INDIANAPOLIS, Nov. 8, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today patients with active psoriatic
arthritis (PsA) treated with Taltz® (ixekizumab), who
were previously intolerant or had inadequate responses to TNF
inhibitors, showed improvements in the signs and symptoms of PsA
across treatment groups for up to 52 weeks. Interim results from
the extension period of the Phase 3 SPIRIT-P2 study will be
presented today in an oral presentation at the American College of
Rheumatology (ACR)/Association of Rheumatology Health Professionals
(ARHP) Annual Meeting in San Diego,
Calif.
Over the 52-week extension period, the majority of patients
treated with Taltz achieved at least a 20-percent improvement in
disease activity, as defined by the American College of
Rheumatology (ACR 20), the primary endpoint of the study
extension.1 Patients also maintained improvements in key
secondary endpoints, including skin clearance and physical
function, as measured by the Psoriasis Area Severity Index (PASI)
and the Health Assessment Questionnaire Disability Index (HAQ-DI)
respectively.
"These data are promising for the more than 37 million people
worldwide who suffer from joint and skin symptoms of psoriatic
arthritis," said Dr. Lotus Mallbris, vice president, immunology
platform team leader, Lilly Bio-Medicines. "In addition to the
efficacy of Taltz for people with skin symptoms, we are pleased to
share new data suggesting that Taltz, if approved, may provide an
option for those with joint symptoms of PsA."
Full SPIRIT-P2 Extension Results
During the extension
period of the SPIRIT-P2 study, the majority of patients treated
with Taltz showed improvements at 52 weeks in disease activity of
PsA. Patients were required to have a diagnosis of PsA for at least
six months, at least three tender and swollen joints and a previous
intolerant or inadequate response to TNF inhibitors.
Patients who received treatment with Taltz during the initial
double-blind treatment period of the SPIRIT-P2 study continued the
same dosing regimen (either 80-mg of Taltz once every two weeks or
80-mg of Taltz once every four weeks) during the extension period.
At 52 weeks, patients who continued treatment with Taltz achieved
the following response rates:
- ACR 20: 68 percent of patients treated with Taltz every
four weeks, 59 percent of patients treated with Taltz every two
weeks.
- ACR 50: 46 percent of patients treated with Taltz every
four weeks, 38 percent of patients treated with Taltz every two
weeks.
- ACR 70: 29 percent of patients treated with Taltz every
four weeks, 21 percent of patients treated with Taltz every two
weeks.
Patients treated with placebo during the initial double-blind
treatment period of the SPIRIT-P2 study were re-randomized during
the extension period at week 16 or 24 to receive either 80-mg of
Taltz once every two weeks or 80-mg of Taltz once every four weeks,
following a 160-mg starting dose. At 52 weeks, patients
re-randomized to Taltz achieving the following response rates:
- ACR 20: 61 percent of patients treated with Taltz every
four weeks and 50 percent of patients treated with Taltz every two
weeks.
- ACR 50: 44 percent of patients treated with Taltz every
four weeks and 35 percent of patients treated with Taltz every two
weeks.
- ACR 70: 24 percent of patients treated with Taltz every
four weeks and 15 percent of patients treated with Taltz every two
weeks.
"Many people living with PsA are seeking an effective treatment
option that will address all of their symptoms including pain,
swelling and stiffness of the joints, as well as painful skin
plaques," said Mark C. Genovese,
M.D., presenting author and professor and director of the
Rheumatology Clinic in the Division of Immunology and Rheumatology,
Stanford University. "This new data
shows the potential impact ixekizumab, if approved, could have for
PsA patients."
The observed safety profile was consistent with initial findings
from the double-blind treatment period of the SPIRIT-P2 study.
During the extension period, the majority of treatment-emergent
adverse events were mild or moderate in severity, including
injection site reaction, upper respiratory infection,
nasopharyngitis and sinusitis. Serious adverse events occurred in
15 patients in the extension period, including one
death.
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. Lilly also
submitted Taltz to the European Medicines Agency (EMA) for the
treatment for 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.
About the SPIRIT-P2 Extension
During the initial
24-week, double-blind treatment period of the SPIRIT-P2 study,
patients were randomly assigned to placebo, 80-mg of Taltz once
every two weeks or 80-mg of Taltz once every four weeks (both Taltz
dosing groups following a 160-mg starting dose). Patients were
required to have a diagnosis of PsA for at least six months, at
least three tender and swollen joints and a previous intolerant or
inadequate response to TNF inhibitors.
Following completion of the double-blind treatment period,
patients who received treatment with Taltz continued the same
dosing regimen during the extension period to evaluate response
rates up to 156 weeks. Patients who received placebo during the
double-blind treatment period were re-randomized at 16 or 24 weeks
to receive 80-mg of Taltz every two weeks or four weeks (following
a 160-mg starting dose).
During the extension period, the primary endpoint was the
percentage of patients achieving at least a 20-percent improvement
in a composite measure of disease activity, as defined by the ACR
20.1 This study also evaluated secondary endpoints
including ACR 50 and ACR 70, which represent 50-percent and
70-percent improvements 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).
Other warnings and precautions for Taltz include pre-treatment
evaluation for tuberculosis, hypersensitivity reactions,
inflammatory bowel disease and immunizations. See Important Safety
Information below.
INDICATIONS AND USAGE FOR TALTZ
Taltz® is indicated for the treatment of adults 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.
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 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
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 18JUL2017
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-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 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 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 potential treatment for
psoriatic arthritis, 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 October 17, 2017.
2 About psoriatic arthritis. National Psoriasis
Foundation website.
https://www.psoriasis.org/about-psoriatic-arthritis. Accessed
October 17, 2017.
3 What is psoriatic arthritis? Arthritis Foundation
website.
http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php.
Accessed October 17, 2017.
4 Classification of psoriatic arthritis. National
Psoriasis Foundation website.
https://www.psoriasis.org/psoriatic-arthritis/classification-of-psoriatic-arthritis.
Accessed October 17, 2017.
Refer to:
Danielle
Neveles, danielle.neveles@lilly.com, 317-796-4564 (Lilly
media)
Phil Johnson,
johnson_philip_l@lilly.com, 317-655-6874 (Lilly investors)
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