– Adult patients with atopic dermatitis treated
with Opzelura experienced rapid and substantial improvement in
itch, which was sustained through Day 28
Incyte (Nasdaq:INCY) today announced new data from the Phase 2
SCRATCH-AD trial evaluating the short-term clinical benefits of
Opzelura® (ruxolitinib) cream 1.5% to control pruritus (itching)
and reduce disease severity in adult patients with atopic
dermatitis (AD), the most common type of eczema. These data were
featured in a poster presentation (Poster #396) at the
Revolutionizing Atopic Dermatitis (RAD) Conference, held from April
29-May 1 in Washington, D.C.
Results showed that patients with AD treated with Opzelura
experienced a rapid and substantial improvement in itch, which was
sustained and further improved through 28 days of treatment.
Specifically, the study met its primary endpoint with
Opzelura-treated patients experiencing a mean (SE) –3.4 (0.28)
reduction in itch from baseline at Day 2 as measured by the peak
pruritus numerical rating scale (PP-NRS; an 11-point scale
evaluating the peak intensity of itch over the course of 24 hours).
Itch reduction was observed beginning as early as 15 minutes (2.3
[0.35]) as measured by modified PP-NRS (a measurement for the
current intensity of itch), and the change from baseline, observed
at four hours after the first application of Opzelura, was 4.2
mPP-NRS [0.31].
"AD is a chronic, immune-mediated skin condition that can be
difficult to manage and causes disruptive and persistent symptoms
like itch that can greatly affect patients’ everyday lives," said
Jim Lee, M.D., Ph.D., Group Vice President, Inflammation &
AutoImmunity, Incyte. "We are pleased that the SCRATCH-AD results
further emphasize the rapid impact of Opzelura on itch reduction
and reinforce its profile as an effective, well-tolerated topical
non-steroidal treatment for AD."
Additional key findings from SCRATCH-AD include:
- At 12 hours post-Opzelura application, improvement in itch was
sustained, with a mean (SE) change from baseline in mPP-NRS of –3.1
(0.31).
- Further improvement in itch was seen with continued Opzelura
treatment, as evidenced by the mean (SE) change from baseline in
PP-NRS increasing through Day 29 (–5.7 [1.60]).
- Overall improvement in AD symptoms reported with Opzelura
treatment increased over time. The mean (SE) change from baseline
in Investigator’s Global Assessment (IGA) score – a five-point
scale measuring the overall severity of AD – on Days 8, 15 and 29
were –1.4 (0.11), –2.0 (0.13) and –2.2 (0.14), respectively.
Opzelura was well tolerated with no serious treatment-emergent
adverse events (TEAEs) during the 28-day study period (n=49). All
TEAEs were mild or moderate, with the most common being COVID-19
(6.1%), back pain (4.1%), headache (4.1%), nasopharyngitis (4.1%)
and upper respiratory tract infection (4.1%). One patient presented
with a treatment-related TEAE (grade 1 application site acne). No
patients discontinued treatment due to a TEAE.
“The intense itch caused by AD can lead to an itch-scratch cycle
which increases inflammation, further damages the skin barrier and
worsen symptoms,” said Robert Bissonnette, M.D., FRCPC, lead
investigator of the SCRATCH-AD study and Chief Executive Officer
and Medical Director at Innovaderm Research. “I am encouraged by
these results showing rapid and substantial itch reduction among AD
patients treated with Opzelura, and its potential to quickly
alleviate this burdensome symptom for patients.”
More information regarding the 8th RAD Conference can be found
at https://revolutionizingad.com/conference.
About Atopic Dermatitis
Atopic dermatitis (AD) – the most common type of eczema – is a
chronic skin disease affecting more than 21 million people aged 12
years and older in the U.S. and is characterized by inflammation
and itch1. Signs and symptoms include irritated and itchy skin that
can cause red lesions that may ooze and crust. People with AD are
also more susceptible to bacterial, viral and fungal
infections2.
About SCRATCH-AD (NCT04839380)
SCRATCH-AD is a single-site Phase 2 open-label, single-arm study
evaluating the safety and efficacy of Opzelura® (ruxolitinib) cream
1.5% in adult patients (age 18 to 65 years) with atopic dermatitis
(AD), with a particular focus on understanding the short-term
clinical benefits of Opzelura to control pruritus (itching) and
reduce AD severity.
The study enrolled 49 patients diagnosed with AD for ≥6 months,
and with chronic itch related to AD for ≥3 months, who had 1%–20%
affected body surface area (BSA; excluding palms, soles, scalp,
genitals, and folds), an Investigator Global Assessment (IGA) of
≥2, and a peak pruritus numerical rating scale (PP-NRS) score ≥4 at
baseline. The primary analysis included 46 patients in the modified
intent-to-treat (mITT) population. For 28 days, patients applied
Opzelura 1.5% cream twice daily (BID) approximately 12 hours apart
to all lesions identified at baseline and any new lesions.
