- Patients who initially experienced limited or
no facial or total body repigmentation at six months achieved
improved repigmentation after continued treatment with Opzelura for
up to two years
- Results were presented in a late-breaking
news session at the European Academy of Dermatology and Venereology
(EADV) Congress 2023
Incyte (Nasdaq:INCY) today announced new results of a pooled
analysis of long-term extension (LTE) data from the pivotal Phase 3
TRuE-V program assessing Opzelura® (ruxolitinib) cream 1.5%
in patients 12 years of age and older with nonsegmental vitiligo
who previously experienced limited or no response to treatment at
Week 24. These data were presented today in a late-breaking oral
presentation (Abstract #6479; Session: D1T01.1I: Late Breaking
News) at the European Academy of Dermatology and Venereology (EADV)
Congress 2023, held from October 11-14 in Berlin.
“We are excited by the TRuE-V LTE study data presented today
during a late-breaking session at EADV. These long-term data
highlight encouraging updates for an important sub-group of
patients with nonsegmental vitiligo, those who initially showed
limited or no response to treatment,” said Jim Lee, M.D., Ph.D.,
Group Vice President, Inflammation & AutoImmunity, Incyte. “The
pooled analysis builds on the positive LTE data previously
presented at the 2023 American Academy of Dermatology (AAD) Annual
Meeting earlier this year and underscores the long-term potential
of this treatment for people with vitiligo who are seeking
repigmentation.”
The analysis assessed participants initially randomized to apply
Opzelura twice-daily (BID) from the TRuE-V1 and TRuE-V2 studies who
had <25% improvement from baseline in facial Vitiligo Area
Scoring Index (F-VASI) or total body Vitiligo Area Scoring Index
(T-VASI) at Week 24 and had non-missing VASI assessments at the
evaluated time points.
Key findings from the pooled analysis include:
- More than half of patients (54.9%) who initially experienced
limited or no facial repigmentation at Week 24 achieved ≥75%
improvement in facial repigmentation from baseline (F-VASI75) with
continued treatment with Opzelura at Week 104.
- For patients with no initial facial repigmentation at Week 24,
improvements in F-VASI were observed in 77.8% (49/63) and 97.1%
(34/35) of patients at Weeks 52 and 104, respectively.
- For patients with limited facial repigmentation at Week 24,
F-VASI improvements were observed in 64.0% (32/50) and 83.3%
(30/36) of patients at Weeks 52 and 104, respectively.
- Half of the patients (50.0%) who initially experienced limited
or no body repigmentation at Week 24 achieved ≥50% improvement in
body repigmentation from baseline (T-VASI50) with continued
treatment with Opzelura at Week 104.
- Among patients with no body repigmentation at Week 24, T-VASI
improvements were observed in 79.6% (39/49) and 93.3% (28/30) of
patients at Weeks 52 and 104, respectively.
- Among patients with limited body repigmentation at Week 24,
T-VASI improvements were observed in 64.5% (80/124) and 81.6%
(62/76) of patients at Weeks 52 and 104, respectively.
- Opzelura was well-tolerated – no serious treatment-related
adverse events (TEAEs) occurred among patients using Opzelura from
Day 1; 6.3% (n=14/224) of these patients experienced ≥1
treatment-related TEAE. Application site pruritus was the only TEAE
that occurred in >1 patient (n=2; 0.9%).
Opzelura is indicated for the topical treatment of nonsegmental
vitiligo in adult and pediatric patients 12 years of age and older.
Use of Opzelura in combination with therapeutic biologics, other
JAK inhibitors, or potent immunosuppressants such as azathioprine
or cyclosporine is not recommended.
“With this analysis, we were able to more closely examine the
impact of continued treatment with Opzelura in patients who showed
limited to no improvements in facial or total body repigmentation
following an initial six-month course of treatment,” said Dr.
Albert Wolkerstorfer, Netherlands Institute for Pigment Disorders,
Department of Dermatology, University of Amsterdam. “These data
highlight the importance of continuing treatment with Opzelura in
patients with vitiligo, even when minimal or no repigmentation is
achieved after six months of treatment.“
Vitiligo is a chronic autoimmune disease characterized by
depigmentation of skin that results from the loss of
pigment-producing cells known as melanocytes. Overactivity of the
JAK signaling pathway is believed to drive inflammation involved in
the pathogenesis and progression of vitiligo. In the United States,
more than 1.5 million people are diagnosed with vitiligo1. The
overall prevalence of the condition is estimated to be
approximately 2-3 million2, with the majority of patients
(approximately 85%) suffering from nonsegmental vitiligo3. Vitiligo
can occur at any age, although many patients with vitiligo will
experience initial onset before the age of 304.
More information regarding the EADV Congress 2023 can be found
at https://eadvcongress2023.org/.
About TRuE-V
The TRuE-V clinical trial program includes two Phase 3 studies,
TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the
safety and efficacy of Opzelura in patients with vitiligo. Each
study enrolled approximately 300 patients (age ≥12 years) who have
been diagnosed with nonsegmental vitiligo.
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-V program,
whether or when Opzelura will provide a successful treatment option
for patients with vitiligo, 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 Bergqvist C, Ezzedine K.
Vitiligo: A Review. Dermatology. 2020;236:571-592. 2 Gandhi K, et
al. Prevalence of vitiligo among adults in the United States. JAMA
Dermatol. 2022;158(1):43-50. 3 Ezzedine K, et al. Seminar:
Vitiligo. Lancet. 2015;386:74–84. 4 Frisoli M, et al. Vitiligo:
mechanisms of pathogenesis and treatment. Annu. Rev. Immunol.
2020;38(1):621-648.
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