INDIANAPOLIS, Feb. 13, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that
Taltz® (ixekizumab) met the primary and all key
secondary endpoints in COAST-V, a Phase 3 study evaluating the
safety and efficacy of Taltz for the treatment of Ankylosing
Spondylitis (AS), also known as radiographic axial
spondyloarthritis (axSpA). The trial included a placebo arm and an
active control arm (adalimumab) for comparison with placebo, and
studied patients who had never received a biologic
disease-modifying anti-rheumatic drug (bDMARD).
Taltz demonstrated a statistically significant improvement in
the signs and symptoms of AS, as measured by the proportion of
patients who achieved Assessment of Spondyloarthritis International
Society 40 (ASAS40) response at 16 weeks, when compared to placebo.
COAST-V is the first registration trial to use ASAS40 as the
primary endpoint, compared to the standard endpoint of ASAS20.
AS is one type of spondyloarthritis that affects the pelvic
joints and spine, and can be characterized by chronic inflammatory
back pain, stiffness and impaired function and
mobility.1 Of those affected by AS, approximately 80
percent will experience symptoms before age 30.2
"Many people with this chronic, debilitating disease are still
searching for an effective treatment. These initial results suggest
that Taltz, if approved for this indication, may have the potential
to help people with this challenging disease," said Dr. Lotus
Mallbris, vice president and immunology platform team leader, Lilly
Bio-Medicines. "At Lilly, the unmet needs of people living with
autoimmune diseases drive our commitment to continue investing in
novel science, developing medicines that may reduce the burden of
disease and aim to raise the bar for treatment
expectations."
In COAST-V, the incidence of treatment-emergent adverse events
was similar with Taltz compared with placebo. The most common
adverse events observed were consistent with the Phase 3 studies of
ixekizumab for the treatment of moderate-to-severe plaque psoriasis
and active psoriatic arthritis.
Lilly plans to submit detailed data from COAST-V for disclosure
at scientific meetings and in peer-reviewed journals later this
year. The company plans to submit for regulatory approvals pending
additional data from the ongoing Taltz development program later
this year.
Indications and Usage
Taltz is approved for the
treatment of adults with active psoriatic arthritis. Taltz is
also approved to treat 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. In clinical trials of 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 patients with psoriatic
arthritis. 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
During Taltz
treatment, monitor patients for onset or exacerbations of
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 in patients with
plaque psoriasis.
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 profile observed in patients with psoriatic
arthritis was consistent with the safety profile in patients with
plaque psoriasis, with the exception of influenza and
conjunctivitis.
Please click to access the Prescribing
Information and Medication Guide.
Please click to access Instructions for
Use included with the device.
About the COAST-V Study
COAST-V is a multicenter,
randomized, double-blind, active and placebo-controlled 16-week
study followed by long-term evaluation of efficacy and safety of
ixekizumab in biologic disease-modifying anti-rheumatic drug
(bDMARD)-naïve patients with as Ankylosing Spondylitis (AS), also
known as radiographic axial spondyloarthritis (axSpA). Patients
were required to have an established diagnosis of AS with active
disease defined by a Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and a total back
pain NRS score ≥4. During the study, ixekizumab-treated patients
received a starting dose of 80-mg or 160-mg, followed by one of two
dosing regimens: either 80-mg administered subcutaneously once
every two weeks or 80-mg administered subcutaneously once every
four weeks. Adalimumab at the approved dose of 40-mg, administered
subcutaneously every two weeks, was selected as the active control
for comparison with placebo. The COAST-V study will also evaluate
the long-term efficacy and safety of ixekizumab in patients with AS
up to one year.
About the Taltz Program in axSpA
The COAST-V study is
part of a clinical development program that aims to evaluate the
efficacy and safety of ixekizumab across various population subsets
of patients with axSpA. The COAST program includes three
registration studies each of one year duration: COAST-V in patients
with AS/active radiographic axSpA who are bDMARD-naïve; COAST-W in
patients with AS/active radiographic axSpA who previously had an
inadequate response to TNF inhibitors; and COAST-X in patients with
non-radiographic axSpA who are bDMARD-naïve. Patients may enroll
into a long-term extension study after completion of any of the
registration studies to receive ixekizumab treatment for up to an
additional two years.
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.
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 www.lilly.com/newsroom/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 potential treatment for
Ankylosing Spondylitis, 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.
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1
Spondyloarthritis. American College of Rheumatology website.
http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Spondyloarthritis.
Accessed February 13, 2018.
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2 Sieper,
J., Braun, J. Overview of axial spondyloarthritis. Clinician's
Manual on Axial Spondyloarthritis. 2014; 11 (96): 84.
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Refer
to:
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Scott MacGregor;
jsmacgregor@lilly.com; 317-440-4699 (media)
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Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (investors)
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SOURCE Eli Lilly and Company