1. OMERACT 8 PsA Module Co-Chairs Dafna Gladman and Philip Mease Steering Committee Alice Gottlieb, Oliver FitzGerald, Philip Helliwell, Arthur Kavanaugh, Gerald Krueger, Peter Nash, Christopher Ritchlin, Vibeke Strand, William Taylor

2. 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”.

3. 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.

4. 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%

5. OMERACT 8: PsA Module u Achieve consensus on the core set of domains to be assessed in PsA clinical trials and in longitudinal observational cohort studies, u Review and endorse outcome measures used to assess these domains based on evidence derived from clinical trials and u Set up a new research agenda to identify other assessment tools. Objectives

6. Initial Voting on Domains for Core Set in PsA Item1 st Vote2 nd Vote2004 Peripheral joint Activity97%96%99% Patient Global95% 96% HRQoL92% 78% Skin Assessment91%86% Enthesitis81%63%60% Imaging74%72%66% Dactylitis77%66%48% Spinal disease75%59%61% Physician Global71%57%41% Acute Phase Reactants56%9%64% Tissue Analysis19%9%38%

7. Essential core set Proposal for Core Set in Psoriatic Arthritis Necessary but not mandatory Research Agenda V. Strand Inner Circle Outer Circle Outer Outer Circle

8. Discussion at GRAPPA meeting of Moderators and Reporters uOf the 4 domains with more than 86% yes vote at plenary: u3 received 100% endorsement: –Peripheral Joint disease activity –Skin –Patient Global To be included in the “inner circle”

9. Peripheral joint activity Skin activity Patient global Proposal for Domains in Psoriatic Arthritis

10. uHRQoL received only 56% in third vote –Extensive discussion re: What is included in HRQoL? »Physical Function »Pain »Fatigue »Participation –These were considered independent domains. u HRQoL u Pain u Physical function –Made the “inner circle”

11. Peripheral joint activity Skin activity Patient global Proposal for Domains in Psoriatic Arthritis HRQoL Pain Physical Function

12. Peripheral joint activity Skin activity Patient global Pain Physical Function HRQoL Dactylitis Radiology Enthesitis Acute phase reactants Nails Spinal Physician Global Proposal for Domains in Psoriatic Arthritis Fatigue

13. Peripheral joint activity Skin activity Patient global Pain Physical Function HRQoL Dactylitis Radiology Enthesitis Acute phase reactants Nails Spinal Physician Global MRI Ultrasound CT Tissue analysis Participation Proposal for Domains in Psoriatic Arthritis Fatigue

14. Proposed Core Set for PsA u Peripheral Joint inflammation »Tender/swollen joint count 68/66 u Patient Global Assessment »Instrument under study u Skin Assessment »PASI (BSA ≥ 3%) »Lesion (erythema, induration, scale) + BSA u Pain »Visual Analogue Scale or Numeric Rating Scale u Physical Function »HAQ / SF-36 PFC u HRQoL »Generic »Disease specific

15. Research Agenda uContinue research of specific instruments for core domains where lacking. uSpecific instruments for skin and nail assessment –In conjunction with dermatologists u Participation u Tissue Analysis uMRI,US,CT(?) uDevelop a responder index for PsA