INDIANAPOLIS, Oct. 30, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced that it will present new data for
baricitinib and Taltz® (ixekizumab) at the American
College of Rheumatology (ACR)/Association of Rheumatology Health
Professionals (ARHP) annual meeting taking place Nov. 3-8, 2017, in San
Diego, Calif.
Lilly will feature new data for baricitinib in 17 abstracts,
including six oral presentations on rheumatoid arthritis (RA)
(Lilly and Incyte Corporation are partners on the development of
baricitinib). Highlights include a new post-hoc analysis from
RA-BEAM, a pivotal Phase 3 study, disclosing outcomes of
patient-reported levels of pain control, as well as new findings
from two safety analyses evaluating cardiovascular safety and
long-term use of baricitinib in RA, respectively.
Additionally, Lilly will present eight abstracts featuring new
data for Taltz, including two oral presentations. Highlights from
the oral presentations include interim results from the extension
period of the SPIRIT-P2 study evaluating the safety and efficacy of
Taltz for the treatment of active psoriatic arthritis (PsA), in
addition to a new analysis from the IXORA-S study comparing Taltz
to Stelara®** (ustekinumab) for the treatment of nail
lesions in patients with moderate-to-severe plaque psoriasis.
An additional eight abstracts will detail results from a
selection of studies evaluating the impact of immune-mediated
diseases.
"At Lilly, patients are at the heart of what we do every day,"
said Lotus Mallbris, M.D., vice president, immunology platform team
leader, Lilly Bio-Medicines. "We are proud to present new data at
ACR/ARHP from our continued research with the goal to help provide
more treatment options for people living with autoimmune
diseases."
Highlighted presentations and posters include:
Baricitinib Data
Oral Presentations (All times PST)
Sunday, Nov. 5
- Abstract 855: 2:30-4:00 p.m.
-
- Rapid and Sustained Pain Improvement in Rheumatoid Arthritis
Patients Treated with Baricitinib Compared to Adalimumab or
Placebo
- Presenter: Peter Taylor, M.A.,
Ph.D., F.R.C.P., F.R.C.P.E., University of
Oxford, Oxford, United
Kingdom
Monday, Nov. 6
- Abstract 1821: 2:30-4:00
p.m.
-
- Dose Reduction of Baricitinib in Patients with Rheumatoid
Arthritis Achieving Sustained Disease Control: Results of a
Prospective Study
- Presenter: Tsutomu Takeuchi,
M.D., Ph.D., Keio University School of
Medicine, Tokyo, Japan
- Abstract 1824: 2:30-4:00
p.m.
-
- Evaluation of Pneumococcal and Tetanus Vaccine Responses in
Patients with Rheumatoid Arthritis Receiving Baricitinib: Results
from a Long-Term Extension Trial Substudy
- Presenter: Kevin Winthrop, M.D.,
M.P.H., Oregon Health and Science University, Portland, OR, United
States
Tuesday, Nov. 7
- Abstract 2787: 2:30-4:00
p.m.
-
- Tuberculosis, Potential Opportunistic Infections, and Other
Infections of Interest in Patients with Moderate to Severe
Rheumatoid Arthritis in the Baricitinib Program
- Presenter: Kevin Winthrop, M.D.,
M.P.H., Oregon Health and Science University, Portland, OR, United
States
- Abstract 2866: 4:30-6:00
p.m.
-
- Microarray Pathway Analysis Comparing Baricitinib and
Adalimumab in Moderate to Severe Rheumatoid Arthritis Patients,
from a Phase 3 Study
- Presenter: Paul Emery, M.D.,
Leeds MSK Biomed/Chapel Allerton Hospital, Leeds, United Kingdom
- Abstract 2870: 4:30-6:00
p.m.
-
- Ex Vivo Comparison of Baricitinib, Upadacitinib, Filgotinib and
Tofacitinib for Cytokine Signaling in Human Leukocyte
Subpopulations
- Presenter: Iain McInnes, M.D.,
Ph.D., University of Glasgow,
Glasgow, United Kingdom
Poster Presentations (All times PST)
Sunday, Nov. 5
- Abstract 409: 9:00-11:00
a.m.
-
- An Evaluation of Absolute Neutrophil Count as a Biomarker of
Inflammatory and Clinical Disease Activity in Baricitinib-Treated
Patients
- Presenter: Iain McInnes, M.D.,
Ph.D., University of Glasgow,
Glasgow, United Kingdom
- Abstract 415: 9:00-11:00
a.m.
