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 u An inflammatory arthritis. u Associated with psoriasis. u Usually seronegative for rheumatoid factor. u Associated Features: »Spondylitis, »Enthesitis, »Dactylitis, »Iritis »Mucous membrane ulcers »Urethritis »Other extra-articular features of SpA.

CASPAR study u Prospective, observational study of consecutive clinic patients with PsA and other inflammatory arthritis u Target sample size of 1012 in total u 30 clinics in 13 countries u Gold-standard of diagnosis based on physician’s opinion u Data collected 02/02 – 03/04 Design

CASPAR Study: Methods uData collected: –Clinical and examination features –X-rays of spine, sacroiliac joints, hands and feet –Rheumatoid factor, [HLA], anti-CCP, stored blood uX-rays were read centrally by 2 readers in tandem, blinded to diagnosis uClinical gold-standard validated by quality control and Latent Class Analysis (statistical modelling) uNew 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 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 Workshop Domains in PsA final vote ItemScore 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% 60% 48% 41% 38% 34% 25% 20%

OMERACT 7 PsA Workshop u Identify optimal joint count. u Develop instrument for patient global to incorporate skin and joint question. u Identify optimal Skin assessment. u Develop tools to define structural damage. u Develop instruments for Axial assessment. u Develop a tool for the assessment of participation. u Develop instruments for the assessment of Enthesitis. u Develop tools for the assessment Dactylitis. u Imaging modalities to assess inflammation and damage. u Differential tissue response to therapies. u Study methods to evaluate Fatigue in PsA. u Develop Composite responder indices. Research Agenda

OMERACT 8: PsA Module u Achieve consensus on the core set of domains to be assessed in PsA clinical trials and in longitudinal observational cohort studies, u Review and endorse outcome measures used to assess these domains based on evidence derived from clinical trials and u Set up a new research agenda to identify other assessment tools. Objectives

Assessment of Psoriatic Arthritis DomainsProposed Instruments Joint assessmentT/S joint count, ACR, PsARC, DAS Axial assessmentClinical measures, BASDAI, BASFI, BASRI Skin assessmentPASI, Target lesion, Global PainVAS Patient globalVAS (global, skin + joints) Physician globalVAS (global, skin + joints) Function/QOLHAQ, SF-36, PsAQoL FatigueKrupp, FACIT, MFI, VAS Enthesitis assessmentMander, MASES, present/absent Dactylitis assessmentHelliwell, present/absent, acute/chronic Acute phase reactantESR, CRP, others ImagingXray, MRI, ultrasound

OMERACT 8: PsA Module Plenary Session TimeTitleSpeaker 08:00-08:05IntroductionD. Gladman 08:05-08:15Peripheral joints/ clinical trialsP. Mease 08:15-08:25Spinal assessment - INSPIRED. Gladman 08:25-08:35DactylitisP. Healy 08:35-08:45EnthesitisP. Helliewell 08:45-08:50ParticipationW. Taylor 08:50-08:55QoLD. Veale 08:55-09:00Patient/physician GAA. Cauli 09:00-09:10Skin assessmentG. Krueger 09:10-09:20RadiologyD. Van der Heijde 09:20-09:30ImmunohistologyO. Fitzgerald 09:30-09:35Patient perspectiveTBA