Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose:
The CAMERA II study (Computer Assisted Management in Early RA) demonstrated that the addition of prednisone to a MTX-based tight control strategy increased effectiveness of therapy, including reductions in disease activity, disability, and joint erosion, increased likelihood of achieving sustained remission, and less frequent need for biological treatment. The purpose of this study was to evaluate changes in biomarker levels over time with MTX and MTX + prednisone treatment.
Methods:
Clinical and biomarker assessments were performed for 104 patients at multiple visits between Baseline (BL) and 1 year. The average number of visits per patient was 4. Clinical assessments were used to calculate the DAS28-ESR, and 12 serum biomarker concentrations were combined to produce a score between 1 and 100 using the MBDA algorithm, which is a validated biomarker-based measure of disease activity. Association between DAS28-ESR response and Multi-Biomarker Disease Activity (MBDA) response was assessed using Spearman’s correlation. Changes from BL were analyzed using the paired t-test.
Results:
There was a significant association between change in DAS28-ESR from BL to 1 year and change in MBDA from BL to 1 year in both the MTX-only arm (r = 0.57, p < 0.001, n = 31) and in the MTX + prednisone arm (r = 0.57, p = 0.002, n = 28). Improvements in DAS28-ESR (p < 0.001) and MBDA (p = 0.01) were observed as early as 1 month post-BL in the MTX + prednisone arm. Significant reduction in disease activity in the MTX-only arm was first observed at 2 months for DAS28-ESR (p = 0.02) and at 4 months for MBDA (p = 0.03).
|
|
DAS28-ESR |
|
MBDA |
||||||
|
Timepoint |
MTX |
MTX + pred. |
|
MTX |
MTX + pred. |
||||
|
|
n |
Mean Chg. |
n |
Mean Chg. |
|
n |
Mean Chg. |
n |
Mean Chg. |
|
1 Month |
16 |
-0.3 (p = 0.24) |
11 |
-1.9 (p < 0.001) |
|
18 |
-3 (p = 0.27) |
14 |
-12 (p = 0.01) |
|
2 Months |
15 |
-0.7 (p = 0.02) |
11 |
-2.4 (p < 0.001) |
|
17 |
-3 (p = 0.25) |
14 |
-11 (p = 0.02) |
|
3 Months |
22 |
-1.3 (p < 0.001) |
13 |
-3.0 (p < 0.001) |
|
25 |
-5 (p = 0.09) |
17 |
-15 (p = 0.002) |
|
4 Months |
13 |
-1.8 (p < 0.001) |
10 |
-3.9 (p < 0.001) |
|
17 |
-9 (p = 0.03) |
14 |
-19 (p = 0.003) |
|
5 Months |
15 |
-2.2 (p < 0.001) |
10 |
-4.2 (p < 0.001) |
|
18 |
-13 (p = 0.006) |
12 |
-21 (p = 0.003) |
|
6 Months |
18 |
-2.8 (p < 0.001) |
12 |
-3.0 (p = 0.001) |
|
29 |
-20 (p < 0.001) |
19 |
-16 (p < 0.001) |
|
9 Months |
17 |
-2.7 (p < 0.001) |
12 |
-3.2 (p = 0.001) |
|
24 |
-24 (p < 0.001) |
17 |
-20 (p < 0.001) |
|
12 Months |
31 |
-2.8 (p < 0.001) |
28 |
-3.1 (p < 0.001) |
|
44 |
-20 (p < 0.001) |
37 |
-16 (p < 0.001) |
Conclusion:
The biomarker-based MBDA test and DAS28-ESR responded quickly to combination therapy with MTX and prednisone and were correlated with one another. MBDA may be useful in combination with clinical assessment to evaluate early response to therapy with MTX or MTX + prednisone.
Disclosure:
J. W. J. Bijlsma,
None;
M. Verhoef-Jurgens,
None;
M. F. Bakker,
None;
J. W. G. Jacobs,
None;
F. P. J. G. Lafeber,
None;
P. M. J. Welsing,
None;
G. Cavet,
Crescendo Bioscience,
1,
Crescendo Bioscience,
3;
D. Chernoff,
Crescendo Bioscience, Inc.,
1,
Crescendo Bioscience, Inc.,
3;
D. J. Haney,
Crescendo Bioscience, Inc.,
1,
Crescendo Bioscience, Inc.,
3.
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