2) The proportion of patients achieving clinical remission, as measured by disease activity score (DAS28 less than 2.6). DAS28 is a measure of joint swelling and tenderness (based on 28 joints), as well as overall disease activity measured by a global health assessment and an objective marker of inflammation (erythrocyte sedimentation rate). DAS28 is a validated tool used in clinical trials.
Other endpoints included low disease activity (DAS28 less than or equal to 3.2), radiographic non-progression (mTSS less than or equal to 0.5), and the number of patients achieving functional remission as measured by Health Assessment Questionnaire (HAQ). This double-blind, randomised, multicenter study consists of two 12-month periods. The data presented at EULAR is from the first 12-month period (52 weeks).
**DART study details:
The DART (Anti-TNF Drug utilization and dosing patterns Assessment: a Retrospective observational study of subjects Treated for rheumatoid arthritis) study is a retrospective observational study involving 739 patients in 44 European centres treated with monoclonal antibodies to TNF-alpha or soluble TNF-alpha receptor over is greater than or equal to 12 month period. The study was designed to assess potential dose escalation and other associated treatment costs on routine clinical practice. Eligible subjects were required to be continuously treated with prescribed anti-TNF agent (ATA) for is greater than or equal to 12 months and have no concurrent diagnosis of any other TNF-mediated conditions.
Participating investigators completed a questionnaire on treatment strategies to overcome loss of response or failure to achieve initial response and whether there were restrictions on dose escalation.
Dosing Patterns and Clinical and Economic Outcomes at Year 1
Etanercept Adalimumab Infliximab
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DAS 28 (0-10) 3.3 3.4 3.7
EULAR Good Response (%) 46 47 31
ATA Dose Escalation (%) <1 8(i) 29(i)
ATA or DMARD intensification 7 16(ii) 36(ii)
(%)
ATA or Steroid Intensification 6 15(ii) 32(ii)
(%)
Inpatient Visit Rate 0.29 (-47) 0.22 (-38) 0.93 (41)
(% change from baseline)
Outpatient visit rate 5.4 (17) 6.3 (29) 8.0 (54)
(% change from baseline)
Total cost of care EUR 19,775 EUR 23,253* EUR 20,348
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*p<0.05; (i)p<0.001; (ii)p<0.01
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References
(1) Abstract OP-0008 from the European League Against Rheumatism (EULAR) congress, 12 June 2008. Emery P. et al. Clinical Remission, Radiographic Non-Progression, And Normalized Function With The Combination Of Etanercept And Methotrexate In The Treatment Of Early Active Rheumatoid Arthritis: 1-Year Results Of The COMET Trial
(2) Abstract OP-0096 from the European League Against Rheumatism (EULAR) congress, 12 June 2008. Anis. A. et al. Work-Related Outcomes In Early Active Rheumatoid Arthritis: Results From The COMET Trial
(3) Abstract FRI0139 from the European League Against Rheumatism (EULAR) congress, 13 June 2008. Moots, R. et al. Dose Escalation Accounts For Differences In Cost Of Care In 739 Patients With Rheumatoid Arthritis (RA) Treated With Anti-TNF Agents (ATAs): Results From The DART Study
(4) Enbrel EMEA SPC (eMC last accessed 25/05/08)
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