Objectives To assess the effect of disease duration (≤2 y vs. >2 y) and severity (moderate [mod] vs. severe [sev]) on treatment outcomes in subjects with RA receiving ETN+MTX or DMARDs+MTX.
Methods Data from subjects with mod-to-sev RA and an inadequate response to MTX were pooled from the APPEAL1 (ETN 25 mg twice weekly+MTX or DMARD+MTX) and LatinRA2 (ETN 50mg once weekly+MTX or DMARD+MTX) studies.3 Endpoints included DAS28 (ESR) remission (<2.6) and LDA (<3.2), CDAI LDA (≤10) and remission (≤2.8), and a normal HAQ score of ≤0.5.
Results 478 subjects received ETN+MTX (≤2 y n=123, >2 y n=348; DAS28 3.2–5.1 [mod] n=45; DAS28 >5.1 [sev] n=431) and 245 subjects received DMARD+MTX (≤2 y n=60, >2 y n=180; DAS28 3.2–5.1 n=19; DAS28 >5.1 n=226). In the total population of each treatment group, ETN+MTX was more effective than DMARD+MTX (Table). Patients with ≤2 y numerically had a better response than >2 y, as did patients with mod compared with sev for both treatment groups. ETN+MTX significantly outperformed DMARD + MTX in the >2 y and sev groups in all endpoints; in the ≤2 y group only DAS28 and CDAI LDA were superior as the ≤2 y and mod group had too few patients to detect a treatment difference. Within the treatment groups, significantly higher proportions of subjects with disease duration of ≤2 y vs. >2 y achieved HAQ ≤0.5 with ETN+MTX (P<0.05) and DAS28 and CDAI remission with DMARDs+MTX (P<0.05 for all). Higher proportions of subjects with mod vs. sev achieved DAS28/CDAI LDA and CDAI remission with ETN+MTX, and DAS28 LDA/remission, CDAI LDA, and HAQ ≤0.5 with DMARDs+MTX (P<0.01).
Conclusions Combination ETN+MTX was more effective than DMARDs+MTX in subjects with disease duration of >2 y and sev disease activity. Achievement of remission and optimal response was generally achieved in a higher number of subjects with shorter disease duration and mod disease activity.
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Fleischmann R, et al. Arthritis and Rheumatism 2012;64:S550.
Acknowledgements This study was sponsored by Pfizer Inc. Medical writing support was provided by Kim Brown of UBC Scientific Solutions and was funded by Pfizer Inc.
Disclosure of Interest R. Fleischmann Grant/research support from: Genentech Inc, Roche, Abbott, Amgen, UCB, Pfizer Inc, BMS, Lilly, Sanofi Aventis, Lexicon, MSD, Novartis, BiogenIdec, Astellas, Astra-Zeneca, Janssen, Consultant for: Roche, Abbott, Amgen, UCB, Pfizer, BMS, Lilly, Sanofi Aventis, Lexicon, Novartis, Astellas, Astra-Zeneca, Janssen, HGS, A. Koenig Employee of: Pfizer Inc., A. Szumski: None Declared, H. Nab Employee of: Pfizer Europe, L. Marshall Employee of: Pfizer Inc., E. Bananis Employee of: Pfizer Inc.