Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial.
BACKGROUND
Present treatment strategies for rheumatoid arthritis include use of disease-modifying antirheumatic drugs, but a minority of patients achieve a good response. We aimed to test the hypothesis that an improved outcome can be achieved by employing a strategy of intensive outpatient management of patients with rheumatoid arthritis--for sustained, tight control of disease activity--compared with routine outpatient care.


METHODS
We designed a single-blind, randomised controlled trial in two teaching hospitals. We screened 183 patients for inclusion. 111 were randomly allocated either intensive management or routine care. Primary outcome measures were mean fall in disease activity score and proportion of patients with a good response (defined as a disease activity score <2.4 and a fall in this score from baseline by >1.2). Analysis was by intention-to-treat.


RESULTS
One patient withdrew after randomisation and seven dropped out during the study. Mean fall in disease activity score was greater in the intensive group than in the routine group (-3.5 vs -1.9, difference 1.6 [95% CI 1.1-2.1], p<0.0001). Compared with routine care, patients treated intensively were more likely to have a good response (definition, 45/55 [82%] vs 24/55 [44%], odds ratio 5.8 [95% CI 2.4-13.9], p<0.0001) or be in remission (disease activity score <1.6; 36/55 [65%] vs 9/55 [16%], 9.7 [3.9-23.9], p<0.0001). Three patients assigned routine care and one allocated intensive management died during the study; none was judged attributable to treatment.


CONCLUSIONS
A strategy of intensive outpatient management of rheumatoid arthritis substantially improves disease activity, radiographic disease progression, physical function, and quality of life at no additional cost.
Grigor
Catriona
C
Gartnavel General Hospital, Glasgow G12 0YN, UK.
Capell
Hilary
H
Stirling
Anne
A
McMahon
Alex D
AD
Lock
Peter
P
Vallance
Ramsay
R
Kincaid
Wilma
W
Porter
Duncan
D
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D001175:Arthrography; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007270:Injections, Intra-Articular; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010146:Pain; D012074:Remission Induction; D016037:Single-Blind Method; D014222:Triamcinolone Acetonide / Q000008:administration & dosage
D000893:Anti-Inflammatory Agents; D018501:Antirheumatic Agents; D014222:Triamcinolone Acetonide