- In the TRuE-AD3 trial, children (age ≥2 to
<12 years old) with atopic dermatitis (AD) treated with
ruxolitinib cream achieved significant efficacy, as defined by the
Investigator’s Global Assessment-treatment success (IGA-TS),
following eight weeks of treatment
- In a second study, treatment with ruxolitinib
cream over eight weeks under maximum-use conditions was well
tolerated in children (age ≥2 to <12 years)
- Data were shared at the European Academy of
Dermatology and Venereology (EADV) Congress 2023
Incyte (Nasdaq:INCY) today announced expanded results from the
pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy
of ruxolitinib cream (Opzelura®) in children (age ≥2 to <12
years) with atopic dermatitis (AD), the most common type of eczema.
These data were presented today in a late-breaking oral
presentation (Abstract #6746; Session: D3T01.3I: Late Breaking
News) at the European Academy of Dermatology and Venereology (EADV)
Congress 2023, held from October 11-14 in Berlin. Additionally,
results from a Phase 1 open-label maximum-use trial evaluating the
safety and tolerability of ruxolitinib cream in children (age ≥2 to
<12 years) treated under maximum-use conditions over an 8-week
trial period were featured as an ePoster at the EADV Congress
2023.
Data from the TRuE-AD3 study, which build upon previously
announced topline results, showed the study met its primary
endpoint with significantly more patients treated with ruxolitinib
cream (0.75% and 1.5%) achieving Investigator’s Global Assessment
Treatment Success (IGA-TS) than patients treated with vehicle
control (non-medicated cream). IGA-TS is defined as an IGA score of
0 (clear) or 1 (almost clear) with at least a two-point improvement
from baseline at Week 8. In addition, secondary endpoints such as
time to NRS4 (≥4-point improvement in itch Numerical Rating Scale
[NRS] score) and patients demonstrating at least a 75% improvement
in the Eczema Area and Severity Index (EASI75) at Week 8 were also
achieved.
"The TRuE-AD3 data presented today at EADV reinforce the strong
safety and efficacy profile of ruxolitinib cream and its potential
to treat younger age groups,” said Jim Lee, M.D., Group Vice
President, Inflammation & AutoImmunity, Incyte. “There is still
a significant medical need for a nonsteroidal topical treatment
that provides rapid and effective control of the signs and symptoms
of AD in children.”
Additional key findings from the TRuE-AD3 study include:
- Fifty-six percent (56.5%) of patients treated with ruxolitinib
cream 1.5% and 36.6% treated with ruxolitinib cream 0.75% achieved
IGA-TS at Week 8 (P<=0.0001 for both) compared to 10.8% of
patients treated with vehicle.
- More than half (67.2%/51.5%) of patients treated with
ruxolitinib cream (1.5% and 0.75% respectively) achieved EASI75
compared to those treated with vehicle at Week 8 (15.4%;
P<0.0001 for both).
- In patients 6 to <12 years old, NRS4 was achieved by 43.4%
(1.5% treatment arm) and 37.5% (0.75% treatment arm) of patients at
Week 8 compared to those treated with vehicle (29.7%).
- Median time to NRS4 was 13.0/11.0 days (1.5% and 0.75%
respectively) compared to 23.0 days for vehicle (hazard ratio,
1.74/1.77; P<0.05 for both).
- The mean steady-state plasma concentrations (Css) of
ruxolitinib at Week 8 were 23.2 nM (1.5% ruxolitinib cream) and
11.3 nM (0.75% ruxolitinib cream), which are well below 281 nM (the
level above which bone-marrow suppression may be induced1),
suggesting meaningful systemic JAK inhibition is highly
unlikely.
- Ruxolitinib cream was well tolerated with no serious
infections, major adverse cardiovascular events (MACE),
malignancies or thromboses reported during the 8-week
vehicle-controlled period. The most common treatment-related
adverse event observed in the ruxolitinib cream arms was
application site pain (2.7% vs 0% in vehicle arm).
