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Atopic dermatitis (AD) is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the U.S. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation.

Arcutis Announces Positive Topline Results from INTEGUMENT-1 Pivotal Phase 3 Trial of ...

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced positive topline results from its INTEGUMENT-1 pivotal Phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, in adults and children six years and older with mild to moderate atopic dermatitis (AD). The study met its primary endpoint with 32.0% of individuals treated with roflumilast cream 0.15% achieving IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 15.2% of individuals treated with vehicle (P<0.0001).

By Arcutis Biotherapeutics, Inc.
Published - Nov 15, 2022, 08:07 AM ET
Last Updated - Apr 25, 2024, 09:09 AM EDT
  •  Study met the primary endpoint and all secondary endpoints
  • For the primary endpoint, 32.0% of individuals treated with roflumilast cream 0.15% achieved Investigator Global Assessment (IGA) Success compared to 15.2% of individuals treated with vehicle (P<0.0001)
  • 43.2% of individuals treated with roflumilast cream 0.15% achieved a 75% reduction in Eczema Area and Severity Index (EASI-75) and 33.6% achieved a clinically meaningful reduction in itch at Week 4
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