INDIANAPOLIS, April 20, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that the investigational
medicine ixekizumab was statistically superior to placebo in the
treatment of patients with active psoriatic arthritis (PsA), as
demonstrated by the proportion of patients achieving an ACR 20
response. ACR 20 is a standard assessment that represents a 20
percent reduction in disease signs and symptoms as defined by the
American College of Rheumatology response criteria. During the
24-week, Phase 3 study, titled SPIRIT-P1, patients who were naïve
to biologic disease-modifying antirheumatic drugs (bDMARD) were
treated with one of two different ixekizumab dosing regimens or
placebo. In both dosing regimens, ixekizumab-treated patients
demonstrated significant improvements versus placebo in signs and
symptoms of active PsA.
PsA is a progressive, chronic and destructive disease that can
cause swelling, stiffness and pain in and around the joints, nail
changes, and impaired physical function. It is one of the most
common rheumatic arthritides, occurring within 0.3 to 1 percent of
the general population, and in up to approximately 30 percent of
people with psoriasis1,2.
"Psoriatic arthritis is a debilitating disease associated with
progressive joint damage and skin involvement, and also has a
significant impact on a person's quality of life," said
J. Anthony Ware, M.D., senior vice
president, Lilly Bio-Medicines Product Development. "These results
strengthen our belief that ixekizumab may have the potential to
help people confronting this challenging disease."
In SPIRIT-P1, the incidence of treatment-emergent adverse events
was more frequent with ixekizumab compared with placebo. The most
common adverse events observed were consistent with the Phase 3
studies of ixekizumab for the treatment of moderate-to-severe
plaque psoriasis. The rates of serious adverse events with
ixekizumab treatment were similar to placebo. Discontinuation rates
due to adverse events were similar between treatment groups.
Lilly plans to submit detailed data from the SPIRIT-P1 study for
disclosure at scientific meetings and in peer-reviewed
journals.
About the SPIRIT-P1 Study
SPIRIT-P1 is a Phase
3 randomized, active- and placebo-controlled study examining the
effect of ixekizumab compared with placebo in patients with
active PsA who are bDMARD-naïve. Patients were required to have an
established diagnosis of PsA and active disease for at least six
months. During the study, ixekizumab-treated patients
received a starting dose of 160 mg administered subcutaneously
(SC), 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. Adalimumab at the approved dose of 40 mg
SC and regimen of every other week was selected as the active
control for comparison with placebo. The SPIRIT-P1 study will also
evaluate the long-term efficacy and safety of ixekizumab in PsA for
up to three years.
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), which research has shown can contribute to autoimmune
diseases, including PsA and psoriasis. Ixekizumab does not bind to
cytokines IL-17B, IL-17C, IL-17D, IL-17E or IL-17F and is
administered via subcutaneous injection (under the skin).
Ixekizumab is also in clinical development for the treatment of
moderate-to-severe plaque psoriasis.
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 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 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.
1 Gladman DD, Antoni C, Mease P, et al. Psoriatic
arthritis: epidemiology, clinical features, course, and outcome.
Ann Rheum Dis. 2005; 64:ii14-ii17.
2 National Psoriasis Foundation, Psoriatic Arthritis
Fact Sheet, June 2013
Refer
to:
|
Tim Coulom;
tim.coulom@lilly.com; 317-771-2241 (media)
|
|
Philip Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (investors)
|
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SOURCE Eli Lilly and Company