Asessments

Question 1

Phase II Dupixent

Assessment tools ?

Answer 1

History
Eczema Area and Severity Index (EASI)
Investigator’s Global Assessment (IGA)
Pruritis Numeric Rating Scale. (PNRS)
SCAR Atopic Dermatitis. (SCARAD)
Dermatology Life Quality Index  (DLQI)

Question 2

Which assessment tool or tools is or are most favoured in Australia?
What is satisfactory tools use to what is best practice tools use gap?

Answer 2

Mmmm.

Question 3

Typical inclusion and Exclusion criteria, using as example, Phase II Dupixent

Answer 3

Inclusion:  ‘Moderate to Severe’
18and over, uncontrolled or unsuitable for Topicals, chronic(atleast 3 years), 
EASI 12 + on screening/16+ baseline
IGA 3+
%Body Surface - 10%+

Exclusion:
Dupixent naive
No Topicals 1 week out
No Systemic Imms 4weeks out
No major Comorbidities or lab abnormalities

Question 4

Typical study protocols ?

Example : Dupixent Phase II

Answer 4

Different active drug doses and different frequencies.
Placebo - same formulation without addition of active agent.
Topical emollient only, fixed before and after first dose, prn after first week.
Antihistamines and antibiotics, only other exception to be used.

Weekly Assessments- combination of clinic visit and phone interviews (weeks5,7,9,11, and 13).
PNRS - completed every day!

Question 5

So what is SCARAD?

Answer 5

Severe Cutaneous Adverse Reactions (SCAR) system of evaluating serious drug reactions.

‘Dr Michelle Goh Of Melbourne discussed toxic epidermal necrolysis (TEN). For us community dermatologists, there is now AUS.SCAR which is based on the European SCAR system’

Question 6

Name me the EASI unit categories of severity.

Answer 6

Clear to Mild- 0.0 -7.0
Moderate. - 7.1- 21.0
Severe. - 21.1-50.0
Very Severe. - 50.1-72.0

A score of 16 means the patient has moderate AD.

Question 7

Typical baseline demographics and baseline clinical characteristics? Use Phase2 Dupixent.

Answer 7

PBO to 300qW2

Average age: PBO qW - 37 (13)
Dup300qW2. - 39(12)

Sex Ratio : Male 66% / 64%

Disease Duration : 30!!! (13) / 31 (16)

EASI : 33 (14) 34 (15)

IGA score 3:4
32(53%) / 34(53%)

Body SA with AD involvement %: 51 (24) / 53 (25)

Total SCORAD score : 67 (14) / 68 (13)