Improvements in PASI scores and disease-related
quality of life observed at week 16 were maintained at week 52 in
patients randomized to OTEZLA at baseline and in patients who
switched from etanercept to OTEZLA at week 16
An exploratory analysis suggested improvements
in itching observed at week 16 were also maintained at week 52 in
patients in both groups
No new safety signals or clinically meaningful
changes in laboratory values for OTEZLA identified through week
52
Celgene International Sàrl, a wholly owned subsidiary of Celgene
Corporation (NASDAQ: CELG), today announced that results from its
ongoing phase III LIBERATE™ trial evaluating Otezla®
(apremilast), the Company’s oral, selective inhibitor of
phosphodiesterase 4 (PDE4), in patients with moderate to severe
plaque psoriasis were presented as a late-breaker at the 24th
European Academy of Dermatology and Venereology (EADV) Congress in
Copenhagen, Denmark, October 7-11, 2015.
“Many patients with moderate to severe plaque psoriasis need
treatment options that can help in managing multiple facets of the
disease, including itching and impact on disease-related quality of
life,” said Kristian Reich, M.D., SCIderm Research Institute and
Dermatologikum Hamburg, Germany. “The encouraging findings
presented at EADV add to the growing body of data which suggest
that treatment benefits observed with OTEZLA at week 16 are
maintained through week 52 of treatment.”
The LIBERATE study evaluated the clinical efficacy and safety of
either oral OTEZLA 30 mg twice daily or weekly subcutaneous (SC)
etanercept 50 mg compared with placebo at week 16 in 250 patients
who had no prior exposure to a biological therapy. It also examined
the relative safety of a switch from etanercept to OTEZLA after
week 16 during an open label extension phase. Primary findings were
previously presented at the 73rd Annual Meeting of the American
Academy of Dermatology (AAD) in San Francisco, California. LIBERATE
was not designed or powered to directly compare OTEZLA to
etanercept.
As shown at AAD, at week 16, 40 percent (33/83) of patients
receiving OTEZLA 30 mg twice daily demonstrated statistically
significant and clinically meaningful improvements compared with 12
percent (10/84) of patients on placebo in the primary endpoint,
Psoriasis Area and Severity Index (PASI)-75 response (P<0.0001).
Statistical significance was also achieved for patients receiving
weekly injections of etanercept 50 mg compared with placebo [48
percent (n=40/83) vs. 12 percent (n=10/84), respectively,
P<0.0001].
New findings presented at EADV showed that 51 percent (42/83) of
patients randomized to OTEZLA at baseline and 55 percent of
patients who switched from etanercept to OTEZLA at week 15 (46/83)
achieved PASI-75 at week 52.
Based on an exploratory analysis, OTEZLA also improved pruritus
(itching), one of the most common and bothersome symptoms of
psoriasis, as measured by a visual analog scale (0 mm=no itch at
all; 100 mm=worst itch imaginable). Significantly greater
improvements in itching scores were seen at week 16 for patients
treated with OTEZLA 30 mg twice daily (decrease of 38 mm; 95%
confidence interval [CI]: -45 to -31 mm) compared with placebo
(decrease of 26 mm; CI: -34 to -19 mm). Improvement in pruritus was
observed as early as week 2 in patients receiving OTEZLA. Lower
itching scores were also observed in patients who received weekly
injections of etanercept 50 mg from baseline to week 16.
Improvements in itching were maintained from week 16 to week 52
(decrease of 36 mm) in patients who received OTEZLA from baseline
and in patients who switched from etanercept to OTEZLA at week 16
(decrease of 35 mm).
Treatment with OTEZLA 30 mg twice daily also significantly
improved disease-related quality of life (a secondary endpoint) at
week 16 compared with placebo. OTEZLA showed a mean improvement
from baseline in total Dermatology Life Quality Index (DLQI) score
(decrease of 8.7; CI: -10.5 to -6.9) vs. placebo (decrease of 4.9;
CI: -6.1 to -3.7) at week 16. A decrease in total DLQI scores was
also observed for patients who received weekly injections of
etanercept 50 mg from baseline to week 16.
Total DLQI scores were maintained from week 16 to week 52 in
patients who received OTEZLA from baseline (decrease of 8.9; CI:
-10.8 to -7.0) and in patients who switched from etanercept to
OTEZLA at week 16 (decrease of 8.0; CI: -9.7 to -6.4).
The safety and tolerability data for OTEZLA observed in the
LIBERATE study were generally consistent with previously reported
data from six other phase III studies of OTEZLA in psoriasis or
psoriatic arthritis; no new safety signals were observed. Adverse
events reported in at least five percent of patients taking OTEZLA
in the LIBERATE study were diarrhea, nausea, upper respiratory
tract infection, nasopharyngitis, headache and tension headache. No
new safety or tolerability issues were observed through week 52 in
patients who switched from etanercept to OTEZLA at week 16.