-
- Baricitinib Reduces GlycA Levels in Phase 2 and Phase 3
Clinical Trials in Patients with Moderate-to-Severe Rheumatoid
Arthritis
- Presenter: Joel Kremer, M.D.,
F.A.C.P., The Center for Rheumatology, Albany, NY, United
States
- Abstract 418: 9:00-11:00
a.m.
-
- Exploratory Analysis to Identify Factors Associated with Risk
of Structural Progression, Defined as Change from Baseline
- Presenter: Désirée van der
Heijde, M.D., Ph.D., Leiden University Medical Center,
Leiden, The Netherlands
- Abstract 499: 9:00-11:00
a.m.
-
- Assessment of Early Improvement in Pain and Other ACR
components as Predictors for Achieving Low Disease Activity or
Remission in Three Phase 3 Trials of Rheumatoid Arthritis Patients
Treated with Baricitin
- Presenter: Michael Weinblatt,
M.D., Brigham and Women's
Hospital, Boston, MA, United States
- Abstract 502: 9:00-11:00
a.m.
-
- Reduction in Disease Activity in Patients with Rheumatoid
Arthritis and an Inadequate Response to Methotrexate: Baricitinib
Compared to Adalimumab and Placebo
- Presenter: Peter Nash, M.D.,
University of Queensland, Queensland, Australia
- Abstract 508: 9:00-11:00
a.m.
-
- Improved Patient-Reported Outcomes in Patients with Rheumatoid
Arthritis Who Failed Adalimumab or Placebo Treatment and Were
Rescued with Baricitinib
- Presenter: Bruno Fautrel, M.D., Ph.D, Pitié Salpêtrière
University, Paris, France
- Abstract 511: 9:00-11:00
a.m.
-
- Safety Profile of Baricitinib for the Treatment of Rheumatoid
Arthritis up to 5.5 Years: An Updated Integrated Safety
Analysis
- Presenter: Mark Genovese, M.D.,
Stanford University Medical Center,
Palo Alto, CA, United States
- Abstract 512: 9:00-11:00
a.m.
-
- Efficacy Response to Baricitinib Based on Baseline
Characteristics in Patients Who Are Inadequate Responders to
Conventional DMARD
- Presenter: Maxime Dougados, M.D., Rene Descartes University,
Cochin Hospital, Paris,
France
- Abstract 513: 9:00-11:00
a.m.
-
- Time to Achieve Moderate/Low Disease Activity and Remission in
Rheumatoid Arthritis Patients on Baricitinib Compared to
Adalimumab, Methotrexate and Placebo
- Presenter: Edward Keystone, M.D., The University of Toronto, Toronto, ON, Canada
Tuesday, Nov. 7
- Abstract 2219: 9:00-11:00
a.m.
-
- Remaining Pain in DMARD-naive Rheumatoid Arthritis Patients
Treated with Baricitinib and Methotrexate
- Presenter: Yvonne Lee, M.D.,
Brigham and Women's Hospital,
Boston, MA, United States
- Abstract 2352: 9:00-11:00
a.m.
-
- Cardiovascular Safety during Treatment with Baricitinib in
Rheumatoid Arthritis
- Presenter: Michael Weinblatt,
M.D., Brigham and Women's
Hospital, Boston, MA, United States
Taltz Data
Oral Presentations (All Times PST)
Monday, Nov. 6
- Abstract 1827: 2:30-4:00
p.m.
-
- Comparison of Ixekizumab and Ustekinumab Efficacy in the
Treatment of Nail Lesions of Patients with Moderate-to-Severe
Plaque Psoriasis: 24-Week Data from a Phase 3 Trial
- Presenter: David Sandoval, Eli
Lilly and Company, Indianapolis,
IN, United States
Wednesday, Nov. 8
- Abstract 2969: 11:00 a.m.-12:30
p.m.
-
- Efficacy and Safety of Ixekizumab in Patients with Active
Psoriatic Arthritis and Previous Inadequate Response to TNF
inhibitors: 52-week Results from a Phase 3 Study
- Presenter: Mark Genovese, M.D.,
Stanford University Medical Center,
Palo Alto, CA, United States
Poster Presentations (All Times PST)
Sunday, Nov. 5
- Abstract 597: 9:00-11:00
a.m.
-
- Ixekizumab Improves Patient-Reported Outcomes Through 52 Weeks
in Patients with Active Psoriatic Arthritis and Previous Inadequate
Response to Tumor Necrosis Factor-Inhibitors
- Presenter: Arthur Kavanaugh,
M.D., University of California, San
Diego, La Jolla, CA,
United States
- Abstract 605: 9:00-11:00
a.m.
