OMERACT 8 PsA Module

Co-ChairsDafna Gladman and Philip Mease

Steering CommitteeAlice Gottlieb, Philip Helliwell,

Arthur Kavanaugh, Gerry Krueger, Peter Nash, Christopher Ritchlin,

Vibeke Stand, William Taylor

Psoriatic arthritis

An inflammatory arthritis.

Associated with psoriasis.

Usually seronegative for rheumatoid factor.

Associated Features: » Spondylitis, » Enthesitis, » Dactylitis, » Iritis » Mucous membrane ulcers» Urethritis» Other extra-articular

features of SpA.

CASPAR study

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

Design

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 CriteriaTaylor 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 psoriasis (one of a, b, c)

a. Current psoriasis* Psoriatic skin or scalp disease present today as judged by a dermatologist or rheumatologist

b. Personal history of 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 juxta-articular 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 WorkshopDomains in PsA final vote

Item ScoreJoint 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

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.

Research Agenda

OMERACT 8: PsA Module

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.

Objectives

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