1. OMERACT 8 PsA Module Proposal Submitted by: Dafna Gladman and Philip Mease

2. OMERACT 7 PsA Workshop Domains in PsA final vote ItemScore Joint activity Patient Global all 3 components Pain assessment Physical function Skin disease Quality of Life Structural damage Acute Phase Reactant Axial involvement Participation Enthesitis Fatigue Dactylitis Physician Global Tissue histology MRI Morning Stiffness Damage joint count 99% 96% 76% 94% 91% 86% 78% 66% 64% 61% 60% 48% 41% 38% 34% 25% 20%

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

4. PsA Module OMERACT 8 Objectives : – 1) achieve consensus on the core set of domains to be assessed in PsA clinical trials and in longitudinal observational cohort studies, – 2) review and endorse outcome measures used to assess these domains based on evidence derived from clinical trials and – 3) set up a new research agenda to identify other assessment tools.

5. PsA Module OMERACT 8 Key domains of PsA for which updated trial data will be available: – 1) Joint assessment – 2) Spine disease – 3) Enthesitis and dactylitis – 4) Imaging modalities – 5) Histologic and immunohistochemical markers – 6) QOL/function/participation – 7) Skin

6. PsA Module OMERACT 8 Process – OMERACT filter Truth, discrimination, feasibility – Each committee to report progress to D. Gladman quarterly. – Review progress at EULAR and ACR 2005, Gene to Clinic Nov. 2005. – GRAPPA meeting at OMERACT Need ~30 GRAPPA members to participate 18 of whom will be scribes – Proceedings to be published in J Rheum