PMID- 12563672
OWN - NLM
STAT- MEDLINE
DCOM- 20030512
LR  - 20221222
IS  - 0315-162X (Print)
IS  - 0315-162X (Linking)
VI  - 30
IP  - 2
DP  - 2003 Feb
TI  - Interleukin 1 receptor antagonist anakinra improves functional status in patients 
      with rheumatoid arthritis.
PG  - 225-31
AB  - OBJECTIVE: This study evaluated the benefit of anakinra, a human recombinant form 
      of interleukin 1 receptor antagonist, on the functional status of patients with 
      active rheumatoid arthritis (RA) despite taking maximally tolerated doses of 
      methotrexate (MTX). METHODS: Patients (n = 419) were randomized to receive, in 
      addition to MTX (15 to 25 mg/wk), placebo or anakinra doses of 0.04, 0.1, 0.4, 1, 
      or 2 mg/kg once daily for 24 weeks. Functional status measured on 8 scales 
      (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and 
      activities) was evaluated at baseline and every 4 weeks with the Health 
      Assessment Questionnaire (HAQ). A weighted sum of the scale scores is the HAQ 
      disability index (HAQ-DI). Primary analysis of the HAQ-DI was based on an omnibus 
      test for a positive dose-response relationship between anakinra treatment and 
      change in HAQ-DI from baseline to week 24. RESULTS: Patients receiving anakinra 
      experienced rapid and sizeable improvements in their HAQ-DI scores in a 
      dose-related fashion. For patients receiving either of the 2 highest doses of 
      anakinra, improvements in the HAQ-DI occurred by week 4 that were of a magnitude 
      considered clinically important and statistically significantly superior to 
      placebo. CONCLUSION: In patients with persistence of RA despite MTX therapy, 
      treatment with anakinra results in a rapid improvement in functional status as 
      measured by the HAQ-DI.
FAU - Cohen, Stanley B
AU  - Cohen SB
AD  - St. Paul Medical Center, Dallas, Texas, USA.
FAU - Woolley, J Michael
AU  - Woolley JM
FAU - Chan, Wing
AU  - Chan W
CN  - Anakinra 960180 Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Canada
TA  - J Rheumatol
JT  - The Journal of rheumatology
JID - 7501984
RN  - 0 (Antirheumatic Agents)
RN  - 0 (IL1RN protein, human)
RN  - 0 (Interleukin 1 Receptor Antagonist Protein)
RN  - 0 (Sialoglycoproteins)
SB  - IM
MH  - *Activities of Daily Living
MH  - Antirheumatic Agents/*administration & dosage
MH  - Arthritis, Rheumatoid/*drug therapy/psychology/rehabilitation
MH  - *Disability Evaluation
MH  - Female
MH  - Health Status
MH  - Humans
MH  - Interleukin 1 Receptor Antagonist Protein
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Sialoglycoproteins/*administration & dosage
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2003/02/04 04:00
MHDA- 2003/05/13 05:00
CRDT- 2003/02/04 04:00
PHST- 2003/02/04 04:00 [pubmed]
PHST- 2003/05/13 05:00 [medline]
PHST- 2003/02/04 04:00 [entrez]
AID - 0315162X-30-225 [pii]
PST - ppublish
SO  - J Rheumatol. 2003 Feb;30(2):225-31.