New analyses of LIBERATE trial assess effect of
OTEZLA or etanercept versus placebo on patient-reported itching
(pruritus) and health-related quality of life
Physician’s Global Assessment and Body Surface
Area (PGAxBSA) composite tool evaluated for the assessment of
disease severity and response to OTEZLA in ESTEEM 1
Pre-clinical study assesses the early potential
of OTEZLA as a treatment for atopic dermatitis
Celgene International Sàrl, a wholly-owned subsidiary of Celgene
Corporation (NASDAQ:CELG), today announced that the latest research
on Otezla® (apremilast), the Company's oral, selective inhibitor of
phosphodiesterase 4 (PDE4), will be presented at the 24th European
Academy of Dermatology and Venereology (EADV) Congress in
Copenhagen, Denmark, October 7-11, 2015. Nine abstracts (one oral
presentation and eight e-posters) evaluating the use of OTEZLA in
plaque psoriasis and pre-clinical data in atopic dermatitis will be
presented at the meeting.
Data to be presented include pre-specified analyses of the
LIBERATE study assessing the impact of either oral OTEZLA 30 mg
twice daily or weekly subcutaneous (SC) etanercept 50 mg, each
compared with placebo, on changes in patient-reported pruritus
(itching) and health-related quality of life through 32 weeks of
treatment in patients with moderate to severe plaque psoriasis.
Efficacy and safety results from the LIBERATE study were previously
presented at this year’s Annual Meeting of the American Academy of
Dermatology in San Francisco, California. LIBERATE was not designed
or powered to directly compare OTEZLA to etanercept.
A retrospective analysis of results from the ESTEEM 1 trial will
examine the potential of an alternate tool to measure psoriasis
disease severity, particularly in patients with moderate psoriasis.
This composite tool, called Physician’s Global Assessment and Body
Surface Area (PGAxBSA), will be compared with the Psoriasis Area
and Severity Index (PASI) in its ability to measure the effect of
treatment with OTEZLA in patients with plaque psoriasis.
Improvement in PASI scores is a measurement typically used in
registrational trials to examine the effectiveness of plaque
psoriasis treatments.
Results from pre-clinical studies assessing the potential of
apremilast, the active ingredient in OTEZLA, as a treatment for
atopic dermatitis will also be presented. The data will evaluate
the effect of apremilast on gene expression in human epidermal
keratinocytes (skin cells) that have been stimulated by T helper 2
(Th2) and Th17 cytokines – proteins thought to be associated with
skin inflammation. The impact of apremilast treatment on gene
expression and skin symptoms in two mouse models of dermatitis will
also be investigated. A phase II trial of apremilast in moderate to
severe atopic dermatitis is ongoing.
“New data to be presented at EADV will not only further evaluate
OTEZLA’s clinical benefit in plaque psoriasis, but also highlight
our ongoing commitment to uncovering the potential of OTEZLA in
other immune-related dermatologic diseases, such as atopic
dermatitis,” said Scott Smith, President, Celgene Inflammation
& Immunology. “Furthermore, we are eager to assess the use of
alternative endpoints in patients with moderate plaque psoriasis,
for which PASI may be a less sensitive measure.”
The following abstracts will be presented at EADV as an exchange
of scientific and clinical information (all times, CEST):
Abstracts at a GlanceOral
Presentation FC08.05; Saturday October 10, 2015, 3:36 - 3:45
PMApremilast Regulates Human Keratinocyte Gene Expression in Vitro
and Reduces Antigen-driven Dermatitis in Vivo; Mary AdamsLocation:
B3M1-4
Poster Number 1652Metabolic and Weight Changes with Apremilast
in Patients with Psoriasis: Pooled Laboratory Analysis of the Phase
3 ESTEEM 1 and 2 Trials; April Armstrong, MDLocation: e-Poster
area
Poster Number P1653Efficacy of Apremilast or Etanercept Compared
with Placebo in Patients with Moderate to Severe Psoriasis: Results
From the LIBERATE Study; Jennifer Soung, MDLocation: e-Poster
area
Poster Number P1655Evaluation of the Physician’s Global
Assessment and Body Surface Area Composite Tool for Assessing
Psoriasis Response to Apremilast Therapy: Results from the ESTEEM 1
Study; Kristina Callis Duffin, MDLocation: e-Poster area
Poster Number 1656Analysis of Psoriasis Area and Severity Index
and Weight Change During Long-term Treatment with Apremilast in
Patients with Moderate to Severe Plaque Psoriasis (ESTEEM 1);
Kristian Reich, MDLocation: e-Poster area
Poster Number P1658Safety of Apremilast and Etanercept Compared
with Placebo in Patients with Moderate to Severe Psoriasis: Results
From the LIBERATE Study; Melinda Gooderham, MDLocation: e-Poster
area
Poster Number P1668Impact of Apremilast or Etanercept on
Pruritus and Health-Related Quality of Life in Patients with
Moderate to Severe Psoriasis: Results From the LIBERATE Study; Kim
Papp, MDLocation: e-Poster area
Poster Number P1706Cost per Responder of Apremilast Versus
Etanercept in Patients with Moderate to Severe Psoriasis Using
Results From LIBERATE; Tom Tencer, MDLocation: e-Poster area
Poster Number P1771Effect of Apremilast and Etanercept on
Patient-Reported Outcomes in Patients with Moderate to Severe
Plaque Psoriasis in the LIBERATE Study; Melinda Gooderham,
MDLocation: e-Poster area
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 ESTEEM
ESTEEM 1 and 2 are two large pivotal phase III randomized,
placebo-controlled studies evaluating OTEZLA in patients with a
diagnosis of moderate to severe plaque psoriasis for at least 12
months prior to screening, and who were also candidates for
phototherapy and/or systemic therapy. Approximately 1,250 patients
were randomized 2:1 to receive either OTEZLA 30 mg twice daily or
placebo after an initial five-day titration period, for the first
16 weeks, followed by a maintenance phase from weeks 16-32 in which
placebo patients were switched to OTEZLA 30 mg twice daily through
week 32, and a randomized withdrawal phase for responders from week
32 to week 52 based on their initial OTEZLA randomization and
Psoriasis Area and Severity Index (PASI)-75 response (ESTEEM 1) or
(PASI)-50 (ESTEEM2).
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 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.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20151009005067/en/
CelgeneInvestors:Patrick E. Flanigan III, 908-673-9969Vice
President, Investor RelationsorMedia:Catherine Cantone,
732-564-3592Director, Corporate Communications
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