INDIANAPOLIS, June 1, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) will present new data from Phase 3 studies that
further demonstrated the long-term efficacy and safety profile of
Taltz® (ixekizumab) among patients with axial
spondyloarthritis (axSpA). These results are being presented at the
virtual Annual European Congress of Rheumatology (EULAR),
June 2-5, 2021.
AxSpA is recognized as a single disease entity, with two
subtypes which are defined depending on the presence (radiographic
axSpA, or r-axSpA) or absence (non-radiographic axSpA, or nr-axSpA)
of defined structural damage of the sacroiliac joints on plain
x-ray films as per the modified New
York (mNY) criteria.
"Patients living with axial spondyloarthritis deal with a range
of chronic, debilitating symptoms, including inflammatory back
pain, and are in need of treatment options that can provide
long-term efficacy," said Lotus Mallbris, M.D., Ph.D., vice
president of immunology development at Lilly. "We are excited to
present a range of new data at EULAR that demonstrate treatment
with Taltz provides consistent, long-term efficacy on common signs
and symptoms over time in axial spondyloarthritis."
Taltz Showed Sustained Long-Term Improvements in axSpA
Through Two Years
In COAST-Y, Taltz showed consistent and sustained long-term
improvements in signs and symptoms, functionality and quality of
life in patients with r- and nr-axSpA. In this study, more than
half of patients (56.7%) treated continuously with Taltz (80 mg
every four weeks, n=157) through two years achieved Assessment of
SpondyloArthritis international Society 40% response (ASAS40).
Among those treated continuously with Taltz every four weeks for
two years:
- 43.9% of patients achieved low disease activity status, as
measured by Ankylosing Spondylitis Disease Activity Score (ASDAS)
<2.1. Mean change from baseline (3.9) in ASDAS score was
-1.6.
- 19.7% achieved ASAS partial remission status.
- Mean change from baseline (6.6) in Bath Ankylosing Spondylitis
Functional Index (BASFI) was -2.8.
- Mean change from baseline (33.9) in Medical Outcomes Survey
Short Form 36 Physical Component Summary (SF-36 PCS) was 8.4.
The safety profile of Taltz was consistent with previously
published safety data, and no new safety signals were observed
after up to two years of treatment.
For methodology, see the "About the Analyses" section below.
Additional results from the Phase 3 COAST-Y study were also
recently published in the Annals of the Rheumatic
Diseases.
Most Patients Treated with Taltz Did Not Show Bone Damage
Progression of r-axSpA Up to Two Years
An analysis of two Phase 3 studies in r-axSpA (COAST-V and
COAST-W) and the long-term extension trial (COAST-Y), found that 9
out of 10 patients treated with Taltz (89.6%, n=206) did not show
radiographic progression for up to two years, as measured by mean
change from baseline of modified Stoke Ankylosing Spondylitis
Spinal Score (mSASSS) <2. Overall mean rates of progression were
low among patients treated with Taltz. These results were similar
among patients who were previously treated with anti-TNF therapy
(88%, n= 106) and those who had not previously been treated with a
biologic (91%, n=100). For methodology, see the "About the
Analyses" section below.
"If left uncontrolled, individuals living with active
radiographic axSpA can experience severe, chronic pain and
structural damage in the spine that can lead to fusion of the spine
and loss of mobility," said Walter P.
Maksymowych, M.D., FRCP (C), Professor of Medicine at the
University of Alberta, and Chief Medical Officer, CARE Arthritis,
Edmonton, CA, and the senior author of this analysis. "Most
patients treated with ixekizumab did not show structural damage
progression at two years, and the degree of progression was small.
In addition to known predictors, the novel finding is that
attainment of remission of inflammation on MRI at one year
protected from progression at two years."
Notably, Lilly will also present new analyses in axSpA and
psoriatic arthritis, including the following:
- Baseline Characteristics and Treatment Response to Ixekizumab
Categorized by Sex in Radiographic and Non-radiographic Axial
Spondyloarthritis Patients Through 52 Weeks: Data From 3 Phase 3
Randomized Controlled Trials
- Ixekizumab Shows a Distinct Pattern of Pain Improvement Beyond
Inflammation in Radiographic Axial Spondyloarthritis
- Ixekizumab Efficacy on Spinal Pain, Disease Activity and
Quality of Life in Patients with Psoriatic Arthritis Presenting
with Symptoms Suggestive of Axial Involvement
More than 175,000 patients have been treated with Taltz
worldwide since launch, giving healthcare providers confidence in
making informed prescribing decisions for the treatment of adults
with active psoriatic arthritis, active ankylosing spondylitis,
active nr-axSpA and moderate to severe plaque psoriasis.
About the Analyses
- Long-term Treatment with Ixekizumab in Patients with Axial
Spondyloarthritis: 2-year Results from COAST-Y
-
- COAST-Y is the two-year extension of the COAST-V, COAST-W and
COAST-X trials. Upon completion of the initial trials, 773 patients
continued with the dose received at the end of the originating
trial at Week 52, either with 80 mg Taltz every two weeks or four
weeks. Patients who had been assigned to adalimumab or placebo were
re-randomized to Taltz every two weeks or every four weeks at Week
16 in COAST-V and COAST-W. Patients who had received placebo for 52
weeks in COAST-X were switched to Taltz every four weeks in
COAST-Y. For this analysis, only patients continuously treated with
Taltz since the originating studies were included. All other
patients were analyzed separately.
