Transcript 5_Dafna_Measurements..

GRAPPA
Committee Reports and
Outcome measures
Dafna D. Gladman, MD, FRCPC
Professor of Medicine, University of Toronto
Director, PsA Program, University Health network
OMERACT 7 PsA Workshop
Research Agenda
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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
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.
Psoriatic Arthritis
What Measurements?
 Peripheral
joint assessment
– 68 tender/66 swollen for entry
– 68 tender/66 swollen for calculation of
ACR20/50/70 and PsARCC
» Both include joint counts, patient and physician
global assessment
» ACR includes ESR/CRP
– Should ACR or PsARC be considered primary
outcome measures?
– Should we develop a new response measure?
New Therapies in PsA
Effect on Joint Disease
Trial
ACR20 % ACR50 % ACR70 % PsARC %
Rx
P Rx
P Rx
P Rx
P
Etanercept 2*
60
74
14
48
5
13
0
87
23
Infliximab 2+
100
69
8
49
9
29
0
76.5
18
Etanercept 3*
205
59
15
38
4
11
0
72
31
Etanercept 3x
205
50
13
37
4
9
1
70
24
Leflunomide 3x
188
38.5
20
NA
NA
NA
NA
57.9
29.7
Onercept 2*
42
NA
NA
NA
NA
NA
NA
86
45
Infliximab 3x
200
58
11
NA
NA
15
1
NA
NA
Efalizumab 2+
107
28
19
NA
NA
NA
NA
NA
NA
Adalimumab 2/3x
315
58
14
36
4
20
1
62
26
Alefacept 2x
185
54
23
18
10
7
3
NA
NA
*12 weeks; + 16 weeks; X24 weeks
Mease et al. Lancet 2000;356:385-90; Antoni et al, A8R 2005; Mease et al. A&R 2004;50:2264-72;
Kaltwasser et al. A&R 2004; 50:1939-50; Serono Website; Kavanaugh et al. ARD 2005; Xoma
website; Mease et al A&R 2004; Mease et al, ARD 2005
Proposed Measurements for Clinical Trials
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Peripheral Joint Count
– Tender
– Swollen
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Dactylitis
– No. digits
– Level of tenderness/swelling
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Enthesitis (4 vs 13 sites)
Spinal assessment (Study to be done)
Skin assessment (PASI, Target)
Patient and Physician Global
HAQ, SF-36
Fatigue Scale (FSS, FACIT)
Committee Reports
Research Committee (P. Helliwell)
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QOL/Participation (P. Mease/W. Taylor)
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PGA/VAS (A. Cauli)
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Tissue Histology (D. Baeten)
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World Congress (PsO/PsA) in Stockholm
May 31-Jun 2, 2006 (P. Mease)
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Reporting from Dermatology (W. Henning)
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Publications Committee (P. Mease)
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