INDIANAPOLIS, Feb. 28, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) will highlight new Phase 3 data evaluating
Taltz® (ixekizumab) for the treatment of
moderate-to-severe plaque psoriasis and active psoriatic arthritis
at the 75th annual meeting of the American Academy of
Dermatology (AAD), which will take place March 3-7, 2017, in Orlando, Fla.
Lilly will present 14 abstracts, including one oral late-breaker
presentation highlighting head-to-head data on the efficacy and
safety of Taltz compared to Stelara®* (ustekinumab) for
the treatment of moderate-to-severe plaque psoriasis at 24
weeks.
"As the world's largest dermatology meeting, the American
Academy of Dermatology annual meeting is an opportunity to
highlight new information and data to experts in the dermatologic
disease field," said Dr. Lotus Mallbris, global brand development
leader, Taltz, Eli Lilly and Company. "Nearly one year after the
approval of Taltz in the U.S. and Europe, we are proud to bring new data further
demonstrating the efficacy and safety of Taltz to the American
Academy of Dermatology annual meeting."
Studies, as well as the times and locations of the data
sessions, are highlighted below.
Oral Late-Breaker Presentation
Saturday, March 4
- Abstract #5174: 9 a.m. –
11 a.m. ET
- Efficacy and Safety of Ixekizumab Compared to Ustekinumab after
24 Weeks of Treatment in Patients with Moderate-to-Severe Plaque
Psoriasis: Results from IXORA-S, a Randomized Head-to-Head
Trial
- Presenter: Kristian Reich, M.D.,
Ph.D., Georg-August-University Göttingen and Dermatologikum
Hamburg, Hamburg, Germany
- Location: F056 - Late-breaking Research: Clinical Trials
Poster Presentations
Sunday, March 5
- Abstract #4622: 8:15 a.m. –
8:20 a.m. ET
- The Effects of Age, Gender, Weight, Age at Onset, Psoriasis
Severity, Nail Involvement and Presence of Psoriatic Arthritis at
Baseline on the Efficacy of Ixekizumab in Patients with
Moderate-to-Severe Psoriasis
- Presenter: Orin Goldblum, M.D.,
Eli Lilly & Company, Indianapolis,
IN
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4663: 8:20 a.m. –
8:25 a.m. ET
- Incidence of Inflammatory Bowel Disease Among
Ixekizumab-treated Patients with Moderate-to-Severe Plaque
Psoriasis and Psoriatic Arthritis: Data from Eight Clinical
Trials
- Presenter: Dana S. Hardin, M.D.,
St. Vincent Indianapolis Hospital & Heart Center, Indianapolis, IN
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4376: 9:15 a.m. –
9:20 a.m. ET
- Efficacy and Safety of Ixekizumab for the Treatment of
Moderate-to-Severe Plaque Psoriasis: Results Through 108 Weeks of a
Randomized, Phase 3 Clinical Trial (UNCOVER-3)
- Presenter: Andrew Blauvelt,
M.D., M.B.A., Oregon Medical Research Center, Portland, OR
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4551: 9:30 a.m. –
9:35 a.m. ET
- Clearing of Psoriasis within Different Body Regions Following
12 Weeks of Treatment with Ixekizumab
- Presenter: Andrew Blauvelt,
M.D., M.B.A., Oregon Medical Research Center, Portland, OR
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4662: 11:25 a.m. –
11:30 a.m. ET
- Ixekizumab Treatment Shows a Neutral Impact on the Glucose and
Lipid Profile of Patients with Moderate-to-Severe Psoriasis:
Results from UNCOVER-1, -2, and -3
- Presenter: Jashin J. Wu, M.D.,
Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4629: 12:50 p.m. –
12:55 p.m. ET
- Ixekizumab Efficacy in Patients with Moderate-to-Severe Plaque
Psoriasis and Co-Morbid Psoriatic Arthritis: Four Year Results from
a Phase 2 Study
- Presenter: Mark Lebwohl, M.D.,
Mount Sinai Hospital, New York
City, NY
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4664: 2:20 p.m. –
2:25 p.m. ET
- Patients' Perspectives on the Impact of Moderate-to-Severe
Genital Psoriasis
- Presenter: Jennifer Clay Cather,
M.D., Baylor University Medical Center,
Dallas, TX
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4550: 2:35 p.m. –
