1. GRAPPA Committee Reports and Outcome measures Dafna D. Gladman, MD, FRCPC Professor of Medicine, University of Toronto Director, PsA Program, University Health network

2. OMERACT 7 PsA Workshop Research Agenda u Identify optimal joint count. u Develop instrument for patient global to incorporate skin and joint question. u Identify optimal Skin assessment. u Develop tools to define structural damage. u Develop instruments for Axial assessment. u Develop a tool for the assessment of participation. u Develop instruments for the assessment of Enthesitis. u Develop tools for the assessment Dactylitis. u Imaging modalities to assess inflammation and damage. u Develop Composite responder indices. u Differential tissue response to therapies. u Study methods to evaluate Fatigue in PsA.

4. GRAPPA research committees TopicResponsible members Peripheral joint assessment Global Assessment Dactylitis and Enthesitis Quality of life, participation Spinal Assessment Treatment Guidelines for PsA Immunohistology and biomarkers Imaging Economic Impact Gladman, Mease, Antoni Cauli Helliwell Mease, Taylor, Veale Olivieri, Helliwell Kavanaugh, Ritchlin Fitzgerald, Ritchlin Van der Heijde Gladman

5. OMERACT Outcome MEasures in RheumAtology Clinical Trials u OMERACT was established at a conference in Maastricht, The Netherlands, in 1992. u An informal international network of clinicians and investigators in the field of rheumatology. u The OMERACT process involves achieving consensus on outcome measures and is based on the “OMERACT filter”.

6. OMERACT Filter u 3 concepts: –Truth: face, content, construct and criterion validity »does the measure address what it was meant to in an unbiased and relevant way. –Discrimination: reliability and sensitivity to change »does the measure discriminate between situations of interest. –Feasibility: »can a measure be applied pragmatically, given financial and interpretation constraints, in longitudinal observational studies and randomized controlled trials.

7. Psoriatic Arthritis u Peripheral joint assessment –68 tender/66 swollen for entry –68 tender/66 swollen for calculation of ACR20/50/70 and PsARCC »Both include joint counts, patient and physician global assessment »ACR includes ESR/CRP –Should ACR or PsARC be considered primary outcome measures? –Should we develop a new response measure? What Measurements?

8. New Therapies in PsA *12 weeks; + 16 weeks; X 24 weeks Mease et al. Lancet 2000;356:385-90; Antoni et al, A8R 2005; Mease et al. A&R 2004;50:2264-72; Kaltwasser et al. A&R 2004; 50:1939-50; Serono Website; Kavanaugh et al. ARD 2005; Xoma website; Mease et al A&R 2004; Mease et al, ARD 2005 Effect on Joint Disease

9. Proposed Measurements for Clinical Trials u Peripheral Joint Count –Tender –Swollen u Dactylitis –No. digits –Level of tenderness/swelling u Enthesitis (4 vs 13 sites) u Spinal assessment (Study to be done) u Skin assessment (PASI, Target) u Patient and Physician Global u HAQ, SF-36 u Fatigue Scale (FSS, FACIT)

10. Committee Reports u Research Committee (P. Helliwell) u QOL/Participation (P. Mease/W. Taylor) u PGA/VAS (A. Cauli) u Tissue Histology (D. Baeten) u World Congress (PsO/PsA) in Stockholm May 31-Jun 2, 2006 (P. Mease) u Reporting from Dermatology (W. Henning) u Publications Committee (P. Mease)