Background/Purpose: Currently, disease activity in Rheumatoid Arthritis (RA) is measured using scoring systems that rely primarily on a collection of subjective measures from patients and clinicians.  To improve care and treatment for RA patients, objective measurements of disease activity and response to treatment are desirable.  Using a small cohort derived from an ongoing study of intravenously administered golimumab (GO-FURTHER), we evaluated the performance of Vectra-DA™ (Crescendo Biosciences), a multi-biomarker serum-based test designed to measure RA disease activity through correlation with DAS28-CRP and sensitive to anti-TNF therapy.¹This analysis examines if Vectra-DA™correlates with disease activity and golimumab response in a clinical trial setting.

Methods: 137 serum samples collected in a Phase III study of intravenously administered golimumab in patients with active RA despite methotrexate (MTX) therapy was analyzed using Vectra-DA™ (Crescendo Bioscience©; San Francisco, CA, USA). Samples were collected at weeks 0, 2, 4, and 14 from patients treated with IV placebo + MTX (PBO; n= 42) or IV golimumab 2mg/kg + MTX (GLM; n=95) who received study medications at Weeks 0, 4, and every 8 weeks thereafter.  Healthy control serum samples (n=21) were obtained from Bioreclamation (Hicksville, NY). 

Results: A subset of subjects was chosen for analysis with Vectra-DA™ from the GO-FURTHER study.  The subset had an ACR50 response to golimumab of 35.8% (PBO 7.1%) at week 14 and 48.4% (PBO 16.7%) at week 24.  Correlation of Vectra-DA™ and DAS28-CRP scores was r=0.51 (95% CI=0.45-0.57) using all four timepoints tested.  Study subjects had statistically higher mean Vectra-DA™ scores (64.2 at wk 0; 45.5 at wk 2; 50.2 at wk4; 44.9 at wk14) compared to healthy controls (35.2).   At baseline, there were no significant differences in GLM and PBO-treated subjects by Vectra-DA™ or DAS28-CRP scores.  As early as week 2, GLM-treated subjects had a significant drop in Vectra-DA™ score of
D= -18.7 (p=<2.2X10-¹⁶).  The decrease in Vectra-DA™ score was maintained through week 14, whereas PBO-treated subjects did not have a significant change in Vectra-DA™ scores from baseline to weeks 2, 4 and 14.  Vectra-DA™ scores were statistically different between GLM-treated subjects who achieved an ACR50 response at week 14 versus non-responders at weeks 0 (p=0.024), 4 (p=0.013), and 14 (p=0.009).  Vectra-DA™ scores were not statistically different between GLM-treated subjects who achieved an ACR50 response at week 24 versus non-responders at all timepoints tested, though a trend was seen at week 14 (p= 0.054).

Conclusion: Vectra-DA™ offers a molecular measurement of RA disease activity that can discriminate between normal and RA subjects, and also PBO and GLM-treated subjects as early as week 2 post-treatment.  GLM treated week 14 responders had significantly lower Vectra-DA™ scores compared with non-responders.  The Vectra-DA™ score reflects a patient’s disease activity before and after the treatment with intravenous golimumab.

¹Weinblatt ME, Shadick NA, Manning W, et al. Use of a Multi-Biomarker Score for Rheumatoid Arthritis Disease Activity (Vectra™ DA) to Assess Response to Therapy. (Poster Session I: May 26, 2011, 11:45 BST). EULAR Congress 2011.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/utility-of-vectra-da-on-assessment-of-rheumatoid-arthritis-disease-activity-and-golimumab-response-results-of-a-pilot-study-from-a-phase-3-trial-in-patients-with-active-rheumatoid-arth/