Identifying Domains of Inquiry in Psoriatic Arthritis Dafna D. Gladman, Professor of Medicine, University of Toronto, Director, Psoriatic Arthritis Program University Health Network

Identifying Domains of Inquiry in Psoriatic Arthritis u Review of existing instruments used to assess health status in PsA (Gladman et al, Arthritis Rheum 2004;50:24-35) u Development of a list of potential domains via discussion amongst steering committee of GRAPPA u Delphi process to rank and prioritize these domains amongst members of CASPAR plus others nominated by the steering committee

Delphi technique u The features of consensus methods are anonymity, iteration, controlled feedback, statistical group response u Useful when evidence on an issue is lacking or contradictory u Delphi involves some kind of questionnaire to indicate agreement with particular issues, the group average and variation are then fed back on subsequent rounds to permit changes in participants’ opinions

Delphi Process u The questionnaire requested 100 points to be distributed amongst 26 possible outcome domains, under the four measurement contexts u The point allocation reflects the relative importance of that domain to the measurement context u Three rounds were held by or fax

Delphi Process u 32 of 54 rheumatologists with an interest in PsA responded to the first round u 32 responded to 2 nd round; 29 responded to 3 rd round (last observation carried forward) u Clear reduction in variability over the three rounds, but the relative ranking of domains didn’t alter a great deal

Disease Controlling Anti-Rheumatic Drugs

Conclusion - DCART u The following domains are ranked highest: –Active joint count, xray damage, patient global, pain, physical function, acute phase response (score 7-12) u Several other possible domains –Dactylitis, enthesitis, damaged joint count, skin disease, physician global, quality of life (score 5)

Identifying Domains of Inquiry in Psoriatic Arthritis u List of possible domains for discussion has been significantly shortened –However, major concern about lack of skin assessment as a domain u Now requires involvement of patients, other rheumatologists and dermatologists, and industry u Next step should probably be face-to-face discussion to refine the core lists Summary of Delphi Process

GRAPPA Objectives for August 15-17, 2003 u Further define domains for the assessment of PsA by a group of rheumatologists, dermatologists, patients and industry u Achieve consensus on those domains. u Identify instruments to be used for the domains. u Develop a research agenda.

GRAPPA participants NY August 15-17, 2003 u Christian Antoni, Germany u Dominique Baeten, Belgium u Jurgen Braun, Germany u Jane Bruckel, SpAA u Gerd Burmester, Germany u David A. Chandler, PsAA u Daniel O. Clegg, USA u John J. Cush, USA u James T. Elder, USA D u Luis R. Espinoza, USA u Steven R. Feldman, USA D u Dafna Gladman, Canada u Peter Gorevic, USA u Alice Gottlieb, USA R+D u Philip S. Helliwell, UK u Joachim Kalden, Germany u Arthur Kavanaugh, USA u Muhammad Asim Khan, USA u James Krueger, USA D u Gerald G. Krueger, USA D u Robert Landewe, Netherlands u Richard Langley, Canada D u Mark G. Lebwohl, USA D u Philip Mease, USA u Alan Menter, USA D u Langdon Morris, USA u Peter Nash, Australia u Ignazio Olivieri, Italy u Jean-Paul Ortonne, France u Proton Rahman, Canada u John Reveille, USA u Christopher Ritchlin, USA u Joseph Smolen, Austria u Vibeke Strand, USA u William Taylor, New Zealand u Filip van Den Bosch, Belgium u Douglas J. Veale, UK u Gail M. Zimmerman, NPF u Clifton Bingham, USA u Joachim Peter Kaltwasser, Germany u Marissa Lassere, Australia u Soumya Reddy, USA u Bruce Strober, USA D

Group exercise – Domains in PsA uProcess –3 Groups »Group leader »Scribe –Starting from the results of the Delphi process, each group to develop a list of domains and vote on the domains that should be included –If possible, identify instruments for each domain –Each Group to present at the combined session which will hopefully lead to a final consensus on domains +/- instruments

Domains in PsA – Breakout Groups Group AGroup BGroup C Room General Session Oxford Room LeaderD. GladmanP. MeaseP. Nash ScribeA. KavanaughP. HelliwellC. Antoni D. ChandlerM.A. KhanG. Zimmerman G. KruegerM. LebwohlJ.T. Elder F. Van den BoschD. BaetenD. Clegg C. RitchlinJ. BraunJ. Smolen R. LandeweL. EspinozaJ. Kalden C. BinghamS. ReddyP. Kaltwasser SponsorsA. BeutlerE. DolceC. Schweiger No VoteM. DanzigS. StevensS. Chioato M. Temples

Domains in PsA Clinical Assessment Joint Disease u Peripheral arthritis –Inflammation u Axial disease –Inflammation u Physician Global

Domains in PsA Clinical Assessment Other Features u Dactylitis –Acute –Chronic u Enthesitis u Tendonitis

Domains in PsA Clinical Assessment Skin Disease u Skin psoriasis –Extent of involvement –+/- lesions

Domains in PsA Imaging u Radiographs –Hands –Feet –Pelvis

Domains in PsA Biomarkers u Acute phase reactants (ESR, CRP)

Domains in PsA Patient derived features u Pain (Patient Global) u Quality of life –Related to joint disease –Related to skin disease –Itching u Function

Domains in PsA Slotted For Further Research u Tendonitis u Change in Nails- determine its importance for disease classification u Cytokines u Genetic Markers u Fatigue u Disability- characterization