INDIANAPOLIS, June 10, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that detailed results of two
pivotal Phase III studies for ixekizumab were published by The
Lancet. The UNCOVER-2 and UNCOVER-3 clinical studies of more
than 2,500 patients found ixekizumab to be statistically superior
to etanercept and placebo on all measures of skin clearance.
Patients treated with ixekizumab also demonstrated significant and
meaningful improvements in health-related quality-of-life measures.
Ixekizumab is the company's investigational medicine for the
treatment of moderate-to-severe plaque psoriasis.
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"These studies show ixekizumab – at two different dosing
regimens – performed significantly better than etanercept or
placebo, inducing a rapid and high level of psoriasis plaque
resolution for patients with moderate-to-severe disease," said
Christopher Griffiths, M.D., FRCP,
professor of dermatology at The University of Manchester, U.K. and primary study
investigator. "Importantly, these clinical results were accompanied
by significant improvements to patient quality of life, and were
achieved with a safety profile comparable to etanercept in these
studies."
In each study, co-primary efficacy objectives assessed whether
ixekizumab administered once every two weeks or once every four
weeks was superior to etanercept and placebo after twelve weeks, as
measured by a Psoriasis Area and Severity Index reduction of at
least 75 percent (PASI 75) and a Static Physician Global Assessment
score of clear or minimal (sPGA 0/1).
PASI is a measure used by healthcare professionals to determine
the severity of psoriasis, including redness, thickness, scaling
and the extent of psoriasis coverage. A PASI 75 score signals at
least a 75 percent reduction in a patient's psoriasis from their
baseline assessment. The sPGA is the physician's assessment of
severity of a patient's psoriasis lesions overall at a specific
point in time.
"The results of UNCOVER-2 and UNCOVER-3 provide a strong reason
to believe that, if approved, ixekizumab may help patients
treat their moderate-to-severe psoriasis quickly and effectively,"
said Brian J. Nickoloff, M.D.,
Ph.D., senior medical fellow, Lilly Bio-Medicines. "We saw
clinically-meaningful improvements in skin clearance as early as
week one of treatment with ixekizumab, and with approximately 40
percent of patients achieving complete skin clearance at 12 weeks,
we're hopeful clear skin may be attainable for more people living
with this hard-to-treat disease."
Rapid Onset of Efficacy; High Levels of Skin
Clearance
In both studies and at both dosing regimens, ixekizumab achieved
superiority to etanercept and placebo for PASI 75 at week 12, with
statistically significant differences seen as early as the first
week of the studies. Approximately 50 percent of all
ixekizumab-treated patients achieved PASI 75 by week four.
Patients treated with ixekizumab also achieved higher rates of
skin clearance as measured by PASI 90 and PASI 100 compared with
etanercept and placebo. PASI 90 reflects at least a 90 percent
reduction in psoriasis symptoms, while PASI 100 is the highest
possible reduction, representing complete skin clearance. Patients
treated with ixekizumab were five to seven times more likely to
achieve a PASI 100 score than with etanercept. At the end of the
12-week study period, patients achieved PASI 90 and PASI 100 at the
following rates:
- Patients receiving ixekizumab every two weeks: 71 percent in
UNCOVER-2 and 68 percent in UNCOVER-3 achieved PASI 90; 41 percent
in UNCOVER-2 and 38 percent in UNCOVER-3 achieved PASI 100;
- Patients receiving ixekizumab every four weeks: 60 percent in
UNCOVER-2 and 65 percent in UNCOVER-3 achieved PASI 90; 31 percent
in UNCOVER-2 and 35 percent in UNCOVER-3 achieved PASI 100;
- Patients receiving etanercept: 19 percent in UNCOVER-2 and 26
percent in UNCOVER-3 achieved PASI 90; 5 percent in UNCOVER-2 and 7
percent in UNCOVER-3 achieved PASI 100.
Quality-of-Life Measures Significantly Improved
Clinical improvements in ixekizumab-treated patients were
accompanied by rapid improvements in health-related quality-of-life
measures. Nearly 60 percent of ixekizumab-treated patients reported
that their psoriasis had no impact on their quality of life by week
12 as measured by the Dermatology Life Quality Index (DLQI). The
DLQI is a standardized tool that evaluates how psoriasis affects
various aspects of a person's quality of life, including itching,
ability to conduct daily activities, and relationships and
intimacy.
