UNVEIL evaluated the efficacy and safety of
oral OTEZLA at 16 weeks in patients with moderate plaque psoriasis
who were naïve to systemic and biologic therapy
Celgene Corporation (NASDAQ:CELG) today announced that findings
from ongoing clinical trials of OTEZLA® (apremilast), the Company's
oral, selective inhibitor of phosphodiesterase 4 (PDE4), conducted
in patients with moderate or moderate to severe plaque psoriasis,
and in adult patients (18 years or older) with active psoriatic
arthritis, will be presented at the 75th Annual Meeting of the
American Academy of Dermatology (AAD) in Orlando, Florida. Ten
abstracts will be presented at the meeting.
Among the data that will be presented is an analysis of the
phase 4 UNVEIL trial, which evaluates the clinical efficacy and
safety of oral OTEZLA 30 mg twice daily compared with placebo at
week 16 in patients with moderate plaque psoriasis [defined as a
body surface area (BSA) involvement of 5-10 percent and a static
Physician’s Global Assessment (sPGA) of 3] who were naïve to
systemic and biologic therapy. At baseline, more than 80 percent of
patients enrolled in the trial had previously received topical
therapy.
"We are excited to present new clinical research to the
scientific community at AAD showing the efficacy and safety of
OTEZLA in a variety of studies in patients with plaque psoriasis,
including longer-term data," said Scott Smith, President, Celgene
Inflammation & Immunology. “Furthermore, we are eager to share
the results from UNVEIL, which is the first trial to evaluate a
systemic therapy in patients with moderate plaque psoriasis who
have not previously been treated with a systemic therapy, including
biologics.”
The following abstracts will be presented at American Academy of
Dermatology as an exchange of scientific and clinical information
(all times, EST):
Abstracts at a GlanceUNVEIL DATAAbstract 4892; Sunday, March 5,
2017, 8:55 – 9:00 AMEfficacy and Safety of Apremilast in Patients
With Moderate Plaque Psoriasis (UNVEIL Phase 4 Study); Bruce
Strober
Abstract 5432; Sunday, March 5, 2017, 10:30 – 10:35 AMEfficacy
of Apremilast on Quality of Life Measures in Patients With Moderate
Plaque Psoriasis (UNVEIL Phase 4 Study); Jerry Bagel
LONG-TERM DATAAbstract 4927;
Sunday, March 5, 2017, 8:40 – 8:45 AMLong-term Safety of Apremilast
Treatment in Psoriasis and Psoriatic Arthritis Patients: Pooled
Analysis for 156 Weeks and Beyond in the ESTEEM 1 and 2 and PALACE
1-3 Phase 3 Trials; Jeffrey Crowley
Abstract 5139; Sunday, March 5, 2017, 11:10 – 11:15
AMApremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated
With Long-term (104-Week) Improvement in Fatigue in Patients With
Psoriatic Arthritis: Pooled Results From 3 Phase III, Randomized,
Controlled Trials; Arthur Kavanaugh
Abstract 5390; Sunday, March 5, 2017, 3:45 – 3:50 PMLow Serious
Infection Rates in Patients with Psoriasis and Psoriatic Arthritis
Treated With Apremilast for 156 Weeks and Beyond: Pooled Analysis
of the Phase 3 ESTEEM 1 and 2 and PALACE 1-3 Trials; David
Pariser
Abstract 5436; Sunday, March 5, 2017, 8:25 – 8:30 AMSafety and
Efficacy of Apremilast Through 104 Weeks in Patients With Moderate
to Severe Psoriasis Who Continued on Apremilast or Switched From
Etanercept Treatment in the LIBERATE Study; Kristian Reich
OTHER DATAAbstract 5413;
Sunday, March 5, 2017, 10:25 – 10:30 AMApremilast Reduces IL-17F,
IL-17A, IL-22, and TNF-α Plasma Protein Levels in Patients With
Moderate to Severe Plaque Psoriasis: Pharmacodynamic and
Correlative Results From Phase 2/3 Studies; James G. Krueger
Abstract 5137; Sunday, March 5, 2017, 11:50 – 11:55 AMFirst
“Real-World” Insights on Apremilast Therapy for Patients With
Plaque Psoriasis From the LAPIS-PSO Study: An Interim Analysis;
Kristian Reich
Abstract 5437; Sunday, March 5, 2017, 1:00 – 1:05 PMReal-World
Burden of Comorbidities in US Patients With Psoriasis; Kamal
Shah
Abstract 5439; Sunday, March 5, 2017, 12:35 – 12:40 PMEvaluation
of the PGAxBSA Composite Tool in Patients With Moderate vs.
