New England Journal of Medicine published
OLUMIANT 36-week alopecia areata data today
INDIANAPOLIS, March 26, 2022 /PRNewswire/ -- Adults with severe
alopecia areata (AA) who took OLUMIANT® (baricitinib)
achieved significant scalp, eyelash and eyebrow hair regrowth and
nearly 75% of those who responded to OLUMIANT 4-mg achieved 90%
scalp coverage at 52 weeks, Eli Lilly and Company (NYSE: LLY) and
Incyte (NASDAQ:INCY) announced today at the American Academy of
Dermatology (AAD) Annual Meeting. In February 2022, the U.S. Food and Drug
Administration (FDA) granted priority review for OLUMIANT in severe
AA as a potential first-in-disease medicine. Lilly expects
regulatory decisions in the U.S., European Union and Japan in 2022.
In the pooled 52-week analysis, patients at baseline had a mean
Severity of Alopecia Tool (SALT) score of 85.5 (85.5% scalp hair
loss, or 14.5% scalp hair coverage); severe AA is defined as having
a SALT score ≥50 (≥50% scalp hair loss). At baseline, 69.4% and
57.9% had significant eyebrow and eyelash hair loss, respectively,
as defined by Clinician-Reported Outcome (ClinRO) scores ≥2.
Patients' average age was 37.6 years, with hair loss starting
around age 25 and a mean of 12.2 years since symptom onset.
Among patients who took OLUMIANT 4-mg, two out of five (39.0%,
n=201/515) achieved significant scalp hair regrowth, defined as a
SALT score ≤20, or 80% or more scalp hair coverage, and nearly
three out of four of those patients (74.1%, n=149/201) also
achieved a SALT score ≤10, or 90% hair coverage, at 52 weeks.
Separately, more than two out of five patients with ClinRO baseline
scores ≥2 (eyebrow: 44.1%, n=154/349; eyelash: 45.3%, n=139/307)
saw full regrowth or regrowth with minimal gaps in eyebrow and
eyelash hair.
Among patients who took OLUMIANT 2-mg, more than one out of five
(22.6%, n=77/340) achieved significant scalp hair regrowth and two
out of three of those patients (67.5%, n=52/77) achieved 90% or
more hair coverage at 52 weeks. Separately, more than one in five
and one in four patients, respectively (eyebrow: 22.9%, n=55/240;
eyelash: 25.5%, n=51/200), saw full regrowth or regrowth with
minimal gaps in eyebrow and eyelash hair.
These 52-week pooled analyses demonstrate continued improvement
in scalp, eyebrows and eyelash hair regrowth from 36-week results
published today in the New England Journal of Medicine and
presented at the 2021 European Academy of Dermatology and
Venereology (EADV) Congress.
"Whether people with alopecia areata suffer loss of all the hair
on their body or bald spots and missing eyebrows or eyelashes, this
autoimmune disease can be devastating. The disease affects people
of all ages," said Brett King, M.D.,
Ph.D., F.A.A.D., associate professor of dermatology at Yale School of Medicine and lead author of these
analyses. "In 2022, OLUMIANT could become the first medicine ever
approved to treat adults with alopecia areata. It's remarkable that
nearly 40% of patients on OLUMIANT 4-mg, all of whom started out
with at least 50% scalp hair loss, experienced full or nearly full
scalp hair coverage, and similar improvements were achieved among
those patients with significant eyebrows or eyelashes
involvement."
In an evaluation of OLUMIANT 4-mg and 2-mg long-term safety,
incidence rates of frequently reported adverse events up to 52
weeks (median 56 weeks exposure) were consistent with the 36-week,
placebo-controlled period and included upper respiratory tract
infection, headache, acne, urinary tract infection and increases in
muscle-related blood markers. There were no new safety signals.
"OLUMIANT's long-term efficacy data reveal significant regrowth
of scalp, eyelash and eyebrow hair and we're delighted by what
these results can mean for patients. Our alopecia areata safety
data adds further evidence to one of the largest and longest sets
of safety data in the JAK inhibitor class, including nine years and
19,000 patient years across our program," said Lotus Mallbris,
M.D., Ph.D., vice president of global immunology development and
medical affairs at Lilly. "We're excited OLUMIANT may be a
potential first-in-disease medicine approved this year for adults
with severe alopecia areata."
