Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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ESTEEM ® Study Design • Evaluated in 2 multicenter, double-blind, placebo- controlled trials of similar design. Patients with moderate to severe plaque psoriasis (N = 1257) were randomized 2:1 to Otezla 30 mg twice daily or placebo for 16 weeks after a 5-day titration 1 • Selected inclusion criteria: age ≥18 years, BSA ≥10%, sPGA ≥3, PASI ≥12, candidates for phototherapy or systemic therapy 1 INDICATIONS Otezla ® (apremilast) is indicated for the treatment of 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. 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 have been reported 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: 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. Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. 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 has a proven efficacy and safety profile, oral dosing, and no label-required lab monitoring—making it a treatment experience patients can respond to 1 Otezla ® (apremilast) significantly increased PASI-75 response (n = 562) at week 16 (primary endpoint) vs placebo (n = 282) (33% vs 5%; P < 0.0001) in ESTEEM 1 1,2 For patients with moderate to severe plaque psoriasis

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