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 Minor 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 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 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

DCART – results #1

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

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