Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: To evaluate outcomes after 2 years of remission steered therapy in early arthritis patients.
Methods: 610 patients with early rheumatoid or undifferentiated arthritis (UA) were treated with methotrexate (MTX) and tapered high dose of prednisone. Patients in early remission (DAS<1.6) after 4 months, tapered prednisone to zero and when remission persisted after 8 months, also tapered MTX. Patients not in early DAS-remission were randomized to either MTX+hydroxychloroquine+sulphasalazine+prednisone (arm 1) or to MTX+adalimumab (arm2). Based on 4-monthly DAS evaluations, medication was restarted, increased or switched in case of no remission and tapered or stopped in case of remission. Proportions of DAS-remission, drug free remission (DFR) and radiological damage progression (increase Sharp-vanderHeijde Score ≥0.5) were analyzed separately for the treatment strategies and patients with RA and UA.
Results: 387 patients achieved early DAS-remission, 83 patients were randomized to arm 1 and 78 to arm 2 and 50 did not follow the protocol. After 2 years, 301/610 (49%) of all patients were in DAS-remission and 131/610 (21%) in DFR. Of the early remission group, 241/387 (62%) were in DAS-remission and 110/387 (28%) were in DFR. In arm 1, 22/83 (27%) were in DAS-remission compared to 24/78 (31%) in arm 2 (p=0.76), 7/83 (8%) were in DFR in arm 1 and 7/78 (9%) in arm 2 (p=0.90). Remission defined according to the proposed ACR/EULAR remission criteria was achieved in 138/610 (23%) patients; 117/387 (30%) in the early remission group, 2/83 (2%) in arm 1 and 14/78 (18%) in arm 2 (arm 1 vs. 2 p=0.001). There were no significant differences in DAS-remission rates between patients with RA (234/479, 49%) and patients with UA (64/122, 52%) (p=0.25). UA patients more often achieved DFR (41/122 (34%)) than RA patients (89/479 (19%), p<0.001). Over the first 2 years, DAS or HAQ were not significant different between arm 1 and 2 (mean difference (95%CI) DAS 0.01 (-0,2;0,2) and HAQ 0.1 (-0.1;0.2)).Of the total study population, 51/610 (8%) had radiological progression (increase SHS≥0.5), in the early remission group 34/387 (9%) patients showed progression, in arm 1 9/83 (11%) and in arm 2 5/78 (6%) (p arm 1 vs. arm 2=0.31). Median (IQR) SHS progression in all groups was 0 (0-0).
Conclusion: Patients who achieved early remission after 4 months most often achieved (drug free) remission after 2 years. Patients in arm 1 and 2 achieved lower but comparable (drug free) DAS-remission rates, probably due to remission steered treatment adjustments. This may also explain negligible radiographic damage progression. These results suggest that there is a window of opportunity where effective anti-rheumatic therapy can induce lasting remission and non-progression.
|
Early remission n = 387 |
Arm 1 n = 83 |
Arm 2 n = 78 |
p-value arm 1 vs. arm 2 |
Baseline |
|
|
|
|
Age in years, mean + SD |
52 ± 14 |
49 ± 14 |
51 ± 14 |
0.20 |
Female, n (%) |
240 (62) |
64 (77) |
58 (74) |
0.68 |
ACPA positive, n (%) |
225 (58) |
40 (48) |
37 (47) |
0.99 |
RA(2010), n (%) |
298 (77) |
66 (80) |
66 (85) |
0.32 |
DAS, mean + SD |
3.0 ± 0.8 |
3.6 ± 0.9 |
3.6 ± 1.0 |
0.91 |
HAQ, mean + SD |
1.0 ± 0.7 |
1.4 ± 0.6 |
1.4 ± 0.6 |
0.47 |
Total SHS, median (IQR) |
0 (0-0.5) |
0 (0-0) |
0 (0-0) |
0.75 |
2 years |
|
|
|
|
DAS, mean + SD |
1.3 ± 0.8 |
2.0 ± 0.7 |
1.9 ± 0.9 |
0.45 |
HAQ, mean + SD |
0.4 ± 0.5 |
0.9 ± 0.7 |
0.8 ± 0.7 |
0.55 |
DAS-remission, n (%) |
241 (62) |
22 (27) |
24 (31) |
0.76 |
Drug free remission, n (%) |
111 (29) |
6 (7) |
7 (9) |
0.73 |
ACR/EULAR remission, n (%) |
117 (30) |
2 (2) |
14 (18) |
0.001 |
Total SHS, median (IQR) |
0 (0-0.5) |
0 (0-1.1) |
0 (0-0) |
0.12 |
SHS progression≥0.5, n (%) |
34 (9) |
9 (11) |
5 (6) |
0.31 |
Disclosure:
L. Heimans,
None;
K. V. C. Wevers-de Boer,
None;
G. Akdemir,
None;
H. K. Ronday,
None;
T. H. E. Molenaar,
None;
J. H. L. M. Van Groenendael,
None;
A. J. Peeters,
None;
I. Speyer,
None;
G. Collee,
None;
P. B. de Sonnaville,
None;
B. A. Grillet,
None;
T. W. J. Huizinga,
Tom WJ Huizinga has received lecture fees/consultancy fees from Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, and Eli Lilly,
5;
C. F. Allaart,
None.
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