Lilly to present head-to-head 24-week data comparing the
efficacy and safety of Taltz and Stelara for the treatment of
moderate-to-severe plaque psoriasis
INDIANAPOLIS, March 4, 2017 /CNW/ -- Eli Lilly and Company
(NYSE: LLY) announced today that patients with moderate-to-severe
plaque psoriasis treated with Taltz® (ixekizumab)
demonstrated superior efficacy at 24 weeks compared to patients
treated with Stelara®* (ustekinumab). Detailed results
from the IXORA-S study were presented during the American
Academy of Dermatology (AAD) Annual Meeting taking place
March 3-7 in Orlando, Fla.
At 24 weeks, patients treated with Taltz achieved significantly
higher response rates compared to patients treated with Stelara,
including 83 percent of patients who achieved Psoriasis Area
Severity Index (PASI) 90—the study's primary endpoint—compared to
59 percent of patients who achieved PASI 90 after treatment with
Stelara.
"For many years, achieving PASI 75 – or 75 percent improvement
in skin plaques – has been the standard treatment goal for
moderate-to-severe plaque psoriasis," said Kristian Reich, M.D., Ph.D., lead author and
professor, Georg-August-University Göttingen and Dermatologikum
Hamburg, Hamburg, Germany. "With
the introduction of treatments like Taltz, dermatologists can offer
treatment options that allow more patients to achieve PASI 90 or
PASI 100. The data of the IXORA-S study is significant, as it
demonstrates both high levels of skin improvement for patients
treated with Taltz, consistent with pivotal Phase 3 trials, as well
as higher response rates over Stelara, which is one of the most
frequently used biologics in the treatment of moderate-to-severe
plaque psoriasis."
In the IXORA-S study, patients were randomized to receive either
Stelara (45 mg or 90 mg weight-based dosing per label) or Taltz (80
mg every two weeks for 12 weeks followed by 80 mg every four
weeks), following a 160-mg starting dose, for a total of 52
weeks.
This study also evaluated PASI 75, PASI 100 and static
Physician's Global Assessment score (sPGA) 0 or 1 with at least a
two-point improvement from baseline. PASI measures the extent and
severity of psoriasis by assessing average redness, thickness and
scaliness of skin lesions (each graded on a zero to four scale),
weighted by the body surface area of involved skin.1 The sPGA is the physician's
assessment of severity of a patient's psoriasis lesions overall at
a specific point in time and is a required measure the FDA uses to
evaluate effectiveness.1
At 24 weeks, patients treated with Taltz achieved significantly
higher response rates compared to patients treated with Stelara, as
demonstrated by the following:
- 91.2 percent of patients treated with Taltz achieved PASI 75
compared to 81.9 percent of patients treated with Stelara
(p=0.015);
- 83.1 percent of patients treated with Taltz achieved PASI 90
compared to 59.0 percent of patients treated with Stelara
(p<0.001);
- 49.3 percent of patients treated with Taltz achieved PASI 100
compared to 23.5 percent of patients treated with Stelara
(p=0.001).
Additionally, 86.6 percent of patients treated with Taltz
achieved sPGA 0 or 1 compared to 69.3 percent of patients treated
with Stelara after 24 weeks (p<0.001).
The majority of treatment-emergent adverse events were mild or
moderate. There were no statistically significant differences
between treatment groups in overall treatment-emergent adverse
events. The safety profile for Taltz was consistent with previous
clinical trials.
"The approval of Taltz in the U.S., Canada and Europe nearly one year ago introduced a
treatment option that could help patients with moderate-to-severe
plaque psoriasis achieve virtually clear or completely clear skin,"
said Dr. Lotus Mallbris, global brand development leader, Taltz,
Eli Lilly and Company. "We are thrilled with the opportunity to
share this new data with dermatologists at AAD, as it reinforces
the clinical benefits of Taltz for patients with moderate-to-severe
plaque psoriasis."
Results from Phase 3 trials evaluating Taltz for the treatment
of active psoriatic arthritis are expected to be presented later
this year. Taltz is also in Phase 3 trials for the treatment of
axial spondyloarthritis.
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.2 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.2,3
Psoriasis can occur on any part of the body and is associated with
other serious health conditions, such as diabetes and heart
disease.2 The most
common form of psoriasis, plaque psoriasis, appears as raised, red
patches covered with a silvery white buildup of dead skin
cells.2
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] Feldman SR, Krueger GG. Psoriasis assessment tools in
clinical trials. Ann Rheum Dis. 2005;64:ii65-ii68.
http://ard.bmj.com/content/64/suppl_2/ii65.full. Accessed
March 1, 2017.
[2] Psoriasis media kit. National Psoriasis Foundation website.
https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf.
Accessed March 1, 2017.
[3]Psoriasis. American Academy of Dermatology website.
https://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis.
Accessed March 1, 2017.
* ©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.
Refer to:
Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly Bio-Medicines)
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SOURCE Eli Lilly and Company