The LIBERATE study is ongoing.
The views expressed and the techniques presented by the speakers
at the 24th EADV Congress in Copenhagen, Denmark are not
necessarily shared or endorsed by the European Academy of
Dermatology and Venereology.
About LIBERATE
LIBERATE (PSOR-010; EvaLuatIon from a PlaceBo-controllEd Study
of ORal ApremilasT and Etanercept in Plaque Psoriasis) is a phase
IIIb, multicenter, randomized, placebo-controlled, double-blind,
double-dummy study of the efficacy and safety of OTEZLA, etanercept
and placebo, in subjects with moderate to severe plaque psoriasis.
The primary objective of the LIBERATE study was to evaluate the
clinical efficacy and safety of oral OTEZLA 30 mg twice daily
compared with placebo at week 16. Secondary objectives of the study
included: the evaluation of the clinical efficacy and safety of
etanercept 50 mg SC once weekly (QW) compared with placebo at week
16 and the evaluation of the relative safety of a crossover from
etanercept to OTEZLA 30 mg twice daily, as compared with OTEZLA
dosed since week 0, after week 16. Subjects were required to have
inadequate response, intolerance or contraindication to at least
one conventional systemic agent and no prior exposure to biologics.
The study enrolled 250 subjects who were randomized 1:1:1 to
receive OTEZLA 30 mg twice daily, etanercept 50 mg QW or placebo,
for 16 weeks. Following the first 16 weeks, all subjects were
switched to (or continued on) OTEZLA 30 mg twice daily through week
104. The primary endpoint was the proportion of subjects with
either OTEZLA 30 mg twice daily or placebo who achieved PASI-75 at
week 16. Secondary endpoints included other measures of disease
activity and quality of life for the comparison of OTEZLA 30 mg
twice daily versus placebo and the comparison of etanercept 50 mg
SC QW versus placebo.
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 which is
thought to indirectly modulate the production of inflammatory
mediators. The specific mechanism(s) by which OTEZLA exerts its
therapeutic action in patients with psoriasis or psoriatic
arthritis is not well defined.
OTEZLA is approved:
- In the European Union:
- For the treatment of moderate-to-severe
chronic plaque psoriasis in adult patients who failed to respond to
or who have a contraindication to, or are intolerant to other
systemic therapy including cyclosporine, methotrexate or psoralen
and ultraviolet-A light (PUVA)
- Alone or in combination with Disease
Modifying Antirheumatic Drugs (DMARDs), for the treatment of active
psoriatic arthritis (PsA) in adult patients who have had an
inadequate response or who have been intolerant to a prior DMARD
therapy
- In Switzerland:
- For the treatment of adult patients
with moderate to severe plaque psoriasis who have not responded to
another systemic therapy or do not tolerate such therapy or where
such therapy is contraindicated
- As monotherapy or in combination with
disease-modifying anti-rheumatic drugs (DMARDs) for the treatment
of active psoriatic arthritis in adults who have not responded to a
previous DMARD therapy, who have not tolerated it, or where DMARD
therapy is contraindicated
- In the U.S.:
- For the treatment of adults with active
psoriatic arthritis
- For the treatment of patients with
moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy
- In Canada:
- For the treatment of patients with
moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy
- For the treatment of active psoriatic
arthritis, alone or in combination with methotrexate, in adult
patients who have had an inadequate response, intolerance or
contraindication to a prior disease-modifying anti-rheumatic drug
(DMARD).
- In Australia:
- For the treatment of signs and symptoms
of active psoriatic arthritis in adult patients
- For the treatment of adult patients
with moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy
Important Safety Information (based on US labeling)
Contraindications
Otezla® (apremilast) 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 Psoriasis
Psoriasis is an immune-mediated, non-contagious chronic
inflammatory skin disorder of unknown cause. The disorder is a
chronic recurring condition which varies in severity from minor
localized patches to complete body coverage. Plaque psoriasis is
the most common type of psoriasis. About 80 percent of people who
develop psoriasis have plaque psoriasis, which appears as patches
of raised, reddish skin covered by silvery-white scales. These
patches, or plaques, frequently form on the elbows, knees, lower
back, and scalp. Psoriasis occurs nearly equally in males and
females. An estimated 125 million people worldwide have psoriasis.
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. Follow Celgene on Social Media:
@Celgene, Pinterest, LinkedIn and YouTube.
OTEZLA® is a registered trademark and LIBERATE™ is a trademark
of Celgene Corporation. All other trademarks are the property of
their respective owners.
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. Celgene Corporation undertakes 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 Celgene’s
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 Celgene’s Annual Report on Form 10-K and other reports
filed with the U.S. Securities and Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151012005131/en/
For inquiries, please contact:Celgene
CorporationInvestors:Patrick E. Flanigan IIIVice President,
Investor Relations908-673-9969orMedia:Catherine CantoneDirector,
Corporate Communications732-564-3592
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