Psoriatic Arthritis WorkshopOMERACT May 14th, 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

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 ProcessObjectives

Outcome Measures in PsA

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.

Delphi ProcessMethods

Outcome Measures in PsA

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

Delphi ProcessMethods

Group median scores for DCART

0

2

4

6

8

10

12

14

Active

JC

Xray

damag

e

Patien

t glob

alPain

Physic

al fu

nctio

n

Acute

phas

eQOL

Dactyl

itis

Enthes

itis

Damag

ed J

CSkin

Physic

ian g

lobal

Mornin

g sti

ffnes

s

Spinal

mobilit

y - l

umba

r

Utility

index

Sleep

Extra-

skele

tal

Fatig

ue

Sacro

iliac

tests

Xray

joint

inflam

mation

Spinal

mobilit

y - t

hora

cic

Spinal

mobilit

y - c

ervic

al

Tend

initis

Obser

ved

phys

ical

Wor

k lim

itatio

ns

Wor

k inc

apac

ity

Round1 Median Round2 Median Round3 Median

Disease Controlling Anti-Rheumatic Drugs

Results of Delphi ExerciseDMARD

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

List of possible domains for discussion has been significantly shortened– However, major concern about lower ranking

of skin assessment as a domain

Now requires involvement of patients, other rheumatologists and dermatologists, and industry

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

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. Develop a research agenda.

Outcome Measures in PsAClinical Disease Activity

Domain Proposed Instrument

Peripheral arthritis ACR joint count(68/66; 78/76)

Axial Disease To be determined

Skin Disease To be determined (PASI, Target, Nails)

Physician Global Visual analogue scale

Biomarkers ESR, CRP (cytokines, Genetic markers)

Outcome Measures in PsA

Other Features

Domain Instrument

Dactylitis(Acute, chronic)

To be determined

Enthesitis To be determined

Tendonitis To be determined

Outcome Measures in PsA

Patient derived features

Domain Proposed instrument

Pain VAS

Quality of life SF-36, (DLQI,PsAQoL)

Function HAQ (Other)

Fatigue To be determined(Krupp, FACIT, MFI)

Outcome Measures in PsA

Damage

Domain Instrument

Imaging Radiographs

Hands, feet, AP pelvis

(MRI, US)

Outcome Measures in PsA

Delphi process and nominal group process identified domains and some instruments for the assessment of PsA.

These require confirmation by a larger group.

How do these function in clinical trials?