About BRAVE-AA1 and BRAVE-AA2
In these double-blind, placebo-controlled Phase 3 trials, 1,200
patients with severe AA were randomized to receive once-daily
OLUMIANT 4-mg, OLUMIANT 2-mg or placebo. Patients randomized to
OLUMIANT received the same treatment for 52 weeks while placebo
non-responders were rescued to OLUMIANT at 36 weeks. The primary
endpoint was SALT score ≤20 (≤20% scalp hair loss). Secondary
endpoints included the proportion of patients who achieved a SALT
score ≤10 (≤10% scalp hair loss), Clinician-Reported Outcome
(ClinRO) Measure for Eyebrow Hair Loss™ and ClinRO Measure for
Eyelash Hair Loss™ scores of patients achieving eyebrow and eyelash
hair loss scores of 0 or 1 (full coverage or minimal gaps) with a
≥2-point improvement from baseline among patients with baselines
scores ≥2. In the BRAVE studies, 51.7% of patients were white
(n=620/1,200), 36.3% were Asian (n=435/1,200), 8.2% were Black
(n=98/1,200).
About OLUMIANT®
OLUMIANT, a once-daily, oral JAK inhibitor was discovered by
Incyte and licensed to Lilly. It is approved in the U.S. and more
than 75 countries as a treatment for adults with moderate to severe
rheumatoid arthritis and is approved in more than 50 countries,
including the European Union and Japan, for the treatment of adult patients
with moderate to severe atopic dermatitis who are candidates for
systemic therapy. To date, more than 343,000 patients have been
treated with OLUMIANT worldwide across approved indications.
Marketing authorization for the treatment of hospitalized patients
with COVID-19 has been granted for OLUMIANT in multiple countries.
The U.S. FDA-approved labeling for OLUMIANT includes a Boxed
Warning for Serious Infections, Mortality, Malignancy, Major
Adverse Cardiovascular Events, and Thrombosis. See the full
Prescribing Information here. OLUMIANT is also being investigated
in COVID-19, alopecia areata (AA) and juvenile idiopathic arthritis
(JIA).
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of OLUMIANT and
certain follow-on compounds for patients with inflammatory and
autoimmune diseases.
Indication and Usage for OLUMIANT (baricitinib) tablets (in
the United States) for RA
patients
OLUMIANT® (baricitinib) 2 mg is indicated for the treatment of
adult patients with moderately to severely active rheumatoid
arthritis who have had an inadequate response to one or more tumor
necrosis factor (TNF) antagonist therapies. Limitation of Use: Not
recommended for use in combination with other JAK inhibitors,
biologic disease-modifying antirheumatic drugs (DMARDs), or with
potent immunosuppressants such as azathioprine and
cyclosporine.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib)
tablets
WARNING: SERIOUS INFECTIONS, MALIGNANCY, MAJOR ADVERSE
CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS
Patients treated with Olumiant are at risk for developing
serious infections that may lead to hospitalization or death. Most
patients who developed these infections were taking concomitant
immunosuppressants such as methotrexate or corticosteroids. If a
serious infection develops, interrupt Olumiant until the infection
is controlled. Reported infections include:
- Active tuberculosis (TB), which may present with pulmonary
or extrapulmonary disease. Test patients for latent TB before
initiating Olumiant and during therapy. If positive, start
treatment for latent infection prior to Olumiant use.
- Invasive fungal infections, including candidiasis and
pneumocystosis. Patients with invasive fungal infections may
present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic
pathogens.
Carefully consider the risks and benefits of Olumiant prior
to initiating therapy in patients with chronic or recurrent
infection.
Closely monitor patients for the development of signs and
symptoms of infection during and after treatment with Olumiant
including the possible development of TB in patients who tested
negative for latent TB infection prior to initiating
therapy.
The most common serious infections reported with Olumiant
included pneumonia, herpes zoster, and urinary tract infection.
Among opportunistic infections, tuberculosis, multidermatomal
herpes zoster, esophageal candidiasis, pneumocystosis, acute
histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were
reported with Olumiant. Some patients have presented with
disseminated rather than localized disease, and were often taking
concomitant immunosuppressants such as methotrexate or
corticosteroids.
