INDIANAPOLIS,
June 13, 2017 /PRNewswire/
-- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation
(NASDAQ: INCY) announced today that new data on safety and
long-term efficacy from the Olumiant® (baricitinib)
clinical trials will be presented in 21 abstracts, including one
oral presentation, at the Annual European Congress of Rheumatology
(EULAR 2017) in Madrid,
June 14-17, 2017.
Lilly will also present six abstracts evaluating
Taltz® (ixekizumab) for the treatment of
psoriatic arthritis (PsA), including two oral presentations
highlighting data from two Phase 3 studies (SPIRIT-P1 and
SPIRIT-P2).
Additionally, Lilly will present two abstracts from its ongoing
research to advance the understanding of rheumatologic diseases.
One abstract is focused on the relationship between the degree of
skin involvement and joint activity in patients with PsA based on
information from the Corrona® registry, and
the other abstract is on the symptomology, disease status and
remission rate of non-radiographic axial spondyloarthritis and
ankylosing spondylitis patients in Europe.
"Rheumatoid arthritis, psoriatic arthritis and psoriasis are
chronic, debilitating diseases that significantly impact the
physical wellbeing of millions of people worldwide, many of whom
are not currently achieving their treatment goals with existing
therapies," said J. Anthony Ware,
M.D., senior vice president, product development, Lilly
Bio-Medicines. "We are excited to present new data for Olumiant and
Taltz at EULAR 2017, all of which highlight our commitment to the
ongoing research and development of innovative therapies for people
living with these immune-mediated diseases."
Studies, as well as dates and times of the data sessions, are
highlighted below.
Olumiant Data
Thursday, June 15, 11:45 –
13:30 CEST – POSTER
PRESENTATIONS
- Differences in Patient-Reported Outcomes (PROs) Between
Baricitinib (BARI) and Comparators among Patients with Rheumatoid
Arthritis (RA) Who Achieved Low Disease Activity (LDA) or Remission
(Presenting author: Bruno Fautrel) Abstract: THU0081
- Concomitant Use of Conventional Synthetic DMARDs and Response
to Baricitinib (Presenting author: Arthur
Kavanaugh) Abstract: THU0078
- Structural Damage Progression in Patients Treated with
Methotrexate, Baricitinib Monotherapy or Baricitinib + Methotrexate
Based on Their Level of Clinical Response: RA-BEGIN Study
Sub-analysis (Presenting author: Désirée van der Heijde) Abstract: THU0088
- Effects of Smoking on Baricitinib Efficacy in Patients with
Rheumatoid Arthritis: Pooled Analysis from Two Phase 3 Clinical
Trials (Presenting author: Jeffrey R.
Curtis) Abstract: THU0114
Friday, June 16, 10:15 –
10:45 CEST – ORAL
PRESENTATION
- Serious Infection and Associated Risk Factors in Patients with
Moderate-to-Severe Rheumatoid Arthritis Treated with Baricitinib
(Presenting author: Kevin Winthrop)
Abstract: OP0248 / Presentation Location: South Auditorium
Friday, June 16, 11:45 –
13:30 CEST – POSTER
PRESENTATIONS
- Pain Reduction is Associated with Improved Work Productivity in
Patients with Rheumatoid Arthritis (Presenting author: Kaleb Michaud) Abstract: FRI0099
- A High Level of Clinical Response Based on Composite Indices is
Associated with Improved Health-Related Quality of Life: Analyses
from a Phase 3 Clinical Trial in Patients with Rheumatoid Arthritis
(Presenting author: Maxime Dougados) Abstract: FRI0116
- Effect of Starting Dose of Baricitinib in Achieving Sustained
Low Disease Activity (Presenting author: Jeffrey R. Curtis) Abstract: FRI0089
- Low Rates of Radiographic Progression of Structural Joint
Damage over 2 Years of Baricitinib Treatment in Patients with
Rheumatoid Arthritis (RA) (Presenting author: Désirée van der Heijde) Abstract: FRI0087
- Effects of Baricitinib on Haemoglobin and Related Laboratory
Parameters in Rheumatoid Arthritis Patients (Presenting author:
Jonathan Kay) Abstract: FRI0092
- Temporary Interruptions of Study Drug During the Baricitinib
Phase 3 Rheumatoid Arthritis Program (Presenting author:
Paul Emery) Abstract: FRI0124
- Efficacy and Safety Data Based on Historical or Pre-existing
Conditions at Baseline for Patients with Active Rheumatoid
Arthritis Who Were Treated with Baricitinib (Presenting author:
Bernard Combe) Abstract:
FRI0086
- Analysis of Neutrophils, Lymphocytes, and Platelets in Pooled
