INDIANAPOLIS, Feb. 14, 2018 /PRNewswire/
-- Eli Lilly and Company (NYSE: LLY) announced
that it will present new data for Taltz® (ixekizumab),
baricitinib and mirikizumab at the American Academy of Dermatology
(AAD) annual meeting taking place Feb.
16-20, 2018, in San Diego,
Calif.
The data include eight abstracts for Taltz, featuring two oral
presentations highlighting patient-reported outcomes from a Phase 3
clinical trial evaluating Taltz for the treatment of
moderate-to-severe genital psoriasis, as well as findings from the
Corrona Psoriasis Registry on Taltz patient clinical
characteristics and treatment history. Two abstracts evaluating the
efficacy and safety of Taltz for the treatment of active psoriatic
arthritis will also be presented.
Additionally, Lilly will present Phase 2 efficacy, safety and
patient-reported outcomes data for mirikizumab in
moderate-to-severe plaque psoriasis. Lilly will also present a
late-breaker abstract on patient-reported outcomes data from a
Phase 2 study evaluating baricitinib for the treatment of
moderate-to-severe atopic dermatitis (Lilly and Incyte Corporation
are partners in the development of baricitinib). One abstract from
the Closer Together Survey, a survey where nearly 2,000 people
with moderate-to-severe psoriasis from 17 countries
cross Europe and Canada shared how psoriasis
impacts their quality of life and their overall satisfaction with
treatment, will also be presented. An additional three abstracts
will detail results from studies investigating immune-mediated
diseases.
"The data being presented at AAD demonstrates our commitment to
developing treatment advancements to help patients with severe
diseases such as psoriasis and atopic dermatitis find relief," said
Lotus Mallbris, M.D., vice president, immunology platform team
leader, Lilly Bio-Medicines. "We are pleased to share data
underscoring the potential of our immunology portfolio."
Studies, as well as the times and locations of the data
sessions, are highlighted below.
Taltz Data
Oral Presentations
Saturday, Feb. 17
- Abstract #6061: 11:25–11:30 a.m. PST, ePoster Presentation
Center 2
-
- Ixekizumab Patient Clinical Characteristics and Treatment
History in Routine Clinical Practice: Findings from the Corrona
Psoriasis Registry
- Presenter: Jashin J. Wu, M.D.,
Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA
Monday, Feb. 19
- Abstract #5935: 10:41–10:49 a.m. PST, Room 1A
-
- Ixekizumab Provides Greater Improvement Versus Placebo on the
Impact of Genital Psoriasis on Sexual Activity for Patients with
Moderate-to-Severe Genital Psoriasis in a Randomized, Double-Blind
Phase 3b Clinical Trial
- Presenter: Jennifer Clay Cather,
M.D., Modern Research Associates, Dallas,
TX
Posters
- Abstract #6037: Ixekizumab Provides Rapid and Greater
Improvement of the Symptoms of Genital Psoriasis Compared to
Placebo in a Randomized, Double-Blind, Phase 3b Clinical Trial
-
- Lead author: Gil Yosipovitch, M.D., University of Miami, Miami, FL
- Abstract #6041: Ixekizumab Improves Nail and Skin Lesions
through 52 Weeks in Patients with Active Psoriatic Arthritis and
Inadequate Response to Tumor Necrosis Factor Inhibitors
-
- Lead author: Joseph F. Merola,
M.D., Harvard Medical School and
Brigham and Women's Hospital, Boston,
MA
- Abstract #6062: Ixekizumab Patient Demographics and
Self-Reported Burden in Routine Clinical Practice: Findings from
the Corrona Psoriasis Registry
-
- Lead author: Jashin J. Wu, M.D.,
Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA
- Abstract #6581: Long-Term Efficacy and Safety of Ixekizumab for
the Treatment of Moderate-to-Severe Plaque Psoriasis Sustained for
3 Years: Results of a Randomized, Controlled Phase 3 Study
(UNCOVER-3)
-
- Lead author: Craig Leonardi,
M.D., St. Louis University School of
Medicine, St. Louis, MO
- Abstract #6587: Ixekizumab Reduces Disease Activity up to 52
Weeks in Active Psoriatic Arthritis Patients with Inadequate
Response to Tumor Necrosis Factor Inhibitors: An Assessment Using
Minimal Disease Activity Scores
-
- Lead author: Joseph F. Merola,
