Trial End Points

Question 1

Phase 2 Dupixent Efficacy End Points?

Answer 1

Baseline to Week 16 / reporter assessed

1 —- % D EASI

2 —-   Abs D EASI
   —-   % IGA 0,1.
   —-   Abs & % PNRS
   —-   % D SCORAD
   —-   Proportion reductions EASI-50/75/90%

3 Exploratory
—- Weekly % D EASI ; % D PNRS; % D SCORAD
—- Proportion reductions PNRS 3+
—- Body S Area reductions, D Abs and %
—- DLQI D Abs and %

Question 2

How was Safety assessed ?

Answer 2

Safety Outcomes were Monitored till week 32.
TEAEs
Site Reactions and severity,
Example of Signs -erythema, oedema, inflammation.
Symptoms - pain.

Other/ Vital Signs, Lab Results, ECG.

Question 3

EASI - categories of severity? Example - what does the EASI of 16 mean?

Answer 3

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 4

What classified a non-responder?

Answer 4

1) Received rescue treatment such as topical (other than emollients) or systemic drugs.
2) Withdrew without reason ascertained.