Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis.
OBJECTIVE
To investigate the effectiveness of 4 different treatment strategies for recent-onset rheumatoid arthritis (RA) on 2-year patient-reported outcomes, including functioning and quality of life.


METHODS
A total of 508 patients with recent-onset RA were randomly assigned to 1) sequential monotherapy, 2) step-up combination therapy, both starting with methotrexate, 3) initial combination therapy, including a tapered high-dose prednisone, or 4) initial combination therapy with methotrexate and infliximab. Treatment was adjusted every 3 months if the Disease Activity Score (DAS) remained >2.4. The McMaster Toronto Arthritis Patient Preference Disability Questionnaire, the Short Form 36 (SF-36), and scores for pain, global health, and disease activity measured on a 100-mm visual analog scale (VAS) were compared between groups at baseline and every 3 months thereafter for 2 years.


RESULTS
After 2 years, all patient-reported outcomes had improved significantly from baseline, irrespective of the treatment strategy. SF-36 subscale scores approached population norms for 3 physical components, and achieved population norms (P > 0.05) for bodily pain and 4 mental components. Improvement in functioning, VAS scores, and physical items of the SF-36 occurred significantly earlier in patients treated with initial combination therapies (all comparisons after 3 months: overall P < 0.001; P < 0.05 for groups 1 and 2 versus groups 3 and 4).


CONCLUSIONS
All 4 DAS-driven treatment strategies resulted in substantial improvements in functional ability, quality of life, and self-assessed VAS scores after 2 years. Initial combination therapy led to significantly faster improvement in all patient-reported measures.
van der Kooij
S M
SM
Leiden University Medical Center, Leiden, The Netherlands. smvanderkooij@lumc.nl
de Vries-Bouwstra
J K
JK
Goekoop-Ruiterman
Y P M
YP
Ewals
J A P M
JA
Han
K H
KH
Hazes
J M W
JM
Kerstens
P J S M
PJ
Peeters
A J
AJ
van Zeben
D
D
Breedveld
F C
FC
Huizinga
T W J
TW
Dijkmans
B A C
BA
Allaart
C F
CF
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D010147:Pain Measurement; D010361:Patients / Q000523:psychology; D011241:Prednisone / Q000627:therapeutic use; D011788:Quality of Life / Q000523:psychology; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D000069285:Infliximab; D011241:Prednisone; D008727:Methotrexate