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Adalimumab response in patients with early versus established rheumatoid arthritis: DE019 randomized controlled trial subanalysis

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Abstract

In recent years, there has been a shift in the therapeutic approach to rheumatoid arthritis (RA), with emphasis on early therapy. The DE019 trial demonstrated adalimumab efficacy in patients with RA. This subanalysis compares response to adalimumab based on clinical, functional, and radiographic outcomes in patients with early versus established RA. Patients enrolled in the DE019 trial were divided into two groups based on disease duration (≤3 years = early RA; >3 years = established RA). Data from 407 patients with RA were included, with 78 early (41 adalimumab, 37 placebo) and 329 established (166 adalimumab, 163 placebo) patients. Patients with early disease achieved slightly greater American College of Rheumatology 20 (20% or more improvement or ACR20), 50, and 70 responses of 61%, 46.3%, and 24.4%, respectively, at 52 weeks, compared with those with established disease, with ACR20, 50, and 70 responses of 56%, 37.3%, and 19.9%, respectively. The Health Assessment Questionnaire score improvement between adalimumab and placebo in patients with early disease (0.44) was greater than that for those with established disease (0.25). With adalimumab treatment, there was a statistically significant mean reduction in total Sharp score progression relative to placebo (5.32) in early disease compared with established disease (2.06). While adalimumab is effective for RA of all disease durations, there is a trend toward superior clinical, functional, and radiographic outcomes in patients with early disease.

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Acknowledgments

The authors acknowledge the assistance of Ms. Correna LeCoure with preparing this manuscript. The authors also thank Lori W. Lush, PharmD, of JK Associates, and Michael A. Nissen, ELS, of Abbott Laboratories for additional editorial assistance. The original DE019 trial and this subanalysis were funded by Abbott Laboratories, Abbott Park, IL, USA.

Disclosures

Shahin Jamal has nothing to disclose. Kaushik Patra is employed by Abbott. Edward C. Keystone has received research grants from Abbott, Centocor, and Amgen and consulting fees from Abbott, Centocor, and Amgen.

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Authors and Affiliations

  1. University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada

    Shahin Jamal

  2. Abbott Laboratories, Parsippany, NJ, USA

    Kaushik Patra

  3. University of Toronto, Joseph and Wolf Lebovic Building, 2nd Floor, 60 Murray Street, Toronto, ON, M5G 1X5, Canada

    Edward C. Keystone

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  1. Shahin Jamal
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  2. Kaushik Patra
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  3. Edward C. Keystone
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Correspondence to Shahin Jamal.

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Jamal, S., Patra, K. & Keystone, E.C. Adalimumab response in patients with early versus established rheumatoid arthritis: DE019 randomized controlled trial subanalysis. Clin Rheumatol 28, 413–419 (2009). https://doi.org/10.1007/s10067-008-1064-0

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  • DOI: https://doi.org/10.1007/s10067-008-1064-0

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