GRAPPAGroup for Research and

Assessment of Psoriasis and Psoriatic Arthritis

Philip Mease MD

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?

Acknowledgements• Major Sponsors

– Abbott – Amgen– Biogen– Centocor– Genentech– Novartis – Schering-Plough – Serono – Wyeth

• Minor Sponsors – Aventis

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

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

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

GRAPPA Membership

• ~ 100 members from US, Canada, Europe and Australia/New Zealand

• ~ 50% rheums

• ~ 10% derms

• ~ 40% industry, regulatory, patient service league representatives

Personnel

• Project Manager– Robin Shapiro (Health Advocacy Strategies)

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

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.

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

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

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

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DCART – results #1

Core Sets in PsA• 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

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

OMERACT FILTER

• Truth (validity)

• Discrimination (reproducibility and responsiveness)

• Feasibility

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

Center Page

This is the initial page you access after logging in, which

lists all of the conferences that are available to you.

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.

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

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