17 abstracts, including eight oral abstracts with one
late-breaker presentation, will feature new sub-analyses for Taltz
in moderate-to-severe plaque psoriasis
INDIANAPOLIS, Sept. 27, 2016 /CNW/ -- Eli Lilly and
Company (NYSE: LLY) will highlight clinical and patient-related
health outcomes data evaluating Taltz® (ixekizumab) for
the treatment of adult patients with moderate-to-severe plaque
psoriasis at the annual European Academy of Dermatology and
Venereology Congress (EADV), which will take place Sept. 28-Oct. 2, 2016, in Vienna, Austria.
A total of 17 abstracts, including eight oral abstracts with one
late-breaker presentation, will feature sub-analyses from pivotal
Phase 3 data of Taltz for the treatment of moderate-to-severe
plaque psoriasis across a number of areas.
"EADV represents a tremendous opportunity for dermatologists to
exchange information that helps better address unmet needs for
patients," said Dr. Lotus Mallbris, Lilly's global brand
development leader for Taltz. "Lilly is excited to support the
evolution of new treatments in dermatology as we share new data for
Taltz in the treatment of moderate-to-severe plaque psoriasis."
Studies, as well as the times and locations of each session, are
highlighted below. All times are listed in Central European Time
(CET).
Oral Presentations
Thursday, September 29
- Abstract FC03.05: 13:55 – 14:05
- Safety and Tolerability of Ixekizumab: Integrated Analysis of
Safety in Patients with Moderate-to-Severe Psoriasis with More Than
7800 Patient-Years of Exposure to Ixekizumab from 7 Clinical
Trials
- Presenter: Alexandra Kimball,
Massachusetts General Hospital, Boston,
MA, United States
- Location: Hall N
- Abstract FC03.06: 14:05 – 14:15
- Indirect Comparison of Ixekizumab and Secukinumab Using
Matched-Adjusted Indirect Comparisons
- Presenter: Alexander Schacht,
Eli Lilly & Company, Indianapolis,
IN, United States
- Location: Hall N
- Abstract FC03.08: 14:25 – 14:35
- Efficacy and Safety of Ixekizumab in Patients with
Moderate-to-Severe Plaque Psoriasis Plus Significant Palmoplantar
Involvement: 60-Week Outcomes from UNCOVER-3
- Presenter: Alan Menter,
Baylor University Medical Center,
Dallas, TX, United States
- Location: Hall N
- Abstract FC03.09: 14:35 – 14:45
- Ixekizumab Treatment Enables Rapid Improvements in
Health-Related Quality of Life and Itch: Results from UNCOVER-2 and
UNCOVER-3
- Presenter: Andrew Blauvelt,
Oregon Medical Research Center, Portland,
OR, United States
- Location: Hall N
- Abstract FC04.01: 15:00 – 15:10
- Sustained Response with Ixekizumab Treatment of Scalp Psoriasis
in Patients with Moderate-to-Severe Psoriasis: Results from a Phase
3 Trial (UNCOVER-3)
- Presenter: Kristian Reich,
Dermatologikum Hamburg, Hamburg,
Germany
- Location: Hall N
- Abstract FC04.03: 15:20 – 15:30
- Efficacy and Safety of Ixekizumab Treatment Stratified by Body
Weight in Patients with Psoriasis
- Presenter: Luis Puig, Hospital
de la Santa Creu I Sant Pau, Dermatology, Barcelona, Spain
- Location: Hall N
Saturday, October 1
- Late-Breaking Abstract D3T01.1K: 16:10 – 16:20
- Efficacy and Safety of Ixekizumab Compared to Ustekinumab in
Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized
Head-to-Head Trial
- Presenter: Kristian Reich,
Dermtologikum Hamburg, Hamburg,
Germany
- Location: Hall A
- Abstract FC08.08: 16:10 - 16:20
- Ixekizumab Treatment is Associated with Early Clearance of
Facial Psoriasis and Subsequent Overall Plaque Clearance
- Presenter: Lyn Guenther,
University of Western Ontario,
London, ON, Canada
- Location: Hall N
e-Poster Presentations
Wednesday, September 28 –
Sunday, October 2
Location/Time: Hall N, 13:25 – 14:45
- Safety and Tolerability of Ixekizumab: Integrated Analysis of
Injection-Site Reactions in Patients with Moderate-to-Severe
Psoriasis Treated with Ixekizumab Compared with Placebo or
Etanercept from Three Phase 3 Trials
- Continued Treatment with Ixekizumab Maintained Long-Term
Improvements in Itch: Results from UNCOVER-3
- Relationship of Itch and Psoriasis Area and Severity Index
Improvement in Patients with Moderate-to-Severe Psoriasis Treated
with Ixekizumab or Etanercept
- Impact of Ixekizumab Treatment Withdrawal on Skin Symptoms in
Responder Patients: Results from UNCOVER-1 and UNCOVER-2, Two
Randomized Phase 3 Trials
- Sustained Efficacy of Ixekizumab in Patients with
Moderate-to-Severe Plaque Psoriasis and Concomitant Psoriatic
Arthritis: A Subanalysis of UNCOVER-3
- Efficacy and Safety of Ixekizumab in Patients Previously
Treated with Etanercept
- Efficacy and Safety of Ixekizumab in Patients with Plaque
Psoriasis Across Different Degrees of Disease Severity (Results
from UNCOVER-2 and UNCOVER-3)
- Ixekizumab Allows Patients to Maintain Relationship
Improvements over 60 Weeks: Integrated Results from UNCOVER-1 and
-2
- Using the Absolute Psoriasis Area and Severity Index for
Comparison of the Efficacy of Ixekizumab to Etanercept and Placebo
in Patients with Moderate-to-Severe Plaque Psoriasis
Indications and Usage
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
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. 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 22MAR2016
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 September 27, 2016.
2 Psoriasis. American Academy of Dermatology website.
https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis.
Accessed September 27, 2016.
Refer to: Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly BioMedicines)
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