OMERACT Workshop Outcome Measures in Psoriatic Arthritis Dafna D. Gladman MD, FRCPC Director, Psoriatic Arthritis Program, University Health Network Centre for Prognosis Studies in the Rheumatic Diseases Toronto Western Hospital Toronto Western Hospital

Psoriatic Arthritis

Psoriatic Spondyloarthritis 

Dactylitis and entheisis in PsA

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”

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.

Outcome Measures in PsA Delphi Process Methods Review of existing assessment tools in PsA Gladman et al. A&R 2004;50:24-35 Development of a list of potential domains via email discussion. Delphi process to rank and prioritize these domains with controlled feedback. Questionnaires sent to 54 rheumatologists, 32 responded and were included in 2 further rounds.

Outcome Measures in PsA Delphi Process Methods The questionnaire requested 100 points to be distributed amongst 26 possible outcome domains, under the four measurement contexts The point allocation reflects the relative importance of that domain to the measurement context Clear reduction in variability over the three rounds, but the relative ranking of domains didn’t alter a great deal

Disease Controlling Anti-Rheumatic Drugs

Results of Delphi Exercise DMARD Active Joint Count Pain Patient global X-ray damage Physical function Acute Phase Reactant Quality of Life Physician global Skin disease Damaged Joint Count Enthesitis Dactylitis Morning stiffness Lumbar mobility Work disability Work limitation Performance Tendonitis Cervical mobility Thoracic mobility MRI/US Sacroiliac signs Fatigue Extra-skeletal Sleep Utility indices

GRAPPA Meeting August 15-17, 2003 Further define domains for the assessment of PsA by a group of rheumatologists, dermatologists, patients and industry, through a nominal group process (3 breakout groups). Achieve consensus on those domains. Identify instruments to be used for the domains.

Outcome Measures in PsA Results of nominal group process Domain Instrument Measures of inflammation Peripheral arthritis Axial Disease Skin Disease Physician Global Biomarkers Dactylitis Enthesitis Tendonitis Patient derived measures Pain Quality of life Function Fatigue Damage Imaging ACR joint count (68/66; 78/76) To be determined To be determined (PASI, Target, Nails) Visual analogue scale ESR, CRP (cytokines, Genetic markers) (Acute, chronic) To be determined VAS SF-36, (DLQI,PsAQoL) HAQ (Other) To be determined (Krupp, FACIT, MFI) Radiographs Hands, feet, AP pelvis, MRI, US

Psoriatic Arthritis Workshop OMERACT May 14th, 2004 Steering Committee Dafna Gladman, Philip Mease, Gerald Krueger, Christian Antoni, Désirée van der Heijde, Philip Helliwell, Arthur Kavanaugh, Peter Nash, Christopher Ritchlin, Vibeke Strand, William Taylor

OMERACT 7 PsA Workshop Outline Review of domains identified in previous iterations (D. Gladman). Review of instruments used in clinical trials in PsA and psoriasis (P. Mease, G. Krueger). Review of radiographic methods used in PsA. (D. van der Heijde) Break out groups. Analysis of instruments used in clinical trials (C. Antoni). Review of results of breakout group and votes.

OMERACT 7 PsA Workshop Breakout Composite Scores

OMERACT 7 PsA Workshop Domains in PsA final vote Item Score 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%

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.

GRAPPA research committees Topic Responsible 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

PsA Module Proposal 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.

PsA Module Proposal 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