M.D., Harvard Medical School and
Brigham and Women's Hospital, Boston,
MA
- Abstract #7534: Ixekizumab Provides Greater Cumulative Benefits
Versus Ustekinumab over 24 Weeks for Patients with
Moderate-to-Severe Psoriasis in a Randomized, Double-Blind Phase
3b Clinical Trial
-
- Lead author: Andrew Blauvelt,
M.D., M.B.A., Oregon Medical Research Center, Portland, OR
Baricitinib Data
Late-Breaker Presentation
Saturday, Feb. 17
- Abstract F061: 1 p.m. –
3 p.m. PST, Ballroom 20A
-
- Patient-Reported Outcomes from a Phase 2 Double-Blinded,
Randomized, Multi-Center, Placebo-Controlled Study of Baricitinib
in Adult Patients with Moderate-to-Severe Atopic Dermatitis
- Presenter: Emma Guttman-Yassky,
M.D., Ph.D., Icahn School of Medicine, Mount Sinai Medical Center,
New York, NY
Mirikizumab Data
Poster
- Abstract #6131: Efficacy, Safety and Quality of Life in
Patients with Moderate-to-Severe Plaque Psoriasis Treated with
Mirikizumab (LY3074828) in a Phase 2 Study
-
- Lead author: Phoebe Rich, M.D.,
Oregon Dermatology & Research Center, Portland, OR
Additional Data
Posters
- Abstract #6109: The Impact of Psoriasis on Quality of Life in
Europe and Canada
-
- Lead author: Prof. Manuelle
Viguier, Centre Hospitalier Universitaire de Reims, Reims,
France
- Abstract #6110: Demographics and Disease Burden of Patients on
IL-17A Inhibitors as Compared to Other Biologics: Data from the
Corrona Psoriasis Registry
-
- Lead author: Jashin J. Wu, M.D.,
Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA
- Abstract #6459: Prevalence of Inflammatory Bowel Disease among
Patients Enrolled in the Corrona Psoriasis Registry
-
- Lead author: Elsie Grace, Ph.D.,
Eli Lilly and Company, Indianapolis,
IN
- Abstract #7086: Patient Perspective on the Burden of Skin and
Joint Symptoms of Psoriatic Arthritis: Results of a Multi-National
Patient Survey
-
- Lead author: Joseph F. Merola,
M.D., Harvard Medical School and
Brigham and Women's Hospital, Boston,
MA
INDICATIONS AND USAGE FOR TALTZ
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 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 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
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. 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. 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 see accompanying Prescribing Information
and Medication Guide. Please see
Instructions for Use included with the device.
IX HCP ISI 01DEC2017
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 Baricitinib
Baricitinib is a once-daily oral JAK
inhibitor currently in clinical studies for inflammatory and
autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2,
JAK3 and TYK2. JAK-dependent cytokines have been implicated in the
pathogenesis of a number of inflammatory and autoimmune diseases,
suggesting that JAK inhibitors may be useful for the treatment of a
broad range of inflammatory conditions, including rheumatoid
arthritis and atopic dermatitis.
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of baricitinib
and certain follow-on compounds for patients with inflammatory and
autoimmune diseases. Baricitinib was submitted for regulatory
review seeking marketing approval for the treatment of rheumatoid
arthritis in the U.S., the European Union and Japan in 2016. Baricitinib was approved in the
EU in February 2017 and in
Japan in July 2017. In April
2017, the U.S. Food and Drug Administration issued a
Complete Response Letter on the New Drug Application for
baricitinib. In January 2018 the FDA
has accepted the resubmission of baricitinib for rheumatoid
arthritis. The resubmission package included new safety and
efficacy data. Baricitinib remains under review in other markets.
It is also being studied for the treatment of atopic dermatitis and
systemic lupus erythematosus.
About Mirikizumab
Mirikizumab is a humanized IgG4
monoclonal antibody that binds to the P19 subunit of interleukin
23. Mirikizumab is being studied for the treatment of immune
diseases, including psoriasis, ulcerative colitis and Crohn's
disease.
