INDIANAPOLIS, June 3, 2020 /PRNewswire/ --
Taltz® (ixekizumab) demonstrated consistent
efficacy and long-term potential to help patients with psoriatic
arthritis (PsA) in new data to be presented virtually on
June 5 at the European Congress of
Rheumatology 2020 (EULAR).
Eli Lilly and Company (NYSE: LLY) shared new results today from
a subgroup analysis of the Phase 3b/4, 52-week SPIRIT-Head-to-Head (SPIRIT-H2H)
study of Taltz versus Humira (adalimumab) in biologic-naïve
patients with active psoriatic arthritis (PsA). SPIRIT-H2H was the
first superiority study versus Humira in PsA with a primary
endpoint of simultaneous achievement of ACR50 (at least 50%
improvement in disease activity as defined by the American College
of Rheumatology) and PASI 100 (100% improvement in the Psoriasis
Area and Severity Index) at Week 24.
In this prespecified analysis, efficacy outcomes through Week 52
were compared between Taltz and Humira in subgroups of patients on
monotherapy, concomitant methotrexate (MTX), or concomitant MTX
along with an additional conventional synthetic disease-modifying
antirheumatic drug (csDMARD), including sulfasalazine,
cyclosporine, or leflunomide. Results at 52 weeks showed
improvements were seen with Taltz across multiple endpoints, with
or without the use of MTX or other csDMARDs.
A higher proportion of patients treated with Taltz achieved
Minimal Disease Activity (MDA) compared to Humira in the
monotherapy subgroup (49% versus 33%), while response rates were
similar between Taltz and Humira in the concomitant MTX subgroup
(47% vs 47%) and concomitant csDMARD subgroup (47% vs 44%). MDA is
an endpoint that includes fulfilling at least five of seven
rheumatology outcome measures and is the treatment target according
to multiple professional organizations.
More Taltz patients achieved the primary endpoint of
simultaneous achievement of ACR50 and PASI 100 at Week 52 in all
three subgroups:
- Monotherapy: Taltz 38%, Humira 19%
- Concomitant MTX: Taltz 39%, Humira 30%
- Concomitant csDMARDS: Taltz 40%, Humira 29%
A greater proportion of patients treated with Taltz versus
Humira achieved PASI 100 when used as monotherapy (66% vs 35%), in
combination with MTX (63% vs 44%), or in combination with csDMARDs
(64% vs 44%) and the proportion of patients achieving ACR50 was
comparable between Taltz and Humira, regardless of monotherapy (51%
vs 42%), concomitant MTX (48% vs 56%), or concomitant csDMARD use
(49% vs 53%).
"In this subgroup analysis of the SPIRIT-H2H study, ixekizumab
showed greater improvement than adalimumab across multiple PsA
endpoints when taken as monotherapy, and at least comparable
efficacy when used in combination with methotrexate or other
csDMARDs," said Josef Smolen, M.D.,
emeritus professor of medicine at the Medical University of
Vienna, Austria and lead author of
the abstract. "Head-to-head studies provide important insights for
physicians when making treatment decisions. The results of this
analysis reinforce the efficacy of ixekizumab, even as monotherapy,
for patients with PsA who have had an inadequate response to
csDMARDs."
The observed safety profile for Taltz in the SPIRIT-H2H study
was consistent with that reported for ixekizumab in patients with
moderate to severe plaque psoriasis (PsO) and PsA.
Lilly also highlighted notable results from two additional
studies. The SPIRIT-P2 study demonstrated sustained improvement in
signs and symptoms of PsA, as measured by ACR responses, as well as
manifestations of PsA, including enthesitis, dactylitis, and skin
outcomes, for up to three years in patients with prior inadequate
response or intolerance to one or two tumor necrosis factor
inhibitors (TNFi). In the Phase 3 COAST-X study in patients with
active non-radiographic axial spondyloarthritis (nr-axSpA),
patients treated with Taltz saw improvement in fatigue, spinal pain
and stiffness at Week 16. In both studies, the safety profile of
Taltz was consistent with previously reported results and no
unexpected safety signals were found.