Phase 2 and Phase 3 Studies of Baricitinib for Rheumatoid Arthritis
(Presenting author: Joel M. Kremer)
Abstract: FRI0090
- Durability and Maintenance of Efficacy Following Prolonged
Treatment with Baricitinib (Presenting author: Josef S. Smolen) Abstract: FRI0096
Saturday, June 17, 10:15 –
12:00 CEST – POSTER
PRESENTATIONS
- Dose Reduction of Baricitinib in Patients with Rheumatoid
Arthritis (RA) Achieving Sustained Disease Control: Results of a
Prospective Study (Presenting author: Tsutomo Takeuchi) Abstract: SAT0072
- Effects of Baricitinib on Patients who Stop Methotrexate
Monotherapy and Switch to Baricitinib Monotherapy (Presenting
author: Roy Fleischmann) Abstract:
SAT0058
- Baricitinib Versus Adalimumab* in Patients with Active
Rheumatoid Arthritis (RA): Analysis of Patients Achieving a
Moderate EULAR Response at Week 4 (Presenting author: Tore K. Kvien) Abstract: SAT0070
- A RAPID3-like Index Documents Superior Efficacy of Baricitinib
to Adalimumab and Placebo, Similar to DAS28 and CDAI in the RA-BEAM
Clinical Trial in Patients with Rheumatoid Arthritis (Presenting
author: Ted Pincus) Abstract:
SAT0069
- Baricitinib Showed Rapid and Greater Reduction in Pain Compared
to Adalimumab or Placebo in Patients with Rheumatoid Arthritis
(Presenting author: Peter Taylor)
Abstract: SAT0055
PUBLISHED ONLY – NO PRESENTATION
- Effect of Baseline Disease Activity on Achieving Sustained Low
Disease Activity in Baricitinib Phase 3 Studies (Lead author:
Jeffrey R. Curtis) Abstract:
AB0235
- Characterization of Changes in Lymphocyte Subsets in
Baricitinib-Treated Patients with Early, DMARD Naïve, Rheumatoid
Arthritis in a Phase 3 Study (Lead author: Tsutomu Takeuchi)
Abstract: AB0281
Taltz Data
Thursday, June 15, 16:35 CEST – ORAL PRESENTATION
- A Phase 3 Study of the Efficacy and Safety of Ixekizumab in
Patients with Active Psoriatic Arthritis and Inadequate Response to
Tumor Necrosis Factor Inhibitor(s) (Presenting author: Peter Nash) Abstract: OP0201
Friday, June 16, 11:10 CEST – ORAL PRESENTATION
- Radiographic Progression of Structural Joint Damage in Patients
with Active Psoriatic Arthritis Treated with Ixekizumab Over 52
weeks (Presenting author: Désirée van der
Heijde) Abstract: OP0221
Friday, June 16, 11:45 –
13:30 CEST – POSTER
PRESENTATION
- Ixekizumab Reduces Disease Activity in Active Psoriatic
Arthritis Patients Who Had Previous Inadequate Response to Tumor
Necrosis Factor-Inhibitors (Presenting author: Laura Coates) Abstract: FRI0502
Saturday, June 17, 10:15 –
12:00 CEST – POSTER
PRESENTATION
- Ixekizumab Improves Patient-Reported Outcomes in Patients with
Active Psoriatic Arthritis and Previous Inadequate Response to
Tumor Necrosis Factor-Inhibitors (Presenting author: Arthur Kavanaugh) Abstract: SAT0446
Saturday, June 17, 11:00 CEST – GUIDED POSTER TOUR
- Ixekizumab Improves Nail and Skin Lesions in Patients with
Active Psoriatic Arthritis and Prior TNF Inadequate Response
(Presenting author: Lars Kristensen)
Abstract: SAT0437
PUBLISHED ONLY – NO PRESENTATION
- Efficacy of Ixekizumab Improving SF-36 Scores in Biologic
DMARD-Naive Patients with Active Psoriatic Arthritis: Results from
a Phase 3 Study (SPIRIT-P1) (Lead author: Vibeke Strand) Abstract: AB0793
Additional Data
Friday, June 16, 11:45 –
13:30 CEST – POSTER
PRESENTATIONS
- Differences between RA Patients with and without ILD from a
United States Tertiary Referral Center (Presenting author:
Richard Meehan) Abstract:
FRI0164
Saturday, June 17, 10:15 –
12:00 CEST – POSTER
PRESENTATION
- Symptomology, Disease Status, and Remission Rates of
Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis
Patients in Europe (Presenting
author: Theresa Hunter) Abstract:
SAT0425
Saturday, June 17, 10:50 CEST – GUIDED POSTER TOUR
- Longitudinal Analysis of Response, Costs and Resource Use of
Patients with Rheumatoid Arthritis Initiating Biologic
Disease-Modifying Antirheumatic Drugs (bDMARDs) in Taiwan Using the National Health Insurance
Research Database (Presenting author: Qiang Shi) Abstract:
SAT0720-HPR
PUBLISHED ONLY – NO PRESENTATION
- The Relationship Between the Degree of Skin Involvement and
Joint Activity in Patients with PSA: Experience from the
Corrona® Registry (Lead author: Philip Mease) Abstract: AB0783
Baricitinib was approved in February
2017 for the treatment of adults with moderate-to-severe RA
in the European Union and is marketed as Olumiant.
