Patients with moderate to severe plaque
psoriasis showed meaningful improvements in skin, itch and
quality-of-life measures among PASI 75 non-responders treated with
OTEZLA, according to a post hoc sub-analysis of data from the phase
3 ESTEEM 1 trial
Findings suggest a broad assessment of skin
lesions, itching and quality of life may offer meaningful benefit
with OTEZLA therapy in patients with moderate to severe plaque
psoriasis
A separate post hoc sub-analysis of data from
the phase 3 ESTEEM 1 and 2 and phase 4 UNVEIL trials showed
improvement in areas such as the scalp and nails with OTEZLA versus
placebo
Celgene Corporation (NASDAQ:CELG) today announced the results of
two post hoc sub-analyses of clinical trials for OTEZLA®
(apremilast) at the 27th European Academy of Dermatology and
Venereology (EADV) Congress in Paris, France. Findings suggest
OTEZLA offered meaningful improvements in outcomes important to
patients with moderate to severe plaque psoriasis, which may not be
captured by common measures of treatment efficacy that focus only
on skin clearance, such as Psoriasis Area Severity Index (PASI)
75.
Plaque psoriasis is a multi-faceted disease that can manifest in
numerous ways. Each patient has a different experience, and many
are concerned about effects that go beyond the skin. This need for
patient-centric care has been recognized by the World Health
Organization – a shift in the focus from treating the skin lesions
of psoriasis to addressing the needs of the whole patient.
“Only considering skin clearance may not fully capture the
effect a treatment may have on an individual’s disease burden and
its impact on daily life,” said Dr. Denis Jullien, Department of
Dermatology and Venereology, Edouard Herriot Hospital, Lyon, France
and an author of the study. “For example, itching, which is not
accounted for by PASI, is cited by over a third of patients as
their overriding quality-of-life issue. These new analyses of
OTEZLA studies can help inform both prescribers and patients when
evaluating treatment decisions.”
The findings include a new post hoc sub-analysis of the phase 3
ESTEEM 1 trial assessing clinical and quality-of-life outcomes for
patients with moderate to severe plaque psoriasis who did not
achieve PASI 75 (a 75 percent reduction in PASI) at either weeks 32
or 52, but continued OTEZLA treatment in this time period
(n=203/844).
For patients who did not achieve a PASI 75 at weeks 32 or 52,
more than half achieved a 50 percent reduction in PASI score (PASI
50) at weeks 32 and 52 following treatment with OTEZLA. This
improvement, when taken together in disease-specific
quality-of-life measures, may more reliably indicate clinically
meaningful benefit. For example, itching, as measured by Visual
Analogue Scale (VAS), was reduced from baseline by approximately 30
percent during weeks 4 to 52 in those patients (n=134) who were
treated with OTEZLA from baseline and weeks 20 to 52 in patients
(n=69) who were switched from placebo to OTEZLA at week 16. Quality
of life, as measured by the Dermatology Life Quality Index (DLQI),
was improved by at least 5 points in the two groups during the same
time period.
Manifestations that are highly visible, such as scalp and nail
psoriasis, can have a substantial effect on quality of life. A
separate post hoc sub-analysis of the ESTEEM 1, 2 and UNVEIL
studies examined changes in scalp and nail psoriasis, along with
quality of life, following treatment with OTEZLA. The sub-analysis
included patients who had nail psoriasis (n=768 in ESTEEM 1 and 2
and 73 in UNVEIL) or moderate to very severe scalp psoriasis
(n=1,049 in ESTEEM 1 and 2 and 129 in UNVEIL) at baseline.
At week 32 in ESTEEM and UNVEIL, clearance of nail psoriasis
[Nail Psoriasis Severity Index (NAPSI)=0] among patients receiving
OTEZLA from baseline was achieved by 31.3 percent (n=146/466) and
36.2 percent (n=17/47) of patients, respectively. Among patients
who were switched from placebo to OTEZLA at week 16, NAPSI
clearance at week 32 was achieved by 15.5 percent (n=37/239) and
26.1 percent (n=6/23) of patients, respectively.
Among patients with moderate to severe scalp psoriasis at
baseline, clear or minimal involvement of scalp psoriasis [Scalp
Physician’s Global Assessment (ScPGA) response of 0 or 1] was
achieved by greater proportions of patients receiving OTEZLA versus
placebo at week 16 in both trials: 45.2 percent (n=351/694) versus
22.5 percent (n=80/355), respectively, in ESTEEM and 44.1 percent
(n=30/68) versus 33.3 percent (n=23.3) in UNVEIL.
Of patients who had nail psoriasis or moderate to very severe
scalp psoriasis at baseline, a DLQI of 0 or 1 was achieved by
greater proportions of patients receiving OTEZLA versus placebo at
week 16 [28.7 percent (n=206/719) versus 8.1 percent (n=29/358),
respectively, in ESTEEM and 23.7 percent (n=23/97) versus 10.6
percent (n=5/47) in UNVEIL].
“The ESTEEM and UNVEIL clinical trials continue to provide
important learnings about OTEZLA for the treatment of psoriasis as
well as quality of life for people who live with this chronic
condition,” said Volker Koscielny, Vice President Global Medical
Affairs, Inflammation & Immunology at Celgene. “These
sub-analyses of UNVEIL and ESTEEM suggest that appropriate patients
with moderate to severe plaque psoriasis who experience
manifestations beyond skin may benefit from treatment with
OTEZLA.”
About Psoriasis
Psoriasis affects 125 million people worldwide, including around
14 million people in Europe and 7.5 million people in the United
States. It is a chronic and systemic inflammatory disorder, and is
immune-mediated, meaning it is caused by an immune reaction in the
body.
Psoriasis lesions can often be found on areas close to the
joints such as the elbows and knees but can also appear on the
scalp. Nail psoriasis affects up to 50 percent of people with
psoriasis. Up to 84 percent of people with psoriasis experience
itching, and over a third of patients actually cite itch as the
most important factor contributing to their disease.
Around 75 percent of people living with psoriasis believe it has
a negative impact on their quality of life and 83 percent of
patients with psoriasis actively conceal the visible signs of their
disease.
About ESTEEM
ESTEEM 1 and 2 are two large pivotal phase 3 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 (ESTEEM 2). A 5-year extension study of ESTEEM 1 and 2 is
ongoing.
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 (percent) at week 16.
About OTEZLA® (apremilast)
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 is not well defined.
U.S. PRESCRIBING INFORMATION
INDICATIONS
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
Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea,
and vomiting were associated with the use of OTEZLA. Most events
occurred within the first few weeks of treatment. In some cases,
patients were hospitalized. Patients 65 years of age or older and
patients taking medications that can lead to volume depletion or
hypotension may be at a higher risk of complications from severe
diarrhea, nausea, or vomiting. Monitor patients who are more
susceptible to complications of diarrhea or vomiting; advise
patients to contact their healthcare provider. Consider OTEZLA dose
reduction or suspension if patients develop severe diarrhea,
nausea, or vomiting
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 depression. During
clinical trials, 1.3% (12/920) of patients reported depression
compared to 0.4% (2/506) on placebo; 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
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
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)
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 pharmaceutical 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.
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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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