Results from the maximum-use trial (MUsT) in children (age ≥2 to
<12 years) with at least 35% of their body surface area affected
by AD showed ruxolitinib cream was well tolerated, with efficacy
results consistent with data from an adolescent and adult
maximum-use study and a pilot pharmacokinetics (PK)/safety
pediatric study2,3.
Key findings from the MUsT study include:
- About 20% (20.7%) of patients treated with ruxolitinib cream
1.5% reported treatment emergent adverse events (TEAEs) through
Week 8; none were serious or led to treatment interruption or
discontinuation. No TEAEs suggestive of systemic JAK inhibition
were reported.
- The mean (SD) Css of ruxolitinib cream through Week 4 was 98.2
(148) nM, which is well below 281 nM, suggesting meaningful
systemic JAK inhibition is highly unlikely.
- Approximately 54% of patients achieved an IGA of 0 or 1 and
approximately 73% achieved NRS4 by Week 4.
Opzelura is indicated for the topical short-term and
non-continuous chronic treatment of mild to moderate 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.
“AD is a chronic immune-mediated disease that impacts about 13
percent of children in the U.S., yet there remains a need for new
treatment options to help this age group manage this difficult to
treat skin condition,” said Dr. Lawrence Eichenfield, Chief of
Pediatric and Adolescent Dermatology at Rady Children’s Hospital
San Diego. “As a clinician, I have been extremely pleased with the
results achieved by many of my adolescent and adult patients with
AD prescribed ruxolitinib cream, and I am excited about the
potential to have a safe, well tolerated and effective
non-steroidal topical treatment option available to my pediatric
patients in the future.”
AD – the most common type of eczema – is a chronic skin disease,
which in the U.S. affects an estimated 2-3 million patients ages
2-11 and more than 21 million people 12 years of age and older4,5.
It is characterized by inflammation and itch. 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 infections6.
More information regarding the EADV Congress 2023 can be found
at https://eadvcongress2023.org/.
About TRuE-AD3
TRuE-AD3 (NCT04921969) is a randomized, double-blind,
vehicle-controlled Phase 3 study evaluating the safety and efficacy
of ruxolitinib cream compared to vehicle (non-medicated cream) in
children with atopic dermatitis (AD). The study enrolled over 300
patients (age ≥2 to <12 years) diagnosed with AD for at least
three months and who were candidates for topical therapy.
Patients with an Investigator’s Global Assessment (IGA) score of
2 to 3 (a measure of disease severity), and with AD on 3% to 20% of
their Body Surface Area (BSA; excluding scalp) were randomized
2:2:1 to receive ruxolitinib cream 0.75% administered twice daily
(BID); ruxolitinib cream 1.5% BID; or vehicle (non-medicated cream)
BID. Patients who successfully completed an efficacy assessment at
Week 8 were offered participation in the 44-week long-term safety
treatment extension period with their same treatment group
(ruxolitinib cream 0.75% or 1.5% BID). Patients initially
randomized to vehicle cream were re-randomized (1:1) in a blinded
manner to one of the active treatment groups.
The primary endpoint of TRuE-AD3 is the proportion of patients
achieving an Investigator’s Global Assessment Treatment Success
(IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear)
with at least a two-point improvement from baseline at Week 8.
Secondary endpoints include: the proportion of patients achieving
at least a 75% improvement in the Eczema Area and Severity Index
(EASI75) – another measurement of disease extent and severity – the
proportion of patients (age ≥6 to <12 years) with at least a
4-point improvement in the itch numerical rating scale (NRS4 at
Week 8 and time to achieve NRS4). The study is also tracking the
frequency, duration and severity of adverse events associated with
the use of ruxolitinib cream.
For more information about the study, please visit
https://www.clinicaltrials.gov/study/NCT04921969.
About MUsT (NCT05034822)
The MUsT pediatric maximum-use study (NCT05034822) is a Phase 1
open-label trial evaluating the safety, pharmacokinetics (PK),
efficacy and patient-reported outcomes (PRO) of ruxolitinib cream
after topical application twice daily (BID) in children over a
52-week treatment period.
