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Research ArticleArticle

Uptake and Clinical Utility of Multibiomarker Disease Activity Testing in the United States

Jeffrey R. Curtis, Fenglong Xie, Shuo Yang, Maria I. Danila, Justin K. Owensby and Lang Chen
The Journal of Rheumatology November 2018, jrheum.180071; DOI: https://doi.org/10.3899/jrheum.180071
Jeffrey R. Curtis
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. Dr. Curtis receives support from the US National Institutes of Health (NIH; P60 AR064172) and the Patient-Centered Outcome Research Institute. Dr. Curtis also had research grants and/or consulting fees from Amgen, BMS, Corrona, Janssen, Myriad Genetics, Pfizer, and UCB. Dr. Danila receives support from the NIH (P60 AR064172) and has had research grants from Pfizer. This study had additional support from Myriad Genetics. The manuscript content and decision to submit for publication was solely the purview of the authors and not conditional on external approval. J.R. Curtis, MD, MS, MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; F. Xie, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; S. Yang, MS, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; M.I. Danila, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; J.K. Owensby, PharmD, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; L. Chen, PhD, University of Alabama at Birmingham. Address correspondence to Dr. J.R. Curtis, 510 20th St. South, UAB FOT 802, Birmingham, Alabama 35294, USA. E-mail: jrcurtis@uabmc.edu. Accepted for publication July 26, 2018.
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Fenglong Xie
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. Dr. Curtis receives support from the US National Institutes of Health (NIH; P60 AR064172) and the Patient-Centered Outcome Research Institute. Dr. Curtis also had research grants and/or consulting fees from Amgen, BMS, Corrona, Janssen, Myriad Genetics, Pfizer, and UCB. Dr. Danila receives support from the NIH (P60 AR064172) and has had research grants from Pfizer. This study had additional support from Myriad Genetics. The manuscript content and decision to submit for publication was solely the purview of the authors and not conditional on external approval. J.R. Curtis, MD, MS, MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; F. Xie, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; S. Yang, MS, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; M.I. Danila, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; J.K. Owensby, PharmD, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; L. Chen, PhD, University of Alabama at Birmingham. Address correspondence to Dr. J.R. Curtis, 510 20th St. South, UAB FOT 802, Birmingham, Alabama 35294, USA. E-mail: jrcurtis@uabmc.edu. Accepted for publication July 26, 2018.
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Shuo Yang
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. Dr. Curtis receives support from the US National Institutes of Health (NIH; P60 AR064172) and the Patient-Centered Outcome Research Institute. Dr. Curtis also had research grants and/or consulting fees from Amgen, BMS, Corrona, Janssen, Myriad Genetics, Pfizer, and UCB. Dr. Danila receives support from the NIH (P60 AR064172) and has had research grants from Pfizer. This study had additional support from Myriad Genetics. The manuscript content and decision to submit for publication was solely the purview of the authors and not conditional on external approval. J.R. Curtis, MD, MS, MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; F. Xie, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; S. Yang, MS, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; M.I. Danila, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; J.K. Owensby, PharmD, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; L. Chen, PhD, University of Alabama at Birmingham. Address correspondence to Dr. J.R. Curtis, 510 20th St. South, UAB FOT 802, Birmingham, Alabama 35294, USA. E-mail: jrcurtis@uabmc.edu. Accepted for publication July 26, 2018.
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Maria I. Danila
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. Dr. Curtis receives support from the US National Institutes of Health (NIH; P60 AR064172) and the Patient-Centered Outcome Research Institute. Dr. Curtis also had research grants and/or consulting fees from Amgen, BMS, Corrona, Janssen, Myriad Genetics, Pfizer, and UCB. Dr. Danila receives support from the NIH (P60 AR064172) and has had research grants from Pfizer. This study had additional support from Myriad Genetics. The manuscript content and decision to submit for publication was solely the purview of the authors and not conditional on external approval. J.R. Curtis, MD, MS, MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; F. Xie, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; S. Yang, MS, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; M.I. Danila, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; J.K. Owensby, PharmD, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; L. Chen, PhD, University of Alabama at Birmingham. Address correspondence to Dr. J.R. Curtis, 510 20th St. South, UAB FOT 802, Birmingham, Alabama 35294, USA. E-mail: jrcurtis@uabmc.edu. Accepted for publication July 26, 2018.
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Justin K. Owensby
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. Dr. Curtis receives support from the US National Institutes of Health (NIH; P60 AR064172) and the Patient-Centered Outcome Research Institute. Dr. Curtis also had research grants and/or consulting fees from Amgen, BMS, Corrona, Janssen, Myriad Genetics, Pfizer, and UCB. Dr. Danila receives support from the NIH (P60 AR064172) and has had research grants from Pfizer. This study had additional support from Myriad Genetics. The manuscript content and decision to submit for publication was solely the purview of the authors and not conditional on external approval. J.R. Curtis, MD, MS, MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; F. Xie, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; S. Yang, MS, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; M.I. Danila, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; J.K. Owensby, PharmD, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; L. Chen, PhD, University of Alabama at Birmingham. Address correspondence to Dr. J.R. Curtis, 510 20th St. South, UAB FOT 802, Birmingham, Alabama 35294, USA. E-mail: jrcurtis@uabmc.edu. Accepted for publication July 26, 2018.
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Lang Chen
From the Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA. Dr. Curtis receives support from the US National Institutes of Health (NIH; P60 AR064172) and the Patient-Centered Outcome Research Institute. Dr. Curtis also had research grants and/or consulting fees from Amgen, BMS, Corrona, Janssen, Myriad Genetics, Pfizer, and UCB. Dr. Danila receives support from the NIH (P60 AR064172) and has had research grants from Pfizer. This study had additional support from Myriad Genetics. The manuscript content and decision to submit for publication was solely the purview of the authors and not conditional on external approval. J.R. Curtis, MD, MS, MPH, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; F. Xie, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; S. Yang, MS, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; M.I. Danila, MD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; J.K. Owensby, PharmD, PhD, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham; L. Chen, PhD, University of Alabama at Birmingham. Address correspondence to Dr. J.R. Curtis, 510 20th St. South, UAB FOT 802, Birmingham, Alabama 35294, USA. E-mail: jrcurtis@uabmc.edu. Accepted for publication July 26, 2018.
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Abstract

