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

被引:32
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
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
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.
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页数:8
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