INDIANAPOLIS, Oct. 29, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today it will share new
Taltz® (ixekizumab) data from multiple long-term
and post-hoc analyses that indicate sustained efficacy in patients
with psoriasis and psoriatic arthritis. Notably, Lilly will share
results from the extension period of UNCOVER-3 demonstrating
five-year sustained efficacy of Taltz in patients with
psoriasis in treating challenging body areas, such as the scalp,
nails, palms and soles. These studies will be presented at the
29th annual European Academy of Dermatology and
Venereology (EADV) Congress, taking place virtually October 29-31, 2020.
"Finding an effective long-term treatment option that can clear
hard-to-treat body areas that patients find particularly
burdensome, such as the scalp and nails, is one of the most
important considerations when treating psoriasis," said
Andrew Blauvelt, M.D., M.B.A., a
board-certified dermatologist, President of Oregon Medical Research
Center, and lead author of the UNCOVER-3 five-year disclosure.
"These data demonstrate that Taltz was able to provide sustained
responses in these challenging skin areas and should help
physicians make informed treatment decisions for their psoriasis
patients."
Taltz psoriasis data from UNCOVER-3
Taltz demonstrated sustained efficacy in adult psoriasis patients
with baseline scalp, nail and palmoplantar (skin on the palms of
the hands and soles of the feet) involvement with the following
results at five years (Week 264):
- Complete clearance: With Taltz, 83%, 73% and 89% of
patients reported complete clearance in scalp, nail and
palmoplantar psoriasis, respectively.
- Mean percent improvements: Patients reported mean
percent improvements of 89%, 88% and 95% from baseline in scalp,
nail and palmoplantar psoriasis, respectively.
In the UNCOVER-3 study, adult patients were initially randomized
across four treatment arms to receive placebo, Taltz 80 mg every
two weeks or every four weeks following an initial dose of Taltz
160 mg, or etanercept (marketed as Enbrel®) 50 mg twice
weekly in the 12-week induction period. At Week 12, eligible
patients entered the long-term extension period and received the
FDA-approved dose of Taltz for psoriasis – 80 mg every four weeks.
This analysis examines the patients who received the label-approved
dose of Taltz. For these patients, Psoriasis Scalp Severity Index
(PSSI), the Nail Psoriasis Severity Index (NAPSI) and/or the
Palmoplantar Psoriasis Area and Severity Index (PPASI) were
assessed through 264 weeks.
In the UNCOVER-3 study, the safety profile of Taltz over five
years remained consistent with previous reports, with no unexpected
safety outcomes and no new adverse events. The majority of the
treatment–emergent adverse events (TEAEs) were mild to moderate in
nature with nasopharyngitis and upper respiratory tract infection
the most frequently reported.
Additional Taltz data in psoriatic arthritis
Lilly will also be highlighting notable results from two studies in
psoriatic arthritis. In the SPIRIT-P2 study, Taltz demonstrated
persistent clearance of nail and skin psoriasis plaques in patients
with active psoriatic arthritis, as measured by NAPSI, Psoriasis
Area and Severity Index (PASI) and static Physician's Global
Assessment (sPGA) responses, for up to three years in patients with
prior inadequate response or intolerance to one or two tumor
necrosis factor inhibitors (TNFi).
In a post-hoc analysis of patients with nail psoriasis at
baseline from the SPIRIT-H2H study of TNFi treatment-naïve patients
with both active psoriatic arthritis and active psoriasis, 83% of
patients treated with Taltz maintained complete resolution of nail
psoriasis up to 52 weeks vs. 72% of patients treated with
adalimumab (marketed as Humira®).
In both studies, the safety profile of Taltz was consistent with
previously reported results and no unexpected safety signals were
found.
"These long-term studies provide healthcare providers and people
living with psoriasis and psoriatic arthritis valuable information
regarding the effectiveness of Taltz in helping patients achieve
and sustain complete skin clearance, even in these particularly
burdensome skin areas," said Lotus Mallbris, M.D., Ph.D., vice
president of immunology development at Lilly. "The data presented
across Lilly's dermatology portfolio at this year's virtual EADV
Congress reflect our commitment to continuously improving the
standard of care for the treatment of psoriasis and other
autoimmune conditions."
