THU0209 Disease Activity and Structural Damage-Related Differences in Functional Disability in Early and Established Rheumatoid Arthritis
Authors: J.S. Smolen, A. Kavanaugh, D. van der Heijde, S. Florentinus, S.S. Rathmann, H. Kupper, E.C. Keystone
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> A measure of functional impairment, the Health Assessment Questionnaire Disability Index (HAQ), consists of a reversible disease activity-related component (ACT-HAQ) and a joint damage component that increases with time (DAM-HAQ). <h3>Objectives</h3> To assess baseline ACT-HAQ and DAM-HAQ and response to treatment in early and established rheumatoid arthritis (RA) patients (pts). <h3>Methods</h3> PREMIER was a 2-year (yr) randomized, double-blind (DB), controlled phase 3 study in methotrexate (MTX)-naïve pts with RA duration &lt;3 yr. OPTIMA was a 78-week (wk), randomized, DB, controlled phase 4 study in MTX-naïve pts with RA duration &lt;1 yr. The DB period was 26 wks. DE019 was a DB, placebo (PBO)-controlled study in established disease in incomplete MTX responders after ≥3 mo treatment with weekly MTX. In this <i>post hoc</i> analysis, HAQ and modified Total Sharp Score (mTSS) were assessed at baseline (BL), and wk 24 or 26 in pts treated with ADA 40 mg every other wk+MTX or PBO+MTX. DAM-HAQ was calculated, DAM-HAQ=0.01*mTSS; ACT-HAQ=HAQ – DAM-HAQ.<sup>1</sup> <h3>Results</h3> Mean disease duration was 0.8 yrs in PREMIER, 0.4 yrs in OPTIMA, and 11 yrs in DE019. At baseline (BL), HAQ scores were indicative of substantial functional disability (table); ACT-HAQ scores improved at wk 26 in all studies. In established RA pts (DE019), DAM-HAQ accounted for almost 50% of the BL HAQ, reflecting the extent of pre-existing joint damage in pts with long-standing RA. In both early and established RA pts, joint damage did not progress with 26 wks of treatment as reflected by the DAM-HAQ. In clinical responders (DAS28&lt;3.2 at wk 26), ACT-HAQ improved in both treatment groups, with greater extent of improvement in the ADA+MTX group. The DAM-HAQ scores remained stable with treatment. <h3>Conclusions</h3> In both early and established RA pts, baseline disease activity measured by the HAQ indicated substantial functional impairment. In early RA pts, disease activity is an important determinant of the HAQ, while structural damage is the primary component of the HAQ in established RA pts. In both early RA and established RA, ACT-HAQ improved dramatically on appropriate therapy, with the extent of improvement greater with ADA+MTX therapy. <h3>References</h3> Smolen JS, <i>et al. Ann Rheum Dis</i> 2010;69:1058–64. <h3>Acknowledgements</h3> AbbVie Inc funded the studies (NCT00195663, PREMIER; NCT00420927, OPTIMA; NCT00195702, DE019). AbbVie was responsible for the study designs, research, analysis, data collection, interpretation of data, and writing, reviewing, and approving of the publication. Medical writing support was provided by Kathleen V. Kastenholz, PharmD, MS, of AbbVie. <h3>Disclosure of Interest</h3> J. Smolen Grant/research support from: AbbVie, Amgen, Astra-Zeneca, BMS, Celgene Centocor-Janssen, Glaxo, Lilly, Pfizer (Wyeth), MSD (Schering-Plough), Novo-Nordisk, Roche, Sandoz, UCB, Consultant for: AbbVie, Amgen, Astra-Zeneca, BMS, Celgene Centocor-Janssen, Glaxo, Lilly, Pfizer (Wyeth), MSD (Schering-Plough), Novo-Nordisk, Roche, Sandoz, UCB, A. Kavanaugh Grant/research support from: AbbVie, Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, Consultant for: AbbVie, Amgen, Astra-Zeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB, D. van der Heijde Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen Biologica, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Chugai, Daiichi, Eli Lilly, GSK, Janssen Biologica, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Vertex; Director of Imaging Rheumatology BV, S. Florentinus Shareholder of: AbbVie, Employee of: AbbVie, S. Rathmann Shareholder of: AbbVie, Employee of: AbbVie Inc, H. Kupper Shareholder of: AbbVie, Employee of: AbbVie Deutschland GmbH &amp; Co. KG, E. Keystone Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Centocor, Genzyme, Merck, Novartis, Pfizer, Roche, UCB, Consultant for: AbbVie, AstraZeneca, Biotest, BMS, Centocor, Genentech, Merck, Nycomed, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Merck, Pfizer, Roche, UCB