Transcript gladmaneadv87

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
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Disease Controlling Anti-Rheumatic Drugs
Round1 Median
Round2 Median
Round3 Median
Group median scores for DCART
14
12
10
8
6
4
2
0
Results of Delphi Exercise
DMARD
Active Joint Count
Work disability
Pain
Work limitation
Patient global
Performance
X-ray damage
Tendonitis
Physical function
Cervical mobility
Acute Phase Reactant
Thoracic mobility
Quality of Life
MRI/US
Physician global
Sacroiliac signs
Skin disease
Fatigue
Damaged Joint Count
Extra-skeletal
Enthesitis
Sleep
Dactylitis
Utility indices
Morning stiffness
Lumbar mobility
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
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
Instrument
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 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
Group
1
2
Domain
RANK
Joint activity
2
1
Patient global
1
3
Pain
3
2
Physical function
5
4
Structural Damage
6
6
Skin disease
7
7
QOL
5
Enthesitis
9
Physician global
10
Acute phse reactants
8
Dactylitis
13
Axial involvement
12
Morning stiffness
11
Damaged joint count
14
work disability
axial
Radiology (inflammatory)
Sacroiliac signs
Fatigue
15
Synovial/skin tissue
Sleep
15
work disability
17
3
4
5
6
1
2
8
6
9
5
10
3
12
7
3
11
14
13
1
2
4
7
5
3
9
8
6
11
15
10
12
17
19
2
4
3
5
7
1
8
10
6
9
11
12
14
13
8
6
5
5
3
4
5
1
3
3
2
2
1
13
18
16
14
7
8
9 10 11 12
1 1 1
3 2 3
2 3 2
5 6 5
4 4 10
10 5 6
7
4
8 8 8
6
7
10 7 12
9
9
12 10 13
13
14
14 8 11
1
3
2
9
4
10
7
5
11
8
13
14
12
6
9
1
3
2
5
4
8
7
11
8
6
12
13
10
14
1
0
3
4
8
5
6
21
32
39
66
70
71
68
71
7 76
9 90
87
2 111
101
104
Sum
1.75
2.67
3.25
5.5
5.83
5.91
6.8
7.1
7.6
8.18
9.67
10.1
11.2
13
Score
1
2
3
4
5
6
7
8
9
10
11
12
13
14
OMERACT 7 PsA Workshop
Domains in PsA final vote
Item
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
Score
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 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