More than 170,000 patients have been treated with Taltz
worldwide since launch, giving healthcare providers confidence in
making informed prescribing decisions for patients with psoriasis
and psoriatic arthritis, as well as in other approved conditions
including ankylosing spondylitis and non-radiographic axial
spondyloarthritis.
INDICATIONS AND USAGE FOR TALTZ
Taltz is approved for the treatment of patients 6 years of age and
older with moderate-to-severe plaque psoriasis who are candidates
for systemic therapy or phototherapy and for the treatment of
adults with active psoriatic arthritis, active ankylosing
spondylitis, or active non-radiographic axial spondyloarthritis
with objective signs of inflammation.
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. In
clinical trials of adult patients with plaque psoriasis, the Taltz
group had a higher rate of infections than the placebo group (27%
vs 23%). A similar increase in risk of infection was seen in
placebo-controlled trials of adult patients with psoriatic
arthritis, ankylosing spondylitis, non-radiographic axial
spondyloarthritis, and pediatric patients with plaque psoriasis.
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. Closely monitor patients receiving Taltz 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
Patients treated with Taltz may be at an increased risk of
inflammatory bowel disease. In clinical trials, Crohn's disease and
ulcerative colitis, including exacerbations, occurred at a greater
frequency in the Taltz group than the placebo group. During
Taltz treatment, monitor patients for onset or exacerbations of
inflammatory bowel disease and if IBD occurs, discontinue Taltz and
initiate appropriate medical management.
Immunizations
Prior to initiating therapy with
Taltz, consider completion of all age-appropriate immunizations
according to current immunization guidelines. Avoid use of live
vaccines in patients treated 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. Overall, the safety profiles observed
in adult patients with psoriatic arthritis, ankylosing spondylitis,
non-radiographic axial spondyloarthritis, and pediatric patients
with plaque psoriasis were consistent with the safety profile in
adult patients with plaque psoriasis, with the exception of
influenza and conjunctivitis in psoriatic arthritis and
conjunctivitis, influenza, and urticaria in pediatric
psoriasis.
Please see full Prescribing Information and Medication Guide
for Taltz. See Instructions for Use included with the
device.
IX HCP ISI 07MAY2020
About Taltz®
Taltz 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.
About Moderate to Severe Plaque Psoriasis
Psoriasis
is a chronic, immune disease that affects the skin. 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. The most common form of psoriasis, plaque
psoriasis, appears as raised, red patches covered with a silvery
white buildup of dead skin cells. Patients with plaque psoriasis
often have other serious health conditions, such as diabetes and
heart disease and experience negative impact on their quality of
life.
About 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 and
impaired physical function. It occurs when an overactive immune
system sends out faulty signals that cause inflammation, leading to
swollen and painful joints and tendons. PsA can affect peripheral
joints in the arms and legs (elbows, wrists, hands and feet). If
left untreated, PsA can cause permanent joint damage. Up to 30
percent of people with psoriasis also develop PsA.
About Lilly in Dermatology
By following the science
through uncharted territory, we continue Lilly's legacy of
delivering innovative medicines that address unmet needs and have
significant impacts on people's lives around the world.
Skin-related diseases are more than skin deep. We understand the
devastating impact this can have on people's lives. At Lilly, we
are relentlessly pursuing a robust dermatology pipeline to provide
innovative, patient-centered solutions so patients with
skin-related diseases can aspire to live life without
limitations.
About Eli Lilly and Company
Lilly is a global health
care leader that unites caring with discovery to create medicines
that 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 lilly.com and lilly.com/news.
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 patients with
psoriasis or psoriatic arthritis 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 or 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.
Refer
to:
|
Carla Cox;
cox_carla@lilly.com; 317-750-3923 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (investors)
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/new-data-at-eadv-2020-confirm-taltz-ixekizumab-demonstrates-sustained-long-term-efficacy-in-patients-with-psoriasis-and-psoriatic-arthritis-301162144.html
SOURCE Eli Lilly and Company