Long-Term Safety and Efficacy with Roflumilast Cream 0.15% in Patients Aged ≥6 Years with Atopic Dermatitis: A Phase 3 Open-Label Extension Trial

被引：2

作者：

Simpson, Eric L. ^{[1
]}

Eichenfield, Lawrence F. ^{[2
]}

Papp, Kim A. ^{[3
,4
]}

Forman, Seth B. ^{[5
]}

Hebert, Adelaide A. ^{[6
]}

Gonzalez, Mercedes E. ^{[7
]}

Gooderham, Melinda J. ^{[8
,9
]}

Hong, H. Chih-ho ^{[10
,11
]}

Prajapati, Vimal H. ^{[12
,13
]}

Guttman-Yassky, Emma ^{[14
]}

Silverberg, Jonathan I. ^{[15
]}

Seal, Melissa S. ^{[16
]}

Krupa, David ^{[16
]}

Almaraz, Erin ^{[16
]}

Hanna, Diane ^{[16
]}

Burnett, Patrick ^{[16
]}

Snyder, Scott ^{[16
]}

Chu, David H. ^{[16
]}

Higham, Robert C. ^{[16
]}

Berk, David R. ^{[16
]}

机构：

[1] Oregon Hlth & Sci Univ, Portland, OR USA

[2] Univ Calif La Jolla, Radys Childrens Hosp, San Diego, CA USA

[3] Prob Med Res & Alliance Clin Trials, Waterloo, ON, Canada

[4] Univ Toronto, Temerty Fac Med, Div Dermatol, Toronto, ON, Canada

[5] ForCare Med Ctr, Tampa, FL USA

[6] UTHealth, McGovern Med Sch, Houston, TX USA

[7] Pediat Skin Res LLC, Miami, FL USA

[8] Queens Univ, SKiN Ctr Dermatol, Peterborough, ON, Canada

[9] Queens Univ, Peterborough, ON, Canada

[10] Univ British Columbia, Dept Dermatol & Skin Sci & Prob Med Res, Surrey, BC, Canada

[11] Univ British Columbia, Dept Dermatol & Skin Sci, Surrey, BC, Canada

[12] Skin Hlth & Wellness Ctr, Dermatol Res Inst, Skin Hlth Wellness Ctr, Calgary, AB, Canada

[13] Univ Calgary, Calgary, AB, Canada

[14] Icahn Sch Med Mt Sinai, New York, NY USA

[15] George Washington Univ, Sch Med & Hlth Sci, Dept Dermatol, Washington, DC USA

[16] Arcutis Biotherapeut Inc, Westlake Village, CA USA

来源：

DERMATITIS | 2025年

关键词：

TACROLIMUS OINTMENT; PLAQUE PSORIASIS; RATING-SCALE; DOUBLE-BLIND; SEVERITY; 0.3-PERCENT; ADOLESCENTS; RELIABILITY; POPULATION; INSTRUMENT;

D O I：

10.1089/derm.2024.0418

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

Background: Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials.Objective: Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.15% in AD. Methods: In this open-label extension (OLE) trial (INTEGUMENT-OLE; NCT04804605), patients aged >= 6 years who completed one of the 4-week phase 3 trials applied roflumilast for up to 52 weeks. After 4 weeks of once-daily application, patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) of clear (0) switched to twice-weekly (BIW) application to normal-appearing flare-prone areas (proactive treatment). Results: Among 657 patients treated, 36.7% reported adverse events, including 4.7% that were treatment related. Application site pain and stinging/burning that caused definite discomfort at any visit were reported for 0.5% and 0.4%-2.1% of patients, respectively. Patients who achieved vIGA-AD 0 and switched to proactive BIW application maintained vIGA-AD 0/1 (almost clear) for a median of 281 days (Kaplan-Meier estimate). Conclusion: Roflumilast cream 0.15% was well tolerated for up to 56 weeks. BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment.

引用

页数：9

共 42 条

[1] Epidemiology of atopic dermatitis in adults: Results from an international survey [J].