AMGEN AND LANCE BASS PARTNER TO ENCOURAGE PEOPLE TO DO A 'DOUBLE TAKE' TO RECOGNIZE THE EARLY SIGNS OF PSORIATIC ARTHRITIS
Campaign Drives Awareness of Potential Early Symptoms of Psoriatic Arthritis and Empowers People to Take Action
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
"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
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) 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® 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
CYP450enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.
- 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.
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