BOUDRY, Switzerland. - Friday, October 10th 2014 [ME NewsWire]
Apremilast treatment resulted in improved health-related quality of life during 16 weeks of therapy in ESTEEM 2
Apremilast significantly increased work productivity and improved
work limitations compared with placebo at week 16 in pooled analyses of
ESTEEM 1 and 2
23rd European Academy of Dermatology and Venereology Congress
(BUSINESS WIRE) Celgene
International Sàrl, a wholly-owned subsidiary of Celgene Corporation
(NASDAQ: CELG) today announced that patient-reported health outcomes
data for OTEZLA® (apremilast) were presented at the
23rd European Academy of Dermatology and Venereology (EADV) Congress in
Amsterdam. The analyses from the phase III ESTEEM clinical trial program
assessed the effect of apremilast on health-related quality of life
measures and on work productivity/work limitation. Apremilast is the
Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), for
patients with moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy.
A new analysis of the ESTEEM 2 trial demonstrated that treatment with
apremilast 30 mg twice daily after 16 weeks significantly improved
health-related quality of life compared with placebo. Significant
improvement was seen in a variety of these standardized measures,
including the Dermatology Quality of Life Index (DLQI), the Patient
Health Questionnaire, the European Quality of Life 5 Dimensions
Questionnaire and the Short-Form Health Survey mental component summary
and physical component summary.
At Week 16, more than 70 percent of patients who received apremilast
30 mg twice daily achieved clinically meaningful improvement in DLQI of
at least 5-points. Approximately half of patients treated with
apremilast 30 mg twice daily also achieved at least a 50 percent
improvement from baseline in the PASI-50 score versus placebo, along
with a 5-point or greater DLQI improvement, thereby meeting treatment
goal criteria from National Institute for Health and Care Excellence
(NICE) and European S3 guidelines.
“Psoriasis can affect many aspects of patients' lives, including
emotional health, day-to-day activities and functional and social
skills,” said Melinda Gooderham, MD, FRCPC, dermatologist and medical
director at the Skin Centre for Dermatology, Peterborough, Ontario,
Canada. “The results from this analysis showed improvement in important
health-related outcomes indicating that patients taking apremilast could
potentially see improvement in disease-related quality of life that is
important to their overall well-being.”
The results of a work productivity analysis of pooled data from 1250
patients from the ESTEEM 1 and 2 trials demonstrated that, compared with
placebo, treatment with apremilast significantly increased work
productivity (P=0.031) and reduced work limitations (P=0.035) at 16 weeks.
Patients in this study completed the Work Limitation Questionnaire
(WLQ)—a 25-item questionnaire that assessed the degree to which employed
individuals are experiencing on-the-job limitations due to their health
problems as well as the health-related productivity loss—at baseline
and week 16. Four categories of work limitations were used to calculate
the WLQ index—physical demands, mental demands, time management demands
and output demands. The WLQ scale scores were then converted into an
estimate of productivity loss.
“The toll of psoriasis on patients, the healthcare system, and the
economy is significant and underappreciated,” said Scott Smith,
President, Celgene Inflammation & Immunology. “These analyses
further underscore the importance of continued investment in medical
innovation to help patients live better, healthier and more productive
lives.”
Apremilast was approved on March 21, 2014, by the U.S. Food and Drug
Administration (FDA) for the treatment of adults with active psoriatic
arthritis and on September 23, 2014 for the treatment of patients with
moderate to severe plaque psoriasis who are candidates for phototherapy
or systemic therapy. A New Drug Submission (NDS) based on the combined
data from the PALACE 1, 2 and 3 trials for psoriatic arthritis was
submitted to health authorities in Canada in the second quarter of 2013.
A NDS for psoriasis in Canada as well as a combined psoriatic
arthritis/plaque psoriasis Marketing Authorization Application (MAA) in
Europe were all submitted to health authorities in the fourth quarter of
2013.
The views expressed and the techniques presented by the speakers
at the 23rd EADV Congress in Amsterdam, The Netherlands are not
necessarily shared or endorsed by the European Academy of Dermatology
and Venereology.
About ESTEEM 1 and 2
ESTEEM 1 and 2 are two large pivotal phase III randomized,
placebo-controlled studies evaluating apremilast 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 or
systemic therapy. Approximately 1,257 patients were randomized 2:1 to
receive either apremilast 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 apremilast 30 mg twice daily through week 32, and a
randomized withdrawal phase for responders from week 32 to week 52 based
on their initial apremilast randomization and Psoriasis Area and
Severity Index (PASI)–75 response. Approximately 30 percent of all
patients had received prior phototherapy and 54 percent had received
prior conventional systemic and/or biologic therapy. Approximately
one-third of patients had not received prior phototherapy, conventional
systemic nor biologic therapy. A total of 18 percent of patients had a
history of psoriatic arthritis.
About Apremilast
Apremilast 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 apremilast exerts its therapeutic
action in psoriasis or psoriatic arthritis is not well defined.
INDICATIONS
Apremilast is indicated for the treatment of patients with moderate
to severe plaque psoriasis who are candidates for phototherapy or
systemic therapy.
Apremilast is also indicated for the treatment of adult patients with active psoriatic arthritis.
IMPORTANT SAFETY INFORMATION
Contraindications
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 apremilast is associated with an increase
in adverse reactions of depression. During clinical trials, 1.3%
(12/920) of patients treated with apremilast reported depression
compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of apremilast
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 apremilast, compared to none in placebo-treated
patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of
patients on apremilast, compared to 0.2% (1/506) on placebo. One patient
treated with apremilast attempted suicide; one patient on placebo
committed suicide.
Carefully weigh the risks and benefits of treatment with apremilast
for patients with a history of depression and/or suicidal
thoughts/behavior, or in patients who develop such symptoms while on
apremilast. 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 apremilast and in 5% (19/382) of patients
treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784)
of patients treated with apremilast 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 apremilast.
Drug Interactions: Apremilast exposure was decreased when apremilast
was co-administered with rifampin, a strong CYP450 enzyme inducer; loss
of apremilast efficacy may occur. Concomitant use of apremilast with
CYP450 enzyme inducers (eg, rifampin, phenobarbital, carbamazepine,
phenytoin) is not recommended.
Adverse Reactions
Adverse reactions reported in ≥5% of patients were
(apremilast%, 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: apremilast 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 apremilast is administered to a
nursing woman.
Renal Impairment: apremilast 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. Psoriasis is believed to be most common in
Caucasians and slightly less common in other ethnic groups. Worldwide,
psoriasis is most common in Scandinavia and other parts of northern
Europe. 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.
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 other reports filed with the Securities and Exchange
Commission.
Contacts
Celgene International Sàrl
Investors:
Patrick E. Flanigan III, 908-673-9969
Vice President, Investor Relations
Media:
Catherine Cantone, 732-564-3592
Director, Corporate Communications
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