Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes

被引：71

作者：

Bathon, J. ^{[1
]}

Robles, M. ^{[2
]}

Ximenes, A. C. ^{[3
]}

Nayiager, S. ^{[4
]}

Wollenhaupt, J. ^{[5
]}

Durez, P. ^{[6
]}

Gomez-Reino, J. ^{[7
]}

Grassi, W. ^{[8
]}

Haraoui, B. ^{[9
]}

Shergy, W. ^{[10
]}

Park, S-H ^{[11
]}

Genant, H. ^{[12
,13
]}

Peterfy, C. ^{[14
]}

Becker, J-C ^{[15
]}

Covucci, A. ^{[15
]}

Reed, D. Moniz ^{[15
]}

Helfrick, R. ^{[15
]}

Westhovens, R. ^{[16
]}

机构：

[1] Columbia Univ, Coll Phys & Surg, New York, NY 10023 USA

[2] Ctr Med Toluca, Mentpec, Mexico

[3] Hosp Geral Goiania, Goiania, Go, Brazil

[4] St Augustines Hosp, Durban, South Africa

[5] Klinikum Eilbek, Hamburg, Germany

[6] Catholic Univ Louvain, B-1200 Brussels, Belgium

[7] Hosp Clin Univ, Santiago De Compostela, Spain

[8] Univ Politecn Marche, Ancona, Italy

[9] Inst Rhumatolgie Montreal, Montreal, PQ, Canada

[10] Univ Alabama, Huntsville, AL 35899 USA

[11] Seoul St Marys Hosp, Seoul, South Korea

[12] Univ Calif San Francisco, Dept Radiol, San Francisco, CA USA

[13] SYNARC, San Francisco, CA USA

[14] Spire Sci LLC, San Francisco, CA USA

[15] Bristol Myers Squibb Co, Princeton, NJ USA

[16] Katholieke Univ Leuven, UZ Gasthuisberg, Louvain, Belgium

来源：

ANNALS OF THE RHEUMATIC DISEASES | 2011年 / 70卷 / 11期

关键词：

COSTIMULATION MODULATOR ABATACEPT; DOUBLE-BLIND; CONTROLLED-TRIAL; INADEQUATE RESPONSE; PHYSICAL FUNCTION; CLINICAL-TRIALS; TASK-FORCE; PHASE IIB; COMBINATION; THERAPY;

D O I：

10.1136/ard.2010.145268

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Objective To assess the efficacy and safety of abatacept plus methotrexate versus methotrexate alone in early erosive rheumatoid arthritis (RA). Methods The AGREE was a 2-year phase IIIb multinational study in early (<= 2 years) RA. During the double-blind period (year 1), patients were randomly assigned 1:1 to receive abatacept+methotrexate or methotrexate alone; all patients received open-label abatacept+methotrexate during year 2. Clinical outcomes assessed included 28-joint disease activity score (DAS28) defined remission, low disease activity score (LDAS), American College of Rheumatology (ACR) responses and physical function. Radiographic outcomes were assessed using the Genant-modified Sharp total score (TS). Safety was monitored throughout. Results Of the 459 patients completing year 1, 433 patients (94.3%) completed year 2. DAS28-defined remission, LDAS, ACR and physical function were sustained through year 2 in the original abatacept+methotrexate group, with 55.2% in remission at 2 years. Upon introduction of abatacept in the methotrexate-alone group, additional patients achieved DAS28-defined remission (44.5% vs 26.9%), LDAS (60.4% vs 43.2%) and improved ACR 70 (49.8% vs 31.7%) for year 2 versus year 1. Less radiographic progression was observed at 2 years in the original abatacept+methotrexate group than the methotrexate-alone group (change in TS 0.84 vs 1.75, p<0.001). No new safety issues were seen. Similar rates of serious adverse events, serious infections and autoimmune events were observed in years 1 and 2. Conclusions The AGREE trial was the first to examine the impact of T-cell co-stimulation modulation with abatacept in patients with early erosive RA. Early treatment with abatacept+methotrexate resulted in greater sustainable clinical, functional and radiographic benefits than methotrexate alone, with acceptable safety and tolerability.

引用

页码：1949 / 1956

页数：8

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