CORRECTION: In a press release issued earlier today under the same headline, please note that the p-value for WI-NRS should have been P<0.01 not P<0.0001.
“Atopic dermatitis is a chronic and burdensome disease, especially common with children, that has a significant need for rapid-acting topical treatment options outside of corticosteroids, which aren’t suitable for long-term care due to local side effects, safety concerns, and potential for rebound or withdrawal,” stated
Roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on all secondary endpoints, including 43.2% of individuals treated with roflumilast cream 0.15% achieving a 75% reduction in Eczema Area and Severity Index (
In addition, the study measured reduction in itch in individuals 12 years of age and older, with 33.6% of individuals treated with roflumilast cream achieving a four-point reduction in Worst Itch Numeric Scale (WI-NRS) at Week 4 (vs. 20.7% for vehicle-treated subjects, [P<0.01]).
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in
“Today’s positive data from INTEGUMENT-1 adds to the growing body of evidence for the overall potential of roflumilast cream as an effective and well-tolerated treatment in atopic dermatitis,” said
Roflumilast cream was well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. There were no treatment-related Serious Adverse Events (SAEs). Overall, adverse events were uncommon, with no adverse event occurring in more than 2.5% of subjects in either arm. The most frequent adverse events (>1%) included headache, nausea, application site pain, nasopharyngitis, COVID-19, diarrhea, and vomiting. Over 93% of patients who were randomized to roflumilast cream in the study completed the full four weeks, and there were few discontinuations due to adverse events (1.4% and 1.4% in the roflumilast cream and vehicle groups, respectively).
The Company is anticipating topline results from the identically designed pivotal Phase 3 trial INTEGUMENT-2 by the end of 2022, and is planning to host an investor call to discuss both trials at that time. If successful, the Company intends to submit a supplemental New Drug Application (sNDA) in 2023 for roflumilast cream 0.15% for the treatment of mild to moderate AD in individuals aged six years and older.
The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis” 1 (INTEGUMENT-1) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.15% or vehicle is applied once daily for four weeks to individuals six years of age and older with mild to moderate AD involving ≥3% body surface area. A total of 654 individuals were enrolled in the study. The primary endpoint was Investigator Global Assessment (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. Multiple secondary endpoints were also evaluated, including itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) as well as the proportion of subjects who attained at least a 75% reduction in the Eczema Area and Severity Index (
After completing INTEGUMENT-1 and INTEGUMENT-2, individuals were eligible to enroll in an open label extension study (INTEGUMENT-OLE) evaluating treatment with once daily roflumilast cream 0.15% for up to 12 months.
Arcutis is enrolling a third pivotal Phase 3 trial, the “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) to evaluate roflumilast cream 0.05% in children two to five years of age with mild to moderate AD. The Company plans to report topline data from this study in 2023.
About Atopic Dermatitis
Atopic dermatitis (AD) is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the
About Roflumilast Cream
Roflumilast cream is a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. For atopic dermatitis, roflumilast cream is being evaluated at lower doses: 0.15% for adults and children six years of age and older and 0.05% for children two to five years.
Roflumilast cream 0.3% (ZORYVE™) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, among others, statements regarding the potential for roﬂumilast to be approved for the treatment of adults and children with atopic dermatitis, the potential to use roﬂumilast cream over a long period of time, or chronically, the potential to use roﬂumilast cream anywhere on the body, including the face and sensitive areas, timing for anticipated data of INTEGUMENT-2 and INTEGUMENT-PED, the potential sNDA ﬁling and the potential for roﬂumilast to advance the standard of care in atopic dermatitis and other inﬂammatory dermatologic conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with
Source: Arcutis Biotherapeutics, Inc.