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

BMC Musculoskeletal Disorders

Amitabh Singh⁵  Ron Pedersen⁵  Bonnie Vlahos⁵  Andrew S Koenig⁵  Henk W Nab⁴  Rezaul Khandker⁵  Chi Chiu Mok³  Suk Chyn Gun¹  Sang-Cheol Bae² 

[1] Department of Medicine, Hospital Tuanku Ja’afar Seremban, Seremban, Malaysia;Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul 133-792, Korea;Department of Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong;Pfizer Inc., Europe, Rome, Italy;Pfizer Inc., Specialty Care Business Unit, 500 Arcola Road, Collegeville, PA, 19426, USA

关键词: Health outcomes assessments;    Asia-Pacific;    Rheumatoid arthritis;    Etanercept;    Patient reported outcomes;   

Others  :  1134247
DOI  :  10.1186/1471-2474-14-13

 received in 2012-05-03, accepted in 2012-12-17,  发布年份 2013

【 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.

Trial registration

clintrials.gov # NCT00422227

【 授权许可】

   
2013 Bae et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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