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A10.22 Response to MTX Plus Prednisone in Camera II Using a Multi-Biomarker Disease Activity (Vectra™DA) TEST and DAS28-ESR
  1. JWJ Bijlsma1,
  2. MS Jurgens1,
  3. JWG Jacobs1,
  4. M Bakker1,
  5. FPJ Lafeber1,
  6. PMJ Welsing1,
  7. G Cavet2,
  8. D Chernoff2,
  9. EH Sasso2,
  10. W Li2,
  11. DJ Haney2
  1. 1University Medical Center Utrecht, Utrecht, The Netherlands
  2. 2Crescendo Bioscience, Inc., South San Francisco, CA, USA

Abstract

Background and Objectives The CAMERA II study (Computer Assisted Management in Early RA) demonstrated that the addition of prednisone versus placebo to a MTX-based tight-control strategy increased effectiveness of therapy and reduced need for biological treatment. The present study evaluated changes in biomarker levels over time with MTX+placebo and MTX+prednisone treatment, using the Multi-Biomarker Disease Activity (MBDA) blood test.

Materials and Methods Clinical and biomarker assessments were performed at monthly visits to 1 year for 92 patients who had MBDA test results available at baseline and ≥1 subsequent visit. Average number of visits with non-missing disease activity measures was 3.7 per patient. Concentrations of 12 serum biomarkers were combined to produce a score between 1 and 100 using the MBDA algorithm, which generates a validated measure of disease activity. Biomarker responses were also assessed individually but only to 5 months, to avoid subsequent protocol-mandated exposures to non-MTX DMARDs for insufficient responders. Association between DAS28-ESR response and MBDA response was assessed using Spearman’s correlation. Changes from baseline and comparisons of change over time for MTX+placebo versus MTX+prednisone were analysed by t-tests. Biomarker concentrations were analysed as fractions relative to baseline using Mann Whitney U tests.

Results Changes from baseline to 1 year in DAS28-ESR and MBDA scores showed a significant correlation in the MTX+placebo arm (r = 0.57, p < 0.001, n = 31) and the MTX+prednisone arm (r = 0.57, p = 0.002, n = 28). Improvements in DAS28-ESR (p < 0.001) and MBDA (p = 0.01) scores were observed as early as 1 month post-BL in the MTX+prednisone arm. Significant reduction in disease activity in the MTX+placebo arm was first observed at 2 months for DAS28-ESR (p = 0.02) and 4 months for MBDA (p = 0.03). Overall, DAS28-ESR and MBDA response profiles were similar, with mean changes at month 5 for MTX+placebo and MTX+prednisone being –2.2/–4.2 for DAS28-ESR, and –13/–21 for MBDA score. Individual biomarker response profiles differed: for some biomarkers, MTX+placebo had little/no effect but MTX+prednisone had significant effect (e.g., MMP-1, TNF-R1, VCAM-1); for others, MTX+placebo had a significant effect that was augmented (e.g., CRP, IL-6, VEGF) or not affected (SAA) by prednisone.

Conclusions Responses assessed with the biomarker-based MBDA test and DAS28-ESR were greater and more rapid for therapy with MTX+prednisone than MTX+placebo, even though individual biomarkers differed in their response profiles. The MBDA test may be useful in combination with clinical assessment to evaluate early response to therapy with MTX or MTX+prednisone.

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