Data from UNVEIL, the first trial of patients
with moderate plaque psoriasis (BSA 5-10 percent) who were naïve to
systemic and biologic therapy, presented at American Academy of
Dermatology Congress
OTEZLA demonstrated significant improvements
versus placebo for the primary and key secondary endpoints at week
16
Safety profile for OTEZLA in UNVEIL was
consistent with that of previous trials
Celgene Corporation (NASDAQ:CELG) today announced that results
from its phase 4 UNVEIL trial evaluating OTEZLA® (apremilast), the
Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4),
in patients with moderate plaque psoriasis with a body surface area
(BSA) of 5-10 percent, were presented at the American Academy of
Dermatology's Annual Meeting in Orlando, Florida.
The UNVEIL study evaluated the clinical efficacy and safety of
oral OTEZLA 30 mg twice daily compared with placebo at week 16 in
221 patients with moderate plaque psoriasis [defined as a 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. The primary
endpoint was the mean percentage change from baseline in the
product of PGA and BSA (PGA×BSA) at week 16. The PGAxBSA composite
tool is a simple assessment that has been developed as a measure of
clinically meaningful responses of psoriasis patients in clinical
trials.
At week 16, patients who received OTEZLA had a significantly
greater improvement in mean percentage change from baseline in
PGA×BSA compared with those who received placebo (-48.1 vs. -10.2,
respectively; P<0.0001). In addition, a 75 percent or greater
improvement in PGA×BSA score was achieved by 35.1 percent of
patients treated with OTEZLA vs. 12.3 percent of patients treated
with placebo (P<0.0001). A significantly greater percentage of
patients receiving OTEZLA versus placebo achieved a PGA score of 0
(clear) or 1 (almost clear) at week 16 (30.4 percent vs. 9.6
percent; P<0.0001).
In other secondary endpoints, enrolled patients who had scalp
psoriasis (n=167), a significantly greater percentage who received
OTEZLA achieved a Scalp Physician’s Global Assessment score of 0
(clear) or 1 (minimal) with a greater than two-point reduction from
baseline compared with placebo (38.0 percent vs. 20.0 percent,
respectively; P=0.0178).
“Patients with moderate plaque psoriasis are often inadequately
treated, and there remains an unmet medical need for safe and
effective treatment options in this population,” said Dr. Bruce
Strober, professor and chair of the Department of Dermatology at
UConn Health. “While most trials focus on moderate to severe plaque
psoriasis, this is the first randomized clinical trial of patients
with moderate plaque psoriasis, and the results provide encouraging
data for patients.”
In a separate pre-specified analysis, patients in UNVEIL
reported satisfaction scores based on the Treatment Satisfaction
Questionnaire version II that were significantly greater with
OTEZLA than placebo in global satisfaction (63.2 vs. 48.7,
respectively; P<0.0001) and effectiveness (57.3 vs. 38.8;
P<0.0001) at week 16. Patients reported no significant
difference versus placebo in terms of convenience (66.9 vs. 65.7;
P=NS) or side effects (78.5 vs. 75.0; P=NS).
Adverse events reported in at least five percent of patients
taking OTEZLA and greater than placebo in the UNVEIL study were
diarrhea (29 percent vs. 16 percent), headache (20 percent vs. 11
percent), nausea (18 percent vs. 10 percent), upper respiratory
tract infection (7 percent vs. 4 percent) and vomiting (6 percent
vs. 3 percent). The safety and tolerability data for OTEZLA
observed in the UNVEIL study were consistent with previously
reported data from six phase 3 studies of OTEZLA in psoriasis or
psoriatic arthritis; no new safety signals were observed.
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.
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 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.
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: 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.
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% 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. 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
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).
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
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 our other reports filed with the U.S.
Securities and Exchange Commission.
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Celgene CorporationInvestors:Patrick E. Flanigan III,
908-673-9969Corporate Vice President, Investor
RelationsorMedia:Catherine Cantone, 908-897-4256Senior Director,
Corporate Communications
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