-
- Ixekizumab Exhibits a Favorable Safety Profile During 24 Weeks
of Treatment in Subjects with Active Psoriatic Arthritis:
Integrated Safety Analysis of Two Randomized, Placebo Controlled,
Phase 3 Clinical Trials
- Presenter: Philip J. Mease,
M.D., Swedish Medical Center and University of
Washington, Seattle, WA, United
States
- Abstract 624: 9:00-11:00
a.m.
-
- Ixekizumab Provides Sustained Improvement in Signs and Symptoms
in Patients with Active Psoriatic Arthritis: Two Year Results from
a Phase 3 Trial
- Presenter: Philip S. Helliwell,
St. Luke's Hospital and University of Leeds, Bradford,
United Kingdom
- Abstract 625: 9:00-11:00
a.m.
-
- Rapid Onset of Efficacy in Patients with Active Psoriatic
Arthritis Treated with Ixekizumab: A Pooled Analysis of Data from
Two Phase 3 Clinical Trials
- Presenter: Atul A. Deodhar,
M.D., M.R.C.P., Oregon Health and Science University, Portland, OR, United
States
- Abstract 626: 9:00-11:00
a.m.
-
- Radiographic Progression of Structural Joint Damage in Patients
with Active Psoriatic Arthritis Treated with Ixekizumab over 52
Weeks
- Presenter: Désirée van der
Heijde, M.D., Ph.D., Leiden University Medical Center,
Leiden, The Netherlands
- Abstract 628: 9:00-11:00
a.m.
-
- Integrated Efficacy Results from Two Phase 3 Trials of
Ixekizumab for the Treatment of Psoriatic Arthritis
- Presenter: Bernard Combe, M.D.,
Ph.D., CHU Lapeyronie and Montpellier University, Montpellier, France
Additional Data
Poster Presentations (All Times PST)
Monday, Nov. 6
- Abstract 1001: 9:00-11:00
a.m.
-
- Persistence, Discontinuation, and Switching Patterns Among
Ankylosing Spondylitis Patients Newly Initiating Biologic
Therapy
- Presenter: Theresa Hunter, Eli
Lilly and Company, Indianapolis,
IN, United States
- Abstract 1513: 9:00-11:00
a.m.
-
- Clinical Characteristics and Peripheral Joint Involvement at
the Time of Diagnosis of Non-Radiographic Axial Spondyloarthritis
Patients in the United States and
Europe
- Presenter: David Sandoval, Eli
Lilly and Company, Indianapolis,
IN, United States
- Abstract 1555: 9:00-11:00
a.m.
-
- Treatment Changes by Joint Activity and Skin Severity in
Patients with Comorbid Active PsA and PsO
- Presenter: William Malatestinic,
Eli Lilly and Company, Indianapolis,
IN, United States
- Abstract 1842: 2:30-4:00
p.m.
-
- Subsetting Systemic Lupus Erythematosus by Interferon Gene
Signatures and Serologies (anti-dsDNA and Low Complement) Uncovers
Significant Clinical Diversity
- Presenter: Michelle Petri, M.D.,
M.P.H., Johns Hopkins University,
Baltimore, MD, United States
Tuesday, Nov. 7
- Abstract 2532: 9:00-11:00
a.m.
-
- The Relationship between the Degree of Skin Involvement and
Joint Activity in Patients with PsA: Experience from the Corrona
Registry
- Presenter: William Malatestinic,
Eli Lilly and Company, Indianapolis,
IN, United States
- Abstract 2533: 9:00-11:00
a.m.
-
- Current PsA Therapy Impacts the Relationship between the Degree
of Skin Involvement and Joint Activity
- Presenter: William Malatestinic,
Eli Lilly and Company, Indianapolis,
IN, United States
- Abstract 2539: 9:00-11:00
a.m.
-
- The Contribution of Skin and Joint Improvements to the
Health-Related Quality of Life of Patients with Active Psoriatic
Arthritis
- Presenter: Arthur Kavanaugh,
M.D., University of California, San
Diego, La Jolla, CA,
United States
- Abstract 2549: 9:00-11:00
a.m.,
-
- Achievement of Minimal Disease Activity Is Associated with
Improvements in Health-Related Quality of Life and Productivity in
Psoriatic Arthritis Patients
- Presenter: Laura C. Coates,
MBChB, MRCP, PhD, University of Leeds, Leeds, United
Kingdom
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 angioedema and urticaria (each ≤0.1%), occurred in the
TALTZ group in clinical trials. Anaphylaxis, including cases
leading to hospitalization, has been reported in post-marketing use
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 18JUL2017
*The brand listed is a registered trademark owned or licensed
by AbbVie, its subsidiaries or affiliates, and is not a trademark
of Eli Lilly and Company. The maker of this brand is not affiliated
with and does not endorse Lilly or their products.
