INDIANAPOLIS, Nov. 9, 2021 /PRNewswire/
-- OLUMIANT® (baricitinib) maintained a
consistent safety profile in a long-term, integrated safety
analysis of patients with rheumatoid arthritis (RA) who received
OLUMIANT for 14,744 patient years of exposure, in line with
previously published findings. Eli Lilly and Company (NYSE: LLY)
and Incyte (NASDAQ: INCY) will present these results, along
with real-world safety results from 3,445 patients with RA in
Japan, at ACR Convergence 2021,
the American College of Rheumatology's virtual annual meeting
taking place November 3-9, 2021.
Detailed and additional results from the long-term, integrated
safety study for OLUMIANT were recently published in the Annals
of the Rheumatic Diseases.
"Rheumatoid arthritis is a chronic inflammatory disease that
requires long-term treatment to manage symptoms, including joint
pain, swelling and tenderness, and if left uncontrolled, can be
associated with significant morbidity complications," said
Professor Peter C. Taylor, M.D.,
Ph.D., Professor of Musculoskeletal Sciences at the University of Oxford, and lead author of this
analysis. "As one of the longest safety trials for a JAK inhibitor
in this disease, these data can help healthcare providers and
people living with rheumatoid arthritis in better understanding
OLUMIANT when considering treatment options that can be used for
prolonged periods of time."
OLUMIANT RA Safety Profile Remains Consistent Up to 9.3
Years
A pooled analysis across nine randomized studies and one
long-term extension study evaluated the safety of OLUMIANT 4-mg and
OLUMIANT 2-mg over time in 3,770 patients with RA, who were exposed
to treatment for a total of 14,744 patient years of exposure.
Participants had a median exposure of 4.6 years and a maximum
exposure of 9.3 years.
Among those treated with OLUMIANT, the overall incidence rate of
adverse events per 100 patient years of exposure was 22.6, and the
incidence rate of serious adverse events was 7.4. Incidence rates
remained stable over time across the 14,744 patient years of
exposure. The incidence rate of serious infections was 2.58 per 100
patient years of exposure.
Adverse events of special interest included venous
thromboembolic events (pulmonary embolism, incidence rate=0.26;
deep vein thrombosis, incidence rate=0.35; deep vein thrombosis
and/or pulmonary embolism, incidence rate=0.49) and major adverse
cardiovascular events (incidence rate=0.51) within the range of
incidence rates described in epidemiological studies in the general
RA population. Incidence rates of safety events of special interest
among those treated with OLUMIANT remained stable through exposures
up to 9.3 years and were generally similar between the OLUMIANT
2-mg and 4-mg groups. In a subgroup of patients over 50 years old
who had at least one cardiovascular risk factor (current smoker,
hypertension, high-density lipoprotein cholesterol <40 mg/dL,
diabetes, or arteriosclerotic cardiovascular disease), the
incidence rate of major adverse cardiovascular events (MACE) was
0.77 per 100 patient years of exposure vs. 0.51 in the total study
population.
In this study, age-adjusted incidence rates for malignancy
(incidence rate=0.92) and mortality (incidence rate=0.6) for
patients treated with OLUMIANT appear similar to the general U.S.
population.
For methodology, see the full abstract on the ACR
website.
Real-World Evidence Study Reinforces OLUMIANT 4-mg and 2-mg
Safety Profile at 24-Weeks
A post-marketing surveillance study of 3,445 patients with RA in
Japan evaluated the safety of
OLUMIANT 4-mg and OLUMIANT 2-mg in clinical practice and no new
safety signals were identified. Of the population, 54% were 65
years or older, and 65% started with an initial dose of OLUMIANT
4-mg/day. Three out of four patients in the study (74%) continued
treatment for 24 weeks, and the majority of patients maintained a
consistent dosage.
Overall, 26% of patients (n=887) reported an adverse event and
4% of patients (n=122) reported a serious adverse event, with six
deaths, none of which were related to deep vein thrombosis or
pulmonary embolisms. Priority survey events included herpes zoster
(3%, n=100), liver dysfunction (3%, n=100), serious infection
(1.5%, n=51), anemia (1%, n=41), hyperlipidemia (1%, n=40),
malignancy (0.3%, n=11), interstitial pneumonia (0.2%, n=8), MACE
(0.1%, n=5) and venous thromboembolism (0.1%, n=3).
