Campaign Encourages Open Dialogue With Doctor
About Unmanaged Symptoms to Find the Right Treatment Option
THOUSAND
OAKS, Calif., Oct. 1, 2024
/PRNewswire/ -- Amgen (NASDAQ: AMGN) has partnered
with multi-talented actress, producer and entrepreneur La La
Anthony to share her personal journey living with plaque psoriasis,
and to inspire people to be open with their doctors about how the
disease affects their daily lives. As one of the more than 6
million people in the United
States living with plaque psoriasis, La La understands the
frustrations of living with this disease. Symptoms can distract
from everyday moments, big and small, even influencing clothing or
makeup choices.1,2
Experience the full interactive Multichannel News Release
here: https://www2.multivu.com/amgen/9292951-en-la-la-anthony-amgen-partner-to-encourage-open-dialogue-about-plaque-psoriasis
In a new interactive video, La La offers an intimate,
behind-the-scenes look at how plaque psoriasis has affected her
personal and professional life – and her realization of how
important it is to advocate for treatment options that work well
for her, and to help others do the same.
"I have spent so much time and energy trying different methods
to manage my plaque psoriasis that were often messy or inconvenient
to apply, like a prescription shampoo for my scalp psoriasis. It
required daily hair washing, which is not practical for my hair,"
said La La. "I was hesitant to tell my doctor that some treatments
didn't work with my lifestyle, but I realized that doctors can only
help if they know the full picture. I want to encourage people
living with plaque psoriasis to be vocal about how the disease and
treatments are impacting their daily lives."
Although common, plaque psoriasis is a frequently misunderstood
disease. Many people think it is a skin condition, but it is an
autoimmune disease that starts as inflammation inside the
body.1 The inflammation presents as itchy, flaky patches
that may cover large portions of the skin or only a few
areas.1
Research shows that people with plaque psoriasis and their
doctors aren't always on the same page about how severe their
condition is – with patients believing their symptoms to be more
severe than their doctor's assessment.3
Many people are prescribed topical treatments for plaque
psoriasis patches, like creams or ointments. While these topical
medications may provide relief, they are only treating the symptoms
of the disease – not a root cause of inflammation – and are often
viewed by patients as messy to apply.4-7
"Plaque psoriasis is a chronic inflammatory condition and each
patient's experience is unique," said board-certified dermatologist
Meagen McCusker M.D., M.S., FAAD.
"The good news is advances in the field have given us a multitude
of treatment options. For many patients who struggle with topical
therapies, or who feel like their symptoms are not well managed by
their current routine, I suggest talking to your doctor about a
treatment option that helps reduce the underlying inflammation.
Disease severity and lifestyle are key factors that influence a
patient's choice for treatment – there is no one-size-fits all
approach."
To interact with La La in her new video, access resources to
help facilitate an open conversation about plaque psoriasis
treatment with your doctor and learn about Otezla®
(apremilast), an oral treatment option, visit MomentsWithLaLa.com.
La La is not currently on treatment or taking Otezla.
Amgen is committed to supporting plaque psoriasis patients to
ensure that appropriate patients have affordable access to Otezla.
For more information, please visit Otezla.com.
About Psoriasis
Psoriasis is a chronic disease where skin cells build up quickly,
typically causing red or discolored, scaly, and itchy patches on
the skin.1 Approximately 125 million people
worldwide have psoriasis, including more than 8 million people
in the United
States.8,9 About 80% of those patients have
plaque psoriasis.2
About Otezla® (apremilast)
Otezla® (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 Otezla exerts its therapeutic action in
patients is not well defined.
Since its initial FDA approval in 2014, Otezla has been
prescribed to more than 1 million patients worldwide.
INDICATIONS
Otezla® (apremilast) is
indicated for the treatment of:
- Adult patients with plaque psoriasis who are candidates for
phototherapy or systemic therapy
- Pediatric patients 6 years of age and older and weighing at
least 20 kg with moderate to severe plaque psoriasis who are
candidates for phototherapy or systemic therapy
- Adult patients with active psoriatic arthritis
- Adult patients with oral ulcers associated with Behçet's
Disease
IMPORTANT SAFETY INFORMATION
Contraindications
- Otezla is contraindicated in patients with a known
hypersensitivity to apremilast or to any of the excipients in the
formulation
Warnings and Precautions
- Hypersensitivity: Hypersensitivity reactions, including
angioedema and anaphylaxis, have been reported during postmarketing
surveillance. If signs or symptoms of serious hypersensitivity
reactions occur, discontinue Otezla and institute appropriate
therapy
- 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
- Plaque Psoriasis: Treatment with Otezla is associated with an
increase in depression. During clinical trials in adult patients
with moderate to severe plaque psoriasis, 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
- Psoriatic Arthritis: Treatment with Otezla is associated with
an increase in depression. During clinical trials, 1.0% (10/998)
reported depression or depressed mood compared to 0.8% (4/495)
treated with placebo. Suicidal ideation and behavior was observed
in 0.2% (3/1441) of patients on Otezla, compared to none in
placebo-treated patients. Depression was reported as serious in
0.2% (3/1441) of patients exposed to Otezla, compared to none in
placebo-treated patients (0/495). Two patients who received placebo
committed suicide compared to none on Otezla
- Behçet's Disease: Treatment with Otezla is associated with an
increase in depression. During the clinical trial, 1% (1/104)
reported depression or depressed mood compared to 1% (1/103)
treated with placebo. No instances of suicidal ideation or behavior
were reported in patients treated with Otezla or treated with
placebo
- Weight Decrease: Monitor body weight regularly; evaluate
unexplained or clinically significant weight loss, and consider
discontinuation of Otezla
- Plaque Psoriasis: Body weight loss of 5-10% occurred in 12%
(96/784) of adult patients with moderate to severe plaque psoriasis
treated with Otezla and in 5% (19/382) of patients treated with
placebo. Body weight loss of ≥10% occurred in 2% (16/784) of adult
patients treated with Otezla compared to 1% (3/382) of patients
treated with placebo. Body weight loss of 5%-10% occurred in 12%
(19/163) of pediatric patients with moderate to severe plaque
psoriasis treated with Otezla compared to 2.5% (2/80) with placebo.
