Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Long term studies with treat-to-target therapy are essential to guide treatment strategies. We report on a study that compared clinical and radiological outcomes of four treatment strategies in early rheumatoid arthritis (RA) patients after ten years of treat-to-target therapy.
Methods: The BeSt (Dutch acronym for Treatment Strategies) study enrolled 508 patients with recent onset RA. Patients were randomized to 1 of 4 treatment strategies: 1 sequential monotherapy, 2 step-up therapy, 3 initial combination therapy with prednisone, 4 initial combination therapy with infliximab. Treatment adjustments were made based on 3-monthly disease activity scores (DAS) measurements (DAS > 2.4: next treatment step; DAS ≤ 2.4 for ≥ 6 months: taper to maintenance dose, next if DAS < 1.6 for ≥ 6 months: stop last Disease-Modifying AntiRheumatic Drug). Functional ability (Health Assessment Questionnaire, HAQ) was analyzed with a linear mixed model (LMM) with time, treatment and time x treatment as independent variables. Annual radiographs were scored in one session by two independent and blinded readers (IM and GA) using the Sharp van der Heijde Score (SHS).
Results: Baseline characteristics in all groups were comparable (over all groups mean DAS 4.4, mean HAQ 1.4). 200 of 508 (39%) have dropped out of the study. Of them, 6 returned for the final visit. Thus, in total 314 patients (62%) completed 10 years follow-up.
Mean age of completers was 61 years and 68% were female. Mean (SD) DAS was 1.6 (0.8) and mean HAQ (SD) was 0.6 (0.6), comparable among the groups. 82% had a DAS ≤ 2.4, 53% had a DAS < 1.6 (DAS-remission), 15% were in drug free remission (DFR) with a mean (median) duration of 52 (58) months. After 10 years, 39% were still on the initial treatment step. Toxicity was similar in all groups. In table 1, outcomes per treatment strategy are shown.
Across groups, the initial functional improvement is maintained after 10 years of follow-up. Over time patients in group 4 have a significantly lower HAQ than patients in group 2 (0.52 versus 0.70, p= 0.03, other comparisons between groups non-significant).
After 10 years follow up there was no longer a significant difference in radiographic damage progression between groups, and progression was low in all groups. In patients with longstanding DFR mean SHS progression was 0.21 (median (IQR) 0.0 (0.0, 0.0)) per person year. Patients in longstanding DAS-remission (defined as mean DAS < 1.6 during year 5 to 10) had a mean SHS progression of 0.56 per year (median (IQR) 0.0 (0.0, 2.0)).
|
|
Group 1 |
Group 2 |
Group 3 |
Group 4 |
|
|
|
n=126 |
n=121 |
n=133 |
n=128 |
p-value |
|
Clinical Outcomes |
|||||
|
DAS, mean ± SD * |
1.7 ± 0.7 |
1.7 ± 0.8 |
1.5 ± 0.8 |
1.6 ± 0.8 |
0.333 |
|
HAQ, mean ± SD * |
0.6 ± 0.6 |
0.7 ± 0.6 |
0.5 ± 0.5 |
0.6 ± 0.6 |
0.121 |
|
DAS ≤ 2.44, n (%) * |
61 (85) |
43 (71) |
59 (84) |
75 (84) |
0.102 |
|
DAS < 1.6, n (%) * |
36 (50) |
28 (46) |
40 (57) |
50 (56) |
0.507 |
|
Drug free remission, n (%) * |
11 (14) |
11 (15) |
12 (15) |
13 (13) |
0.604 |
|
Still on initial treatment step, n (%) * |
21 (28) |
13 (19) |
33 (43) |
52 (59) |
< 0.001˟ |
|
Current use of infliximab, n (%) * |
14 (18) |
7 (10) |
9 (12) |
22 (24) |
0.080 |
|
Drop out, n (%) |
50 (40) |
53 (44) |
55 (41) |
36 (28) |
0.163 |
|
SAE, total n |
124 |
97 |
126 |
126 |
0.665 |
|
Patients with SAE, n (%) |
60 (48) |
50 (41) |
61 (46) |
63 (49) |
0.630 |
|
SHS progression |
|
|
|
|
|
|
Year 0-10, median (IQR)* |
2.0 (0.0 – 11.0) |
2.5 (0.0 – 13.5) |
3.0 (0.3 – 11.3) |
1.5 (0.0 – 6.0) |
0.390 |
|
Patients with ΔSHS > 5, n (%)* |
24 (38) |
23 (42) |
27 (42) |
21 (27) |
0.190 |
|
Patients with ΔSHS > 10, n (%)* |
16 (25) |
16 (29) |
18 (28) |
12 (15) |
0.196 |
|
* Completers analysis; ˟ Group 1 and 2 vs 4: p < 0.001, group 3 vs group 4 p < 0.05, group 2 vs group 3 p < 0.05 |
|||||
Conclusion: Ten years follow up in the BeSt study shows the benefit of continued treat-to-target therapy, steering at low disease activity. Of 508 patients, 62% completed follow up. After initial improvement no decline in function occurred. 53% of completers were in DAS remission, and 15% in prolonged drug free remission. Radiologic damage progression was low and no longer different between groups.
Disclosure:
I. M. Markusse,
None;
G. Akdemir,
None;
M. van den Broek,
None;
L. Dirven,
None;
R. J. Goekoop,
None;
K. H. Han,
None;
M. van Oosterhout,
None;
P. J. S. M. Kerstens,
None;
W. F. Lems,
W. F. Lems received speakers fee from roche, abbott, pfizer, merck,
5;
T. W. J. Huizinga,
TWJ 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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