ACTIVE trial in biologic-naïve patients met its
primary endpoint, demonstrating significant improvement in ACR20
response rate at week 16 with OTEZLA versus placebo
Improvements in ACR20 and other measures of
disease seen as early as week 2
ACR20 response rate increased from 38 percent
at week 16 to 67 percent at week 52 for patients who received
OTEZLA therapy from baseline
Celgene Corporation (NASDAQ: CELG) today announced findings from
the ACTIVE phase 3b clinical trial of OTEZLA® (apremilast), the
Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4),
at the 2016 American College of Rheumatology/Association of
Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in
Washington, D.C. The trial met its primary endpoint of significant
improvement in the proportion of patients achieving an ACR20
response at week 16 with OTEZLA versus placebo in patients with
active psoriatic arthritis who have not previously been treated
with a biologic therapy.
The ACTIVE trial randomized 219 patients who may have had one
prior conventional therapy and were not previously treated with a
biologic to either OTEZLA 30 mg twice daily (n=110) or placebo
(n=109). An objective of the study was to determine the clinical
effects of OTEZLA compared with placebo, by examining efficacy
outcomes at earlier time points than in previous studies.
“These findings show a separation from placebo as early as two
weeks with oral OTEZLA in patients with psoriatic arthritis who
have not been previously treated with biologics,” said Dr. Jacob
Aelion, director of the West Tennessee Research Institute and
clinical professor of Medicine/Rheumatology at the University of
Tennessee in Memphis. “Early responses at week 2 across several
measures of disease activity, including morning stiffness and
enthesitis, were also seen at week 16.”
A separation between OTEZLA and placebo was seen at week 2, the
study’s first efficacy assessment time point, with 16.4 percent of
patients in the OTEZLA arm achieving ACR20, compared with 6.4
percent in the placebo arm. Improvements versus placebo were also
seen at week 2 in 28-joint count Disease Activity Score (C-reactive
protein) [−0.59 vs. −0.31, respectively], health assessment
questionnaire disability index (HAQ-DI) [−0.13 vs. −0.05], morning
stiffness severity [42.7 percent vs. 21.1 percent], and enthesitis
(inflammation at sites where tendons or ligaments insert into
bone), as measured by a change in Gladman Enthesitis Index (GEI)
[−1.1 vs. −0.4]. A trend to decrease in swollen joint count was
also observed in patients receiving OTEZLA compared with those on
placebo (−27.7 percent for OTEZLA vs. −17.5 percent for
placebo).
At week 16, 38.2 percent of patients in the OTEZLA arm achieved
an ACR20 response, compared with 20.2 percent in the placebo arm.
Improvements were also seen at week 16 in other measures of
disease, including: 28-joint count Disease Activity Score
(C-reactive protein) (−1.07 with OTEZLA vs. −0.39 with placebo),
swollen joint count (−46.4 percent vs. 4.2 percent, respectively),
HAQ-DI (−0.21 vs. −0.06), improvement in morning stiffness
severity (46.4 percent vs. 25.7 percent), and enthesitis (−1.5 vs.
−0.4).
At week 24, placebo patients crossed over to active treatment
with OTEZLA. Responses demonstrated in the placebo-controlled phase
were maintained through week 52. For patients who were on OTEZLA
from baseline, ACR20, ACR50, and ACR70 response rates at week 52
were 67.1 percent, 36.7 percent and 21.3 percent, respectively, and
observed percent change in swollen joint count was −77.5 percent.
Among patients who had enthesitis at baseline, GEI of 0 was 69.8
percent.
The most commonly reported adverse events during the
placebo-controlled period were nasopharyngitis (8.3 percent with
OTEZLA vs. 6.4 percent with placebo), nausea (8.3 percent vs. 1.8
percent, respectively), headache (7.3 percent vs. 3.7 percent),
hypertension (6.4 percent vs. 6.4 percent), diarrhea (14.7 percent
vs. 11.0 percent) and upper respiratory tract infection (4.6
percent vs. 10.1 percent). Serious adverse events in the OTEZLA and
placebo arms were 2.8 percent and 4.6 percent, respectively. No
increase in adverse event incidence or severity was seen through
week 52.
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.
INDICATION
Otezla® (apremilast) is indicated 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: 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 and
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, and of continued treatment with OTEZLA for
patients with these symptoms. 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.
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 is decreased when OTEZLA
is co-administered with strong CYP450 inducers, such as rifampin,
which may result in loss of efficacy of OTEZLA. Concomitant use of
OTEZLA with CYP450 enzyme inducers (e.g., 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 to www.discoverpsa.com.
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. Celgene 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 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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