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is
a chronic, immune disease that affects the
skin.1 It occurs when the immune system sends
out faulty signals that speed up the growth cycle of skin
cells. Psoriasis affects approximately 125 million people
worldwide, approximately 20 percent of whom have moderate-to-severe
plaque psoriasis.1,2 Psoriasis can occur on any part of
the body, including the genital area.1 Between 32
percent and 63 percent of patients with plaque psoriasis have or
will develop psoriasis in the genital area.3 The most
common form of psoriasis, plaque psoriasis, appears as raised, red
patches covered with a silvery white buildup of dead skin
cells.1 Patients with plaque psoriasis often have other
serious health conditions, such as diabetes and heart
disease.1
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.4 It occurs when an
overactive immune system sends out faulty signals that cause
inflammation, leading to swollen and painful joints and
tendons.6 Psoriatic arthritis can affect peripheral
joints in the arms and legs (elbows, wrists, hands and
feet).6 If left untreated, PsA can cause permanent joint
damage.6 Up to 30 percent of people with psoriasis also
develop PsA.6
About Atopic Dermatitis
Atopic dermatitis (AD), a
serious form of eczema, is a chronic, relapsing skin disease
characterized by intense itching, dry skin and inflammation that
can be present on any part of the body.5 AD is a
heterogeneous disease both clinically and biologically, but may be
characterized by chronic baseline symptoms of itch, redness and
skin damage that are often punctuated with episodic, sometimes
unpredictable, flares or exacerbations.6,7 AD affects
approximately 1-3 percent of adults worldwide.8
Moderate-to-severe AD is characterized by intense itching,
resulting in visibly damaged skin and sleep loss.9 Like
other chronic inflammatory diseases, AD is immune-mediated and
involves a complex interplay of immune cells and inflammatory
cytokines.10
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.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization
of proprietary therapeutics. For additional information on Incyte,
please visit the Company's web site at www.incyte.com.
Follow @Incyte on Twitter
at https://twitter.com/Incyte.
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 active psoriatic arthritis,
and as a potential treatment for moderate-to-severe genital
psoriasis; and mirikizumab as a potential treatment for
moderate-to-severe plaque psoriasis, and reflects Lilly's current
belief. This press release also contains forward-looking statements
(as that term is defined in the Private Securities Litigation
Reform Act of 1995) about baricitinib as a potential treatment for
moderate-to-severe atopic dermatitis, and reflects Lilly's
and Incyte's current belief. 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 future study results will be
consistent with the results to date, that Taltz, baricitinib or
mirikizumab will receive additional regulatory approvals, or be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's and Incyte'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 and Incyte undertake no duty to update
forward-looking statements to reflect events after the date of this
release.
1 Psoriasis media kit. National Psoriasis
Foundation website.
https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf.
Accessed February 14, 2018.
2 Skin Conditions by the Numbers. American
Academy of Dermatology website.
https://www.aad.org/media/stats/conditions/skin-conditions-by-the-numbers.
Accessed February 14, 2018.
3 Cather JC, Ryan C, Meeuwis, K et al.
Patients' Perspectives on the Impact of Genital Psoriasis: A
Qualitative Study. Dermatology Therapy. 2017 Dec; 7(4):
447–461.
4 Ritchlin C, et. al. Psoriatic Arthritis.
New England Journal of Medicine. 2017;376:957-70.
5 Zuberbier T, Orlow SJ, Paller AS, et al.
Patient perspectives on the management of atopic dermatitis. The
Journal of Allergy and Clinical Immunology. 2006;118:
226-32.
6 Thijs JL, Strickland I, Bruijnzeel-Koomen C,
et. al. Moving toward endotypes in atopic dermatitis:
identification of patient clusters based on serum biomarker
analysis. The Journal of Allergy and Clinical Immunology.
2017.
7 Langan SM, Thomas
KS, Williams HC. What is meant by "flare" in atopic
dermatitis? A systematic review and proposal. Arch Dermatol.
2006;142:1190-1196.
8 Nutten S. Atopic dermatitis: global
epidemiology and risk factors. Annals of Nutrition and
Metabolism. 2015;66(suppl 1): 8-16.
9 Yosipovitch G, Papoiu AD. What causes itch in
atopic dermatitis? Current Allergy and Asthma Reports.
2008;8:306-311.
10 Weidinger, S, Novak, N. Atopic dermatitis.
The Lancet Volume 387. 2016;10023:1109-1122.
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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