Interleukin 1 receptor antagonist anakinra improves functional status in patients with rheumatoid arthritis.
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.


CONCLUSIONS
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.
Cohen
Stanley B
SB
St. Paul Medical Center, Dallas, Texas, USA.
Woolley
J Michael
JM
Chan
Wing
W
D000203:Activities of Daily Living; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000523:psychology / Q000534:rehabilitation; D004185:Disability Evaluation; D005260:Female; D006304:Health Status; D006801:Humans; D053590:Interleukin 1 Receptor Antagonist Protein; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012795:Sialoglycoproteins / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D018501:Antirheumatic Agents; C507763:IL1RN protein, human; D053590:Interleukin 1 Receptor Antagonist Protein; D012795:Sialoglycoproteins