The primary endpoint is change from baseline in PP-NRS on Day 2
(24 hours after the first application of Opzelura). Secondary
endpoints included change from baseline in modified PP-NRS
(mPP-NRS; current itch intensity) at 15 and 30 minutes and at 1-,
2-, 4-, 6- and 12-hours post-treatment on Day 1, as well as change
from baseline in PP-NRS from Days 3 through 29, change from
baseline in IGA at Days 8, 15, and 29, and safety.
For more information about this Phase 2 study, please visit:
https://clinicaltrials.gov/ct2/show/NCT04839380.
About Opzelura® (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food &
Drug Administration for the topical treatment of nonsegmental
vitiligo in patients 12 years of age and older, is the first and
only treatment for repigmentation approved for use in the United
States. Opzelura is also approved in the U.S. for the topical
short-term and non-continuous chronic treatment of mild to moderate
atopic dermatitis (AD) in non-immunocompromised patients 12 years
of age and older whose disease is not adequately controlled with
topical prescription therapies, or when those therapies are not
advisable. Use of Opzelura in combination with therapeutic
biologics, other JAK inhibitors, or potent immunosuppressants, such
as azathioprine or cyclosporine, is not recommended.
In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for
the treatment of non-segmental vitiligo with facial involvement in
adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of
Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA is for use on the skin only. Do not use OPZELURA in
your eyes, mouth, or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA contains ruxolitinib.
Ruxolitinib belongs to a class of medicines called Janus kinase
(JAK) inhibitors. JAK inhibitors are medicines that affect your
immune system. JAK inhibitors can lower the ability of your immune
system to fight infections. Some people have had serious infections
while taking JAK inhibitors by mouth, including tuberculosis (TB),
and infections caused by bacteria, fungi, or viruses that can
spread throughout the body. Some people have been hospitalized or
died from these infections. Some people have had serious infections
of their lungs while taking OPZELURA. Your healthcare provider
should watch you closely for signs and symptoms of TB during
treatment with OPZELURA.
OPZELURA should not be used in people with an active, serious
infection, including localized infections. You should not start
using OPZELURA if you have any kind of infection unless your
healthcare provider tells you it is okay. You may be at a higher
risk of developing shingles (herpes zoster) while using
OPZELURA.
Increased risk of death due to any reason (all causes):
Increased risk of death has happened in people 50 years of age and
older who have at least 1 heart disease (cardiovascular) risk
factor and are taking a medicine in the class of medicines called
JAK inhibitors by mouth.
Cancer and immune system problems: OPZELURA may increase
your risk of certain cancers by changing the way your immune system
works. Lymphoma and other cancers have happened in people taking a
medicine in the class of medicines called JAK inhibitors by mouth.
People taking JAK inhibitors by mouth have a higher risk of certain
cancers including lymphoma and lung cancer, especially if they are
a current or past smoker. Some people have had skin cancers while
using OPZELURA. Your healthcare provider will regularly check your
skin during your treatment with OPZELURA. Limit the amount of time
you spend in the sunlight. Wear protective clothing when you are in
the sun and use a broad-spectrum sunscreen.
Increased risk of major cardiovascular events: Increased
risk of major cardiovascular events such as heart attack, stroke,
or death have happened in people 50 years of age and older who have
at least 1 heart disease (cardiovascular) risk factor and taking a
medicine in the class of medicines called JAK inhibitors by mouth,
especially in current or past smokers.
Blood clots: Blood clots in the veins of your legs (deep
vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen
in some people taking OPZELURA. This may be life-threatening. Blood
clots in the vein of the legs (deep vein thrombosis, DVT) and lungs
(pulmonary embolism, PE) have happened more often in people who are
50 years of age and older and with at least 1 heart disease
(cardiovascular) risk factor taking a medicine in the class of
medicines called JAK inhibitors by mouth.
Low blood cell counts: OPZELURA may cause low platelet
counts (thrombocytopenia), low red blood cell counts (anemia), and
low white blood cell counts (neutropenia). If needed, your
healthcare provider will do a blood test to check your blood cell
counts during your treatment with OPZELURA and may stop your
treatment if signs or symptoms of low blood cell counts happen.
Cholesterol increases: Cholesterol increase has happened
in people when ruxolitinib is taken by mouth. Tell your healthcare
provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if
you:
- have an infection, are being treated for one, or have had an
infection that does not go away or keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune
system
- have TB or have been in close contact with someone with TB
- have had shingles (herpes zoster)
- have or have had hepatitis B or C
- live, have lived in, or have traveled to certain parts of the
country (such as the Ohio and Mississippi River valleys and the
Southwest) where there is an increased chance for getting certain
kinds of fungal infections. These infections may happen or become
more severe if you use OPZELURA. Ask your healthcare provider if
you do not know if you have lived in an area where these infections
are common.
