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

Outcome Measures in Psoriatic Arthritis Results of Dephi exercise and Nominal Group Process Dafna D. Gladman, Professor of Medicine, University of Toronto, Director, Psoriatic Arthritis Program University Health Network

Psoriatic Arthritis Patterns

Psoriatic Spondyloarthropathy 

Dactylitis in PsA Acute Chronic

Outcome Measures in PsA u To arrive at a consensus-based list of core domains that should be used in outcome studies of PsA, including: –Disease controlling anti-rheumatic therapy trials –Symptom modifying anti-rheumatic therapy trials –Clinical record keeping and observational studies –Rehabilitation intervention studies Delphi Process Objectives

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

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

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

Identifying Domains of Inquiry in Psoriatic Arthritis u List of possible domains for discussion has been significantly shortened –However, major concern about lower ranking of skin assessment as a domain u Now requires involvement of patients, other rheumatologists and dermatologists, and industry u Next step should probably be face-to-face discussion to refine the core lists Summary of Delphi Process

GRAPPA Objectives for August 15-17, 2003 u 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). u Achieve consensus on those domains. u Identify instruments to be used for the domains. u Develop a research agenda.

Outcome Measures in PsA Clinical Disease Activity DomainProposed Instrument Peripheral arthritisACR joint count (68/66; 78/76) Axial DiseaseTo be determined Skin DiseaseTo be determined (PASI, Target, Nails) Physician GlobalVisual analogue scale BiomarkersESR, CRP (cytokines, Genetic markers)

Outcome Measures in PsA Other Features DomainInstrument Dactylitis (Acute, chronic) To be determined EnthesitisTo be determined TendonitisTo be determined

Outcome Measures in PsA Patient derived features DomainProposed instrument PainVAS Quality of lifeSF-36, (DLQI,PsAQoL) FunctionHAQ (Other) FatigueTo be determined (Krupp, FACIT, MFI)

Outcome Measures in PsA Damage DomainInstrument ImagingRadiographs Hands, feet, AP pelvis (MRI, US)

Outcome Measures in PsA u Delphi process and nominal group process identified domains and some instruments for the assessment of PsA. u These require confirmation by a larger group. u How do these function in clinical trials?