1. GRAPPA Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
Philip Mease MD

2. Agenda GRAPPA: History, objectives, projects – Mease
PsA domains of inquiry and instruments of assessment. OMERACT – Gladman
Skin assessments – Krueger
Can GRAPPA be of use to dermatologists? Where do we go from here?

3. Acknowledgements Major Sponsors Minor Sponsors Abbott Amgen Biogen
Centocor
Genentech
Novartis
Schering-Plough
Serono
Wyeth
Minor Sponsors
Aventis

4. Needs
Background of burgeoning interest in psoriasis and PsA treatment with advent of biologics
Improve awareness of and communication between experts in PsA and PSO, especially between rheumatologists and dermatologists
Identify and study key domains of inquiry in PsA and PSO
Develop updated classification criteria of PsA (CASPAR)
Validate and standardize outcome assessment tools in PsA and PSO, both for basic clinical and therapeutic studies
Improve awareness of and communication between PsA/PSO experts and other interested entities, including patient leagues, regulatory agencies industry, other physicians, and the public
Improve educational efforts about PsA and PSO
Improve conduct and standardization of clinical registries
Development of treatment guidelines

5. History
Model: ASAS (Assessments in Ankylosing Spondylitis) working group est. 1995
Core rheumatology group: CASPAR est. 2000
Idea conception: NY AS meeting 8/02
Idea discussion: Gent SpA meeting 10/02
PsA working group authorized: CASPAR meeting, ACR 10/02
Initial rheumatology group meetings: EULAR, Lisbon 6/03, ACR Orlando 2003
Inaugural combined rheum-derm meeting planning: 8/03 NYC

6. GRAPPA Steering Committee
Christian Antoni
Dafna Gladman
Desiree van der Heijde
Philip Helliwell
Joachim (Jochen) Kalden
Artie Kavanaugh
Gerald (Jerry) Krueger
Philip Mease
Alan Menter
Peter Nash
Christopher (Chris) Ritchlin
Josef Smolen
William (Will) Taylor

7. GRAPPA Membership
~ 100 members from US, Canada, Europe and Australia/New Zealand
~ 50% rheums
~ 10% derms
~ 40% industry, regulatory, patient service league representatives

8. Personnel
Project Manager
Robin Shapiro (Health Advocacy Strategies)

9. GRAPPA Projects
Meetings: Specialty specific meetings adjacent to ACR, EULAR, ?AAD, ?EADV
Publications: Supplement to Annals of Rheumatic Disease. ? GRAPPA journal
Classification criteria: CASPAR
Prioritization of domains of inquiry: Delphi exercise
Outcome measures: Standardization and validation; OMERACT

10. ARD Journal Supplement Table of Contents
GRAPPA - Introduction
ASAS Working Group as a Model for GRAPPA
PsA and PsO: Clinical Features, Pathophysiology, Immunology
PsA Clinical Features I: History of Identification, Criteria Efforts
PsA Clinical Features II: Epidemiology, Clinical Features, QOL
PsA Clinical Features III: Update on Clinical Picture through Trial Cohorts
Psoriasis Epidemiology, Clinical Features and QOL
DISCUSSION: Clinical Features, Epidemiology, Classification Criteria
PsA Immunology and Synovial and Extra-articular Histopathology
PsA Genetics and Genetic Epidemiology
Psoriasis Genetics
Psoriasis Pathophysiology
DISCUSSION: Immunology, Cellular Pathology, Genetics, Etc.

11. Supplement Table of Contents
PsA and Pso: Treatment
PsA Treatment: NSAIDs and DMARDs
PsA Treatment: Anti-TNF Medications
PsA Treatment: Emerging Biologics
PsO Treatment: Traditional Therapies
PsO Treatment: Current and Emerging Directed Therapies
DISCUSSION: treatment of PsA and Pso

12. Supplement Table of Contents
Lessons from Clinical Trials, Clinical Practice
Pros/Cons of lumping spondylarthropathies together
Role of Patients, Patient Service Organizations
Assessment: Domains and Instruments
Science of Assessments
PsA Assessment Tools in Clinical Trials
PsA Assessment Instruments: Imaging
PsO Assessment Tools in Clinical Trials
Ethics, Practical Issues in Conducting Clinical Trials
DISCUSSION:Assessment

13. Supplement Table of Contents
PsA Clinical Registries and Genomics
Introduction/Overview on Clinical Registries
PsO Clinical Registries and Genomics
Developing Assessment Methodology in PsA
ASAS Working Group Process
OMERACT Process
Delphi Exercise on Domains in PsA
Consensus Exercise on Domains in PsA
OMERACT
EPILOGUE

14. DCART – results #1

15. Core Sets in PsA Domain Instrument Joint assessment Axial assessment*
Skin assessment
Pain
Patient global
Physician global
Function*
Fatigue*
Enthesial assessment*
Dactylitis assessment*
Stiffness
Acute phase reactants
Xray*
MRI*
Ultrasound*
Clinical subset response*
*Needs development/validation
Instrument
T/S joint count ?
PASI, Target lesion, Global
VAS
HAQ, SF-36, DLQI
Krupp, MFI, FACIT, one question
Mander, MASES, San Francisco
0-4 scale
Duration minutes
ESR, CRP
MSharp, Larsen, Steinbrocker
Need clear guidelines to define clinical subsets in order to assess subset response

16. OMERACT
International organization of rheumatologists, industry and regulatory representatives
Development of standardized and validated outcome measures in all fields of rheumatology, developed in an evidence-based and consensual fashion
Meets every two years; next is OMERACT VII in US (CA), May 12-16

17. OMERACT FILTER Truth (validity)
Discrimination (reproducibility and responsiveness)
Feasibility

18. GRAPPA Projects (cont.)
Treatment guidelines
Support of patient service leagues in education process
Support, standardization of clinical registries
Intranet web site for online work and communication: Big Mind Catalyst
Joint rheum-derm meetings

19. Center Page This is the initial page you access after logging in, which lists all of the conferences that are available to you.

20. Topic Page: This is the heart of the Catalyst workspace where all of the content is posted. Each topic is a single conversation on a particular topic and is displayed linearly.

21. How GRAPPA Can use BigMind Catalyst
Create, edit and distribute documents
Asynchronous discussion within a subcommittee
Create and distribute agendas and minutes
Library of documents, including links to websites and webcasts
Shared calendar of events
Work through issues with international membership present in the conversation
Create “group memory”over time… helping to develop and standardize language and procedures
Search conversation history
Web site for public access
Links to OMERACT, patient service leagues

22. Do Psoriasis Thought Leaders Have Any Use for GRAPPA?
Forum and methodological support for evolution of skin, QOL and other derm measures
Forum for communication with rheums
Fostering joint research projects
Collaboration re. clinical registries, genetics investigations
Derm-rheum collaboration with patient service leagues
Publications
Joint derm-rheum meetings