- think you have an infection or have symptoms of an infection
such as: fever, sweating, or chills, muscle aches, cough or
shortness of breath, blood in your phlegm, weight loss, warm, red,
or painful skin or sores on your body, diarrhea or stomach pain,
burning when you urinate or urinating more often than usual,
feeling very tired
- have ever had any type of cancer, or are a current or past
smoker
- have had a heart attack, other heart problems, or a stroke
- have had blood clots in the veins of your legs or lungs in the
past
- have high cholesterol or triglycerides
- have or have had low white or red blood cell counts
- are pregnant or plan to become pregnant. It is not known if
OPZELURA will harm your unborn baby. There is a pregnancy exposure
registry for individuals who use OPZELURA during pregnancy. The
purpose of this registry is to collect information about the health
of you and your baby. If you become exposed to OPZELURA during
pregnancy, you and your healthcare provider should report exposure
to Incyte Corporation at 1-855-463-3463.
- are breastfeeding or plan to breastfeed. It is not known if
OPZELURA passes into your breast milk. Do not breastfeed during
treatment with OPZELURA and for about 4 weeks after the last
dose.
After starting OPZELURA:
- Call your healthcare provider right away if you have any
symptoms of an infection. OPZELURA can make you more likely to get
infections or make worse any infections that you have.
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than
a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or
stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your healthcare provider right away if you have any signs
and symptoms of blood clots during treatment with OPZELURA,
including: swelling, pain, or tenderness in one or both legs,
sudden, unexplained chest or upper back pain, or shortness of
breath or difficulty breathing.
- Tell your healthcare provider right away if you develop or have
worsening of any symptoms of low blood cell counts, such as:
unusual bleeding, bruising, tiredness, shortness of breath, or
fever.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
The most common side effects of OPZELURA in people treated
for atopic dermatitis include: common cold (nasopharyngitis),
diarrhea, bronchitis, ear infection, increase in a type of white
blood cell (eosinophil) count, hives, inflamed hair pores
(folliculitis), swelling of the tonsils (tonsillitis), and runny
nose (rhinorrhea).
The most common side effects of OPZELURA in people treated
for nonsegmental vitiligo include: acne at the application
site, itching at the application site, common cold
(nasopharyngitis), headache, urinary tract infection, redness at
the application site, and fever.
These are not all of the possible side effects of OPZELURA. Call
your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088. You may also report side
effects to Incyte Corporation at 1-855-463-3463.
Please see the Full Prescribing Information, including Boxed
Warning, and Medication Guide for OPZELURA.
INDICATIONS AND USAGE
OPZELURA is a prescription medicine used on the skin (topical)
for:
- short-term and non-continuous chronic treatment of mild to
moderate eczema (atopic dermatitis) in non-immunocompromised adults
and children 12 years of age and older whose disease is not well
controlled with topical prescription therapies or when those
therapies are not recommended
- the treatment of a type of vitiligo called nonsegmental
vitiligo in adults and children 12 years of age and older
The use of OPZELURA along with therapeutic biologics, other JAK
inhibitors, or strong immunosuppressants such as azathioprine or
cyclosporine is not recommended.
It is not known if OPZELURA is safe and effective in children
less than 12 years of age with atopic dermatitis or nonsegmental
vitiligo.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has
formed the foundation of the company. Today, we are building on
this legacy as we discover and develop innovative dermatology
treatments to bring solutions to patients in need.
Our research and development efforts in dermatology are
initially focused on leveraging our knowledge of the JAK-STAT
pathway. We are exploring the potential of JAK inhibition for a
number of immune-mediated dermatologic conditions with a high unmet
medical need, including atopic dermatitis, vitiligo, hidradenitis
suppurativa, lichen planus, lichen sclerosus and prurigo
nodularis.
To learn more, visit the Dermatology section of Incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the SCRATCH-AD trial and the potential for Opzelura to
provide itch reduction in patients with AD, contain predictions,
estimates and other forward-looking statements.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte and its partners’ clinical trials, supply chain,
other third-party providers and development and discovery
operations; determinations made by the U.S. FDA and other
regulatory authorities outside of the United States; the efficacy
or safety of Incyte and its partners’ products; the acceptance of
Incyte and its partners’ products in the marketplace; market
competition; sales, marketing, manufacturing and distribution
requirements; and other risks detailed from time to time in
Incyte’s reports filed with the Securities and Exchange Commission,
including its annual report for the year ended December 31, 2022.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
__________________________ 1 U.S. Census Bureau (2020). 2020
Decennial Census. Retrieved from
https://data.census.gov/cedsci/table?q=Populations%20and%20People&tid=DECENNIALPL2020.P1
[data.census.gov]. 2 Boguniewicz M, et al. Ann Allergy Asthma
Immunol. 2018;120(1):10-22.
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