Session Information
Title: Rheumatoid Arthritis - Clinical Aspects: Novel Biomarkers and Other Measurements of Disease Activity
Session Type: Abstract Submissions (ACR)
Background/Purpose The prediction of radiographic progression in early rheumatoid arthritis (eRA) patients is important for optimal treatment. We previously demonstrated that a multi-biomarker disease activity (MBDA) score (Vectra DA®) at baseline (BL) was predictive for radiographic progression over the first year of treatment of eRA patients from the Swedish Farmacotherapy (SWEFOT) trial. The objective of this study was to evaluate the MBDA score, at different time-points and its change during treatment, as a predictor of radiographic progression over the first two years of treatment in eRA patients.
Methods The analyses were performed on radiographic progression of patients from the SWEFOT trial, assessed by van der Heijde modified Sharp scores (SHS) from BL to years 1 and 2 (n=220) and from Year 1 to Year 2 (n=133); and on the MBDA and disease activity scores (DAS28) and C-reactive protein (CRP) at BL (n=220), Month 3 (n=220) and Year 1 (n=133). Radiographic progression was defined as ΔSHS>5. Mann-Whitney U and Chi-square tests were used for comparisons of disease activity measures between progressors and non-progressors, and for determining significance of proportion of radiographic progressors.
Results
The median values for year 1-progressors (n=41) and non-progressors (n=179) were MBDA score, 70 and 58 (p=0.001); CRP (mg/L) 28 and 18 (p=0.049); and DAS28, 6.1 and 5.7 (p=0.136), respectively. After 3 months of MTX therapy the corresponding values were 48 and 40 (p=0.001), 9 and 9 (p=0.213), and 4.8 and 4.0 (p=0.009), respectively. At BL, 3 months and 1 year, patients with low MBDA score had a lower mean ΔSHS and a smaller proportion of subsequent radiographic progressors than those with low CRP or low DAS28 (table).
The highest risk for progression from BL to year 1 or 2 (25% and 41%, respectively), or from year 1 to year 2 (32%), was observed among patients with high MBDA score at BL which remained high at 3 or 12 months. In contrast, much lower risk of radiographic progression from BL to year 1 and 2 was detected among those patients whose BL high MBDA score dropped to low by month 3 (6% and 18% respectively) and very low risk of radiographic progression from Year 1 to Year 2 was among those patients who achieved low MBDA score by month 12 (4%). All patients with persistent low MBDA score throughout 1 year did not progress radiographically over 2 years. Those who had a moderate MBDA score at BL and achieved low MBDA at months 3 or 12 did not progress either.
|
Disease activity time-point |
Time-period for radiographic progression |
Proportion of Radiographic progressors (DSHS>5) |
||||||||
|
MBDA score |
CRP (mg/L) |
DAS28 |
||||||||
|
Low (<30) |
Moderate (>29-44) |
High (>44) |
Low (≤10) |
Moderate (>10-30) |
High (>30) |
Low (≤3.2) |
Moderate (>3.2-5.1) |
High (>5.1) |
||
|
BL |
From BL to year 2 (n=220) |
0/5 0.0% |
5/28 17.9% |
60/187 32.1% |
13/66 19.7%* |
18/72 25.0%* |
34/82 41.5%* |
NA |
18/64 28.1% |
47/156 30.1% |
|
Month 3 |
From BL to year 1 (n=220) |
1/33 3.0%* |
14/91 15.4%* |
24/96 25.0%* |
23/157 14.6% |
5/39 12.8%* |
11/24 45.8% |
10/78 12.8% |
14/87 16.1% |
15/55 27.3% |
|
|
From BL to year 2 (n=205) |
3/33 9.1%* |
21/82 25.6%* |
37/90 41.1%* |
34/147 23.1%* |
16/38 42.1%* |
11/20 55.0%* |
17/72 23.6% |
26/82 31.7% |
18/51 35.3% |
|
Year 1 |
From year 1 to year 2 (n=133) |
2/60 3.3%* |
3/36 8.3%* |
12/37 32.4%* |
10/112 8.9%* |
4/14 28.6%* |
3/7 42.9%* |
4/66 6.1%* |
8/54 14.8%* |
5/13 38.5%* |
|
|
ΔSHS Mean (median) |
|||||||||
|
BL |
ΔSHS from BL to year 1 |
0.8 (0) |
1.1 (0) |
3.4 (1) |
2.1 (0) |
2.1 (0) |
4.7 (2) |
NA |
2.4 (1) |
3.3 (1) |
|
Month 3 |
ΔSHS from BL to year 1 |
0.5 (0) |
2.3 (1) |
4.7 (3) |
2.1 (0) |
3.9 (3) |
7.6 (4.5) |
2.1 (0) |
2.7 (1) |
5.0 (1) |
|
|
ΔSHS from BL to year 2 |
1.5 (0) |
3.6 (2) |
7.2 (4.5) |
3.5 (1) |
6.1 (4.5) |
12.3 (6) |
3.7 (1) |
3.9 (2) |
8.0 (3) |
|
Year 1 |
ΔSHS from year 1 to year 2 |
0.6 (0) |
1.0 (0) |
4.8 (2.5) |
1.3 (0) |
4.5 (2.5) |
8.4 (4) |
1.2 (0) |
2.3 (0) |
6.1 (3) |
|
*Significantly different proportions of progressors (defined by Chi-square test). |
||||||||||
|
NA – not applicable |
||||||||||
Conclusion MBDA scores at BL and at 3 and 12 months of treatment, as well as change in MBDA category were predictive of subsequent radiographic progression during up to 2 years. At all measured time points, having a low MBDA score was associated with low risk for subsequent radiographic progression.
Disclosure:
K. Hambardzumyan,
None;
R. J. Bolce,
Crescendo Bioscience,
4,
Crescendo Bioscience,
3;
S. Saevarsdottir*,
None;
K. Forslind,
None;
I. F. Petersson,
UCB Pharma, Pfizer, AbbVie,
8;
P. Geborek,
None;
E. H. Sasso,
Crescendo Bioscience,
4,
Crescendo Bioscience,
3;
D. Chernoff,
Crescendo Bioscience,
4,
Crescendo Bioscience,
5;
S. Cruickshank,
Crescendo Bioscience,
5;
R. F. van Vollenhoven,
AbbVie, BMS, GSK, Pfizer, Roche, UCB,
2,
AbbVie, Biotest, BMS, Crescendo, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex,
5.
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