INTEGUMENT-2
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
58.0% female
42.0% male
N = 683
683 patients (395 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=451 roflumilast cream (0.15% cream once daily for 4 weeks).
N=232 vehicle cream (placebo cream once daily for 4 weeks).
Primary outcome
Validated Investigator Global Assessment for Atopic Dermatitis success at week 4
28.9%
12%
28.9 %
21.7 %
14.4 %
7.2 %
0.0 %
Roflumilast
cream
Vehicle
cream
Significant
increase ▲
NNT = 5
Significant increase in Validated Investigator Global Assessment for Atopic Dermatitis success at week 4 (28.9% vs. 12%; AD 16.5%, 95% CI 6.71 to 26.29).
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 (32.9% vs. 13.1%; AD 19.1%, 95% CI 7.77 to 30.43).
Significant increase in achievement of at least 75% reduction in Eczema Area and Severity Index at week 4 (42% vs. 19.7%; AD 22.3%, 95% CI 9.07 to 35.53).
Significant increase in Validated Investigator Global Assessment for Atopic Dermatitis success at week 2 (17.7% vs. 5.3%; AD 12.4%, 95% CI 5.04 to 19.76).
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.
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