INDICATIONS AND USAGE FOR OLUMIANT
Therapeutic indications
Olumiant is indicated for the
treatment of moderate to severe active rheumatoid arthritis in
adult patients who have responded inadequately to, or who are
intolerant to one or more disease-modifying anti-rheumatic drugs.
Olumiant may be used as monotherapy or in combination with
methotrexate.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT
CONTRAINDICATIONS
Hypersensitivity to the active
substance or to any of the excipients.
Pregnancy.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Infections
Baricitinib is associated with an
increased rate of infections such as upper respiratory tract
infections compared to placebo. In treatment naïve patients,
combination with methotrexate resulted in increased frequency of
infections compared to baricitinib monotherapy. The risks and
benefits of treatment with Olumiant should be carefully considered
prior to initiating therapy in patients with active, chronic or
recurrent infections. If an infection develops, the patient should
be monitored carefully and Olumiant therapy should be temporarily
interrupted if the patient is not responding to standard therapy.
Olumiant treatment should not be resumed until the infection
resolves.
Tuberculosis
Patients should be screened for
tuberculosis (TB) before starting Olumiant therapy. Olumiant should
not be given to patients with active TB. Anti-TB therapy should be
considered prior to initiation of Olumiant in patients with
previously untreated latent TB.
Haematological Abnormalities
Absolute Neutrophil
Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte
Count (ALC) < 0.5 x 109 cells/L and haemoglobin <
8 g/dL were reported in less than 1% of patients in clinical
trials. Treatment should not be initiated, or should be temporarily
interrupted, in patients with an ANC < 1 x 109
cells/L, ALC < 0.5 x 109 cells/L or haemoglobin <
8 g/dL observed during routine patient management.
The risk of lymphocytosis is increased in elderly patients with
rheumatoid arthritis. Rare cases of lymphoproliferative disorders
have been reported.
Viral Reactivation
Viral reactivation, including
cases of herpes virus reactivation (e.g., herpes zoster, herpes
simplex), were reported in clinical studies. Herpes zoster was
reported more commonly in patients ≥ 65 years of age who had
previously been treated with both biologic and conventional DMARDs.
If a patient develops herpes zoster, Olumiant treatment should be
temporarily interrupted until the episode resolves.
Screening for viral hepatitis should be performed in accordance
with clinical guidelines before starting therapy with Olumiant.
Patients with evidence of active hepatitis B or C infection were
excluded from clinical trials. Patients, who were positive for
hepatitis C antibody but negative for hepatitis C virus RNA, were
allowed to participate. Patients with hepatitis B surface antibody
and hepatitis B core antibody, without hepatitis B surface antigen,
were also allowed to participate; such patients should be monitored
for expression of hepatitis B virus (HBV) DNA. If HBV DNA is
detected, a liver specialist should be consulted to determine if
treatment interruption is warranted.
Vaccination
No data are available on the response to
vaccination with live or inactivated vaccines in patients receiving
baricitinib. Use with live, attenuated vaccines during, or
immediately prior to, Olumiant therapy is not recommended.
International treatment guidelines on vaccination in rheumatoid
arthritis patients should be followed when varicella zoster
vaccination is considered prior to treatment with Olumiant.
Lipids
Dose dependent increases in blood lipid
parameters were reported in patients treated with baricitinib
compared to placebo. Elevations in LDL cholesterol decreased to
pre-treatment levels in response to statin therapy. Lipid
parameters should be assessed approximately 12 weeks following
initiation of Olumiant therapy and thereafter patients should be
managed according to international clinical guidelines for
hyperlipidaemia. The effect of these lipid parameter elevations on
cardiovascular morbidity and mortality has not been determined.
