INTEGUMENT-1
Trial question
What is the role of roflumilast cream in patients with atopic dermatitis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 654
654 patients (366 female, 288 male).
Inclusion criteria: patients ≥ 6 years with mild-to-moderate atopic dermatitis.
Key exclusion criteria: inability to discontinue treatment with therapies for atopic dermatitis before the baseline visit and during the trial; planned excessive exposure of treated area to natural or artificial sunlight, tanning bed, or other light emitting device; previous treatment with roflumilast cream or foam; treatment with oral roflumilast in the past 4 weeks.
Interventions
N=433 roflumilast cream (0.15% cream once daily for 4 weeks).
N=221 vehicle cream (placebo cream once daily for 4 weeks).
Primary outcome
Validated Investigator Global Assessment for Atopic Dermatitis success at week 4
32%
15.2%
32.0 %
24.0 %
16.0 %
8.0 %
0.0 %
Roflumilast
cream
Vehicle
cream
Significant
increase ▲
NNT = 5
Significant increase in Validated Investigator Global Assessment for Atopic Dermatitis success at week 4 (32% vs. 15.2%; AD 17.4%, 95% CI 7.08 to 27.72).
Secondary outcomes
Significant increase in Validated Investigator Global Assessment for Atopic Dermatitis success at week 4 in patients with baseline Validated Investigator Global Assessment for Atopic Dermatitis score of 3 (35% vs. 17.5%; AD 17.4%, 95% CI 7.08 to 27.72).
Significant increase in achievement of at least 75% reduction in Eczema Area and Severity Index at week 4 (43.2% vs. 22%; AD 21.2%, 95% CI 8.62 to 33.78).
Significant increase in Validated Investigator Global Assessment for Atopic Dermatitis success at week 2 (21.2% vs. 6.4%; AD 14.8%, 95% CI 6.02 to 23.58).
Safety outcomes
No significant differences in treatment-related adverse events, treatment-emergent adverse events.
Conclusion
In patients ≥ 6 years with mild-to-moderate atopic dermatitis, roflumilast cream was superior to vehicle cream with respect to Validated Investigator Global Assessment for Atopic Dermatitis success at week 4.
Reference
Eric L Simpson, Lawrence F Eichenfield, Javier Alonso-Llamazares et al. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Sep 18:e243121.
Open reference URL