Children ages ≥2 to <12 years old with an atopic dermatitis
(AD) diagnosis for >three months,
an Investigator’s Global Assessment (IGA) score of 3 (moderate) or
4 (severe), with AD on ≥35% of their body surface area (BSA;
excluding scalp) and with an itch Numerical Rating Scale (NRS)
score of ≥4 (for patients 6 to <12 years of age) were eligible.
Patients enrolled applied ruxolitinib cream 1.5% twice daily (BID)
to baseline lesions for four weeks (maximum use trial period), then
only to active lesions for an additional four weeks (treatment
extension period), for a total treatment period of eight weeks.
Eligible patients were offered the option to continue into a
44-week long-term safety (LTS) period continuing this regimen
as-needed to active lesions. All study patients will have a 30-day
safety follow-up visit.
The primary outcome measure of the pediatric maximum-use study
is the number of treatment emergent adverse events (TEAEs), defined
as any adverse event reported for the first time or worsening of a
pre-existing event after first application of ruxolitinib cream.
Secondary outcome measures included concentration of ruxolitinib in
plasma, steady-state plasma concentration (Css) of ruxolitinib and
accumulation ratio of ruxolitinib between plasma concentrations at
one hour post application.
For more information about the study, please visit
https://clinicaltrials.gov/study/NCT05034822.
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 is a registered trademark of Incyte.
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with oral Janus kinase inhibitors for
inflammatory conditions are at risk for developing serious
infections that may lead to hospitalization or death. Reported
infections include:
- Active tuberculosis, which may present with pulmonary or
extrapulmonary disease.
- Invasive fungal infections, including cryptococcosis and
pneumocystosis.
- Bacterial, viral, including herpes zoster, and other
infections due to opportunistic pathogens.
Avoid use of OPZELURA in patients with an active, serious
infection, including localized infections. If a serious infection
develops, interrupt OPZELURA until the infection is controlled.
Carefully consider the benefits and risks of treatment prior to
initiating OPZELURA in patients with chronic or recurrent
infection. Closely monitor patients for the development of signs
and symptoms of infection during and after treatment with
OPZELURA.
Serious lower respiratory tract infections were reported in the
clinical development program with topical ruxolitinib.
No cases of active tuberculosis (TB) were reported in clinical
trials with OPZELURA. Cases of active TB were reported in clinical
trials of oral Janus kinase inhibitors used to treat inflammatory
conditions. Consider evaluating patients for latent and active TB
infection prior to administration of OPZELURA. During OPZELURA use,
monitor patients for the development of signs and symptoms of
TB.
Viral reactivation, including cases of herpes virus reactivation
(e.g., herpes zoster), were reported in clinical trials with Janus
kinase inhibitors used to treat inflammatory conditions including
OPZELURA. If a patient develops herpes zoster, consider
interrupting OPZELURA treatment until the episode resolves.
Hepatitis B viral load (HBV-DNA titer) increases, with or
without associated elevations in alanine aminotransferase and
aspartate aminotransferase, have been reported in patients with
chronic HBV infections taking oral ruxolitinib. OPZELURA initiation
is not recommended in patients with active hepatitis B or hepatitis
C.
MORTALITY
In a large, randomized, postmarketing safety study in
rheumatoid arthritis (RA) patients 50 years of age and older with
at least one cardiovascular risk factor comparing an oral JAK
inhibitor to tumor necrosis factor (TNF) blocker treatment, a
higher rate of all-cause mortality, including sudden cardiovascular
death, was observed with the JAK inhibitor. Consider the
benefits and risks for the individual patient prior to initiating
or continuing therapy with OPZELURA.
MALIGNANCIES
Malignancies were reported in patients treated with OPZELURA.
Lymphoma and other malignancies have been observed in patients
receiving JAK inhibitors used to treat inflammatory conditions. In
RA patients treated with an oral JAK inhibitor, a higher rate of
malignancies (excluding non-melanoma skin cancer (NMSC)) was
observed when compared with TNF blockers. Patients who are current
or past smokers are at additional increased risk.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with OPZELURA, particularly in
patients with a known malignancy (other than successfully treated
non-melanoma skin cancers), patients who develop a malignancy when
on treatment, and patients who are current or past smokers.