Hepatic transaminase elevations
Increases in alanine
transaminase (ALT) and aspartate transaminase (AST) to ≥ 5 and ≥ 10
x upper limit of normal (ULN) were reported in less than 1% of
patients in clinical trials. In treatment-naïve patients,
combination with methotrexate resulted in increased frequency of
hepatic transaminase elevations compared with baricitinib
monotherapy. If increases in ALT or AST are observed during routine
patient management and drug-induced liver injury is suspected,
Olumiant should be temporarily interrupted until this diagnosis is
excluded.
Malignancy
The risk of malignancies including
lymphoma is increased in patients with rheumatoid arthritis.
Immunomodulatory medicinal products may increase the risk of
malignancies including lymphoma. The clinical data are insufficient
to assess the potential incidence of malignancies following
exposure to baricitinib. Long-term safety evaluations are
ongoing.
Laboratory Monitoring
Please refer to the SmPC for
laboratory measures and monitoring guidance.
Immunosuppressive Medicinal Products
Combination with
biologic DMARDs or other Janus kinase (JAK) inhibitors is not
recommended, as a risk of additive immunosuppression cannot be
excluded. Data concerning use of baricitinib with potent
immunosuppressive medicinal products (e.g., azathioprine,
tacrolimus, ciclosporin) are limited and caution should be
exercised when using such combinations.
ADVERSE REACTIONS
Undesirable Effects: Summary of safety profile
The most commonly reported adverse drug reactions (ADRs) occurring
in ≥ 2% of patients treated with Olumiant monotherapy or in
combination with conventional synthetic DMARDs were increased LDL
cholesterol (33.6%), upper respiratory tract infections (14.7%) and
nausea (2.8%). Infections reported with Olumiant treatment included
Herpes zoster.
Please see Summary of Product
Characteristics.
INDICATIONS AND USAGE FOR TALTZ
Taltz® is indicated for the treatment of adults with
moderate-to-severe plaque psoriasis who are candidates for systemic
therapy or phototherapy.
IMPORTANT SAFETY INFORMATION FOR TALTZ
CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious
hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to
any of the excipients.
WARNINGS AND PRECAUTIONS
Infections
Taltz may increase the risk of infection.
The Taltz group had a higher rate of infections than the placebo
group (27% vs. 23%). Serious infections have occurred. Instruct
patients to seek medical advice if signs or symptoms of clinically
important chronic or acute infection occur. If a serious infection
develops, discontinue Taltz until the infection resolves.
Pre-Treatment Evaluation for Tuberculosis
Evaluate
patients for tuberculosis (TB) infection prior to initiating
treatment with Taltz. Do not administer to patients with active TB
infection. Initiate treatment of latent TB prior to administering
Taltz. Patients receiving Taltz should be monitored closely for
signs and symptoms of active TB during and after treatment.
Hypersensitivity
Serious hypersensitivity reactions,
including anaphylaxis, angioedema and urticaria, have been reported
with Taltz. If a serious hypersensitivity reaction occurs,
discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel Disease
Crohn's disease and
ulcerative colitis, including exacerbations, occurred at a greater
frequency in the Taltz group (Crohn's disease 0.1%, ulcerative
colitis 0.2%) than in the placebo group (0%) during clinical
trials. During Taltz treatment, monitor patients for onset or
exacerbations of inflammatory bowel disease.
Immunizations
Prior to initiating therapy with Taltz,
consider completion of all age-appropriate immunizations according
to current immunization guidelines. Live vaccines should not be
given with Taltz.
ADVERSE REACTIONS
Most common adverse reactions (>1%) associated with Taltz
treatment are injection site reactions, upper respiratory tract
infections, nausea, and tinea infections.
Please see accompanying Prescribing Information
and Medication Guide. Please see
Instructions for Use included with the device.
IX HCP ISI 18JAN2017
About Rheumatoid Arthritis
Rheumatoid arthritis (RA)
is an autoimmune disease characterized by inflammation and
progressive destruction of joints. More than 23 million people
worldwide suffer from RA.i Approximately three
times as many women as men have the
disease.ii Current treatment of RA includes the use
of non-steroidal anti-inflammatory drugs (NSAIDs), oral
conventional disease-modifying antirheumatic drugs (cDMARDs) – such
as methotrexate, the current standard of care, and injectable and
intravenous biological disease-modifying antirheumatic drugs
(bDMARDs) that target selected mediators implicated in the
pathogenesis of RA.iii Despite current treatment
options, many patients do not reach their therapeutic goals or are
not able to achieve sustained remission.iv There remains
an important need to provide additional treatment options to
improve overall patient care.
