INDIANAPOLIS, Feb. 19, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that patients with
moderate-to-severe genital psoriasis treated with Taltz®
(ixekizumab) reported a greater decrease in the impact of their
condition on sexual activity compared to placebo after 12 weeks of
treatment. Results from the Phase 3b
trial will be presented in an oral presentation today at the annual
meeting of the American Academy of Dermatology, taking place
February 16-20, in San Diego,
Calif.
"Over the course of their disease, up to 63 percent of psoriasis
patients experience genital psoriasis, which can be difficult to
treat and can have a significant impact on their sexual health,"
said Dr. Lotus Mallbris, vice president, immunology platform team
leader, product development. "We look forward to fostering a
discussion at AAD about the need for healthcare providers to
address this important issue affecting people living with
psoriasis."
In the study, 149 patients with moderate-to-severe genital
psoriasis were randomized to receive Taltz (80 mg every two weeks,
following a 160-mg starting dose) or placebo. The impact of genital
psoriasis on sexual activity was measured at 12 weeks by
pre-specified patient-reported outcomes, including the Genital
Psoriasis Sexual Impact Scale (GPSIS), which is composed of the
Sexual Activity Avoidance (Avoidance) and Impact of Sexual Activity
on Genital Psoriasis Symptoms (Impact) subscales. Patient-reported
outcomes were also measured by the Sexual Frequency Questionnaire
(SFQ) item 2, evaluating the impact of genital psoriasis on the
frequency of sexual activity, and the Dermatology Life Quality
Index (DLQI) item 9, evaluating the impact of skin symptoms on
sexual difficulties.
At 12 weeks, patients reported the following outcomes:
- DLQI Item 9 0/1: 92.0 percent of patients treated with
Taltz compared to 56.8 percent of patients treated with placebo
(p<0.001) reported no (0) or little (1) sexual difficulties
caused by skin symptoms.
- SFQ Item 2 0/1: 78.4 percent of patients treated with
Taltz compared to 21.4 percent of patients treated with placebo
(p<0.001) reported the frequency of sexual activity was either
never (0) or rarely (1) limited by genital psoriasis.
- GPSIS-Avoidance 1/2: 76.7 percent of patients treated
with Taltz compared to 25.7 percent of patients treated with
placebo (p<0.001) reported never (1) or rarely (2) avoiding
sexual activity due to genital psoriasis.
- GPSIS-Impact 1/2: 85.7 percent of patients treated with
Taltz compared to 52.9 percent of patients treated with placebo
(p=0.062) reported worsening of genital psoriasis symptoms during
or after sexual activity was very low/none at all (1) or low
(2).
Taltz was superior to placebo as early as week one on the
limitations on frequency of sexual activity due to genital
psoriasis (p<0.05), week two for the sexual difficulties caused
by skin symptoms (p<0.001).
"Genital psoriasis can be an uncomfortable and burdensome
condition for patients to manage," said Jennifer Clay Cather, M.D., Modern Research
Associates, Dallas, Texas. "This
condition can have a significant impact on patients' sexual health
and experience."
The most common (≥4 percent) adverse events observed in patients
treated with Taltz in this study were upper respiratory tract
infections, injection-site reactions, headache, oropharyngeal pain
and pruritus. The safety outcomes were consistent with the overall
safety profile of Taltz.
Taltz was first approved by the FDA in March 2016 for the
treatment of adult patients with moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or phototherapy.
In December 2017, Taltz was also approved for the treatment of
adults with active psoriatic arthritis.
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 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 Up to 63 percent of
psoriasis patients experience genital psoriasis over the course of
their disease.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 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) in patients with moderate-to-severe
plaque psoriasis, who also have psoriasis in the genital area, and
reflects Lilly's current belief. Lilly considers patients with
genital psoriasis as a sub-population of patients with
moderate-to-severe plaque psoriasis. 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 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 Psoriasis media kit. National Psoriasis Foundation
website.
https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf.
Accessed February 19, 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 19, 2018.
3 Ryan C, et al. J Am Acad Dermatol. 2015;72:978-983
Refer to:
Danielle Neveles,
danielle.neveles@lilly.com; 317-796-4564 (Lilly media)
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 (Lilly investors)
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SOURCE Eli Lilly and Company