ZORYVE® (Roflumilast) Topical Foam, 0.3% Clears Seborrheic Dermatitis in Individuals Who Previously Reported an Inadequate Response to Topical Steroids
14 January 2024 - 8:00PM
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a
commercial-stage biopharmaceutical company focused on developing
meaningful innovations in immuno-dermatology, today announced a new
subgroup analysis highlighting that adults and adolescents with
seborrheic dermatitis who are contraindicated, intolerant, or
unresponsive to topical steroids were 3.5 times more likely to
achieve IGA Success with ZORYVE® (roflumilast) topical foam, 0.3%,
compared to vehicle (78.8% ZORYVE foam; 48.3% vehicle;
p<0.001)i. ZORYVE foam is a once-daily steroid-free topical for
use in all skin and hair types that effectively clears and controls
seborrheic dermatitis. Data were presented at the 2024 Winter
Clinical Dermatology Conference – Hawaii held January 12-17, 2024,
in Honolulu.
Treatment with ZORYVE foam significantly increased the odds of
achieving a meaningful improvement in quality of life at Weeks 2,
4, and 8, compared to vehicle as measured by the Dermatology Life
Quality Index (DLQI) (odds ratio (OR) 6:97; 95% confidence interval
(CI) 3.97, 12.24; p<0.001). DLQI was measured in patients 17
years of age and older. 72.5% of individuals achieved a minimally
important differenceii in DLQI score as early as 2 weeks,
increasing to 86.6% at the end of the study, Week 8 (compared to
28.1% p=0.001 and 53.6% p=0.001 for vehicle, respectively).
“Seborrheic dermatitis is a chronic, recurrent skin disease that
can negatively impact the quality of life of affected individuals,
including their self-esteem, emotional well-being, and ability to
perform everyday tasks like work or social activities. This new
analysis quantifies a meaningful improvement in both the signs and
symptoms of seborrheic dermatitis as well as quality of life for
individuals treated with ZORYVE foam,” said Matthew Zirwas, MD,
founder of the Bexley Dermatology Research Clinic and an
investigator in the trial. “As a practitioner, this large subgroup
analysis provides me with the confidence to include ZORYVE foam as
an important new treatment in my armamentarium to prescribe to my
patients, including those who have failed topical steroids which
are commonly prescribed for seb derm.”
“This subgroup analysis builds upon the existing evidence for
ZORYVE foam as an effective once-a-day treatment option for use in
all skin and hair types to clear and control seborrheic dermatitis,
including among those who previously experienced inadequate
response or intolerance to topical steroids,” said Patrick Burnett,
MD, PhD, FAAD, chief medical officer of Arcutis. “As the first
topical drug approved with a new mechanism of action for this
condition in 20 years, ZORYVE foam represents an important
advancement in treatment and addresses a truly significant need in
this population.”
ZORYVE foam was well-tolerated with a favorable safety and
tolerability profile. 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, the most common adverse reactions (≥1%) included
nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
The STudy of Roflumilast foam Applied Topically for the
redUction of seborrheic derMatitis (STRATUM) evaluated ZORYVE foam
vs vehicle once daily for 8 weeks. The subgroup analysis included
189 adults and adolescents 9 years of age and older with
moderate-to-severe seborrheic dermatitis who reported an inadequate
response, intolerance, or contraindication to steroids prior to
enrollment in the STRATUM study (41.4% of the total study
population).
About ArcutisArcutis Biotherapeutics, Inc.
(Nasdaq: ARQT) is a commercial-stage medical dermatology company
that champions meaningful innovation to address the urgent needs of
individuals living with immune-mediated dermatological diseases and
conditions. With a commitment to solving the most persistent
patient challenges in dermatology, Arcutis has a growing portfolio
including two FDA approved products that harness our unique
dermatology development platform coupled with our dermatology
expertise to build differentiated therapies against biologically
validated targets. Arcutis’ dermatology development platform
includes a robust pipeline with multiple clinical programs for a
range of inflammatory dermatological conditions including scalp and
body psoriasis, atopic dermatitis, and alopecia areata. For more
information, visit www.arcutis.com or follow Arcutis on
LinkedIn, Facebook, and X.
INDICATIONSZORYVE foam, 0.3%, is indicated for
treatment of seborrheic dermatitis in adult and pediatric patients
9 years of age and older.
IMPORTANT SAFETY INFORMATIONZORYVE is
contraindicated in patients with moderate to severe liver
impairment (Child-Pugh B or C).
Flammability: The propellants in ZORYVE foam are flammable.
Avoid fire, flame, and smoking during and immediately following
application.
The most common adverse reactions (≥1%) for ZORYVE foam include
nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Please see full Prescribing Information for ZORYVE foam.
ZORYVE is for topical use only and not for ophthalmic, oral, or
intervaginal use.
Forward-Looking StatementsArcutis 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, but are not
limited to, statements regarding the potential for ZORYVE to
simplify disease management for care of seborrheic dermatitis; the
potential of real-world use results of roflumilast foam, as well as
the commercial launch of ZORYVE in seborrheic dermatitis. 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 U.S. Securities and
Exchange Commission (SEC) on February 28, 2023, as well as any
subsequent filings with the SEC. You should not place undue
reliance on any forward-looking statements in this press release.
We undertake no obligation to revise or update information herein
to reflect events or circumstances in the future, even if new
information becomes available. All forward-looking statements are
qualified in their entirety by this cautionary statement, which is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
Contacts:MediaAmanda Sheldon,
Head of Corporate Communicationsasheldon@arcutis.com
InvestorsDerek ColeInvestor Relations Advisory
Solutionsderek.cole@iradvisory.com
i IGA success was defined as at least a 2-point reduction in IGA
score from baseline and an IGA score of 0 (clear) or 1 (almost
clear)ii Meaninful important difference defined as at least a
4-point reduction in baseline DLQI score, and achievement of a DLQI
score of 0 or 1
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