1. Group for Research and Assessment in Psoriasis and Psoriatic Artritis PGA/VAS Patient and Physician Perception of disease in Psoriatic Arthritis (3PPsA) GRAPPA meeting, Vienna 8th June 2005 Alberto Cauli Rheumatology Division University of Cagliari, Italy Director Prof. A Mathieu

2. BACKGROUND VAS are popular in the assessment of chronic arthritis DAS 28 include VAS on general health status PsARC: improvement in Patient and Physician global ACR 20/50/70 response (Patient and Physician global) PsA: joints + skin ± psycological involvement Are Patients Global, Joint and Skin disease evaluation by means of VAS a reliable tool to easily define disease status or, conversely they are not and therefore we should not employ them in clinical trials and even in routine out patient clinics? Same question for doctors

3. BACKGROUND Item in 2004 GRAPPA research agenda In previous GRAPPA meetings it has been decided to differentiate Global, Joint and Skin questionaire (Patients and Physicians) In Berlin it was decided to perform a proper study To keep it simple, easy to perform. Preliminary concise protocol discussed in San Antonio. Followed discussion (also via e-mail)

4. Partecipating colleagues Behrens Frank Carneiro Sueli Cauli Alberto Elkayam Ori Flynn John Foley Peter Gladman Dafna Gruenke Mathias Helliwell Philip Kalden Joachim Khan Muhammad Korman Neil Lubrano Ennio Marchesoni Antonio Mathieu Alessandro Mease Philip Mielants Herman Ogilvie Alexandra Oliver Sue Olivieri Ignazio Ritchlin Christopher Salvarani Carlo Scarpa Raffaele Sueiro JL Fernandez Taylor Will Tak Paul Peter Theander Elke Ujfalussy Ilona Veale Douglas

5. AIMS To test if G, J, S disease evaluation by means of VASs are reliable in PsA To define the different impact of specific joints and skin areas To define the impact of dactylitis and enthesitis Differences in PsA subsets, sex, job, disease duration Patients perception of disease should be taken into account when proposing treatment guidelines or reimbursement policies? To define when a physician consider PsA disease “mild”, “moderate” or “severe”

6. QUESTIONAIRES (PATIENTS) Global In all the ways in which your PSORIASIS and ARTHRITIS, as a whole, affects you, how would you rate the way you felt over the past week? Excellent ____________________________________ Poor Joints In all the ways your ARTHRITIS affects you, over the past week, how has your arthritis affected you? Not at all ____________________________________ Severely Skin In all the ways your PSORIASIS affects you, how would you rate the way you felt over the past week? Excellent ____________________________________ Poor Random order of administration (each question on a different form)

7. QUESTIONAIRES (PHYSICIANS) Global How would you rate global skin and joint disease in this patient? Quiet ____________________________________ Very severe Joints How would you rate joint disease in this PsA patient? (10 cm line) Quiet ____________________________________ Very severe Skin How would you rate PSORIASIS in this PsA patient? (10 cm line) Quiet ____________________________________ Very severe

8. METHODS Any consecutive PsA patient, regardless disease activity, treatment or disease subset. W 0= demographic, medical history + objective evaluation (68T/66S JC + PASI) + questionaires W 1= repeat questionaire + objective evaluation in order to determine the reliability of the instrument W 12= as in W 1

14. Methods Print out the CRF, fill the boxes and administer questionaires and then: Fill the electronic forms in your PC and send them by e-mail. Each patient is one file. Or make a copy and send them as they are by ordinary mail or courier Always keep a copy

15. Data statistically analysed as appropriate OUTCOMES We will better understand how patients and physicians perceive the disease and the impact of the different clinical manifestations and specific variables. Help in improving PsA response criteria The results may even affect our approach to treatment …

16. Thank You