"To date, Taltz has reported positive results from five H2H
superiority studies across PsA and PsO, including SPIRIT-H2H,
IXORA-S, UNCOVER-2, UNCOVER-3 and IXORA-R, and we're pleased to
share additional data from the SPIRIT-H2H subgroup analysis which
provides further evidence for the use of Taltz as a first-line
monotherapy treatment for patients living with PsA," said Lotus
Mallbris, M.D., Ph.D., vice president of immunology development at
Lilly. "The full breadth of Taltz data being presented at EULAR
reinforce the efficacy of Taltz in treating patients with PsA and
axSpA."
INDICATIONS AND USAGE FOR TALTZ
Taltz is approved for
the treatment of adult patients with active non-radiographic axial
spondyloarthritis with objective signs of inflammation, active
psoriatic arthritis, or active ankylosing spondylitis, and 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.
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.1 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.1
About the SPIRIT-H2H Study
SPIRIT H2H study is a Phase
3b/4, multicenter, randomized,
open-label, parallel-group study with blinded outcomes assessments
evaluating the efficacy and safety of Taltz versus Humira in
patients with PsA who are biologic DMARD-naive during a 52-week
treatment period. The primary endpoint of the study was the
simultaneous achievement of ACR50 and PASI 100 response at Week 24.
This primary endpoint is an innovative approach that
comprehensively measures clinically meaningful improvements across
multiple domains of PsA. The major secondary endpoints were the
demonstration of non-inferiority in ACR50 and superiority in PASI
100 at week 24. Patients with active PsA and plaque psoriasis with
a body surface area involvement of at least three percent, who had
inadequate response to at least one conventional DMARD, were
enrolled in the study.
About the SPIRIT-P2 Study
SPIRIT-P2 is a Phase 3
multicenter, randomized, double-blind, placebo-controlled 24-week
study followed by long term evaluation of efficacy and safety of
Taltz in patients with prior inadequate response or intolerance to
1 or 2 tumor necrosis factor inhibitors (TNFi). The primary
endpoint of the study was percentage of patients achieving ACR20 at
Week 24. The 24-week study was followed by an extension period
through three years.
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.2 It occurs when an
overactive immune system sends out faulty signals that cause
inflammation, leading to swollen and painful joints and
tendons.2 PsA can affect peripheral joints in the
arms and legs (elbows, wrists, hands and feet).2 If
left untreated, PsA can cause permanent joint damage. Up to 30
percent of people with psoriasis also develop PsA.2
About the COAST-X Study
COAST-X is a multicenter,
randomized, double-blind, placebo-controlled 52-week study
evaluating the efficacy and safety of Taltz for the treatment of
non-radiographic axial spondyloarthritis (nr-axSpA) in patients
with objective signs of inflammation. Patients were required to
have an established diagnosis of nr-axSpA and active disease
defined by a Bath Ankylosing Spondylitis Disease Activity Index
(BASDAI) Numeric Rating Scale (NRS) score ≥4 and total back pain ≥4
at screening and baseline, and were required to have objective
signs of inflammation by presence of sacroiliitis on MRI or
presence of elevated CRP.
About the Taltz Program in AxSpA
The COAST-X study is
part of a clinical development program that aims to evaluate the
efficacy and safety of Taltz 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
Ankylosing Spondylitis (AS)/radiographic axSpA who are
biologic-naive; COAST-W in patients with AS/radiographic axSpA who
previously had an inadequate response or were intolerant to tumor
necrosis factor (TNF) inhibitors; and COAST-X in biologic-naive
nr-axSpA patients with objective signs of inflammation. Patients
may enroll into a long-term extension study (COAST-Y) after
completion of any of these registration studies to receive Taltz
treatment for up to an additional two years.
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
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
psoriatic arthritis or non-radiographic axial spondyloarthritis 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 Taltz Prescribing Information, 2020.
2 Ritchlin C, et. al. Psoriatic Arthritis. New England
Journal of Medicine. 2017;376:957-70.
Refer
to:
|
Carla Cox;
cox_carla@lilly.com; 317-750-3923 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (investors)
|
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SOURCE Eli Lilly and Company