GRAPPA Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

1. GRAPPAGroup 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 • 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 • 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 • PsA Clinical Registries and Genomics • 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. Domain 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 VAS 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 Core Sets in PsA

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 PageThis 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