Transcript First International Psoriatic Arthritis Working Group Meeting: 8/15

GRAPPA
Group 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
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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
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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
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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
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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
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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
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ASAS Working Group Process
OMERACT Process
Delphi Exercise on Domains in PsA
Consensus Exercise on Domains in PsA
• OMERACT
• EPILOGUE
DCART – results #1
Round1 Median
Round2 Median
Round3 Median
Group median scores for DCART
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• Domain
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Core Sets
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PsA
• 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
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T/S joint count
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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
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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
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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