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Abstract Number: 1789

In Early Rheumatoid Arthritis, The 12 Individual Biomarkers That Comprise The Multiple Biomarker Disease Activity Score Relate Differentially To Clinical Response and Radiographic Progression: Results From a Randomized Trial

Karen Hambardzumyan1, Saedis Saevarsdottir2, Rebecca Bolce3, Kristina Forslind4, Sofia Ernestam5, Ingemar F. Petersson6, Pierre Geborek7, David Chernoff3, Douglas J. Haney3, Eric H. Sasso3 and Ronald F van Vollenhoven8, 1ClinTRID, the Karolinska Institute, Stockholm, Sweden, 2Karolinska Institutet, Stockholm, Sweden, 3Crescendo Bioscience Inc., South San Francisco, CA, 4Department of Medicine, Karolinska Institute, Stockholm, Department of Medicine, Karolinska Institute,, Stockholm, Sweden, 5Huddinge Hospital, Karolinska University Hospital, Huddinge, Sweden, 6Lund University, Lund, Sweden, 7Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden, 8ClinTRID, Department of Medicine, Karolinska Institutet, Stockholm, Sweden

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: biomarkers and serologic tests, Clinical Response, Early Rheumatoid Arthritis

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Session Information

Session Title: Rheumatoid Arthritis - Clinical Aspects III: Predictors of Disease Course in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose:

In early rheumatoid arthritis (eRA), clinical and radiographic predictors would be very useful for optimizing available therapies. Individual biomarkers and their combinations, such as the multi-biomarker disease activity (MBDA, Vectra DA) test, can be considered for these purposes.  In the SWEFOT study, patients with eRA (symptom duration < 1 year) were started on methotrexate (MTX); at 3 months, responders (DAS28 < 3.2) continued MTX monotherapy and were followed in regular care, whereas non-responders were randomized into triple DMARD therapy or the addition of infliximab group. 

The objective of this study was to assess the 12 individual biomarkers that comprise the MBDA score at baseline (BL) as predictors of clinical response at 3 months and radiographic progression at 1 year in eRA.

Methods:

Analyses were performed for patients from the SWEFOT trial who had BL and 3-month data of DAS28 (based on ESR), the MBDA score (which has been validated to assess disease activity in RA patients) and the 12 individual biomarkers at BL; and for a subset of patients who also had radiographs at BL and 1 year (assessed using the Van der Heijde modified Sharp score [SHS]).  Patients with DAS28 > 3.2 at 3 months were considered clinical non-responders, and patients with a change in SHS > 0 as radiographic progressors (“radiological non-responders”). Group comparisons of biomarkers were performed by Mann-Whitney U test.

Results:

The results are summarized in the table below. Clinical non-responders had significantly higher BL values for CRP and IL-6 compared to responders. TNF-R1 and VCAM-1 were significantly lower for non-responders, while other biomarkers and the MBDA did not differ. The patients who progressed radiographically had, at BL, significantly higher MBDA scores, inflammatory biomarkers (CRP, SSA and IL-6), MMP-1, MMP-3 and TNF-R1, as well as a trend towards higher VEGF.

Biomarkers   at BL (mean±SEM)

 clinical   responders (n=112)

clinical   non-responders (n=190)

P   value

 

Radiographic   non-progressors (n=116)

Radiographic   progressors (n=120)

P   value

CRP

45.8±6.22

65.5±5.42

0.048

48.2±6.39

73.35±6.84

<0.001

SAA

38.3±5.04

41.9±3.49

N.S.

33.9±4.31

48.6±4.73

0.004

IL-6

82.7±9.01

114.2±10.36

0.051

89.83±11.68

121.7±13.33

0.002

TNF-R1

2.05±0.06

1.8±0.04

0.002

1.85±0.05

2.01±0.06

0.047

MMP-1

12.1±0.94

13.9±0.71

N.S.

12.4±0.87

14.4±0.86

0.038

MMP-3

76.9±8.55

90.21±6.5

N.S.

73.4±8.26

97.64±8.21

0.010

YKL-40

103.5±9.93

106.9±6.44

N.S.

115.4±11.3

107.9±7.35

N.S.

Leptin

12.8±1.17

15.1±1.09

N.S.

16.3±1.81

13.32±1.13

N.S.

Resistin

7.23±0.26

7.31±0.21

N.S.

7.23±0.28

7.3±0.21

N.S.

EGF

196.05±12.1

187.9±8.29

N.S.

195.2±9.7

182.6±11.65

N.S.

VEGF

474±27.99

469.34±22.7

N.S.

437.4±27.24

511.2±29.12

0.069

VCAM-1

0.74±0.019

0.66±0.012

<0.001

0.67±0.016

0.72±0.018

N.S.

MBDA

57±1.3

59.6±1.14

N.S.

55.7±1.4

63.3±1.19

<0.001

Conclusion:

In eRA patients treated initially with MTX, some individual biomarkers at BL may help identify those patients who are less likely to achieve DAS28 < 3.2 after 3 months of MTX therapy.  Other biomarkers, as well as the MBDA score, may identify patients at higher risk for radiographic progression during the first year of therapy. These results suggest that biomarkers can differentially predict aspects of disease course in eRA.


Disclosure:

K. Hambardzumyan,
None;

S. Saevarsdottir,
None;

R. Bolce,

Crescendo Bioscience Inc.,

1,

Crescendo Bioscience Inc.,

3;

K. Forslind,
None;

S. Ernestam,
None;

I. F. Petersson,
None;

P. Geborek,
None;

D. Chernoff,

Crescendo Bioscience Inc.,

1,

Crescendo Bioscience Inc.,

5;

D. J. Haney,

Crescendo Bioscience Inc.,

1,

Crescendo Bioscience Inc.,

3;

E. H. Sasso,

Crescendo Bioscience Inc.,

1,

Crescendo Bioscience Inc.,

3;

R. F. van Vollenhoven,

AbbVie, BMS, GSK, MSD, Pfizer, Roche, UCB,

2,

AbbVie, BMS, GSK, MSD, Pfizer, Roche, UCB,

5.

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