ME NewsWire/Business Wire
BOUDRY, Switzerland. - Friday, June 13th 2014
Clinically
meaningful improvements in measures of disease activity with OTEZLA
seen at week 16 and were sustained for up to 52 weeks of treatment
OTEZLA
demonstrated a consistent safety profile with no clinically meaningful
changes in laboratory measurements across three PALACE phase III studies
of 1,493 patients over 52 weeks
OTEZLA increased work productivity compared with placebo based on a separate 16-week analysis of PALACE 1
EULAR 2014
Celgene
International Sàrl, a wholly-owned subsidiary of Celgene Corporation
(NASDAQ:CELG), today announced results of additional analyses from the
phase III clinical trials of OTEZLA, the Company’s oral, selective
inhibitor of phosphodiesterase 4 (PDE4). These included long-term
(52-week) analyses from the PALACE 1, 2 and 3 trials of the impact of
OTEZLA on psoriatic arthritis disease activity, safety and tolerability,
in addition to a separate 16-week work productivity analysis from
PALACE 1. The findings were presented at the European League Against
Rheumatism Annual Congress (EULAR 2014) in Paris, France.
“People
with psoriatic arthritis live with persistent symptoms of this painful
disease,” said Georg Schett, M.D., Ph.D., director of the Department of
Internal Medicine III - Rheumatology and Immunology, University Hospital
Erlangen, Germany. “These analyses of one-year data from the PALACE
trials suggest that, based on the efficacy and safety data we’ve seen
to-date, OTEZLA has the potential to help patients for the long-term
management of manifestations of their psoriatic arthritis.”
PALACE 1, PALACE 2 and PALACE 3: Measures of Disease Activity
Long-term
(52-week) results from three studies demonstrated that treatment with
OTEZLA improved measures of psoriatic arthritis disease activity,
including tender and swollen joints, compared with placebo at 16 weeks.
Disease activity was evaluated using the Disease Activity Score of 28
joint counts (DAS-28), as measured by the level of C-reactive protein
(CRP), modified Psoriatic Arthritis Response Criteria (PsARC) response
and good or moderate European League Against Rheumatism (EULAR)
response. All three measurements of disease activity demonstrated
sustained improvements through week 52 among patients who were
continuously treated with OTEZLA.
PALACE 1, PALACE 2 and PALACE 3: Pooled 52-week Safety Data
Long-term
safety results from an analysis of pooled data from the PALACE 1, 2 and
3 trials (including 1,493 patients) identified no new safety findings
for patients with psoriatic arthritis who were treated with OTEZLA for
up to 52 weeks, compared with the previously reported 24-week safety
results. The nature, incidence and severity of adverse events (AEs) were
comparable through the 24-week and 52-week periods.
Most AEs
were mild or moderate in severity. Discontinuation due to AEs was low
(OTEZLA 20 mg BID, 7.5 percent; OTEZLA 30 mg BID, 8.3 percent) and
primarily occurred in the first 24 weeks of treatment. The incidence and
severity of AEs were comparable through the 24-week and 52-week
periods. The most commonly reported AEs were nausea, diarrhea, headache,
upper respiratory tract infection and nasopharyngitis. Serious AEs
occurred in 6.8 percent of patients receiving OTEZLA 20 mg BID and 7.2
percent of patients receiving OTEZLA 30 mg BID. One death occurred
(OTEZLA 20 mg BID) due to multiorgan failure not suspected to be
treatment-related.
Exposure-adjusted incidence rates per 100
subject years of major adverse cardiac events, serious infections,
including opportunistic infections or malignancies, were comparable with
those of placebo.
Similar to 24-week data previously reported
from PALACE 1, 2 and 3, the 52-week data do not indicate a need for
laboratory monitoring with OTEZLA treatment.
PALACE 1: Work Productivity
The
results of a work productivity analysis of 261 patients from PALACE 1
demonstrated that treatment with OTEZLA increased work productivity and
improved work limitations compared with placebo at 16 weeks. Patients in
this study completed the Work Limitation Questionnaire (WLQ)—a 25-item
questionnaire that assessed the impact of chronic health conditions on
work performance and productivity—at baseline and week 16. Four
categories of work limitations, physical demands, mental demands, time
management demands and output demands, were used to calculate the WLQ
index.
About PALACE Program
PALACE 1, 2 and 3 are the
pivotal phase III multi-center, double-blind, placebo-controlled,
parallel-group studies with two active-treatment groups. Across these
studies, approximately 1,500 patients were randomized 1:1:1 to receive
either OTEZLA 20 mg twice daily, OTEZLA 30 mg twice daily or
identically-appearing placebo, for 16 weeks. At week 16, some
placebo-treated patients were randomized to one of the two OTEZLA
groups, while others remained on placebo through week 24. After week 24,
patients began a subsequent long term, open-label, active treatment
phase. The PALACE 1, 2 and 3 studies included a wide spectrum of
patients with active psoriatic arthritis, including those who had been
previously treated with oral disease-modifying antirheumatic drugs
(DMARDs), and/or biologics, with some patients who had previously failed
a tumor necrosis factor (TNF) blocker.
The primary endpoint of
the PALACE 1, 2, and 3 studies was the modified American College of
Rheumatology criteria for 20 percent improvement (ACR20) at week 16.
Secondary endpoints included other measures of signs and symptoms of
psoriatic arthritis, physical functioning, and patient-reported
outcomes.
Taken together, the PALACE program is the largest psoriatic arthritis program to date intended for regulatory submission.