Avoid use of Olumiant in patients with an active, serious
infection, including localized infections. Consider the risks and
benefits of treatment prior to initiating Olumiant in patients:
with chronic or recurrent infection; who have been exposed to TB;
with a history of a serious or an opportunistic infection; who have
resided or traveled in areas of endemic tuberculosis or endemic
mycoses; or with underlying conditions that may predispose them to
infection.
Consider anti-TB therapy prior to initiation of Olumiant in
patients with a history of latent or active TB in whom an adequate
course of treatment cannot be confirmed, and for patients with a
negative test for latent TB but who have risk factors for TB
infection.
Viral reactivation, including cases of herpes virus reactivation
(e.g., herpes zoster), were reported in clinical studies with
Olumiant. If a patient develops herpes zoster, interrupt Olumiant
treatment until the episode resolves. The impact of Olumiant on
chronic viral hepatitis reactivation is unknown. Screen for viral
hepatitis in accordance with clinical guidelines before initiating
Olumiant.
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 another Janus
kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, 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 Olumiant.
MALIGNANCIES
Lymphoma and other malignancies have been observed in
patients treated with Olumiant. In RA patients treated with another
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. A higher rate of lymphomas was
observed in patients treated with the JAK inhibitor compared to
those treated with TNF blockers. A higher rate of lung cancers and
an additional increased risk of overall malignancies were observed
in current or past smokers treated with the JAK inhibitor compared
to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with Olumiant, particularly in
patients with a known malignancy (other than successfully treated
NMSC), patients who develop a malignancy, and patients who are
current or past smokers.
NMSCs have been reported in patients treated with Olumiant.
Periodic skin examination is recommended for patients who are at
increased risk for skin cancer.
MAJOR ADVERSE CARDIOVASCULAR EVENTS
In RA patients 50 years of age and older with at least one
cardiovascular risk factor treated with another JAK inhibitor, a
higher rate of major adverse cardiovascular events (MACE) (defined
as cardiovascular death, myocardial infarction [MI], and stroke)
was observed when compared with TNF blockers. Patients who are
current or past smokers are at additional increased risk.
Discontinue Olumiant in patients that have experienced a myocardial
infarction or stroke.
Consider the benefits and risks for the individual patient prior
to initiating or continuing therapy with Olumiant, particularly in
patients who are current or past smokers and patients with other
cardiovascular risk factors. Inform patients about the symptoms of
serious cardiovascular events and the steps to take if they
occur.
THROMBOSIS
Thrombosis, including deep venous thrombosis (DVT) and
pulmonary embolism (PE), has been observed at an increased
incidence in patients treated with Olumiant compared to placebo. In
addition, there were cases of arterial thrombosis. Many of these
adverse events 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 another JAK inhibitor, a higher rate of
thrombosis was observed when compared with TNF blockers. Avoid
Olumiant in patients at risk. Discontinue Olumiant and promptly
evaluate patients with symptoms of thrombosis.
GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in Olumiant
clinical studies, although the role of JAK inhibition in these
events is not known. Use Olumiant with caution in patients who may
be at increased risk for gastrointestinal perforation (e.g.,
patients with a history of diverticulitis). Promptly evaluate
patients who present with new onset abdominal symptoms for early
identification of gastrointestinal perforation.
LABORATORY ABNORMALITIES
Neutropenia – Olumiant treatment was
associated with an increased incidence of neutropenia (absolute
neutrophil count [ANC] <1000 cells/mm3) compared to
placebo. Avoid initiation or interrupt Olumiant treatment in
patients with an ANC <1000 cells/mm3. Evaluate at
baseline and thereafter according to routine patient
management.
Lymphopenia – Absolute lymphocyte count (ALC)
<500 cells/mm3 were reported in Olumiant
clinical trials. Lymphocyte counts less than the lower limit of
normal were associated with infection in patients treated with
Olumiant, but not placebo. Avoid initiation or interrupt Olumiant
treatment in patients with an ALC <500 cells/mm3.
Evaluate at baseline and thereafter according to routine patient
management.
Anemia – Decreases in hemoglobin levels to
<8 g/dL were reported in Olumiant clinical trials. Avoid
initiation or interrupt Olumiant treatment in patients with
hemoglobin <8 g/dL. Evaluate at baseline and thereafter
according to routine patient management.