- Standardized efficacy measures were used. Missing data were
handled by non-responder imputation for categorical data and
modified baseline observation carried forward for continuous data.
Safety data were analyzed for all patients who received ≥1 dose of
Taltz.
- Evaluation of Spinal Radiographic Progression in Patients
with Radiographic Axial Spondyloarthritis Receiving Ixekizumab
Therapy over 2 Years
-
- These analyses included biologic-naïve patients with active
r-axSpA (COAST-V) or patients with prior inadequate response or
intolerance to one or two TNF inhibitors (COAST-W) who received 80
mg Taltz every two weeks or four weeks for two years (108 weeks, of
which 56 weeks were the COAST-Y long-term extension study).
- Mean change from baseline of mSASSS (average score from two
selected readers, blinded for time order) for patients treated with
Taltz for two years with data at both baseline and year 2 is
presented (n=230; 54% of total randomized patients). Of the 657
patients who entered COAST-V or -W, 527 patients re-consented to
enter COAST-Y; however, 104 patients had either baseline or Year 2
mSASSS data missing. Of 423 patients with baseline and Year 2
mSASSS data, 230 (54%) were treated with Taltz for at least two
years. Of these, 110 were biologic-naïve and 120 were
TNFi-experienced.
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, oropharingeal pain 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 (also common).
Adverse drug reactions in patients with radiographic axial
spondyloarthritis (ankylosing spondylitis) were similar with the
exception of inflammatory bowel disease (common) and rhinitis
(common). In patients with non-radiographic axial
spondyloarthritis, adverse events were also similar to
inflammatory bowel disease (common), influenza (common) and
conjunctivitis (common).
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 Axial Spondlyoarthritis
Axial spondyloarthritis
(axSpA), which includes both radiographic axSpA (r-axSpA) and
non-radiographic axSpA (nr-axSpA), is a disease predominantly
affecting the sacroiliac joints and the spine. Common symptoms
include chronic inflammatory back pain, fatigue and
stiffness.1,2,3 It is estimated that 2.3 million
people in the U.S. have axSpA, and approximately half of those
individuals live with nr-axSpA.2,4 For patients
with r-axSpA, the disease is characterized by the presence of
structural damage of the sacroiliac joints that appears on an
X-ray, while patients with nr-axSpA do not have clearly detectable
structural damage radiographically.5 These two
patient subsets share a similar burden of disease and similar
clinical features, but approved biologic treatment options for
patients with nr-axSpA are much more limited and patients are often
underdiagnosed.5,6
About Lilly in Immunology
Lilly is bringing our
heritage of championing groundbreaking, novel science to immunology
and is driven to change what's possible for people living with
autoimmune diseases. There are still significant unmet needs, as
well as personal and societal costs, for people living with a
variety of autoimmune diseases and our goal is to minimize the
burden of disease. Lilly is investing in leading-edge clinical
approaches across its immunology portfolio in hopes of transforming
the autoimmune disease treatment experience. We've built a deep
pipeline and are focused on advancing cutting edge science to find
new treatments that offer meaningful improvements to support the
people and the communities we serve.
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
Lilly Forward-Looking Statement
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 ankylosing spondylitis,
radiographic and non-radiographic axial spondylorarthritis, and
psoriatric arthritis, and reflects Lilly's current beliefs and
expectations. 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 Reveille JD, et al.
Prevalence of axial spondylarthritis in the United States:
Estimates from a cross-sectional survey. Arthritis Care Res.
2012;64(6):905-910.
|
2 Strand V, et al.
Prevalence of axial spondyloarthritis in United States rheumatology
practices: Assessment of SpondyloArthritis International Society
criteria versus rheumatology expert clinical diagnosis. Arthritis
Care Res. 2013;65(8):1299-306.
|
3 Kiltz U, et al. Do
patients with non-radiographic axial spondylarthritis differ from
patients with ankylosing spondylitis? Arthritis Care Res.
2012;64(9):1415-22.
|
4 U.S. Census Bureau,
Population Estimates Program (PEP)
https://www.census.gov/quickfacts/fact/table/US# accessed on April
30, 2020.
|
5 Deodhar A, et al.
The concept of axial spondyloarthritis: joint statement of the
spondyloarthritis research and treatment network and the Assessment
of SpondyloArthritis International Society in response to the US
Food and Drug Administration's comments and concerns. Arth Rheum.
2014;66(10):2649-2656.
|
6 De Miguel Mendieta
E, et al. Ann Rhuem Dis. 2018;77:1156. Abstract AB0857.
|
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Refer to:
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Jen Dial;
dial_jennifer_kay@lilly.com; +317-220-1172 (media)
|
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Kevin Hern;
hern_kevin_r@lilly.com; +1-317-277-1838 (Lilly
investors)
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