Article Text
Abstract
Objectives To compare the effectiveness of adding synthetic disease-modifying antirheumatic drugs (sDMARDs) versus tumour necrosis factor α inhibitors (TNFi) to methotrexate (MTX) in patients with rheumatoid arthritis (RA) who were MTX inadequate responders (IR). Second, to examine outcomes in patients receiving MTX+TNFi for whom the MTX+sDMARD combination had also failed.
Methods Patients with RA (disease duration ≤ 5 years, MTX IR and naïve to other DMARDs) starting treatment with MTX+TNFi or MTX+sDMARDs were included. From the latter group a subgroup of patients who went on to receive MTX+TNFi was identified.
Results Patients receiving MTX+TNFi (n=98) and MTX+sDMARDs (n=129) had similar baseline disease activity when starting combination therapy (mean Disease Activity Score 28 (DAS28) = 4.90 and 4.96, respectively). Three- and 6-month effectiveness and 2-year drug survival were better for MTX+TNFi than for MTX+sDMARDs: mean ∆DAS28 was −1.61 versus −0.85 after 3 months (p<0.001) and −1.91 versus −1.03 after 6 months (p=0.01); DAS28<2.6 was reached by 29.0% versus 11.6% after 3 and 34.5% versus 12.9% after 6 months. Effectiveness was somewhat better with triple therapy than other MTX+sDMARD combinations but was generally inferior compared with MTX+TNFi. For the patients who received MTX+TNFi as a third step after MTX+sDMARDs had failed (n=38) there was a tendency towards lower remission rates, worse disease activity states and inferior drug survival compared with patients who received MTX+TNFi directly after the failure of MTX.
Conclusions Effectiveness was better for MTX+TNFi than for MTX+sDMARDs. Patients who started MTX+TNFi after two synthetic DMARD regimens had failed had a tendency to less favourable disease states after 3 months than patients who switched directly from MTX to MTX+TNFi.
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Footnotes
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Funding The work was supported by Eastern Norway Regional Health Authority. The Norwegian Disease-Modifying Antirheumatic Drug study has received unrestricted grant support from Abbott, Amgen, Wyeth, Aventis, MSD, Schering-Plough/Centocor, BristolMyers Squibb, UCB, Roche and the Norwegian Directorate for Health and Social Affairs.
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Competing interests The NOR-DMARD register is financially supported by pharmaceutical companies but the sponsors are not involved in the analyses and presentation of data. Most of the authors have received speaker and/or consultancy honoraria from companies marketing biological DMARDs.
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Ethics approval This study was conducted with the approval of the regional ethics committee and by the Data Inspectorate. Patients gave written informed consent before participation.
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Provenance and peer review Not commissioned; externally peer reviewed.