For methodology, see the full abstract on the ACR website.
"OLUMIANT has one of the largest and longest sets of available
safety data in the JAK inhibitor class, spanning 19,000 total
patient years of exposure, including almost 15,000 patient years in
RA, over a period of over nine years across the clinical
development program," said Lotus Mallbris, M.D., Ph.D., vice
president of global immunology development and U.S. and global
medical affairs at Lilly. "We are pleased to present this extensive
set of data at ACR, which illustrate OLUMIANT's long-term safety
profile in rheumatoid arthritis. When taken in totality with
previously published, well-established efficacy data, these new
insights further characterize the benefit/risk profile of OLUMIANT
and support better informed treatment decisions by HCPs and
patients affected by this painful disease."
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. 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,
Malignancy, and Thrombosis. See the full Prescribing
Information here. Baricitinib is also being investigated
in alopecia areata (AA), juvenile idiopathic arthritis (JIA) and
systematic lupus erythematosus (SLE).
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of baricitinib
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, 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.
MALIGNANCIES: Lymphoma and other malignancies have been
observed in patients treated with Olumiant.
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.
Patients with symptoms of thrombosis should be promptly
evaluated.
WARNINGS AND PRECAUTIONS
SERIOUS INFECTIONS: 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 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.
Closely monitor patients for infections during and after
Olumiant treatment. Interrupt Olumiant if a patient develops a
serious infection, an opportunistic infection, or sepsis. Do not
resume Olumiant until the infection is controlled.
Tuberculosis – Before initiating
Olumiant, evaluate and test patients for latent or active
infection and treat patients with latent TB with standard
antimycobacterial therapy. Olumiant should not be given to patients
with active TB. Consider anti-TB therapy prior to initiating
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. Monitor patients for TB during Olumiant
treatment.
Viral Reactivation – 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.
MALIGNANCY AND LYMPHOPROLIFERATIVE
DISORDERS: Malignancies were observed in Olumiant
clinical studies. Consider the risks and benefits of Olumiant prior
to initiating therapy in patients with a known malignancy other
than a successfully treated non-melanoma skin cancer (NMSC) or when
considering continuing Olumiant in patients who develop a
malignancy. NMSCs were reported in patients treated with Olumiant.
Periodic skin examination is recommended for patients who are at
increased risk for skin cancer.
THROMBOSIS: Thrombosis, including DVT and PE,
has been observed at an increased incidence in Olumiant-treated
patients compared to placebo. In addition, arterial thrombosis
events in the extremities have been reported in clinical studies
with Olumiant. Many of these adverse events were serious and some
resulted in death. There was no clear relationship between platelet
count elevations and thrombotic events. Use Olumiant with
caution in patients who may be at increased risk of thrombosis. If
clinical features of DVT/PE or arterial thrombosis occur, evaluate
patients promptly and treat appropriately.
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.
USE IN SPECIFIC POPULATIONS
PREGNANCY AND LACTATION: No information is available
to support the use of Olumiant in pregnancy or lactation. Advise
women not to breastfeed during treatment with Olumiant.
HEPATIC AND RENAL IMPAIRMENT: Olumiant is not
recommended in patients with severe hepatic impairment or in
patients with severe renal impairment.
Please click to access full Prescribing
Information, including Boxed Warning about Serious infections,
Malignancies, and Thrombosis, and Medication Guide.
BA HCP ISI 09JUL2020
About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease characterized by
inflammation and progressive destruction of joints.1,2
More than 23 million people worldwide suffer from RA.3
Approximately three times as many women as men have the
disease.5 Patients and physicians indicate there remains
an important opportunity to improve patient care. Current treatment
of RA includes the use of non-steroidal anti-inflammatory drugs,
oral disease-modifying anti-rheumatic drugs such as methotrexate,
and injectable biological response modifiers that target selected
mediators implicated in the pathogenesis of RA.4
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.
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.
P-LLY
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.
1. Klareskog L, Catrina AI, Paget S. Lancet.
2009;373:659-672.
2. 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.
3. WHO Global Burden of Disease Report, (table 7,
page 32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
4. 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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