DERMIS 1 and DERMIS 2

Question 1

What phase(s) were DERMIS I and II?

Answer 1

Phase 3

Question 2

DERMIS I and II background

Answer 2

phase 3, randomized, double-blind, controlled, 8-week, multicenter trials

Question 3

which product did DERMIS I and II assess

Answer 3

roflumilast 0.3% CREAM

Question 4

how old did patients have to be to be enrolled in DERMIS trials?

Answer 4

≥2 years old

Question 5

how long did patients have to have psoriasis to be enrolled in the DERMIS trials?

Answer 5

≥6 months for adults, ≥3 months for children

Question 6

Baseline IGA had to be what to be included in DERMIS?

Answer 6

mild

Question 7

Baseline PASI to be included in DERMIS

Answer 7

≥2

Question 8

could patients with non-plaque psoriasis be included?

Answer 8

no

Question 9

DERMIS randomization

Answer 9

2:1 once daily 0.3% cream to vehicle cream

Question 10

primary efficacy endpoint

Answer 10

success on IGA scale by week 8

Question 11

IGA scale success definition

Answer 11

achievement of clear or almost clear plus ≥2 grade improvement from baseline

Question 12

Secondary efficacy endpoints

Answer 12

1. clear/almost clear I-IGA and 2rade improvement at w8
2. I-IGA clear at w8
3. time to 50% reduction from baseline in PASI at w8
4. Change from baseline on PSD at w4 and w8

Question 13

Safety endpoints

Answer 13

1. all TEAEs
2. Physical exam (vitals, weight, labs)
3. S-SSRS (suicidality)
4. Depression (PHQ9, PHQ, CD12)

Question 14

DERMIS 1 N=

Answer 14

286 experimental, 153 placebo

Question 15

DERMIS 2 N =

Answer 15

290 exerimental, 152 placebo

Question 16

A sample size of X was planned for each trial, powered to >99% to detect a Y difference between treatments

Answer 16

~400, 22.4%

Question 17

secondary endpoints in either trial were only tested for significance if the corresponding primary endpoints were

Answer 17

significant

Question 18

primary outcomes were repeated by what group?

Answer 18

age

Question 19

DERMIS 1: how many roflumilast-treated patients discontinued due to AEs? placebo?

Answer 19

5 roflumilast, 2 placebo (1.9% and 1.5%, respectively)

Question 20

DERMIS 2: how many roflumilast-treated patients discontinued due to AEs? placebo?

Answer 20

1 roflumilast treated patient, 2 placebo (0.4% and 1.3%)

Question 21

DERMIS 1 IGA success (zoryve vs placebo)

Answer 21

41.5% vs 5.8%

Question 22

DERMIS 2 IGA success (zoryve vs placebo)

Answer 22

36.7% vs 7.1%

Question 23

IGA success definition one more time!

Answer 23

IGA score of clear (0) or almost clear (1) plus a 2-grade IGA score improvement from baseline at week 8