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Abstract
Objective:
To assess how use of a multi-biomarker disease activity (MBDA) blood test for rheumatoid arthritis (RA) affects treatment decisions made by health care providers (HCPs) in clinical practice.
Research design and methods:
At routine office visits, 101 patients with RA were assessed by their HCPs (N = 6), and they provided blood samples for MBDA testing. HCPs completed surveys before and after viewing the MBDA test result, recording dosage and frequency for all planned RA medications and physician global assessment of disease activity. Frequency and types of change in treatment plan that resulted from viewing the MBDA test result were determined.
Main outcome measure:
Percentage of cases in which the HCP changed the planned treatment after viewing the MBDA test result.
Results:
Prior to HCP review of the MBDA test, disease modifying anti-rheumatic drug (DMARD) use by the 101 patients included methotrexate in 62% of patients; hydroxychloroquine 29%; TNF inhibitor 42%; non-TNF inhibitor biologic agent 19%; and other drugs at lower frequencies. Review of MBDA test results changed HCP treatment decisions in 38 cases (38%), of which 18 involved starting, discontinuing or switching a biologic or non-biologic DMARD. Other changes involved drug dosage, frequency or route of administration. The total frequency of use of the major classes of drug therapy changed by <5%. Treatment plans changed 63% of the time when the MBDA test result was perceived as being not consistent or somewhat consistent with the HCP assessment of disease activity.
Study limitations:
Limited sample size; lack of control group; no longitudinal follow-up.
Conclusions:
The addition of the MBDA test to clinical assessment led to meaningful changes in the treatment plans of 38% of RA patients being cared for by HCPs in office practice. Even though treatment was potentially improved, the overall quantity of drug use was minimally affected.
Acknowledgments
The authors thank the study personnel who made this research possible. Participating investigators in the study were: Anthony S. Padula, Northern California Arthritis Center, Walnut Creek, CA, USA; Alexander Torres, Highlands Advanced Rheumatology and Arthritis Center, Sebring, FL, USA; Nancy Eisenberger, Carolina Health Specialists, Myrtle Beach, SC, USA; Brady Nelson, Valley Arthritis Care, Peoria, AZ, USA; Victoria Merrill, office of Roy Kaplan, Encinitas, CA; Robert A. Sylvester, PA, Lewiston, ME, USA. The authors also thank Linda Kahl for editorial assistance; and Paula Adduci for preparing the figures.
Transparency
Declaration of funding
This study was funded by Crescendo Bioscience.
Declaration of financial/other relationships
W.L., E.H.S., G.C. and K.F. have disclosed that they are (W.L., E.H.S.) or were (G.C., K.F.) employees of Crescendo Bioscience. D.E. has disclosed that he is a consultant to Crescendo Bioscience.
CMRO peer reviewers on this manuscript have each received an honorarium for their role in the review process, but have no other relevant financial relationships to disclose.