AB0389
NUMBER OF CARDIOVASCULAR RISK FACTORS MAY BE ASSOCIATED WITH HIGHER DISEASE ACTIVITY SEVERITY. EXPLORATORY ANALYSIS OF BASELINE DATA FROM THE CANADIAN MTX AND ETANERCEPT OUTCOME STUDY: A RANDOMIZED TRIAL OF ETANERCEPT AND MTX VS ETANERCEPT ALONE IN RA
J. E. Pope 1,*E. Keystone 2B. Haraoui 3C. Thorne 4M. Poulin-Costello 5
1St. Joseph's Healthcare, London, 2University of Toronto, Toronto, 3Institut de rhumatologie de Montreal, Montreal, 4Southlake Regional Health Centre, Newmarket, 5Amgen Canada Inc., Mississauga, Canada
Objectives: This ongoing real-world rheumatoid arthritis (RA) non-inferiority trial compared the proportion of patients with low disease activity while on etanercept (ETN) monotherapy vs ETN + methotrexate (MTX). Baseline data were explored to determine if cardiovascular (CV) risk factors correlate with higher baseline disease activity (Table 1). Two studies suggest increased erosions in those with low body mass index (BMI) in early RA.1,2
Methods: Baseline characteristics of established RA patients who, despite MTX therapy, had active disease (≥3 swollen joints), DAS28≥3.2, and were TNF-inhibitor naïve were studied. A post-hoc exploratory analysis of baseline data examined the impact of CV risks on baseline DAS (adjusted for sex, age, prior RA medications, and disease duration) using analysis of variance (ANOVA). Model selection was done by backwards elimination for p<0.1.
Results: 258 patients with active RA (76% female; mean age 54.7±12.5 yrs; DAS28 5.4±1.1; duration of RA 8.9±8.4 yrs) were enrolled. Mean baseline health assessment questionnaire (HAQ) score was 1.38±0.61. Mean duration of MTX treatment was 4.9±4.7 yrs (mean dose, 20.5±4.1 mg/wk). Higher baseline disease activity was statistically correlated with an increased number of CV risk factors (p<0.0001), although each CV risk was not significant. No other factors had a significant statistical correlation with DAS28. In addition, BMI and DAS were not related statistically.
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Conclusions: There is a statistical suggestion from this trial’s baseline data that an increase in the number of CV risks were associated with worse baseline DAS28 scores.
References: 1. Velpula UD, et al. J Rheumatol. 2011;38(3):434-8. Epub 2010 Nov 15; 2. Kaufmann J, et al. J Rheumatol. 2003;30(11):2350-5.
Disclosure of Interest: J. Pope Grant / Research support from: Amgen Consultant for: Amgen and PfizerE. Keystone Grant / Research support from: Abbott Laboratories, Amgen Inc, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, Centocor Inc, F. Hoffmann-LaRoche Inc, Genzyme, Merck, Novartis Pharmaceuticals, Pfizer Pharmaceuticals, UCB Consultant for: Abbott Laboratories, AstraZeneca Pharmaceuticals LP, Biotest, Bristol-Myers Squibb, Centocor Inc, F. Hoffmann-LaRoche Inc, Genentech Inc, Merck, Nycomed, Pfizer Pharmaceuticals, UCB Speakers Bureau: Abbott Laboratories, Bristol-Myers Squibb, F. Hoffmann-LaRoche Inc, Merck, Pfizer Pharmaceuticals, UCBB. Haraoui Grant / Research support from: Abbott, Amgen, Bristol-Myers Squibb, Merck, Pfizer, Roche, UCB Consultant for: Abbott, Amgen, Bristol-Myers Squibb, Merck, Pfizer, Roche, UCB Speakers Bureau: Abbott, Amgen, Bristol-Myers Squibb, Merck, Pfizer, Roche, UCBC. Thorne Grant / Research support from: Amgen, Pfizer, Abbott, Bristol-Myers Squibb, Roche, UCB, Merck, Centocor Consultant for: Amgen, Pfizer, Abbott, Bristol-Myers Squibb, Roche, UCB, MerckM. Poulin-Costello Employee of: Amgen