Chronos Blauvelt

Question 1

Describe the main unmet medical need the authors stated in the Introduction.

Answer 1

Moderate to Severe AD requires continuous long term therapy. All the traditional agents can be used have an unfavourable benefits to risk ratio with use beyond the acute timeframe. Dupixent provides the potential to be the first chronic therapy in its class.

Question 2

Briefly describe the objective of the study.

Answer 2

To compare the efficacy of adding Dupixent to rescue medication of episodic TCS with or without TCIs over 1 year.

Question 3

What are the three parallel treatment groups?

Answer 3

1) In all three arms, TCS is used at medium to low potency continuously; in the latter two arms Dupixent 300mg is added either weekly or bi-weekly.
2) Rescue from flares can mean increasing the TCS potency and dose/ also Immunosuporessants.

Question 4

Inclusion criteria?

Answer 4

18+. Chronic3+.
Inadequate control on med-high potency TCS
Or
Inadequate control with immunosuppressant
With
IGA3+
EASI16+

Question 5

Primary and secondary end-points ?

Answer 5

Week 16
1A. IGA 0/1 and 2 pt reduction
1B. EASI -75

Week 52
2a IGA 0/1 and 2 pt reduction
2b EASI -75

2c Peak Pr NRS 4+/3+
@ to week 16 ( ‘peak of last 24 hrs’ avge 7 days)
@ to week 52 (avge peak per week)

2d+ percentage changes from baseline
EASI, SCORAD, GISS!, PEAK PNRS,
BSA, POEM HADS DLQI.

2a

Question 6

Baseline patient characteristics ?

Answer 6

Age - 34-40
Caucasian 66%
Duration Dis.  26-28
EASI 30;  IGA 48:52
Peak PNRS. 7.6
SCORAD 64-69
Poem 20
DLQI. 14
HADS. 12
CoMorbs  
  Asthma ARh FoodAll: 41/43-48%/ 30-36%
   “Associated Th2immune diseases were common”