INDIANAPOLIS, June 3, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) will present new data for Olumiant®
(baricitinib) at the virtual European Congress of Rheumatology
(EULAR 2020) taking place June 3-6,
2020. Highlights from Olumiant data being presented at the
virtual meeting include new long-term data in patients living with
rheumatoid arthritis (RA) as well as data from an investigational
trial in patients with systemic lupus erythematosus (SLE).
"We're pleased to be participating in this year's virtual EULAR
meeting sharing new safety and efficacy data in people living with
RA who have been treated with Olumiant," said Lotus Mallbris, M.D.,
Ph.D., vice president of immunology development at Lilly. "At
Lilly, our focus on patient needs doesn't stop when we launch a
product. We're committed to continuously evaluating potential
treatment options for patients living with rheumatic
conditions."
At this year's meeting, Lilly will share results from a
long-term study that evaluated the efficacy of Olumiant in patients
with moderate to severe RA during three years of treatment. The
study measured the achievement of clinically-relevant outcomes,
including low disease activity (LDA) as measured by the simplified
disease activity index (SDAI ≤11), in DMARD-naïve patients and
patients with an inadequate response to methotrexate (MTX-IR) from
treatment initiation to three years. Patients in this study were
treated with Olumiant 4-mg once daily, an approved dose outside of
North America.
The study found that among patients with an inadequate response
to MTX, 52% of patients initially treated with Olumiant (+MTX) were
in a state of SDAI LDA at week 24 and this rate was maintained
through week 148.
Lilly will also share an updated integrated safety analysis of
Olumiant in the treatment of RA using data from 3,770 patients who
were treated with the medicine for up to 8.4 years. The study found
that Olumiant's safety profile remains consistent with what has
been previously reported, with no increase in the rates of safety
topics of interest, including serious infections, herpes zoster,
major adverse cardiovascular events, deep-vein thrombosis and/or
pulmonary embolism, non-melanoma skin cancer (NMSC), and non-NMSC
malignancies. No new safety signals were identified.
"The results from Lilly's integrated safety analysis help to
further characterize the long-term safety of Olumiant as a
treatment option in patients with RA," said Kevin Winthrop, professor of medicine at the
Oregon Health and Sciences University and author of the Olumiant
safety abstract.
In addition, Lilly will present analyses from an investigational
trial evaluating baricitinib in patients with SLE at EULAR. Data
from its Phase 2 randomized, placebo-controlled, double-blind JAHH
study will be highlighted, which observed whether or not SLE
patients experienced changes in their serum cytokine levels when
being treated with the 4-mg dose of baricitinib.
For more information about the Lilly data being presented at
this year's virtual EULAR congress, please visit
https://www.congress.eular.org/scientific_programme.cfm.
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: Use of OLUMIANT in combination
with other JAK inhibitors, biologic disease-modifying antirheumatic
drugs (DMARDs), or with potent immunosuppressants such as
azathioprine and cyclosporine is not recommended.
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. Treatment for latent
infection should be considered 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 to ≥5x and ≥10x upper
limit of normal were observed for both ALT and AST 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.
ADVERSE REACTIONS
Adverse reactions (≥1%) include:
upper respiratory tract infections (16.3%, 14.7%, 11.7%), nausea
(2.7%, 2.8%, 1.6%), herpes simplex (0.8%, 1.8%, 0.7%) and herpes
zoster (1.0%, 1.4%, 0.4%) for Olumiant 2 mg, baricitinib 4 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 11OCT2019
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 60
countries. Olumiant is developed by Lilly under license from Incyte
Corporation.
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
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 a potential treatment for patients with
systemic lupus erythematosus and 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 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, 2019.
2 Walker JG and Smith MD. J Rheumatol.
2005;32;1650-1653.
Refer to:
|
Kristen Porter Basu,
basu_kristen_porter@lilly.com; 317-447-2199 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838
(investors)
|
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SOURCE Eli Lilly and Company