Radiographic changes in rheumatoid arthritis patients attaining different disease activity states with methotrexate monotherapy and infliximab plus methotrexate: the impacts of remission and tumour necrosis factor blockade

被引:202
作者
Smolen, J. S. [1 ,2 ]
Han, C. [11 ]
van der Heijde, D. M. F. M. [3 ]
Emery, P. [4 ]
Bathon, J. M. [5 ]
Keystone, E. [6 ]
Maini, R. N. [7 ]
Kalden, J. R. [8 ]
Aletaha, D. [1 ]
Baker, D. [10 ]
Han, J. [10 ]
Bala, M. [11 ]
St Clair, E. W. [9 ]
机构
[1] Med Univ Vienna, Dept Internal Med 3, Div Rheumatol, A-1090 Vienna, Austria
[2] Hietzing Hosp, Dept Med 2, Vienna, Austria
[3] Leiden Univ, Med Ctr, Leiden, Netherlands
[4] Univ Leeds, Res Sch Med, Leeds, W Yorkshire, England
[5] Johns Hopkins Univ, Baltimore, MD USA
[6] Mt Sinai Hosp, Ctr Adv Therapeut, Toronto, ON M5G 1X5, Canada
[7] Kennedy Inst, London, England
[8] Nikolaus Fiebiger Ctr, Div Mol Immunol, Erlangen, Germany
[9] Duke Univ, Med Ctr, Durham, NC USA
[10] Centocor Res & Dev Inc, Malvern, PA USA
[11] Worldwide Hlth Econ & Pricing, Johnson & Johnson Pharmaceut Serv, Malvern, PA USA
关键词
ACUTE-PHASE REACTANTS; COMBINATION THERAPY; CLINICAL-PRACTICE; DOUBLE-BLIND; TRIAL; DAMAGE; DEFINITIONS; PROGRESSION; ETANERCEPT; VALIDATION;
D O I
10.1136/ard.2008.090019
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective: To examine the association of radiographic progression and disease activity states in patients with rheumatoid arthritis (RA) treated with methotrexate with or without infliximab. Methods: Patients (n = 1049) with active RA for 3 years or less and no previous methotrexate treatment were randomly assigned (4 : 5 : 5) to receive methotrexate plus placebo or methotrexate plus infliximab 3 or 6 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter to week 46. Disease activity was classified by the simplified disease activity index as remission (<= 3.3), low (> 3.3 to <= 1), moderate (> 11 to <= 26), high (> 26). Radiographic progression was measured as a change from baseline to week 54 in total Sharp score. Results: At weeks 14 and 54, more patients receiving methotrexate plus infliximab than methotrexate plus placebo were in remission (10.7% versus 2.8% week 14; 21.3% versus 12.3% week 54; p < 0.001 for both). Methotrexate plus placebo halted radiographic progression only if patients achieved remission within 3 months, whereas methotrexate plus infliximab also halted or minimised progression in patients with low or moderate activity, respectively. Patients with persistently high disease activity levels had much less progression of joint damage if treated with methotrexate plus infliximab versus methotrexate monotherapy. Even with infliximab plus methotrexate there was a direct relationship between disease activity and radiographic changes, although the slope was deflected when compared with methotrexate monotherapy. Conclusion: With methotrexate, joint damage progresses even at low and moderate disease activity levels, whereas methotrexate plus infliximab inhibits radiographic progression across all disease activity states.
引用
收藏
页码:823 / 827
页数:5
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