Treating to a Target in Established Active Rheumatoid Arthritis Patients Receiving a Tumor Necrosis Factor Inhibitor: Results From a Real-World Cluster-Randomized Adalimumab Trial

Authors

  • Janet E. Pope,

    Corresponding author
    • University of Western Ontario and St. Joseph's Health Care, London, Ontario, Canada
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    • Dr. Pope has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, Pfizer, Roche, Janssen, BMS, and UCB.

  • Boulos Haraoui,

    1. Centre Hospitalier de l'Université de Montréal and Hôpital Notre-Dame, MontréalQuebec, Canada
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    • Dr. Haraoui has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, Pfizer, Roche, Janssen, BMS, and UCB.

  • Emmanouil Rampakakis,

    1. JSS Medical Research and McGill University, Montréal, Quebec, Canada
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  • Eliofotisti Psaradellis,

    1. JSS Medical Research, Montréal, Quebec, Canada
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  • Carter Thorne,

    1. Southlake Regional Health Care, Newmarket, Ontario, Canada
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  • John S. Sampalis,

    1. JSS Medical Research and McGill University, Montréal, Quebec, Canada
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  • on behalf of the Optimization of Adalimumab Trial Investigators


  • ClinicalTrials.gov identifier: NCT01585064.

  • Investigators for the Optimization of Adalimumab Trial are shown in Appendix A.

St. Joseph's Health Care, 268 Grosvenor Street, London, Ontario, Canada, N6A 4V2. E-mail: janet.pope@sjhc.london.on.ca

Abstract

Objective

In early rheumatoid arthritis (RA), treating to a target is more effective than routine care (RC). Our aim was to determine if treating to a target has better outcomes than RC in established active RA.

Methods

We used a real-world, 18-month cluster-randomized trial in established active RA patients treated with adalimumab. Physicians were randomized to RC, treating to a Disease Activity Score in 28 joints (DAS28) of <2.6 (DAS group), or treating to a 0 of 28 swollen joint count (SJC; 0-SJC group).

Results

Among the 308 enrolled patients, 109 (35.4%) were randomized to RC, 100 (32.5%) to the DAS group, and 99 (32.1%) to the 0-SJC group. When adjusting for baseline DAS28, a comparable but significant (P < 0.001) improvement in DAS28 was observed at 12 months for all groups (DAS28 mean score 3.1, 3.4, and 3.2, respectively). There were no significant between-group differences in the improvement of clinical parameters and patient-reported outcomes with the exception of the mean change in patient satisfaction over time (P = 0.020), which was highest in the DAS group. Time to achieving good/moderate European League Against Rheumatism (EULAR) response was significantly shorter in the targeted treatment groups compared to RC (adjusted hazard ratio [HR] for the DAS-group 2.99 [95% confidence interval (95% CI) 1.71–5.24] and HR for the 0-SJC group 1.86 [95% CI 1.09–3.13]). The dropout rate was 52.3% in RC, 27% in the DAS group, and 22.2% in the 0-SJC group (P < 0.001).

Conclusion

All groups experienced significant improvements at 18 months of treatment with adalimumab. Treating to target in established RA did not differ from RC in terms of therapeutic end point achievement for patients remaining on treatment. However, time to achieving good/moderate EULAR response was significantly shorter in the targeted treatment groups compared to RC and, importantly, the dropout rate was significantly lower with targeted treatment.

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