2:40 p.m. ET
- Ixekizumab Treatment Shows No Evidence for Reactivation of
Previous or Latent Tuberculosis Infection in Subjects with
Psoriasis: An Integrated Analysis of Seven Clinical Trials
- Presenter: Ricardo Romiti, M.D.,
Dermatologia e Preceptoria pelo Hospital das Clinicas da
Universidade de Sao Paulo,
Sao Paulo, BR
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4548: 2:55 p.m. –
3:00 p.m. ET
- The Burden of Moderate-to-Severe Genital Psoriasis: Patients'
Perspectives on Symptoms
- Presenter: Caitriona Ryan, M.D.,
Texas A&M Health Science Center,
Dallas, TX
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4530: 3:00 p.m. –
3:05 p.m. ET
- The Effect of Ixekizumab on Scalp and Nail Psoriasis and Health
Outcome Measures Over Four Years of Open-Label Treatment in a Phase
2 Study in Chronic Plaque Psoriasis
- Presenter: Russel Burge, Ph.D.,
Eli Lilly & Company, Indianapolis,
IN
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #4532: 3:20 p.m. –
3:25 p.m. ET
- Ixekizumab and Pregnancy Outcome
- Presenter: Lars Iversen, M.D.,
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
- Location: Psoriasis & Other Papulosquamous Disorders
Section
- Abstract #5105: 4:05 p.m. –
4:10 p.m. ET
- Treatment with Ixekizumab Does Not Interfere with the Efficacy
of Tetanus and Pneumococcal Vaccines in Healthy Subjects
- Presenter: Talia Muram, IU
Health Pathology Laboratory, Indianapolis, IN
- Location: E-Poster Presentation Center #2
- Abstract #4750: 4:20 p.m. –
4:25 p.m. ET
- Absolute and Relative Psoriasis Area and Severity Indices for
Comparison of the Efficacy of Ixekizumab versus Etanercept and
Placebo in Patients with Moderate-to-Severe Plaque Psoriasis
- Presenter: Martin Dossenbach,
M.D., Senior Medical Fellow, Medical Leader Dermatology, Eli Lilly
& Company, Vienna,
Austria
- Location: Psoriasis & Other Papulosquamous Disorders
Section
Indications and Usage
Taltz® (ixekizumab)
is indicated for the treatment of adults with moderate-to-severe
plaque psoriasis who are candidates for systemic therapy or
phototherapy.
IMPORTANT SAFETY INFORMATION
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 Taltz®
(ixekizumab)
Taltz® (ixekizumab) is an
IgG4 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.
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is
a chronic, immune disease that affects the skin.1 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.1,[2] Psoriasis can occur on any part of the
body and is associated with other serious health conditions, such
as diabetes and heart disease.1 The most common form of
psoriasis, plaque psoriasis, appears as raised, red patches covered
with a silvery white buildup of dead skin cells.1
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.
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
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 Taltz
will receive additional regulatory approvals or be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly'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 undertakes no duty to update
forward-looking statements to reflect events after the date of this
release.
_____________________________
1 Psoriasis media kit. National Psoriasis Foundation
website.
https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf.
Accessed February 23, 2017.
2 Psoriasis. American Academy of Dermatology website.
https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis.
Accessed February 23, 2017.
Refer
to: Jen
Dial; dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly
Bio-Medicines)
* ©Lilly USA, LLC 2017. All rights reserved.
Taltz® is a registered trademark owned or licensed
by Eli Lilly and Company, its subsidiaries or affiliates.
Stelara® is a registered trademark owned or licensed by
Janssen Pharmaceutical Companies of Johnson & Johnson, its
subsidiaries or affiliates.
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SOURCE Eli Lilly and Company