1. Group for Research and Assessment in Psoriasis and Psoriatic Artritis PGA/VAS Patient and Physician Perception of disease in Psoriatic Arthritis (3PPsA) GRAPPA study group Preliminary data Data that may influence completion of study are not shown Alberto Cauli University of Cagliari, Italy

2. Partecipating colleagues Carneiro Sueli Cauli Alberto Gladman Dafna Helliwell Philip Kalden Joachim & Gruenke Mathias Lubrano Ennio Marchesoni Antonio Mathieu Alessandro Mease Philip Nash Peter Olivieri Ignazio Salvarani Carlo & Pipitone Nicolò Sueiro JL Fernandez Taylor Will Tak Paul Peter Ujfalussy Ilona

3. BACKGROUND AND MAIN AIM 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) PGA in PsA Core Set for RCT (Omeract 8) Patients and Doctors Global, Joint and Skin disease evaluation by means of VAS are a reliable tool in PsA or not ?

4. AIMS (2) To define the different impact of specific joints and skin areas, dactylitis and enthesitis, clinical subsets and demographical variables. ? Should Patients perception of disease be taken into account when proposing treatment guidelines or reimbursement policies? ? PGA in PsA Disease activity scores? To define when a physician consider PsA disease activity “mild”, “moderate” or “severe”

5. 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)

6. 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? Quiet ____________________________________ Very severe Skin How would you rate PSORIASIS in this PsA patient? Quiet ____________________________________ Very severe

7. 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 BASMI and BASDAI only if axial involvement (in the notes section)

12. In the axial subset only, it is requested to perform the BASMI and BASDAI giving details of the 5 BASMI and 6 BASDAI measurements (in the notes section)

13. DEMOGRAPHIC Male 62% Female 38% June 2006: around 180 patients recruited

14. Onset and Disease duration Median = 11 yrs Median = 16yrs

15. Patients VAS: W0 vs W1 r = 0.88 r = 0.87 r = 0.79

16. Doctors VAS: W0 vs W1 r = 0.94 r = 0.87 r = 0.91

17. Pt. Globalp=0.92ns Pt. Jointp=0.18ns Pt. Skinp=0.82ns Dr. Globalp=0.77ns Dr. Jointp=0.30ns Dr. Skinp=0.92ns VAS: W0 vs W1 (Wilcoxon Test)

18. VASs vs Anxiety and Depression Fibromialgia 3% Psycological inv. 8% r = 0.44 r=0.40r=0.43

19. Anxiety and Depression vs JC & PASI r = 0.14 r = 0.26r = 0.55

20. Patients Perception of Disease r = 0.35 r = 0.37 r = 0.56

21. ESR r = 0.06 r = 0.37

22. SUMMARY VASs are reliable in PsA VASs not influenced by pts Anxiety or Depression One or few joints are important for patients, similarly little skin involvement does matter. ESR does not correlate with skin or joint disease activity therefore …. Physician data: …… secret until completion of study ! (to avoid bias) The multivariate analysis will tell a lot more ….