Liver Enzyme Elevations – Olumiant treatment
was associated with increased incidence of liver enzyme elevation
compared to placebo. Increases of ALT ≥5x upper limit of normal
(ULN) and increases of AST ≥10x ULN were observed in patients in
Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient
management. Promptly investigate the cause of liver enzyme
elevation to identify potential cases of drug-induced liver injury.
If increases in ALT or AST are observed and drug-induced liver
injury is suspected, interrupt Olumiant until this diagnosis is
excluded.
Lipid Elevations – Treatment with Olumiant
was associated with increases in lipid parameters, including total
cholesterol, low-density lipoprotein cholesterol, and high-density
lipoprotein cholesterol. Assess lipid parameters approximately 12
weeks following Olumiant initiation. Manage patients according to
clinical guidelines for the management of hyperlipidemia.
VACCINATIONS
Avoid use of live vaccines with Olumiant. Update immunizations
in agreement with current immunization guidelines prior to
initiating Olumiant therapy.
HYPERSENSITIVITY
Reactions such as angioedema, urticaria, and rash that may
reflect drug sensitivity have been observed in patients receiving
Olumiant, including serious reactions. If a serious
hypersensitivity reaction occurs, promptly discontinue Olumiant
while evaluating the potential causes of the
reaction.
ADVERSE REACTIONS
Most common adverse reactions include: upper respiratory tract
infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex
(0.8%, 0.7%), and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and
placebo, respectively.
PREGNANCY AND LACTATION
Limited data on Olumiant use in pregnant women are not
sufficient to inform a drug-associated risk for major birth defects
or miscarriage. Advise women not to breastfeed during treatment
with Olumiant.
HEPATIC AND RENAL IMPAIRMENT
Olumiant is not recommended in patients with severe hepatic or
severe renal impairment.
Please click to access full Prescribing
Information, including Boxed Warning about Serious
Infections, Mortality, Malignancy, Major Adverse Cardiovascular
Events, and Thrombosis, and Medication
Guide.
BA HCP ISI 06DEC2021
About Lilly in Immunology
Lilly is bringing our heritage of championing groundbreaking,
novel science to immunology and is driven to change what's possible
for people living with autoimmune diseases. There are still
significant unmet needs, as well as personal and societal costs,
for people living with a variety of autoimmune diseases and our
goal is to minimize the burden of disease. Lilly is investing in
leading-edge clinical approaches across its immunology portfolio in
hopes of transforming the autoimmune disease treatment experience.
We've built a deep pipeline and are focused on advancing cutting
edge science to find new treatments that offer meaningful
improvements to support the people and the communities we
serve.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at lilly.com and lilly.com/newsroom. P-LLY
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.
OLUMIANT® is a registered trademark owned or licensed
by Eli Lilly and Company, its subsidiaries, or affiliates.
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about OLUMIANT (baricitinib) as a treatment for patients with
rheumatoid arthritis and as a possible treatment for other
conditions and reflects Lilly's and Incyte's current beliefs and
expectations. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of drug
research, development, and commercialization. Among other things,
there can be no guarantee that planned or ongoing studies will be
completed as planned, that future study results will be consistent
with the results to date, and that OLUMIANT will receive additional
regulatory approvals, or be commercially successful. For further
discussion of these and other risks and uncertainties, see Lilly's
and Incyte's most recent respective Form 10-K and Form 10-Q filings
with the United States Securities and Exchange Commission. Except
as required by law, Lilly and Incyte undertake no duty to update
forward-looking statements to reflect events after the date of this
release.
- Klareskog L, Catrina AI, Paget S. Lancet.
2009;373:659-672.
- Hand Clinics, Advances in the Medical Treatment of Rheumatoid
Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed April 23, 2018.
- WHO Global Burden of Disease Report, (table 7, page 32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
- Hunter TM, et al. Rheumatol Int. 2017;37:1551–1557.
Refer to:
|
Marlo
Scott; scott_marlo@lilly.com; +1-317-407-8879
(Lilly media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; +1-317-277-1838 (Lilly
investors)
|
|
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
|
|
Christine Chiou;
cchiou@incyte.com; +1-302-274-4773 (Incyte investors)
|
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