THOUSAND OAKS, Calif., June 15, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Otezla® (apremilast) have partnered with Allan Avendaño, makeup artist to Hollywood A-listers, for the INSIDE LOOK campaign to share his journey living with plaque psoriasis and the difficulties of being in his demanding role and dealing with a chronic skin condition. No stranger to the fast pace and demands of the entertainment industry, Avendaño knows that the show must go on no matter what obstacles, or plaques, arise—something many people living with plaque psoriasis also experience. Through the INSIDE LOOK campaign, Avendaño aims to raise awareness about plaque psoriasis and what it is like to live with the condition, in hopes of educating others and inspiring them to feel more confident in their own skin.
At a young age, Avendaño's parents noticed white, scaly patches develop on his hands, elbows, knees and face. After seeing a doctor, he was diagnosed with plaque psoriasis—a chronic autoimmune disease that appears on the surface of the skin as raised, red, itchy patches, but actually starts inside the body, caused by dysfunction of the immune system.1 About 80 percent of the over 8 million people living in the U.S. with psoriasis experience plaque psoriasis and like Avendaño, many struggle with diagnosis and management.2 Nonetheless, he always maintained a positive outlook, and now, as a renowned makeup artist in Hollywood, his goal is to bring out and highlight people's favorite features and make them feel their best.
"As someone who is in the public eye, living with plaque psoriasis hasn't been easy," said Avendaño. "In the past, I was especially self-conscious about the plaques on my hands since I am often touching my clients' faces. I was nervous that people would think it was contagious—which it's not. Living with plaque psoriasis for most of my life and not ever letting it define who I am motivated me to speak out about my journey so that those also living with plaque psoriasis could better understand the nature of the disease and realize they are not alone."
As part of the campaign, Avendaño, who does not take Otezla but has lived with plaque psoriasis for most of his life, had the opportunity to give a psoriasis-friendly makeup tutorial to a fan and Otezla patient who is living with moderate to severe plaque psoriasis. Together, they shared their journeys with the condition and took an INSIDE LOOK at how moderate to severe plaque psoriasis can impact the everyday lives of those living with it and the importance of treating from within. Watch the tutorial and their inspiring discussion at www.InsideLookPsO.com.
"Plaque psoriasis is a chronic autoimmune disease in which the immune system overproduces inflammatory proteins which results in red, scaly and thickened areas of skin," said Dr. Jennifer Soung, dermatologist and Director of Clinical Research at Southern California Dermatology in Santa Ana, California. "As the INSIDE LOOK campaign emphasizes, it is important to go beyond the surface of the skin and treat moderate to severe plaque psoriasis from within. A pill called Otezla is one option that treats moderate to severe plaque psoriasis where it starts—inside the body—and can help some people achieve up to 75% clearer skin after four months.3 However, I recommend that people with plaque psoriasis consult their dermatologist, either in-person or through virtual medicine, to determine the right treatment plan for them."
Otezla is a prescription medicine approved for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. The most common side effects reported in more than 5% of patients are diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.
To learn more about the INSIDE LOOK campaign, moderate to severe plaque psoriasis, and Avendaño's personal story, visit www.InsideLookPsO.com.
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.1 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States.4,5 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.
Otezla® (apremilast) U.S. INDICATIONS
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe 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
- 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
- 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
- Behcet's Disease: Treatment with Otezla is associated with an increase in depression. During the phase 3 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
- Psoriasis: During clinical trials, 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
- Psoriatic Arthritis: During clinical trials, 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: During the phase 3 clinical trial, 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
- 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)
- Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
- Behçet's Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)
Use in Specific Populations
- Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
- Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
- 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 Otezla® Full Prescribing Information.
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.
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