- Randomized Phase 2 study met the primary endpoint in patents
with hidradenitis suppurativa (HS), reinforcing efficacy and safety
profile of ruxolitinib cream
- Results presented as a late-breaking oral presentation at the
American Academy of Dermatology (AAD) Annual Meeting
Incyte (Nasdaq:INCY) today announced new results from a Phase 2
study evaluating the efficacy and safety of twice-daily ruxolitinib
cream 1.5% (Opzelura®) in adult patients with Hurley stage 1 or 2
(mild-to-moderate) hidradenitis suppurativa (HS). These data were
presented as a late-breaking oral presentation (Session: S050 –
Late-Breaking Research: Session 2) at the American Academy of
Dermatology (AAD) Annual Meeting, held from March 8-12, 2024, in
San Diego.
The study met its primary endpoint, demonstrating a
significantly greater reduction in abscess and inflammatory nodule
(AN) count in patients treated with ruxolitinib cream 1.5%,
compared to those who applied the vehicle control (least squares
mean change of -3.61 for ruxolitinib cream 1.5% vs. -2.42 for
vehicle control; P<0.05) at Week 16.
“The results presented today reinforce the efficacy and safety
profile of ruxolitinib cream, which shows great potential for
people living with milder HS,” said Jim Lee, M.D., Ph.D., Group
Vice President, Inflammation & AutoImmunity, Incyte. “Despite
its daily impact on the lives of patients, there are currently no
approved therapies for mild-to-moderate HS and the current standard
of care is often inadequate. Today’s data represent an important
step in progressing research for HS with the goal of being able to
provide patients with an effective option to better manage their
condition.”
Additional secondary endpoints of the study included:
- More than three quarters (79.2%) of on-treatment patients
achieved at least a 50% reduction in AN count (AN50), 54.2%
achieved a 75% reduction (AN75), 20.8% achieved 90% reduction
(AN90), and 20.8% achieved complete clearance (100% reduction,
AN100), surpassing the 56.3%, 25.0%, 12.5% and 12.5% reductions,
respectively, in the vehicle control group.
- The majority (79.2%) of patients in the ruxolitinib cream 1.5%
group met the criteria for Hidradenitis Suppurativa Clinical
Response (HiSCR), which indicates a 50% or greater reduction in AN
count without an increase in abscesses or draining fistulas,
compared to 50.0% of patients in the vehicle control group.
- Patients treated with ruxolitinib cream 1.5% showed a greater
mean reduction in the International Hidradenitis Suppurativa
Severity Score System (IHS4) score compared to baseline at Week 16
(-4.46) compared to the vehicle group (-2.66).
Patients treated with ruxolitinib cream 1.5% showed a change
-1.85 and -1.42 from baseline in the Skin Pain Numeric Rating Scale
(NRS) and Itch NRS at Week 16, respectively, versus a -2.61 and
-2.75 change from those in the vehicle control group. Due to
patient eligibility criteria, patients studied did not have high
itch or skin pain scores at baseline; however, additional research
is needed to evaluate treatment impact on skin pain and itch
scores.
The study results showed that ruxolitinib cream 1.5% was
generally well-tolerated. Treatment-emergent adverse events (TEAEs)
occurred in 38.2% of patients who applied ruxolitinib cream 1.5%
versus 42.9% of patients who applied vehicle control. The most
common TEAEs among patients receiving ruxolitinib cream 1.5% were
COVID-19 (5.9%) and nasopharyngitis (5.9%). Discontinuation due to
TEAEs were infrequent (ruxolitinib cream 1.5%, n=2 [5.9%]; vehicle
control, n=0 [0%]), and no serious TEAEs were reported in the
ruxolitinib cream 1.5% group.
“HS is a chronic, debilitating skin condition that unfortunately
has no cure, so managing the signs and symptoms through an
effective treatment is key to ensuring patients are able to live
their lives with minimal impact from this disease,” said Dr.
Martina J. Porter, Beth Israel Deaconess Medical Center. “Better
disease control can help manage the persistent symptoms of HS for
these patients. There still remains a very large need for effective
therapies for patients with HS, particularly for those with milder
HS, and I’m encouraged by the results from this Phase 2 study of
ruxolitinib cream for this patient population.”
More information regarding the AAD Annual Meeting 2024 can be
found at https://www.aad.org/member/meetings-education/am24.
