SAT0058 Using the Multi-Biomarker Disease Activity Score as a Complementary Inclusion Criterion for Clinical Trials in Rheumatoid Arthritis May Enhance Recruitment
Authors: R.F. van Vollenhoven, R. Bolce, K. Hambardzumyan, S. Saevarsdottir, K. Forslind, S. Ernestam, I.F. Petersson, E.H. Sasso, C.C. Hwang, O.G. Segurado, P. Geborek
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> Clinical trials in rheumatoid arthritis (RA) often require elevated C-reactive protein (CRP), e.g., &gt;10 mg/L, to enhance detection of clinical and radiographic efficacy. However, this inclusion criterion may limit recruitment by excluding some patients with active disease. The multi-biomarker disease activity (MBDA) score quantifies disease activity with a score of 1 to 100 and can be high (&gt;44) even when the CRP is ≤10 mg/L. <h3>Objectives</h3> To explore the hypothesis that, by using MBDA score &gt;44 as a clinical trial inclusion criterion complementary to CRP&gt;10mg/L, the number of eligible patients can be increased while maintaining the ability to detect treatment responses. <h3>Methods</h3> In the SWEFOT trial, DMARD-naïve patients with early RA were enrolled, without a CRP requirement, and received methotrexate (MTX) monotherapy from baseline; at 3 months, non-responders to MTX (NR, DAS28&gt;3.2) received treatment intensification. We analyzed: 1) Patients from baseline to 3 months, and 2) MTX non-responders; for the latter population we used data from month 3 as the de facto baseline and changes from month 3 to 12 as the measured response. In both analyses patients were grouped according to CRP (≤10 vs. &gt;10 mg/L) or MBDA score (≤44 vs. &gt;44) and assessed for clinical outcomes from baseline to 3 months following treatment with MTX, and from 3 to 12 months for add-on therapy (triple therapy or anti-TNF). Radiographic progression was assessed by change in SHS from baseline to 1 year for both analyses. <h3>Results</h3> For the DMARD-naïve population (N=220), baseline values and changes from baseline for disease activity measures and ΔSHS were similar for patients with CRP &gt;10 mg/L versus MBDA score &gt;44. Moreover, by adding the 37 patients with MBDA score &gt;44 and CRP ≤10 mg/L to the group with CRP &gt;10 mg/L (N=154), the combined group (N=191) had 24% more patients and similar clinical and radiographic outcomes. Similarly, for the MTX non-responder population (N=127), values at month 3 and changes to month 12 were similar for the CRP &gt;10 mg/L and MBDA &gt;44 groups, and adding the 23 patients with month 3 MBDA score &gt;44 and CRP ≤10 mg/L to the group with CRP &gt;10 mg/L (N=49) created a combined group (N=72) with 47% more patients and similar outcomes. The results are summarized in the table. <h3>Conclusions</h3> These data suggest that if a clinical trial of DMARD-naïve or MTX-non-responder patients were to include all patients with MBDA score &gt;44 and/or CRP &gt;10 mg/L, the number of eligible patients can be increased by 24% and 47%, respectively, compared with enrollment based on CRP &gt;10 mg/L alone, while maintaining clinical and radiographic outcomes. <h3>Disclosure of Interest</h3> R. van Vollenhoven Grant/research support: AbbVie, BMS, GSK, Pfizer, Roche, UCB, Consultant for: AbbVie, Biotest, BMS, Crescendo, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex, R. Bolce Shareholder of: Crescendo Bioscience, Employee of: Crescendo Bioscience, K. Hambardzumyan: None declared, S. Saevarsdottir: None declared, K. Forslind: None declared, S. Ernestam: None declared, I. Petersson Speakers bureau: UCB Phama, Pfizer, AbbVie, E. Sasso Shareholder of: Crescendo Bioscience, Employee of: Crescendo Bioscience, C. Hwang Shareholder of: Crescendo Bioscience, Employee of: Crescendo Bioscience, O. Segurado Shareholder of: Crescendo Bioscience, Employee of: Crescendo Bioscience, P. Geborek: None declared <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.3329