**The brand listed is a registered trademark owned or
licensed by Janssen Pharmaceutical Companies of Johnson &
Johnson, its subsidiaries or affiliates, and is not a trademark of
Eli Lilly and Company. The maker of this brand is not affiliated
with and does not endorse Lilly or their products.
About Rheumatoid Arthritis
Rheumatoid arthritis is a
systemic 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.
Current treatment of RA includes the use of non-steroidal
anti-inflammatory drugs, oral conventional synthetic
disease-modifying antirheumatic drugs (csDMARDs), such as
methotrexate, and injectable, biological disease-modifying
antirheumatic drugs (bDMARDs) that target selected mediators
implicated in the pathogenesis of
RA.4 Despite current treatment options,
many patients do not reach their therapeutic goals or sustained
remission.5,6 There
remains an important need to provide additional treatments to
improve overall patient care.
About Baricitinib
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., the European Union and Japan in 2016. Baricitinib was approved in the
EU in February 2017 and in
Japan in July 2017. In April
2017, the U.S. Food and Drug Administration issued a
Complete Response Letter on the New Drug Application for
baricitinib. Baricitinib remains under review in other markets. It
is also being studied for the treatment of atopic dermatitis and
systemic lupus erythematosus. The Phase 3 program for psoriatic
arthritis is expected to begin in 2018.
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is
a chronic, immune disease that affects the skin.7 It
occurs when the immune system sends out faulty signals that speed
up the growth cycle of skin cells. Psoriasis affects
approximately 125 million people worldwide, approximately 20
percent of whom have moderate-to-severe plaque
psoriasis.11,8 Psoriasis can occur on any part of the
body and is associated with other serious health conditions, such
as diabetes and heart disease.11 The most common form of
psoriasis, plaque psoriasis, appears as raised, red patches covered
with a silvery white buildup of dead skin cells.11
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.9
It occurs when an overactive immune system sends out faulty signals
that cause inflammation, leading to swollen and painful joints and
tendons.10 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).11 If left untreated, PsA can cause
permanent joint damage.14 Additionally, up to 30 percent
of people with psoriasis also develop PsA.14
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. Lilly also submitted Taltz to the
European Medicines Agency (EMA) for the treatment for adult
patients with 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
www.lilly.com/newsroom/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 Taltz (ixekizumab) as a potential treatment for
psoriatic arthritis and baricitinib as a potential treatment for
patients with rheumatoid arthritis, and reflects Lilly'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 baricitinib as a potential treatment for
patients with rheumatoid arthritis, and reflects Lilly's
and Incyte's current belief. 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 Taltz or baricitinib 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 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 American College of Rheumatology, Rheumatoid Arthritis,
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp.
Accessed October 23, 2017.
2 Hand Clinics, Advances in the Medical Treatment of Rheumatoid
Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf.
Accessed October 23, 2017.
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.
Accessed October 23, 2017.
4 Arthritis Foundation, Medications for Rheumatoid Arthritis,
http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php.
Accessed October 23, 2017.
5 Rheumatoid arthritis, Lancet,
https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed October 23, 2017.
6 Sustained rheumatoid arthritis remission is uncommon in clinical
practice, Arthritis Research & Therapy,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed
October 23, 2017.
7 Psoriasis media kit. National Psoriasis Foundation website.
https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf.
Accessed October 23, 2017.
8 Psoriasis. American Academy of Dermatology website.
https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis.
Accessed October 23, 2017.
9 About psoriatic arthritis. National Psoriasis Foundation website.
https://www.psoriasis.org/about-psoriatic-arthritis. Accessed
October 23, 2017.
10 What is psoriatic arthritis? Arthritis Foundation website.
http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php.
Accessed October 23, 2017.
11 Classification of psoriatic arthritis. National Psoriasis
Foundation website.
https://www.psoriasis.org/psoriatic-arthritis/classification-of-psoriatic-arthritis.
Accessed October 23, 2017.
Refer to:
|
Danielle Neveles;
danielle.neveles@lilly.com; 317-796-4564 (Lilly
media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (Lilly
investors)
|
|
Catalina Loveman;
cloveman@incyte.com; 302-498-6171 (Incyte media)
|
|
Michael Booth, DPhil;
mbooth@incyte.com; 302-498-5914 (Incyte investors)
|
SOURCE Lilly; Incyte Corporation