INDIANAPOLIS, June 16, 2017 /CNW/ -- Eli Lilly and Company
(NYSE: LLY) announced today that the majority of patients with
active psoriatic arthritis (PsA) treated with Taltz®
(ixekizumab) exhibited either no progression or minimal progression
of radiographic structural joint damage through 52 weeks of
treatment. Detailed results from the extension period of the
SPIRIT-P1 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.
"Psoriatic arthritis is a chronic, progressive disease that if
left untreated, can result in permanent, structural joint damage
and impaired physical function," said Phillip Mease, M.D., Swedish Medical Center and
University of Washington, Seattle,
United States. "Results from the
extension period of SPIRIT-P1 are encouraging and provide new
information on the potential for Taltz, if approved, to address
unmet needs of patients living with this challenging disease."
During the 24-week, double-blind period of the SPIRIT-P1 study,
patients with active PsA who had never received a biologic
disease-modifying antirheumatic drug (bDMARD) were treated with
either 80 mg of Taltz once every two weeks or every four weeks
(following a 160-mg starting dose), or adalimumab at the approved
dose of 40 mg every two weeks or placebo. Adalimumab was employed
as an active control in the SPIRIT-P1 study and was not powered for
comparison with Taltz treatment groups. Following completion of the
24-week treatment period, patients were re-randomized to receive 80
mg of Taltz every two weeks or four weeks to evaluate response
rates during the extension period through 52 weeks.
Patients treated with Taltz at both dosing regimens experienced
either no progression or minimal radiographic progression of
structural joint damage as measured by the change from baseline in
the van der Heijde modified Total Sharp Score (mTSS) for PsA at 52
weeks. No progression or minimal radiographic progression of
structural joint damage was also observed for patients who switched
from placebo or adalimumab to either dosing regimen of Taltz after
the 24-week treatment period.
During the extension period of SPIRIT-P1, the incidence of
treatment-emergent adverse events was greater with Taltz treatment
compared with placebo. The most common (≥4 percent)
treatment-emergent adverse events observed in all patients treated
with Taltz were nasopharyngitis and injection site reaction. These
events are consistent with those reported in the Phase 3 studies of
Taltz for the treatment of moderate-to-severe plaque psoriasis
(UNCOVER 1, 2, 3).
"For patients living with psoriatic arthritis, it is important
to work with a specialist to find a treatment that manages both the
signs and symptoms of the disease, but also helps prevent further
joint damage," said Dr. Lotus Mallbris, global brand development
leader, Taltz, Eli Lilly and Company. "One year following the
approval of Taltz for moderate-to-severe plaque psoriasis in the
U.S., Canada and Europe, we are excited to present new data to
rheumatologists from around the world at the Annual European
Congress of Rheumatology (EULAR) 2017."
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. Taltz 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-P1 Study
SPIRIT-P1 is a Phase 3
randomized, active- and placebo-controlled study examining the
effect of Taltz compared with placebo in patients with active PsA
who are bDMARD-naïve. Patients were required to have an established
diagnosis of psoriatic arthritis and active disease for at least
six months. The trial included 417 patients (stratified 1:1:1:1
ratio for all treatment groups) with active PsA who had at least
three tender and three swollen joints and the presence of at least
one disease-related joint erosion of the hand or foot as seen on
X-ray or a C-reactive protein (CRP) greater than 6 mg/L at
screening. 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. Adalimumab at the approved dose of 40 mg SC
and regimen of every other week was selected as the active control
for comparison with placebo. The SPIRIT-P1 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.1 It occurs
when an overactive immune system sends out faulty signals that
cause inflammation, leading to swollen and painful joints and
tendons.2 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).3 If left untreated, PsA can cause
permanent joint damage.1 Additionally, up to 30 percent of people
with psoriasis also develop PsA.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 http://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 About psoriatic arthritis. National Psoriasis
Foundation website.
https://www.psoriasis.org/about-psoriatic-arthritis. Accessed
June 7, 2017.
2 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.
3 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