Non-melanoma skin cancers, including basal cell and squamous
cell carcinoma, have occurred in patients treated with OPZELURA.
Perform periodic skin examinations during OPZELURA treatment and
following treatment as appropriate. Exposure to sunlight and UV
light should be limited by wearing protective clothing and using
broad-spectrum sunscreen.
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)
In RA patients 50 years of age and older with at least one
cardiovascular risk factor treated with an oral JAK inhibitor, a
higher rate of major adverse cardiovascular events (MACE) (defined
as cardiovascular death, myocardial infarction, and stroke), was
observed when compared with TNF blockers. Patients who are current
or past smokers are at additional increased risk. Discontinue
OPZELURA in patients who have experienced a myocardial infarction
or stroke.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with OPZELURA, particularly in
patients who are current or past smokers and patients with other
cardiovascular risk factors. Patients should be informed about the
symptoms of serious cardiovascular events and the steps to take if
they occur. Discontinue OPZELURA in patients that have experienced
a myocardial infarction or stroke.
THROMBOSIS
Thromboembolic events were observed in trials with OPZELURA.
Thrombosis, including pulmonary embolism (PE), deep venous
thrombosis (DVT), and arterial thrombosis have been reported in
patients receiving JAK inhibitors used to treat inflammatory
conditions. Many of these adverse reactions were serious and some
resulted in death. In RA patients 50 years of age and older with at
least one cardiovascular risk factor treated with an oral JAK
inhibitor, a higher rate of thrombosis was observed when compared
with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms
of thrombosis occur, discontinue OPZELURA and treat
appropriately.
Thrombocytopenia, Anemia, and Neutropenia
Thrombocytopenia, anemia, and neutropenia were reported in the
clinical trials with OPZELURA. Consider the benefits and risks for
individual patients who have a known history of these events prior
to initiating therapy with OPZELURA. Perform CBC monitoring as
clinically indicated. If signs and/or symptoms of clinically
significant thrombocytopenia, anemia, and neutropenia occur,
patients should discontinue OPZELURA.
Lipid Elevations
Treatment with oral ruxolitinib has been associated with
increases in lipid parameters including total cholesterol,
low-density lipoprotein (LDL) cholesterol, and triglycerides.
Adverse Reactions
In nonsegmental vitiligo, the most common adverse reactions
(incidence ≥1%) are application site acne (6%), application site
pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract
infection (2%), application site erythema (2%), and pyrexia
(1%).
Pregnancy
There is a pregnancy registry that monitors pregnancy outcomes
in pregnant persons exposed to OPZELURA during pregnancy. Pregnant
persons exposed to OPZELURA and healthcare providers should report
OPZELURA exposure by calling 1-855-463-3463.
Lactation
Advise women not to breastfeed during treatment with OPZELURA
and for approximately four weeks after the last dose (approximately
5-6 elimination half-lives).
Please see Full Prescribing Information,
including Boxed Warning, and Medication Guide for
OPZELURA.
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 presentation of data from Incyte’s TRuE-AD3 and MUsT
studies, whether or when ruxolitinib cream will be approved or
commercially available for use in humans anywhere in the world
outside of the already approved indications in specific regions,
and Incyte’s dermatology program generally 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;
determinations made by the FDA, EMA and other regulatory
authorities; the efficacy or safety of Incyte’s products; the
acceptance of Incyte’s 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 and its quarterly report on Form 10-Q
for the quarter ended June 30, 2023. Incyte disclaims any intent or
obligation to update these forward-looking statements.
_____________________________ 1 Cardama A, et
al. Blood. 2010;115(15):3109-3117. 2 Bissonnette R, et al. Am J
Clin Dermatol. 2022;23(3):355-364. 3 Leung DYM, et al. Ann Allergy
Asthma Immunol. 2023;130(4):500-507.e3. 4 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]. 5 Data on file. 6 Boguniewicz M, et al. Ann
Allergy Asthma Immunol. 2018;120(1):10-22.
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