OTEZLA
was approved on March 21, 2014 by the U.S. Food and Drug Administration
(FDA) for the treatment of adults with active psoriatic arthritis. A
combined psoriatic arthritis/psoriasis Marketing Authorization
Application (MAA) in Europe was submitted to health authorities in the
fourth quarter of 2013.
To learn more about OTEZLA visit www.otezla.com.
About OTEZLA
OTEZLA
is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4)
specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition
results in increased intracellular cAMP levels.
Important Safety Information
INDICATION
OTEZLA® (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
Contraindications
OTEZLA
is contraindicated in patients with a known hypersensitivity to
apremilast or to any of the excipients in the formulation.
Warnings and Precautions
Depression:
Treatment with OTEZLA is associated with an increase in adverse
reactions of depression. During clinical trials, 1.0% (10/998) of
patients treated with OTEZLA reported depression or depressed mood
compared to 0.8% (4/495) treated with placebo; 0.3% (4/1441) of patients
treated with OTEZLA discontinued treatment due to depression or
depressed mood compared with none in placebo treated patients (0/495).
Depression was reported as serious in 0.2% (3/1441) of patients exposed
to OTEZLA, compared to none in placebo treated patients (0/495).
Suicidal ideation and behavior were observed in 0.2% (3/1441) of
patients on OTEZLA, compared to none on placebo (0/495). Two patients
who received placebo committed suicide compared to none on OTEZLA.
Carefully
weigh the risks and benefits of treatment with OTEZLA for patients with
a history of depression and/or suicidal thoughts/behavior, or in
patients who develop such symptoms while on OTEZLA. Patients,
caregivers, and families should be advised of the need to be alert for
the emergence or worsening of depression, suicidal thoughts or other
mood changes, and they should contact their healthcare provider if such
changes occur.
Weight Decrease: Body weight loss of 5-10% was
reported in 10% of patients taking OTEZLA and in 3.3% of patients taking
placebo. Monitor body weight regularly; evaluate unexplained or
clinically significant weight loss, and consider discontinuation of
OTEZLA.
Drug Interactions: Apremilast exposure was decreased when
OTEZLA was co-administered with rifampin, a strong CYP450 enzyme
inducer; loss of OTEZLA efficacy may occur. Concomitant use of OTEZLA
with CYP450 enzyme inducers (eg, rifampin, phenobarbital, carbamazepine,
phenytoin) is not recommended.
Adverse Reactions
Adverse
reactions reported in at least 2% of patients taking OTEZLA, that
occurred at a frequency at least 1% higher than that observed in
patients taking placebo, for up to 16 weeks (after the initial 5-day
titration), were (OTEZLA%, placebo%): diarrhea (7.7, 1.6); nausea (8.9,
3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8);
vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain
(2.0, 0.2).
Use in Specific Populations
Pregnancy and
Nursing Mothers: OTEZLA is Pregnancy Category C; it has not been studied
in pregnant women. Use during pregnancy only if the potential benefit
justifies the potential risk to the fetus. It is not known whether
apremilast or its metabolites are present in human milk. Caution should
be exercised when OTEZLA is administered to a nursing woman.
Renal
Impairment: OTEZLA dosage should be reduced in patients with severe
renal impairment (creatinine clearance less than 30 mL/min); for
details, see Dosage and Administration, Section 2, in the Full
Prescribing Information.
Please click here for Full Prescribing Information.
About Psoriatic Arthritis
Psoriatic
arthritis is a painful, chronic inflammatory disease characterized by
pain, stiffness, swelling and tenderness of the joints, inflammation of
specific ligaments and tendons, and decrease in physical functioning. It
is estimated that nearly 38 million people worldwide have psoriatic
arthritis. Psoriatic arthritis can impact day-to-day activities and has
been reported to increase work disability. Common signs and symptoms of
psoriatic arthritis include pain, stiffness, and swelling in joints. To
learn more about psoriatic arthritis, go towww.discoverpsa.com. To learn
more about the role of PDE4 in inflammatory diseases, go to
www.discoverpde4.com.
About Celgene
Celgene International
Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and
international headquarters of Celgene Corporation. Celgene Corporation,
headquartered in Summit, New Jersey, is an integrated global
pharmaceutical company engaged primarily in the discovery, development
and commercialization of innovative therapies for the treatment of
cancer and inflammatory diseases through gene and protein regulation.
For more information, please visit www.celgene.com.
Forward-Looking Statements
This
press release contains forward-looking statements, which are generally
statements that are not historical facts. Forward-looking statements can
be identified by the words “expects,” “anticipates,” “believes,”
“intends,” “estimates,” “plans,” “will,” “outlook” and similar
expressions. Forward-looking statements are based on management’s
current plans, estimates, assumptions and projections, and speak only as
of the date they are made. We undertake no obligation to update any
forward-looking statement in light of new information or future events,
except as otherwise required by law. Forward-looking statements involve
inherent risks and uncertainties, most of which are difficult to predict
and are generally beyond our control. Actual results or outcomes may
differ materially from those implied by the forward-looking statements
as a result of the impact of a number of factors, many of which are
discussed in more detail in our Annual Report on Form 10-K and other
reports filed with the Securities and Exchange Commission.
Contacts
Celgene Corporation
Investors:
Patrick E. Flanigan III, 908-673-9969
Vice President, Investor Relations
Media:
Catherine Cantone, 732-564-3592
Director, Corporate Communications
Permalink: http://www.me-newswire.net/news/11321/en
No comments:
Post a Comment