In a separate, pre-specified analysis evaluating patients that
had achieved PASI 100, 78 percent in UNCOVER-2 and 85 percent in
UNCOVER-3 reported the disease had no impact to their quality of
life as measured by the DLQI.
"Psoriasis is more than just a condition that affects the skin;
it affects a person's relationships with friends and families,
their day-to-day activities and, in many cases, other aspects of
their health," said Aarti Shah,
Ph.D., global brand development leader, Lilly Bio-Medicines. "Based
on these study results, we believe ixekizumab, if approved, could
offer those with moderate-to-severe psoriasis a treatment choice
that may improve both the physical and emotional challenges of
psoriasis."
Adverse Events
The overall rates and severities of adverse events observed were
comparable to those for etanercept in the two active comparator
trials. Most Treatment-Emergent Adverse Events (AEs) were mild or
moderate in severity. The most common (≥2 percent)
Treatment-Emergent AEs in ixekizumab-treated patients were upper
respiratory tract infections, injection site reactions, itching,
headache and arthralgia. Serious Adverse Events (SAEs) were
reported by <2 percent of patients, and there were no deaths in
either study. Rates of SAEs and discontinuations due to AEs were
comparable across treatment groups.
About UNCOVER-2 and UNCOVER-3
UNCOVER-2 and UNCOVER-3 are double-blind, multicenter, Phase III
studies evaluating more than 2,500 patients with moderate-to-severe
psoriasis in 18 countries. In these comparator studies, patients
were assigned to receive either placebo, etanercept (50 mg twice a
week) or ixekizumab (80 mg every two or four weeks) for 12 weeks,
following a 160 mg starting dose. Patients enrolled in the
UNCOVER-2 and 3 studies had a confirmed diagnosis of chronic plaque
psoriasis for at least six months prior to randomization.
Additionally, at screening and at randomization, they demonstrated
at least 10 percent Body Surface Area (BSA) of psoriasis, an sPGA
score of at least 3 and PASI score of at least 12.
About Ixekizumab
Ixekizumab is a monoclonal antibody with high affinity and
specificity that binds to and neutralizes the pro-inflammatory
cytokine interleukin-17A (IL-17A). In psoriasis, IL-17A plays a
major role in driving excess keratinocyte (skin cell) proliferation
and activation. Ixekizumab does not bind to cytokines IL-17B,
IL-17C, IL-17D, IL-17E or IL-17F. Ixekizumab is administered via
subcutaneous injection (under the skin). Ixekizumab is also in
clinical development for the treatment of psoriatic arthritis.
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic, noncontagious autoinflammatory disease
that appears on the skin. It occurs when the immune system sends
out faulty signals that speed up the growth cycle of skin
cells.i It is the most common
inflammatory disease in the United
States, affecting as many as 7.5 million Americans and an
estimated 125 million people
worldwide.ii Psoriasis can occur on any
part of the body and is associated with other serious health
conditions, such as diabetes and heart
disease.iii, iv
The most common form of psoriasis, plaque psoriasis, appears as
raised, red patches covered with a silvery white buildup of dead
skin cells. Approximately 17 percent of psoriasis patients have
moderate-to-severe plaque psoriasis.v
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 http://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 ixekizumab as a potential treatment for
moderate-to-severe plaque psoriasis 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 future study results will be similar to the results
to date or that ixekizumab will receive regulatory approvals. 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.
Refer to: Tim Coulom;
tim.coulom@lilly.com; 317-771-2241 (media)
Philip Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (investors)
i National Psoriasis Foundation®, File,
Communications, Psoriasis,
http://www.psoriasis.org/file/communications---all-documents/MediaKit.pdf
(Accessed January 20, 2015).
ii Ibid.
iii Rapp SR, Feldman SR, Exum ML, Fleischer AB,
Reboussin DM. Psoriasis causes as much disability as other major
medical diseases. J Am Acad Dermatol 1999;41:401-7.
iv Kurd SK, et al. The Risk of Depression, Anxiety, and
Suicidality in Patients With Psoriasis. Arch Dermatol.
2010;146(8):891-895.
v National Psoriasis Foundation®, "Psoriasis
Severity," http://psoriasis.org/about-psoriasis/treatments/severity
(Accessed January 20,
2015).
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