Campaign Drives Awareness of Potential Early
Symptoms of Psoriatic Arthritis and Empowers People to Take
Action
THOUSAND
OAKS, Calif., May 12, 2022
/PRNewswire/ -- Amgen (NASDAQ:AMGN) and Otezla®
(apremilast) have partnered with pop icon and entrepreneur
Lance Bass, for the Double Take
campaign to empower people to take action when it comes to
psoriatic arthritis. As a singer, dancer and entertainer, Bass
understands the importance of staying in tune with your body.
Through the campaign, he has created a fun and educational dance to
help make it easy for everyone to recognize the early signs and
symptoms of psoriatic arthritis, a condition Bass has lived with
for over a decade.
When Bass first started experiencing pain in his hands and
shoulders he blamed it on other factors, such as his active
lifestyle as a dancer and getting older. With support from from his
friends and family, he decided to see a doctor and was diagnosed
with psoriatic arthritis – a chronic, inflammatory form of
arthritis which can cause swelling, stiffness and pain in and
around the joints that worsens over time. About one million
Americans are affected by psoriatic arthritis, which can develop in
up to 30% of patients diagnosed with psoriasis. Like Bass, people
often dismiss the signs and symptoms, attributing them to lifestyle
factors like overexercising or aging. Now Bass, who does not take
Otezla but has been living with the condition for 10 years, is
encouraging others to not dismiss the signs and to do a "Double
Take" if they are experiencing potential symptoms of psoriatic
arthritis.
"I was officially diagnosed with psoriatic arthritis about 5
years ago. When I found out that the symptoms I was experiencing
were a result of psoriatic arthritis, I was surprised and scared –
I was only in my 30s," said Bass. "I've learned the importance of
understanding and recognizing the early symptoms of psoriatic
arthritis. You don't have to brush it off or deal with it. I teamed
up with Amgen on the Double Take campaign to share my story and
empower others to take action."
"Psoriatic arthritis is a form of arthritis that can affect
people who have psoriasis and is caused by overactive inflammation
of cells inside the body," said Alvin F.
Wells, M.D., Ph.D., director of the Rheumatology and
Immunotherapy Center in Oak Creek,
Wisconsin. "As a rheumatologist, I know all too well how the
symptoms of psoriatic arthritis can go beyond pain and the
importance of early diagnosis. Symptoms such as scalp psoriasis or
pitted nails, in addition to joint pain, could point to psoriatic
arthritis. If people see these signs, it's important to speak with
your doctor as soon as possible, especially if you have been
diagnosed with psoriasis."
Made by Amgen, Otezla is a prescription medicine approved for
the treatment of adult patients with active psoriatic arthritis.
The most common side effects reported in more than 5% of patients
are diarrhea, nausea, and headache.
To learn more about Bass' story, the Double Take dance, and the
signs and symptoms of psoriatic arthritis, visit
PsADoubleTake.com.
About Psoriatic Arthritis
Psoriatic arthritis is a
chronic, inflammatory form of arthritis which can cause swelling,
stiffness and pain in and around the joints that worsens over time
and can decrease physical function. Two distinct physical symptoms
of psoriatic arthritis are dactylitis (inflammation of an entire
digit) and enthesitis (inflammation at sites where tendons or
ligaments insert into bone). Patients usually also experience red
patches of skin topped with silvery scales, or skin lesions.
It is estimated that nearly 38 million people worldwide have
psoriatic arthritis. Around a third of people living with psoriasis
may go on to develop psoriatic arthritis. If left untreated,
psoriatic arthritis can have disabling results. Appropriate
diagnosis and treatment can help manage symptoms.
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.
Otezla® (apremilast) U.S.
INDICATIONS
Otezla® (apremilast) is
indicated for the treatment of adult patients with plaque psoriasis
who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with
active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with
oral ulcers associated with Behçet's Disease.
Otezla® (apremilast) U.S. 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
- 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 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 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
patients treated with Otezla compared to 1% (3/382) of patients
treated with placebo.
- 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 patients with mild to moderate plaque psoriasis was consistent
with the safety profile previously 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 is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its expertise to strive for solutions that improve health outcomes
and dramatically improve people's lives. A biotechnology pioneer
since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has
reached millions of patients around the world and is developing a
pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones
Industrial Average and is also part of the Nasdaq-100 index. In
2021, Amgen was named one of the 25 World's Best Workplaces™ by
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For more information, visit www.amgen.com and follow
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CONTACT: Amgen, Thousand
Oaks
Michael Strapazon, 805-313-5553
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