FRI0161 Response to etanercept-methotrexate therapy and etanercept monotherapy in rheumatoid arthritis patients with moderate and severe disease in the cameo trial
Authors: E. Keystone, B. Haraoui, C. Thorne, M. Poulin-Costello, E. Trottier, A. Vieira, J. E. Pope
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> The majority of patients with rheumatoid arthritis (RA) initiating biologics have moderate disease activity (MDA)<sup>1</sup> and achieve better outcomes than those with severe disease activity (SDA).<sup>2</sup> The PRESERVE trial reported similar rates of low disease activity/remission (LDA/REM) at 88 weeks in MDA patients reaching LDA/REM after 36 weeks of etanercept(ETN)+methotrexate(MTX), whether they had continued full or half dose of ETN+MTX.<sup>3</sup> PRESERVE did not address if patients would have done equally well on ETN vs. ETN+MTX. <h3>Objectives</h3> The open-label CAMEO trial sought to determine if withdrawing MTX is as effective as continuing ETN+MTX in MDA and SDA after 6 months of ETN+MTX.<sup>4</sup> This pre-specified post-hoc analysis assessed month 12 response in MDA (3.25.1) patients. <h3>Methods</h3> TNF inhibitor naive, RA patients with active disease [≥3 swollen joints, DAS28≥3.2] despite MTX (≥15mg/wk, or 10mg/wk if intolerant) for &gt;12 weeks were enrolled. Patients received ETN(50mg/wk sc)+MTX for 6 months. At month 6, patients were randomized to continue ETN+MTX or switch to ETN alone for 18 more months. Here we present DAS28 from month 6 to 12 by MDA or SDA at baseline (BL). <h3>Results</h3> 258 patients were enrolled (female: 76%; mean disease duration: 8.9±8.4 yrs; mean # prior DMARDS: 2.7±1.0; prior oral prednisone: 52%). 205 were randomized at month 6, 121(59.0%) with BL SDA vs 84(41.0%) with BL MDA. Nearly twice as many with MDA vs. SDA patients reached LDA/REM(DAS28&lt;3.2) at month 6 (61.3%(49/80) vs. 35.8%(43/120); OR[95%CI]=2.5[1.38-4.41]). MDA patients maintained stable DAS28 to month 12 whether continuing ETN+MTX (mean DAS28 [95% CI]=3.10[2.66-3.53]) or on ETN alone (mean DAS28[95% CI]=3.06[2.59-3.52]). In contrast, patients with SDA continued to improve to month 12 when maintaining ETN+MTX (mean DAS28[95% CI]=3.39[3.02-3.76]) but not on ETN alone (mean DAS28[95% CI]=4.31[3.85-4.76])[Fig1]. <h3>Image/graph</h3> <h3>Conclusions</h3> It may be possible to withdraw MTX in a relatively high proportion of patients initiating treatment with MDA after 6 months of combination ETN+MTX, as more of these patients maintain LDA/REM. Patients with initial SDA, however, may need to continue combination therapy. This analysis provides important information on the disease state required to make a therapeutic adjustment in order to achieve and maintain LDA/REM. <h3>References</h3> PincusT, et al.Arthritis Rheum.2005;52:1009-1019; MaderR, et al.J Rheumatol Suppl.2007;80:16-24; Smolen JS, et al.Lancet.2013.Published Online; PopeJ, et al.Arthritis &amp; Rheum.2012;64(S10):S566 <h3>Acknowledgements</h3> Amgen Canada Inc. oversaw the design, conduct, &amp; collection of data in the study &amp; assisted in the analysis/interpretation of data. <h3>Disclosure of Interest</h3> E. 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, Genentech Inc, Nycomed, Speakers bureau: Abbott Laboratories, Bristol-Myers Squibb, F. Hoffmann-LarRaoche Inc, Merck, Pfizer Pharmaceuticals, UCB, B. Haraoui Grant/research support from: Abbott, Amgen, Bristol-Meyers Squibb, Merck, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, Bristol-Meyers Squibb, Merck, Pfizer, Roche, UCB, Speakers bureau: Abbott, Amgen, Bristol-Meyers Squibb, Merck, Pfizer, Roche, UCB, C. 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, Merck, Centocor, M. Poulin-Costello Employee of: Amgen Canada, E. Trottier Employee of: Amgen Canada, A. Vieira Employee of: Amgen Canada, J. E. Pope Grant/research support from: Abbott, Amgen, Actelion, AstraZeneca, Bristol-Meyers Squibb, Glaxo-Smith Kline, Hoffmann-LaRoche, Janssen, Novartis, Pfizer, UCB, Consultant for: Abbott, Amgen, Actelion, AstraZeneca, Bristol-Meyers Squibb, Glaxo-Smith Kline, Hoffmann-LaRoche, Janssen, Novartis, Pfizer, UCB