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory skin
condition characterized by painful nodules and abscesses that can
lead to irreversible tissue destruction and scarring.1,2
Over-activity of the JAK/STAT signaling pathway is believed to
drive inflammation involved in the pathogenesis and progression of
HS.3 More than 150,000 patients in the U.S. are estimated to have
moderate-to-severe HS.4 Given the debilitating nature of condition,
it can have a profoundly negative effect on patients’ quality of
life.5
About the Phase 2 Study (NCT05635838)
This randomized, double-blind, vehicle-controlled Phase 2
clinical trial is designed to evaluate the safety and efficacy of
ruxolitinib cream 1.5% (Opzelura®) in patients with
mild-to-moderate hidradenitis suppurativa (HS). The study enrolled
69 adult patients (age ≥ 18 years) diagnosed with Hurley stage 1 or
2 HS who have a total abscess and inflammatory nodule (AN) count of
3 to ≤ 10, with no draining tunnels at screening and baseline
visits.
The primary outcome measure of the study is change from baseline
in AN count at Week 16. Secondary outcome measures include
proportion of participants achieving reduction in AN count relative
to baseline, change from baseline in the Skin Pain Numeric Rating
Scale (NRS), change from baseline in the itch NRS score, proportion
of participants who achieve Hidradenitis Suppurativa Clinical
Response (HiSCR), change from baseline in the International
Hidradenitis Suppurativa Severity Score System (IHS4) score and
number of TEAEs.
For more information about the study, please visit
https://clinicaltrials.gov/study/NCT05635838.
About Opzelura® (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food &
Drug Administration for the topical treatment of nonsegmental
vitiligo in patients 12 years of age and older, and 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.
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
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia. For additional
information on Incyte, please visit Incyte.com or follow us on
social media: LinkedIn, X, Instagram, Facebook, YouTube.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the presentation of data from Incyte’s clinical
development pipeline, whether or when ruxolitinib cream might be
approved in HS and/or offer patients with HS an effective
treatment, and Incyte’s goal of improving the lives of patients,
contain predictions, estimates and other forward-looking
statements.
These forward-looking statements are based on our current
expectations and are 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 and the
ability to enroll subjects in accordance with planned schedules;
determinations made by the FDA and regulatory agencies outside of
the United States; our dependence on relationships with and changes
in the plans and expenditures of our collaboration partners; the
efficacy or safety of our products and the products of our
collaboration partners; the acceptance of our products and the
products of our collaboration partners in the marketplace; market
competition; unexpected variations in the demand for our products
and the products of our collaboration partners; the effects of
announced or unexpected price regulation or limitations on
reimbursement or coverage for our products and the products of our
collaboration partners; sales, marketing, manufacturing, and
distribution requirements, including our and our collaboration
partners’ ability to successfully commercialize and build
commercial infrastructure for newly approved products and any
additional new products that become approved; and other risks
detailed from time to time in our reports filed with the U.S.
Securities and Exchange Commission, including our quarterly report
on Form 10-Q for the quarter ended December 31, 2023. We disclaim
any intent or obligation to update these forward-looking
statements.
1
National Center for Advancing
Translational Science Genetic and Rare Diseases Information Center.
Hidradenitis suppurativa.
https://rarediseases.info.nih.gov/diseases/6658/hidradenitis-suppurativa.
Accessed February 7, 2024.
2
Kirby J, et al. Efficacy and Safety of the
Janus Kinase 1 Inhibitor Povorcitinib (INCB054707) in Patients with
Hidradenitis Suppurativa: Results from a Randomized,
Placebo-Controlled, Phase 2 Dose-Ranging Study. Presented at the
31st European Academy of Dermatology and Venereology (EADV)
Congress, September 7-10, 2022.
3
Solimani, F., Meier, K., & Ghoreschi,
K. (2019). Emerging topical and systemic JAK inhibitors in
dermatology. Frontiers in immunology, 10, 2847.
4
McMillan, K. Hidradenitis suppurativa:
number of diagnosed patients, demographic characteristics, and
treatment patterns in the United States. Am J Epidemiol. 2014 Jun
15;179(12):1477-83. doi: 10.1093/aje/kwu078. Epub 2014 May 8.
5
Sabat, R., Jemec, G. B., Matusiak, Ł.,
Kimball, A. B., Prens, E., & Wolk, K. (2020). Hidradenitis
suppurativa. Nature reviews Disease primers, 6(1), 18.
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