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Cluster-Randomized Trial of a Behavioral Intervention to Incorporate a Treat-to-Target Approach to Care of US Patients With Rheumatoid Arthritis

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Harrold LR1, Reed GW1, John A2, Barr CJ3, Soe K3, Magner R4, Saunders KC3, Ruderman EM5, Haselkorn T2, Greenberg JD6, Gibofsky A7, Harrington JT8, Kremer JM9. Arthritis Care Res (Hoboken). 2018 Mar;70(3):379-387. doi: 10.1002/acr.23294. Epub 2018 Feb 6.

Abstract

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1 University of Massachusetts Medical School, Worcester, and CORRONA, LLC, Waltham.

2 Genentech, South San Francisco, California.

3 CORRONA, LLC, Waltham, Massachusetts.

4 University of Massachusetts Medical School, Worcester, Massachusetts.

5 Northwestern University Feinberg School of Medicine, Chicago, Illinois.

6 New York University School of Medicine, New York.

7 Hospital for Special Surgery, New York, New York.

8 Harrington Consulting, LLC, Madison, Wisconsin.

9 Albany Medical College and The Center for Rheumatology, Albany, New York.

Abstract

OBJECTIVE: To assess the feasibility and efficacy of implementing a treat-to-target approach versus usual care in a US-based cohort of rheumatoid arthritis patients.

METHODS: In this behavioral intervention trial, rheumatology practices were cluster-randomized to provide treat-to-target care or usual care. Eligible patients with moderate/high disease activity (Clinical Disease Activity Index [CDAI] score >10) were followed for 12 months. Both treat-to-target and usual care patients were seen every 3 months. Treat-to-target providers were to have monthly visits with treatment acceleration at a minimum of every 3 months in patients with CDAI score >10; additional visits and treatment acceleration were at the discretion of usual care providers and patients. Coprimary end points were feasibility, assessed by rate of treatment acceleration conditional on CDAI score >10, and achievement of low disease activity (LDA; CDAI score ≤10) by an intent-to-treat analysis.

RESULTS: A total of 14 practice sites per study arm were included (246 patients receiving treat-to-target and 286 receiving usual care). The groups had similar baseline demographic and clinical characteristics. Rates of treatment acceleration (treat-to-target 47% versus usual care 50%; odds ratio [OR] 0.92 [95% confidence interval (95% CI) 0.64, 1.34]) and achievement of LDA (treat-to-target 57% versus usual care 55%; OR 1.05 [95% CI 0.60, 1.84]) were similar between groups. Treat-to-target providers reported patient reluctance and medication lag time as common barriers to treatment acceleration.

CONCLUSION: This study is the first to examine the feasibility and efficacy of a treat-to-target approach in typical US rheumatology practice. Treat-to-target care was not associated with increased likelihood of treatment acceleration or achievement of LDA, and barriers to treatment acceleration were identified.