1. 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

2. Psoriatic Arthritis

3. Psoriatic Spondyloarthritis

4. Dactylitis and entheisis in PsA

5. 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”

6. 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.

7. 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 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.

8. 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

9. Disease Controlling Anti-Rheumatic Drugs

10. 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

11. 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.

12. 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

13. 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

14. 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.

15. OMERACT 7 PsA Workshop Breakout Composite Scores

16. 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%

17. 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.

18. 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

19. 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.

20. 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