The effectiveness of early treatment with "second-line" antirheumatic drugs. A randomized, controlled trial.
OBJECTIVE
To compare two therapeutic strategies for patients with recent-onset rheumatoid arthritis.


METHODS
Open, randomized clinical trial.


METHODS
Outpatient clinics of six clinical centers.


METHODS
238 consecutive patients with recently diagnosed rheumatoid arthritis.


METHODS
Delayed or immediate introduction of treatment with slow-acting antirheumatic drugs (SAARDs).


METHODS
Primary end points were functional disability, pain, joint score, and erythrocyte sedimentation rate at 6 and 12 months and progression of radiologic abnormalities at 12 months.


RESULTS
Statistically significant advantages at 12 months for patients receiving the SAARD strategy (immediate treatment with SAARDs) with regard to all primary end points that may be clinically important are indicated by the differences in improvements from baseline and their 95% CIs. These differences were 0.3 (95% CI, 0.2 to 0.6) for disability (range, 0 to 3), 10 mm (CI, 1 to 19 mm) for pain (range, 0 to 100 mm), 39 (CI, 4 to 74) for joint score (range, 0 to 534), and 11 mm/h (CI, 3 to 19 mm/h) for erythrocyte sedimentation rate (range, 1 to 140 mm/h), all in favor of SAARD treatment. The SAARD strategy also appears to be advantageous at 6 months. Radiologic abnormalities progressed at an equal rate in the SAARD and the non-SAARD groups; the difference in progression (range, 0 to 448) was 1 (CI, -3 to 5). Analyses were based on the intention-to-treat principle and thus included 29% of patients in the non-SAARD group who discontinued the non-SAARD treatment strategy; treatment was usually discontinued because of insufficient effectiveness. The SAARD strategy including two alternative SAARDs could not be continued by 8% of patients, usually because of adverse reactions.


CONCLUSIONS
Early introduction of SAARDs may be more beneficial than delayed introduction for patients with recently diagnosed rheumatoid arthritis.
van der Heide
A
A
Department of Public Health, Faculty of Medicine, Erasmus University, Rotterdam, The Netherlands.
Jacobs
J W
JW
Bijlsma
J W
JW
Heurkens
A H
AH
van Booma-Frankfort
C
C
van der Veen
M J
MJ
Haanen
H C
HC
Hofman
D M
DM
van Albada-Kuipers
G A
GA
ter Borg
E J
EJ
Brus
H L
HL
Dinant
H J
HJ
Kruize
A A
AA
Schenk
Y
Y
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D001799:Blood Sedimentation; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000517:prevention & control; D010352:Patient Dropouts; D011859:Radiography
D000305:Adrenal Cortex Hormones; D018501:Antirheumatic Agents; D003692:Delayed-Action Preparations