Improved health outcomes with Etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis

被引：33

作者：

Bae, Sang-Cheol ^{[1
]}

Gun, Suk Chyn ^{[2
]}

Mok, Chi Chiu ^{[3
]}

Khandker, Rezaul ^{[4
]}

Nab, Henk W. ^{[5
]}

Koenig, Andrew S. ^{[4
]}

Vlahos, Bonnie ^{[4
]}

Pedersen, Ron ^{[4
]}

Singh, Amitabh ^{[4
]}

机构：

[1] Hanyang Univ, Dept Rheumatol, Hosp Rheumat Dis, Seoul 133792, South Korea

[2] Hosp Tuanku Jaafar Seremban, Dept Med, Seremban, Malaysia

[3] Tuen Mun Hosp, Dept Med, Hong Kong, Hong Kong, Peoples R China

[4] Pfizer Inc, Specialty Care Business Unit, Collegeville, PA 19426 USA

[5] Pfizer Inc, Europe, Rome, Italy

来源：

BMC MUSCULOSKELETAL DISORDERS | 2013年 / 14卷

关键词：

Patient reported outcomes; Etanercept; Rheumatoid arthritis; Asia-Pacific; Health outcomes assessments; MODIFYING ANTIRHEUMATIC DRUGS; QUALITY-OF-LIFE; CLINICAL-TRIALS; METHOTREXATE; RECOMMENDATIONS; FATIGUE; COMBINATION; DEPRESSION;

D O I：

10.1186/1471-2474-14-13

中图分类号：

R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学（修复外科学）];

学科分类号：

100224 [整形外科学];

摘要：

Background: Patient reported outcomes (PROs) are especially useful in assessing treatments for rheumatoid arthritis (RA) since they measure dimensions of health-related quality of life that cannot be captured using strictly objective physiological measures. The aim of this study was to compare the effects of combination etanercept and methotrexate (ETN + MTX) versus combination synthetic disease modifying antirheumatic drugs (DMARDs) and methotrexate (DMARD + MTX) on PRO measures among RA patients from the Asia-Pacific region, a population not widely studied to date. Patients with established moderate to severe rheumatoid arthritis who had an inadequate response to methotrexate were studied. Methods: Patients were randomized to either ETN + MTX (N = 197) or DMARD + MTX (N = 103) in an open-label, active-comparator, multicenter study, with PRO measures designed as prospective secondary endpoints. The Health Assessment Questionnaire (HAQ), Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue), Medical Outcomes Short Form-36 Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS) and the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) were used. Results: Significantly greater improvements were noted for the ETN + MTX group at week16 for HAQ mean scores and for proportion of patients achieving HAQ score <= 0.5, compared to patients in the DMARD + MTX group. SF-36 Summary Scores for physical and mental components and for 6 of 8 health domains showed significantly greater improvements at week16 for the ETN + MTX group; only scores for physical functioning and role-emotional domains did not differ significantly between the two treatment arms. Greater improvements at week16 were noted for the ETN + MTX group for FACIT-Fatigue, HADS, and WPAI:GH mean scores. Conclusion: Combination therapy using ETN + MTX demonstrated superior improvements using a comprehensive set of PRO measures, compared to combination therapy with usual standard of care DMARDs plus MTX in patients with established rheumatoid arthritis from the Asia-Pacific region.

引用

页数：8

共 28 条

[1]

Agency for Healthcare Research and Quality, 2007, COMP EFF DRUG THER R

[2]

Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations [J].

Aletaha, D. ;

Landewe, R. ;

Karonitsch, T. ;

Bathon, J. ;

Boers, M. ;

Bombardier, C. ;

Bombardieri, S. ;

Choi, H. ;

Combe, B. ;

Dougados, M. ;

Emery, P. ;

Gomez-Reino, J. ;

Keystone, E. ;

Koch, G. ;

Kvien, T. K. ;

Martin-Mola, E. ;

Matucci-Cerinic, M. ;

Michaud, K. ;

O'Dell, J. ;

Paulus, H. ;

Pincus, T. ;

Richards, P. ;

Simon, L. ;

Siegel, J. ;

Smolen, J. S. ;

Sokka, T. ;

Strand, V. ;

Tugwell, P. ;

van der Heijde, D. ;

van Riel, P. ;

Vlad, S. ;

van Vollenhoven, R. ;

Ward, M. ;

Weinblatt, M. ;

Wells, G. ;

White, B. ;

Wolfe, F. ;

Zhang, B. ;

Zink, A. ;

Felson, D. .

ANNALS OF THE RHEUMATIC DISEASES, 2008, 67 (10) :1360-1364

[3]

Measuring function in rheumatoid arthritis - Identifying reversible and irreversible components [J].

Aletaha, Daniel ;

Smolen, Josef ;

Ward, Michael M. .

ARTHRITIS AND RHEUMATISM, 2006, 54 (09) :2784-2792

[4]

THE AMERICAN-RHEUMATISM-ASSOCIATION 1987 REVISED CRITERIA FOR THE CLASSIFICATION OF RHEUMATOID-ARTHRITIS [J].

ARNETT, FC ;

EDWORTHY, SM ;

BLOCH, DA ;

MCSHANE, DJ ;

FRIES, JF ;

COOPER, NS ;

HEALEY, LA ;

KAPLAN, SR ;

LIANG, MH ;

LUTHRA, HS ;

MEDSGER, TA ;

MITCHELL, DM ;

NEUSTADT, DH ;

PINALS, RS ;

SCHALLER, JG ;

SHARP, JT ;

WILDER, RL ;

HUNDER, GG .

ARTHRITIS AND RHEUMATISM, 1988, 31 (03) :315-324

[5]

A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis [J].

Bathon, JM ;

Martin, RW ;

Fleischmann, RM ;

Tesser, JR ;

Schiff, MH ;

Keystone, EC ;

Genovese, MC ;

Wasko, MC ;

Moreland, LW ;

Weaver, AL ;

Markenson, J ;

Finck, BK .

NEW ENGLAND JOURNAL OF MEDICINE, 2000, 343 (22) :1586-1593

[6]

BELZA BL, 1995, J RHEUMATOL, V22, P639

[7]

Carr A, 2003, J RHEUMATOL, V30, P880

[8]

Cella D, 2005, J RHEUMATOL, V32, P811

[9]

Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial [J].

Emery, Paul ;

Breedveld, Ferdinand C. ;

Hall, Stephen ;

Durez, Patrick ;

Chang, David J. ;

Robertson, Deborah ;

Singh, Amitabh ;

Pedersen, Ronald D. ;

Koenig, Andrew S. ;

Freundlich, Bruce .

LANCET, 2008, 372 (9636) :375-382

[10]

Etanercept versus methotrexate in patients with early rheumatoid arthritis - Two-year radiographic and clinical outcomes [J].