Taltz also demonstrated significant improvements in key
secondary measures at 24 weeks
INDIANAPOLIS, June 15, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that patients with active
psoriatic arthritis (PsA) who had inadequate response to one or two
TNF inhibitors or were intolerant of TNF inhibitors treated with
Taltz® (ixekizumab) achieved significant improvement in
signs and symptoms of their disease at 24 weeks when compared to
placebo. Detailed results of the SPIRIT-P2 study, a pivotal Phase 3
trial, will be presented in an oral presentation today during the
Annual European Congress of Rheumatology (EULAR) 2017, taking place
June 14-17, in Madrid. Results
from the SPIRIT-P2 study were also recently published in The
Lancet in May 2017.
"Psoriatic arthritis is a chronic, progressive disease that
affects more than 37 million people worldwide, and can cause a
range of signs and symptoms, including pain, swelling and stiffness
of the joints that can lead to impaired physical function, as well
as itchy and painful skin plaques," said Dr. Lotus Mallbris, global
brand development leader, Taltz, Eli Lilly and Company. "We are
pleased this data will be presented at the Annual European Congress
of Rheumatology (EULAR) 2017, as it represents an invaluable
opportunity to foster discussion among experts from around the
world on the importance of new treatments for this debilitating
disease."
Study Design
The SPIRIT-P2 study evaluated the safety
and efficacy of Taltz (80 mg every four weeks or every two weeks,
following a 160-mg starting dose) compared to placebo after 24
weeks in patients with active PsA who were previously treated with
TNF inhibitors and had an inadequate response to one or two TNF
inhibitors or were intolerant to TNF inhibitors. Patients were
required to have a diagnosis of active PsA for at least six months
and at least three tender and three swollen joints.
In this study, the primary endpoint was the percentage of
patients achieving at least a 20 percent reduction in a composite
measure of disease activity, as defined by the American College of
Rheumatology (ACR20).[1] This study also evaluated
secondary endpoints including ACR50 and ACR70, which represent 50
percent and 70 percent reductions in disease activity; improvement
in physical function as assessed using the Health Assessment
Questionnaire Disability Index (HAQ-DI); and improved skin
clearance as measured by the Psoriasis Area Severity Index
(PASI).
Taltz Demonstrated Significant Improvements in Disease Signs
and Symptoms
Patients treated with either dosing regimen of
Taltz demonstrated significant improvements at 24 weeks compared
with placebo in disease activity of PsA.
At 24 weeks, patients achieved the following response rates:
- ACR 20: 53 percent of patients treated with Taltz every
four weeks, 48 percent of patients treated with Taltz every two
weeks and 19 percent of those treated with placebo
(p<0.0001).
- ACR 50: 35 percent of patients treated with Taltz every
four weeks, 33 percent of patients treated with Taltz every two
weeks and 5 percent of those treated with placebo
(p<0.0001).
- ACR 70: 22 percent of patients treated with Taltz every
four weeks, 12 percent of patients treated with Taltz every two
weeks and zero percent of those treated with placebo
(p<0.0001).
Reduced Disability in Physical Function, Significant
Improvements in Skin Clearance
Patients treated with either
dosing regimen of Taltz also experienced significant improvements
compared with placebo in other key secondary measures, including
physical function as assessed by the HAQ-DI and skin clearance in
patients with at least 3 percent body surface area of skin
involvement as measured by PASI 75, PASI 90 and PASI 100 at 12
weeks and 24 weeks. A PASI 75 score indicates at least a 75
percent reduction in a patient's plaque psoriasis from the
patient's baseline assessment, while PASI 90 reflects a 90 percent
reduction. PASI 100 represents a 100 percent reduction and reflects
complete skin clearance.
"Many patients with psoriatic arthritis have tried a variety of
therapies and have either lost response over time, had an
inadequate response or been intolerant of therapy," said Associate
Professor Peter Nash, lead author,
University of Queensland, Queensland, Australia. "If approved,
ixekizumab may provide physicians with a new option in this
difficult-to-treat patient population."
The incidence of treatment-emergent adverse events was greater
with Taltz treatment compared with placebo. The most common (≥5
percent in Taltz groups combined) treatment-emergent adverse events
observed with Taltz treatment were injection site reaction, upper
respiratory infection, nasopharyngitis and sinusitis. Serious
adverse events and discontinuation rates due to adverse events were
not significantly different between treatment
groups.
Other warnings and precautions for Taltz include pre-treatment
evaluation for tuberculosis, hypersensitivity reactions,
inflammatory bowel disease and immunizations. See Important Safety
Information below.
Lilly has filed a supplemental Biologics License Application
(sBLA) with the U.S. Food and Drug Administration (FDA) for Taltz
as a treatment of 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.
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®
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. Ixekizumab inhibits
the release of pro-inflammatory cytokines and chemokines.
Taltz is also in Phase 3 trials for the treatment of
radiographic and non-radiographic axial spondyloarthritis.
About the SPIRIT-P2 Study
SPIRIT-P2 is a Phase 3,
randomized, double-blind, placebo-controlled study examining the
effect of Taltz compared with placebo in patients with active PsA
who were previously treated with TNF inhibitors and had an
inadequate response to one or two TNF inhibitors or were intolerant
to TNF inhibitors. The trial included 363 patients (randomized at a
1:1:1 ratio) with diagnosis of active PsA for at least six months
and who had at least three tender and three swollen joints. During
the study, patients treated with Taltz received a starting dose of
160 mg administered subcutaneously (SC), as two 80-mg injections,
followed by one of two dosing regimens: either 80 mg administered
SC once every two weeks or 80 mg administered SC once every four
weeks. The SPIRIT-P2 study will also evaluate the long-term
efficacy and safety of Taltz in PsA for up to three years.
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.[2] It
occurs when an overactive immune system sends out faulty signals
that cause inflammation, leading to swollen and painful joints and
tendons.[3] 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).[4] If left untreated, PsA can cause
permanent joint damage.[2] Additionally, up to 30
percent of people with psoriasis also develop
PsA.[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] A proposed revision to the ACR20: the hybrid measure of
American College of Rheumatology response. Arthritis &
Rheumatism. 2007;57:193-202.
http://www.rheumatology.org/Portals/0/Files/A%20Proposed%20Revision%20to%20the%20ACR20.pdf.
Accessed June 7, 2017.
[2] About psoriatic arthritis. National Psoriasis Foundation
website. https://www.psoriasis.org/about-psoriatic-arthritis.
Accessed June 7, 2017.
[3] What is psoriatic arthritis? Arthritis Foundation website.
http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php.
Accessed June 7, 2017.
[4] Classification of psoriatic arthritis. National Psoriasis
Foundation website.
https://www.psoriasis.org/psoriatic-arthritis/classification-of-psoriatic-arthritis.
Accessed June 7, 2017.
Refer to: Danielle
Neveles, danielle.neveles@lilly.com; 317-796-4564
(Media)
Phil Johnson,
johnson_philip_l@lilly.com; 317-655-6874 (Investors)
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SOURCE Eli Lilly and Company