Moderate to Severe Plaque Psoriasis; Kristina Callis Duffin
OTEZLA is not indicated for the treatment of plaque psoriasis
patients with BSA involvement of less than 10 percent or sPGA less
than 3.
About UNVEIL
UNVEIL is the first prospective, randomized, controlled study to
evaluate the clinical efficacy and safety of OTEZLA in patients
with moderate plaque psoriasis (defined as a BSA involvement of
5-10 percent and sPGA of 3 based on a 0 to 5 scale) who were naïve
to systemic and biologic therapies. Patients (n=221) were
randomized 2:1 to receive either OTEZLA 30 mg twice daily or
placebo for 16 weeks, followed by an open-label extension phase in
which placebo patients were switched to OTEZLA through week 52. All
doses were titrated over the first week of treatment. At baseline,
more than 80 percent of patients had previously received topical
therapy. The primary endpoint was the mean percentage change from
baseline in the product of Physician's Global Assessment (PGA) and
BSA (%) at week 16.
About OTEZLA®
OTEZLA® (apremilast) 30 mg tablets 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.
INDICATION
Otezla® (apremilast) is indicated for the treatment of patients
with moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy and for the treatment of adult
patients with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
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: 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.
Psoriasis: Treatment with Otezla is
associated with an increase in adverse reactions of depression.
During clinical trials, 1.3% (12/920) of patients treated with
Otezla reported depression compared to 0.4% (2/506) on placebo;
0.1% (1/1308) of Otezla patients discontinued treatment due to
depression compared with none on placebo (0/506). Depression was
reported as serious in 0.1% (1/1308) of patients exposed to Otezla,
compared to none in placebo-treated patients (0/506). Suicidal
behavior was observed in 0.1% (1/1308) of patients on Otezla,
compared to 0.2% (1/506) on placebo. One patient treated with
Otezla attempted suicide; one patient on placebo committed
suicide.
Psoriatic Arthritis: 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.
Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla.
Psoriasis: Body weight loss of
5-10% occurred in 12% (96/784) of patients treated with Otezla and
in 5% (19/382) of patients treated with placebo. Body
weight loss of ≥10% occurred in 2% (16/784) of patients treated
with Otezla compared to 1% (3/382) of patients treated with
placebo.
Psoriatic Arthritis: 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 (e.g., rifampin, phenobarbital,
carbamazepine, phenytoin) is not recommended.
Adverse Reactions
Psoriasis: Adverse reactions
reported in ≥5% of patients were (Otezla%, placebo%): diarrhea
(17, 6), nausea (17, 7), upper respiratory tract infection (9,
6), tension headache (8, 4), and headache (6, 4).
Psoriatic Arthritis: Adverse
reactions reported in ≥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 Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information please visit www.celgene.com. Follow
Celgene on Social Media: @Celgene, Pinterest,
LinkedIn, FaceBook and YouTube.
Forward-Looking Statements
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Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
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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 our other reports filed with the Securities
and Exchange Commission.
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Celgene CorporationInvestors:Patrick E. Flanigan III,
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RelationsorMedia:Catherine Cantone, 908-897-4256Senior Director,
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