Body weight loss of ≥ 10% occurred in 1% (1/163) of pediatric
patients treated with Otezla twice daily compared to 0% (0/80) of
patients with placebo. Closely monitor growth (height and weight)
in Otezla-treated pediatric patients. Pediatric patients who are
not growing or gaining weight as expected may need to have their
treatment interrupted
- Psoriatic Arthritis: Body weight loss of 5-10% was reported in
10% (49/497) of patients taking Otezla and in 3.3% (16/495) of
patients taking placebo
- Behçet's Disease: Body weight loss of >5% was reported in
4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of
patients taking 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
- Plaque Psoriasis: The most common adverse reactions (≥ 5%) are
diarrhea, nausea, upper respiratory tract infection, and headache,
including tension headache. Overall, the safety profile of Otezla
in adult patients with mild to moderate plaque psoriasis and
pediatric patients with moderate to severe plaque psoriasis was
consistent with the safety profile established in adult patients
with moderate to severe plaque psoriasis
- Psoriatic Arthritis: The most common adverse reactions (≥ 5%)
are diarrhea, nausea, and headache
- Behçet's Disease: The most common adverse reactions (≥ 10%) are
diarrhea, nausea, headache, and upper respiratory tract
infection
Use in Specific Populations
- Otezla has not been studied in pregnant women. Advise pregnant
women of the potential risk of fetal loss
Please click here for the full
Prescribing Information for
Otezla.
About Amgen
Amgen discovers, develops, manufactures
and delivers innovative medicines to help millions of patients in
their fight against some of the world's toughest diseases. More
than 40 years ago, Amgen helped to establish the biotechnology
industry and remains on the cutting-edge of innovation, using
technology and human genetic data to push beyond what's known
today. Amgen is advancing a broad and deep pipeline that builds on
its existing portfolio of medicines to treat cancer, heart disease,
osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative
Companies" by Fast Company and one of "America's Best Large
Employers" by Forbes, among other external recognitions. Amgen
is one of the 30 companies that comprise the Dow Jones Industrial
Average®, and it is also part of the Nasdaq-100
Index®, which includes the largest and most innovative
non-financial companies listed on the Nasdaq Stock Market based on
market capitalization.
For more information, visit Amgen.com and follow Amgen on
X, LinkedIn, Instagram, TikTok, YouTube and Threads.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company (including BeiGene, Ltd. or
Kyowa Kirin Co., Ltd.), the performance of
Otezla® (apremilast) (including anticipated Otezla
sales growth and the timing of non-GAAP EPS accretion), our
acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or
Horizon Therapeutics plc (including the prospective performance and
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CONTACT: Amgen, Thousand
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References
- National Psoriasis Foundation. About Psoriasis. Available
at: https://www.psoriasis.org/about-psoriasis.
Accessed September 10, 2024.
- National Psoriasis Foundation. Plaque Psoriasis. Available
at: https://www.psoriasis.org/about-psoriasis/types/plaque.
Accessed September 10, 2024.
- Lebwohl M, et al. Dermatol Ther (Heidelb). 2021;12:61-78.
- Nestle FO, Kaplan DH, Barker J. N Engl J Med.
2009;361(5):496-509.
- Kim WB, Jerome D, Yeung J. Can Fam Physician.
2017;63(4):278-285.
- Menter A, Gelfand JM, Connor C, et al. J Am Acad Dermatol.
2020;82(6):1445-1486.
- Thaçi, D, de la Cueva P, Pink AE, et al. BJGP Open.
2020;4(5).
- National Psoriasis Foundation. Statistics. Available
at: https://www.psoriasis.org/content/statistics. Accessed
September 30, 2024.
- Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic
agent for the treatment of chronic plaque psoriasis. Eur J
Dermatol. 2004;14(1):41–45.
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SOURCE Amgen