OMERACT WorkshopOutcome 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

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

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 PsAResults 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

To be determined

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 WorkshopOMERACT 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 WorkshopOutline

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.

Group 1 2 3 4 5 6 7 8 9 10 11 12 Sum Score

Domain RANKJoint activity 2 1 1 1 2 8 1 1 1 1 1 1 21 1.75 1Patient global 1 3 2 2 4 6 3 2 3 3 3 0 32 2.67 2Pain 3 2 8 4 3 5 2 3 2 2 2 3 39 3.25 3Physical function 5 4 6 7 5 5 5 6 5 9 5 4 66 5.5 4Structural Damage 6 6 9 5 7 3 4 4 10 4 4 8 70 5.83 5Skin disease 7 7 5 3 1 4 10 5 6 10 8 5 71 5.91 6QOL 5 10 9 8 5 7 4 7 7 6 68 6.8 7Enthesitis 9 3 8 10 1 8 8 8 5 11 71 7.1 8Physician global 10 12 6 6 3 6 7 11 8 7 76 7.6 9Acute phse reactants 8 7 11 9 3 10 7 12 8 6 9 90 8.18 10Dactylitis 13 3 15 11 2 9 9 13 12 87 9.67 11Axial involvement 12 11 10 12 2 12 10 13 14 13 2 111 10.1 12Morning stiffness 11 14 12 14 1 13 14 12 10 101 11.2 13Damaged joint count 14 13 17 13 14 8 11 14 104 13 14work disability 19 6axialRadiology (inflammatory) 13Sacroiliac signs 18Fatigue 15 16 9Synovial/ skin tissue 14Sleep 15work disability 17

OMERACT 7 PsA Workshop Breakout Composite Scores

OMERACT 7 PsA WorkshopDomains 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%

61%

60%

48%

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 ProposalOMERACT 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 ProposalOMERACT 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