About Olumiant
Olumiant® (baricitinib) is a
once-daily oral JAK inhibitor currently in clinical studies for
inflammatory and autoimmune diseases. 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, suggesting that JAK inhibitors may be useful
for the treatment of a broad range of inflammatory conditions,
including rheumatoid arthritis.
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. Baricitinib was submitted for regulatory
review seeking marketing approval for the treatment of rheumatoid
arthritis in the U.S., European Union and Japan in 2016, and was approved in the EU in
February 2017.
About Active Psoriatic Arthritis
Psoriatic arthritis
(PsA) is a chronic, progressive form of inflammatory arthritis that
can cause swelling, stiffness and pain in and around the joints,
nail changes and impaired physical function.v It occurs
when an overactive immune system sends out faulty signals that
cause inflammation, leading to swollen and painful joints and
tendons.vi Typically, psoriatic arthritis affects
peripheral joints in the arms and legs (elbows, wrists, hands and
feet), but can also affect joints in the axial skeleton (spine,
hips and shoulders).vii If left untreated, PsA can cause
permanent joint damage.v Additionally, up to 30 percent
of people with psoriasis also develop PsA.v
About Taltz®
Taltz®
(ixekizumab) is a monoclonal antibody that selectively binds with
interleukin 17A (IL-17A) cytokine and inhibits its interaction with
the IL-17 receptor. IL-17A is a naturally occurring cytokine that
is involved in normal inflammatory and immune
responses. Taltz inhibits the release of
pro-inflammatory cytokines and chemokines.
Lilly has filed a supplemental Biologics License Application
(sBLA) with the U.S. Food and Drug Administration (FDA) for Taltz
for the treatment of active PsA. Taltz is approved for adult
patients with active PsA in Japan.
Submissions to other regulatory agencies around the world are
expected later this year. Taltz is also in Phase 3 trials for the
treatment of radiographic and non-radiographic axial
spondyloarthritis.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to 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 www.lilly.com and
newsroom.lilly.com/social-channels.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization
of proprietary therapeutics. For additional information on Incyte,
please visit the Company's web site at www.incyte.com.
Follow @Incyte on Twitter
at https://twitter.com/Incyte.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about baricitinib as a potential treatment for patients with
rheumatoid arthritis, and reflects Lilly's and Incyte's current
belief. This press release also contains forward-looking statements
(as that term is defined in the Private Securities Litigation
Reform Act of 1995) about Taltz (ixekizumab) as a treatment for
moderate-to-severe plaque psoriasis, and reflects Lilly's current
belief. 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 future study results will be consistent with the
results to date, that baricitinib or Taltz will receive regulatory
approvals, or be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's and Incyte's
most recent 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.
i WHO Global Burden of Disease Report, (table 7, page
32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf
(Accessed: May, 16, 2017)
ii Arthritis Foundation, What is Rheumatoid
Arthritis?,
http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php
(Accessed: May, 16, 2017)
iii Arthritis Foundation, Rheumatoid Arthritis
Treatment,
http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php
(Accessed: May, 16, 2017)
iv McWilliams DF, Kiely PDW, Young A, Walsh DA.
Baseline factors predicting change from the initial DMARD treatment
during the first 2 years of rheumatoid arthritis: experience in the
ERAN inception cohort. BMC Musculoskeletal Disorders.
2013;14:1-7.
v About psoriatic arthritis. National Psoriasis
Foundation website.
https://www.psoriasis.org/about-psoriatic-arthritis. (Accessed:
May 12, 2017)
vi What is psoriatic arthritis? Arthritis Foundation
website.
http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php.
(Accessed: May 12, 2017)
vii Classification of psoriatic arthritis. National
Psoriasis Foundation website.
https://www.psoriasis.org/psoriatic-arthritis/classification-of-psoriatic-arthritis.
(Accessed: May 12, 2017)
Refer to:
Danielle
Neveles; danielle.neveles@lilly.com; +1-317-796-4564 (Lilly
media)
Phil Johnson;
johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly investors)
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914 (Incyte investors)
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/lilly-to-present-new-data-on-olumiant-baricitinib-in-rheumatoid-arthritis-and-taltz-ixekizumab-in-psoriatic-arthritis-at-the-annual-european-congress-of-rheumatology-eular-2017-300473379.html
SOURCE Eli Lilly and Company