INDIANAPOLIS, Nov. 2, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today
positive data for Olumiant® (baricitinib) will be
presented at ACR Convergence 2020, the American College of
Rheumatology's virtual annual meeting taking place November 5-9, 2020. The Olumiant data being
presented at this year's meeting include new long-term studies in
adult patients living with rheumatoid arthritis (RA), along with
real-world evidence (RWE) on safety and efficacy.
At this year's meeting, results from a post-hoc analysis
evaluating the long-term efficacy of Olumiant for patients with
active RA who were inadequate responders (IR) to conventional
synthetic disease-modifying antirheumatic drugs (csDMARD) or
biologic DMARDs (bDMARD) (Abstract #0224) will be shared. In this
analysis, 27.5% of the csDMARD-IR and 18.4% of the bDMARD-IR
patients had Low Disease Activity defined by Simple Disease
Activity Index (LDA; SDAI ≤11) after 2.3 years (at week 120) in a
Non-responder Imputation analysis. For those patients who remained
in the study, 85% and 86% of csDMARD-IR and bDMARD-IR respectively,
maintained low disease activity at 2.3 years. No new safety
concerns were identified.
"In this analysis of the long-term studies of Olumiant in adults
with RA, the medicine demonstrated efficacy over more than two
years as measured by the proportion of patients who achieved low
disease activity," said Alvin Wells,
M.D., Ph.D., director of the Aurora Rheumatology and Immunotherapy
Center. "The safety and efficacy from this study helps support
Olumiant 2-mg once daily as a long-term treatment for patients with
moderate to severe RA."
Lilly will also highlight data from a long-term extension study
that evaluated radiographic progression of structural joint damage
in adult patients with active RA over 5 years of treatment with
Olumiant (Abstract # 1235). The study enrolled patients who had
completed treatment in one of three Phase 3 trials, including
patients who were DMARD-naïve, csDMARD-IR and methotrexate
(MTX)-IR, and assessed baricitinib 4-mg once daily as monotherapy
or in combination with MTX or other csDMARDs and baricitinib 2-mg
once daily in combination with other csDMARD. The data suggest that
the different RA patient populations treated with baricitinib for
up to 5 years can maintain low rates of radiographic progression,
as assessed by the van der Heijde modified Total Sharp Score
(mTSS).
"We are pleased with the data being presented at this year's
virtual ACR meeting highlighting the depth of Lilly's immunology
portfolio and the potential impact our medicines may have for
patients," said Lotus Mallbris, M.D., Ph.D., vice president of
immunology development at Lilly. "Furthermore, the data being
showcased at this meeting demonstrate our commitment to ongoing
evaluation of the long-term safety and efficacy of Olumiant in
patients living with RA."
Additionally, Lilly will showcase RWE from a postmarketing
safety surveillance study (Abstract # 0203). Results include
24-week safety data from 1,992 patients consecutively prescribed
Olumiant in Japan. No new safety
signals were observed during the initial analysis, and the study
will continue to collect serious adverse events for three
years.
An integrated safety analysis of pooled data from nine clinical
trials of Olumiant is also being presented (Abstract # 0202).
Across the trials, 3,770 patients with RA received Olumiant for a
total of 13,148 patient-years of exposure with a median time on
treatment of 4.2 years and up to a maximum of 8.4 years. The data
reinforce the safety profile of Olumiant in the treatment of RA,
with no new safety concerns reported in the analysis.
For more information about the Lilly data being presented at
this year's virtual ACR, please visit
https://www.rheumatology.org/Annual-Meeting.
Olumiant, an oral JAK1/JAK2 inhibitor discovered by Incyte, is
developed by Lilly under license from Incyte.
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 local 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 OLUMIANT®
OLUMIANT
is a once-daily, oral JAK inhibitor approved in the U.S. for the
treatment of adults with moderately- to severely active rheumatoid
arthritis who have had an inadequate response to one or more TNF
inhibitor therapies, and approved outside of the U.S. for patients
with moderately- to severely active rheumatoid arthritis who have
had an inadequate response to one or more
DMARDs.1 There are four known JAK enzymes: JAK1,
JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated
in the pathogenesis of a number of inflammatory and autoimmune
diseases.2 OLUMIANT has greater inhibitory potency
at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of
inhibition of specific JAK enzymes to therapeutic effectiveness is
not currently known.1 OLUMIANT is approved in more
than 70 countries.
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.
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.
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 reflects Lilly's
and Incyte's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee the future study
results will be consistent with the results to date, that OLUMIANT
will receive additional regulatory approvals, or that it will 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 Olumiant Prescribing Information, 2020.
2 Walker JG and Smith MD. J Rheumatol.
2005;32;1650-1653.
Kristen Porter Basu,
basu_kristen_porter@lilly.com; 317-447-2199 (media)
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 (investors)
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914 (Incyte
investors)
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SOURCE Eli Lilly and Company