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Philip Mease 1 Rita Ganguly 2 , L. Wanke 3 , Amitabh Singh 2

How Much Improvement in Functional Status Is Considered Important by Patients With Active Psoriatic Arthritis: Applying the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Group Guidelines. Philip Mease 1 Rita Ganguly 2 , L. Wanke 3 , Amitabh Singh 2

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Philip Mease 1 Rita Ganguly 2 , L. Wanke 3 , Amitabh Singh 2

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  1. How Much Improvement in Functional Status Is Considered Important by Patients With Active Psoriatic Arthritis: Applying the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Group Guidelines Philip Mease1 Rita Ganguly2, L. Wanke3, Amitabh Singh2 1Seattle Rheumatology Associates, Seattle, WA; 2Wyeth Research, Collegeville, PA; 3Amgen, Thousand Oaks, CA

  2. Methods • Data from a double blind, randomized, placebo controlled 24 weeks study was used to assess patients with active Psoriatic Arthritis treated with etanercept 25 mg twice weekly compared to placebo • Alternative measures of MCID for improvement in patients’ functional status as measured by Health Assessment Questionnaire (HAQ) were: • Data-driven MCID: 2.2.5 • Patient Rating-Based MCID: 2.1.5 • Patient Rating-Based Important MCID: 2.1.5

  3. Methods Data-Driven Approach MCID • Upper bound of 95% confidence interval of standard error of measurement (SEM) for HAQ • SEM = σ baseline HAQ 1- rbaselineHAQ whereσ=standard deviation r = Cronbach’s alpha coefficient

  4. Methods Patient Rating-Based MCID Not At Extremely All Important Important How important to you is the amount of change in your physical limitations (such as limitations in walking, standing, gripping reaching, etc.) 1 2 3 4 5 6 7 Minimally Important Very Important Mean change from baseline in HAQ Disability Score for those who improved 0.5 1.0 1.5 2.0 2.5 3.0 0.0

  5. Results

  6. Valued Life Activities (VLA) • Broader array of activities than measured by HAQ, e.g. ability to take part in social activities, taking care of family members, participating in religious activities, etc. • Element of motivation • Importance of meaningfulness

  7. VLA • Katz P Arth Care & Research 1995 • RA patients with decline in basic function and/or loss of valued activities • Deline in basic function (HAQ), no loss of valued activities (30%) • Loss of valued activities, no decline in basic function (57%) • Both (13%)

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