Group for Research and Assessment in Psoriasis and Psoriatic Artritis

PGA/VASPatient and Physician Perception of disease in

Psoriatic Arthritis(3PPsA)

GRAPPA meeting, Vienna 8th June 2005

Alberto Cauli

Rheumatology DivisionUniversity of Cagliari, ItalyDirector Prof. A Mathieu

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

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)

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

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”

QUESTIONAIRES (PATIENTS)

•GlobalIn 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

•SkinIn 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)

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

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

GRAPPA Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Assessment of Patients and Physicians perception of Joint & Skin involvement in Psoriatic

Arthritis through Visual Analogue Scales

Filled by Unit

Data of patient

Initials Date of birth (dd/mm/yy) Sex

PsA subset: Oligo Poly Distal Axial Mutilans

Onset of Psoriasis (Year) Onset of arthritis (Year)

Yes No

Any relative with psoriasis?

Psoriatic arthritis?

Medical history (any disease that may influence VASs?):

Yes No

Does the patient fulfill criteria for fibromialgia?

Psychological involvement?

Job (specify):

manual intellectual contact with the public.

Current treatment (week 0):

Assessment of Patients and Physician perception of Joint & Skin involvement in PsA through Visual Analogue Scales

Patient D.O.B. (dd/mm/yy) Week: 0 1 12 DOCTOR’S VAS •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

ESR CRP (ESR and CRP not to be performed at week 1) Any change in drug treatment?

Right ACR Joint Count:

Left

Temporomandibular Sternoclavicular Acromioclavicular Shoulder Elbow

Wrist

Metacarpophalangeal (MCP) Proximal interphalangeal (PIP) Distal interphalangeal (DIP)

Hip Knee Talo-tibial

Mid-tarsal

Metatarsophalangeal (MTP) Interphalangeal joints of the toes 5 4 3 2 1 5 4 3 2 1 1 2 3 4 5 1 2 3 4 5

Dactilytitis ? Yes/No Specify:

Enthesitis ? Yes/No Specify:

Tender joints (out of 68) Swollen Joints (out of 66)

Patient D.O.B. (dd/mm/yy) Week:

Psoriasis Area Severity Index (PASI)

Area Eritema Infiltration Desquamation Score Head 0 % no involvement no involvement no involvement 1-09 % slight slight slight Face? 10-29 % moderate moderate moderate 30-49 % striking striking striking _______ 50-69 % exceptionally exceptionally exceptionally 70-89 % 90-100 % Trunk 0 % no involvement no involvement no involvement 1-09 % slight slight slight Genitalia? 10-29 % moderate moderate moderate 30-49 % striking striking striking _______ 50-69 % exceptionally exceptionally exceptionally 70-89 % 90-100 % Upper 0 % no involvement no involvement no involvement extremities 1-09 % slight slight slight 10-29 % moderate moderate moderate Hands? 30-49 % striking striking striking _______ 50-69 % exceptionally exceptionally exceptionally 70-89 % 90-100 % Lower 0 % no involvement no involvement no involvement extremities 1-09 % slight slight slight 10-29 % moderate moderate moderate Buttoks or 30-49 % striking striking striking _______ Intergluteal? 50-69 % exceptionally exceptionally exceptionally 70-89 % Feets?

Total

PASI formula PASI Head: 0.1 x A x (E + I + D) PASI Trunk: 0.3 x A x (E + I + D) PASI Upper extremities: 0.2 x A x (E + I + D) PASI Lower extremities: 0.4 x A x (E + I + D) PASI Total: head + trunk + upper extremities + lower extremities Legend Area Score Eritema-Infiltration-Desquamation Score

0 % = 0 no involvement = 0 1-09 % = 1 slight = 1 10-29 % = 2 moderate = 2 30-49 % = 3 striking = 3 50-69 % = 4 exceptionally = 4 70-89 % = 5 90-100 % = 6 Dermatologica 1978; 157:238-244.

FORM TO BE USED IN THE CLINIC

GRAPPA

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Assessment of Patients and Physician perception of Joint & Skin involvement in PsA through Visual Analogue Scales

Patient __ __ __ D.O.B. __ __ / __ __ / __ __ Week: 0 1 12

PATIENT’S QUESTIONAIRE: GLOBAL

Please place a mark on the line below to indicate your answer to the following question relating to the past week: •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

FORM TO BE USED IN THE CLINIC

GRAPPA Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Assessment of Patients and Physician perception of Joint & Skin involvement in PsA through Visual Analogue Scales

Patient __ __ __ D.O.B. __ __ / __ __ / __ __ Week: 0 1 12

PATIENT’S QUESTIONAIRE: JOINTS Please place a mark on the line below to indicate your answer to the following question relating to the past week: •Joints In all the ways your ARTHRITIS affects you, over the past week, how has your arthritis affected you?

Not at all ____________________________________ Severely

FORM TO BE USED IN THE CLINIC

GRAPPA

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Assessment of Patients and Physician perception of Joint & Skin involvement in PsA through Visual Analogue Scales

Patient __ __ __ D.O.B. __ __ / __ __ / __ __ Week: 0 1 12

PATIENT’S QUESTIONAIRE: SKIN

Please place a mark on the line below to indicate your answer to the following question relating to the past week: •Skin In all the ways your PSORIASIS affects you, how would you rate the way you felt over the past week?

Excellent ____________________________________ Poor

Notes:

VAS (0-100 mm) Week 0 Week 1 Week 12 Patient

Global Joints Skin Doctor

Global Joints Skin

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

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 …

Thank You