Objective The clinical utility of the multibiomarker disease activity (MBDA) test for rheumatoid arthritis (RA) management in routine care in the United States has not been thoroughly studied.

Methods Using 2011–2015 Medicare data, we linked each patient with RA to their MBDA test result. Initiation of a biologic or Janus kinase (JAK) inhibitor in the 6 months following MBDA testing was described. Multivariable adjustment evaluated the likelihood of adding or switching biologic/JAK inhibitor, controlling for potential confounders. For patients with high MBDA scores who added a new RA therapy and were subsequently retested, lack of improvement in the MBDA score was evaluated as a predictor of future RA medication failure, defined by the necessity to change RA medications again.

Results Among 60,596 RA patients with MBDA testing, the proportion adding or switching biologics/JAK inhibitor among those not already taking a biologic/JAK inhibitor was 9.0% (low MBDA), 11.8% (moderate MBDA), and 19.7% (high MBDA, p < 0.0001). Similarly, among those already taking biologics/JAK inhibitor, the proportions were 5.2%, 8.3%, and 13.5% (p < 0.0001). After multivariable adjustment, referent to those with low disease MBDA scores, the likelihood of switching was 1.51-fold greater (95% CI 1.35–1.69) for patients with moderate MBDA scores, and 2.62 (2.26–3.05) for patients with high MBDA scores. Among those with high MBDA scores who subsequently added a biologic/JAK inhibitor and were retested, lack of improvement in the MBDA score category was associated with likelihood of future RA treatment failure (OR 1.61, 95% CI 1.27–2.03).

Conclusion The MBDA score was associated with both biologic and JAK inhibitor medication addition/switching and subsequent treatment outcomes.

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Uptake and Clinical Utility of Multibiomarker Disease Activity Testing in the United States
Jeffrey R. Curtis, Fenglong Xie, Shuo Yang, Maria I. Danila, Justin K. Owensby, Lang Chen
The Journal of Rheumatology Nov 2018, jrheum.180071; DOI: 10.3899/jrheum.180071

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Uptake and Clinical Utility of Multibiomarker Disease Activity Testing in the United States
Jeffrey R. Curtis, Fenglong Xie, Shuo Yang, Maria I. Danila, Justin K. Owensby, Lang Chen
The Journal of Rheumatology Nov 2018, jrheum.180071; DOI: 10.3899/jrheum.180071
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