OMERACT 8 introducti..

Report
OMERACT 8
PsA Module
Co-Chairs
Dafna Gladman and Philip Mease
Steering Committee
Alice Gottlieb, Philip Helliwell,
Arthur Kavanaugh, Gerry Krueger,
Peter Nash, Christopher Ritchlin,
Vibeke Stand, William Taylor
Psoriatic arthritis
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An inflammatory
arthritis.
Associated with
psoriasis.
Usually seronegative for
rheumatoid factor.
Associated Features:
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Spondylitis,
Enthesitis,
Dactylitis,
Iritis
Mucous membrane ulcers
Urethritis
Other extra-articular
features of SpA.
CASPAR study
Design
 Prospective,
observational study of
consecutive clinic patients with PsA
and other inflammatory arthritis
 Target sample size of 1012 in total
 30 clinics in 13 countries
 Gold-standard of diagnosis based on
physician’s opinion
 Data collected 02/02 – 03/04
CASPAR Study: Methods
Data collected:
– Clinical and examination features
– X-rays of spine, sacroiliac joints, hands and
feet
– Rheumatoid factor, [HLA], anti-CCP, stored
blood
X-rays were read centrally by 2 readers in
tandem, blinded to diagnosis
Clinical gold-standard validated by quality
control and Latent Class Analysis
(statistical modelling)
New criteria developed using CART and
logistic regression
CASPAR Criteria
Taylor W, et al. A&R 2006 (in press)
Inflammatory musculoskeletal disease (joint, spine, or entheseal)
With 3 or more of the following:
1. Evidence of a. Current psoriasis*
psoriasis (one
b. Personal history of
of a, b, c)
Psoriatic skin or scalp disease present today as
judged by a dermatologist or rheumatologist
psoriasis
A history of psoriasis that may be obtained from
patient, family doctor, dermatologist or
rheumatologist
c. Family history of
psoriasis
A history of psoriasis in a first or second degree
relative according to patient report
2. Psoriatic nail dystrophy
Typical psoriatic nail dystrophy including
onycholysis, pitting and hyperkeratosis observed
on current physical examination
3. A negative test for rheumatoid
factor
By any method except latex but preferably by
ELISA or nephelometry, according to the local
laboratory reference range
4. Dactylitis
either a or b
a. Current Dactylitis
Swelling of an entire digit
b. History of Dactylitis
Recorded by a rheumatologist
5. Radiological evidence of juxtaarticular new bone formation
Ill-defined ossification near joint margins (but
excluding osteophyte formation) on plain xrays of
hand or foot
Specificity 98.7%, sensitivity 91.4%. *Current psoriasis scores 2, others 1.
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
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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.
Differential tissue response to therapies.
Study methods to evaluate Fatigue in PsA.
Develop Composite responder indices.
OMERACT 8: PsA Module
Objectives
 Achieve
consensus on the core set of
domains to be assessed in PsA clinical
trials and in longitudinal observational
cohort studies,
 Review and endorse outcome measures
used to assess these domains based on
evidence derived from clinical trials and
 Set up a new research agenda to identify
other assessment tools.
Assessment of Psoriatic Arthritis
Domains
Proposed Instruments
Joint assessment
T/S joint count, ACR, PsARC, DAS
Axial assessment
Clinical measures, BASDAI, BASFI, BASRI
Skin assessment
PASI, Target lesion, Global
Pain
VAS
Patient global
VAS (global, skin + joints)
Physician global
VAS (global, skin + joints)
Function/QOL
HAQ, SF-36, PsAQoL
Fatigue
Krupp, FACIT, MFI, VAS
Enthesitis assessment
Mander, MASES, present/absent
Dactylitis assessment
Helliwell, present/absent, acute/chronic
Acute phase reactant
ESR, CRP, others
Imaging
Xray, MRI, ultrasound
OMERACT 8: PsA Module Plenary Session
Time
Title
Speaker
08:00-08:05
Introduction
D. Gladman
08:05-08:15
Peripheral joints/ clinical trials P. Mease
08:15-08:25
Spinal assessment - INSPIRE
D. Gladman
08:25-08:35
Dactylitis
P. Healy
08:35-08:45
Enthesitis
P. Helliewell
08:45-08:50
Participation
W. Taylor
08:50-08:55
QoL
D. Veale
08:55-09:00
Patient/physician GA
A. Cauli
09:00-09:10
Skin assessment
G. Krueger
09:10-09:20
Radiology
D. Van der Heijde
09:20-09:30
Immunohistology
O. Fitzgerald
09:30-09:35
Patient perspective
TBA

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