OMERACT 8 PsA Module Co-Chairs Dafna Gladman and Philip Mease

1. OMERACT 8 PsA ModuleCo-ChairsDafna 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 • OMERACT was established at a conference in Maastricht, The Netherlands, in 1992. • An informal international network of clinicians and investigators in the field of rheumatology. • The OMERACT process involves achieving consensus on outcome measures and is based on the “OMERACT filter”.

3. OMERACT Filter • 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 WorkshopDomains in PsA final vote

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

6. Initial Voting on Domains for Core Set in PsA

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

8. Discussion at GRAPPA meeting of Moderators and Reporters • Of the 4 domains with more than 86% yes vote at plenary: • 3 received 100% endorsement: • Peripheral Joint disease activity • Skin • Patient Global To be included in the “inner circle”

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

10. Proposal for Domains in Psoriatic Arthritis • HRQoL received only 56% in third vote • Extensive discussion re: What is included in HRQoL? • Physical Function • Pain • Fatigue • Participation • These were considered independent domains. • HRQoL • Pain • Physical function • Made the “inner circle”

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

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

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

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

15. Research Agenda • Continue research of specific instruments for core domains where lacking. • Specific instruments for skin and nail assessment • In conjunction with dermatologists • Participation • Tissue Analysis • MRI,US,CT(?) • Develop a responder index for PsA