VALIDATION OF REMISSION OF RHEUMATOID ARTHRITIS BY TRADITIONAL DISEASE ACTIVITY SCORE AND PROVISIONAL CRITERIA BY AMERICAN COLLEGE OF RHEUMATOLOGY AND EUROPEAN LEAGUE AGAISNT RHEUMATISM- ANALYSIS BASED ON PATIENT REPORTED OUTCOMES FROM 3 PH ...

Author(s)

Han C1, Keystone E2, Fleischmann R3, Smolen JS4, Emery P5, Genovese M6, Doyle M7, Hsia E71Johnson & Johnson Pharmaceutical Services, LLC, Malvern, PA, USA, 2Mount Sinai Hospital, Toronto, ON, Canada, 3University of Texas, Dallas, TX, USA, 4Medical University of Vienna and Hietzing Hospital, Vienna, Austria, 5University of Leeds, Leeds, United Kingdom, 6Stanford University, Palo Alto, CA, USA, 7Janssen Research & Development, LLC, Spring House, PA, USA

OBJECTIVES: Remission by Boolean-based definition(all scores on the TJC and SJC,CRP(mg/dl), and PGA≤1) and by SDAI(<3.3) were proposed by ACR/EULAR.Using patient reported outcomes as anchors, this analysis validated these remission criteria against traditional DAS28(using CRP<2.6)remission. METHODS: Efficacy of golimumab(GLM) was assessed in MTX-naïve RA patients(GO-BEFORE,N=637),RA patients with inadequate response to MTX(GO-FORWARD,N=444) and RA patients previously treated with biologic anti-TNFα agent(s) with baseline MTX use(GO-AFTER,N=305).Pooled data from patients who received placebo(PBO)+MTX, or GLM(50or100mg)+MTX,q4wks were used for this analysis.Patient reported outcomes were measured using:HAQ, SF-36 PCS and MCS, FACIT-Fatigue, and VAS 0-10 of impact of RA on daily work productivity.Descriptive statistics were provided for patient reported outcomes among patients in remission as defined remission definitions. RESULTS: Greater proportions of patients treated with GLM+MTX vs patients treated with PBO+MTX achieved remission by each remission definition.In the pooled analysis,the remission rate at wk24 was the highest(20.2%)by DAS28 vs remission by SDAI(10.6%,p<0.001) and remission by Boolean-based definition(8.6%p<0.001).Patients with remission by DAS28 achieved normal physical function(HAQ≤0.5),normal SF-36PCS and MCS(≥50) by 67.8%,38.4%,62.2%,respectively;these parameters were numerically lower vs. patients with remission by SDAI(81.3%,62.8%,72.1%,respectively) or by Boolean-based definition(82.0%,63.5%,74.3%, respectively). Patients in remission by DAS28 had higher HAQ scores(0.43±0.49)vs patients in remission by SDAI(0.26±0.41) or Boolean-based criteria(0.28±0.44).Similar results were observed in measures of   FACIT-Fatigue and productivity VAS scores.Among MTX-naive patients in GO-BEFORE who achieved remission by DAS28,71.3% achieved normal physical function vs 86.9% of those in remission by SDAI and 86.5% of patients in remission by Boolean-based definition.Among anti-TNFα experienced patients in GO-AFTER,62.1% of those in remission by DAS28 achieved normal physical function vs. 65.0% of those in remission by SDAI, and 66.7% of patients in remission by Boolean-based definition. CONCLUSIONS: While disease remission has been adapted as a target in the management of RA, more stringent remission criteria proposed by ACR/EULAR can provide optimal patient-reported outcomes.

Conference/Value in Health Info

2012-06, ISPOR 2012, Washington, D.C., USA

Value in Health, Vol. 15, No. 4 (June 2012)

Code

PMS52

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Musculoskeletal Disorders

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