher, respectively, 
      vs placebo; p < 0.001). SF-36 physical function, bodily pain, vitality, social 
      function, and role-physical subscale scores also statistically significantly 
      improved vs placebo. At 24 weeks, 62.6% and 67.2% of the rituximab 500 mg and 
      1000 mg groups, respectively, exceeded the MCID of 0.22 in HAQ (p < 0.001). For 
      FACIT-Fatigue, 55.3% and 65.6% of patients exceeded the MCID of 3.5 points 
      compared with 35.2% of placebo over 24 weeks (p < 0.001). ACR20/50/70 and EULAR 
      responders demonstrated greater improvements in mean baseline to 24 week changes 
      in SF-36 and FACIT-Fatigue scores compared with nonresponders (p < 0.05). 
      CONCLUSION: Both rituximab doses in combination with methotrexate were effective 
      in improving all HRQOL outcomes in patients with active RA consistent with 
      clinical efficacy.
FAU - Mease, Philip J
AU  - Mease PJ
AD  - Seattle Rheumatology Associates, Seattle, WA 98104, USA. pmease@nwlink.com
FAU - Revicki, Dennis A
AU  - Revicki DA
FAU - Szechinski, Jacek
AU  - Szechinski J
FAU - Greenwald, Maria
AU  - Greenwald M
FAU - Kivitz, Alan
AU  - Kivitz A
FAU - Barile-Fabris, Leonor
AU  - Barile-Fabris L
FAU - Kalsi, Jatinderpal
AU  - Kalsi J
FAU - Eames, Jennifer
AU  - Eames J
FAU - Leirisalo-Repo, Marjatta
AU  - Leirisalo-Repo M
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20071115
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Murine-Derived)
RN  - 0 (Immunologic Factors)
RN  - 0 (Immunosuppressive Agents)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Antibodies, Monoclonal/*administration & dosage
MH  - Antibodies, Monoclonal, Murine-Derived
MH  - Arthritis, Rheumatoid/complications/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Immunologic Factors/*administration & dosage
MH  - Immunosuppressive Agents/therapeutic use
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - Pain Measurement
MH  - *Patient Satisfaction
MH  - *Quality of Life
MH  - Rituximab
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2007/12/01 09:00
MHDA- 2008/03/12 09:00
CRDT- 2007/12/01 09:00
PHST- 2007/12/01 09:00 [pubmed]
PHST- 2008/03/12 09:00 [medline]
PHST- 2007/12/01 09:00 [entrez]
AID - 07/13/1115 [pii]
PST - ppublish
SO  - J Rheumatol. 2008 Jan;35(1):20-30. Epub 2007 Nov 15.