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    Drugs in Perspective: Otezla (apremilast)

    Psoriasis is a chronic, inflammatory disease that affects approximately 1% to 3% of the world population.1 Plaque psoriasis is the most common type of psoriasis, affecting approximately 80% to 90% of patients and is characterized by circular to oval, well-demarcated erythematous plaques. Psoriatic arthritis is a spondyloarthritic disease that occurs in approximately 30% of individuals with psoriasis and has an estimated prevalence of 0.1 to 1%. It is characterized by synovitis, enthesitis, dactylitis, and spondylitis. Although there is likely a genetic component, the exact etiology of psoriasis and psoriatic arthritis is unknown. Both share common physiologic mechanisms. Psoriasis, however, typically precedes psoriatic arthritis by approximately 5 to 10 years in most patients.2 Patients with psoriasis and psoriatic arthritis generally experience decreased productivity, functionality, and quality of life, potentially resulting in work absenteeism and long-term disability.1,3

    Otezla (apremilast), a small-molecule inhibitor of phosphodiesterase 4 (PDE4), was approved by FDA on March 21, 2014, for the treatment of adult patients with active psoriatic arthritis.4,5 On September 23, 2014, it was approved for a second indication, the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.5,6 Apremilast inhibits PDE4,  resulting in increased intracellular cyclic adenosine monophosphate (cAMP) levels. The specific mechanism by which apremilast exerts its therapeutic action in patients with psoriasis and psoriatic arthritis is not well defined.5

    Apremilast is available as 30-mg oral tablets and a 2-week starter blister pack containing 10 mg, 20 mg, and 30 mg. Apremilast should be titrated to a maintenance dose of 30 mg orally twice daily with or without food (See Table 1 for titration schedule). Dose should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance <30 mL/min using Cockcroft-Gault equation), and only the morning dose titration schedule should be used in these patients (evening doses should be excluded). There are no dose adjustments for patients with hepatic impairment.5

    Table 1 Apremilast titration schedule

     

    AM dose

    PM dose

    Day 1

    10 mg

    -

    Day 2

    10 mg

    10 mg

    Day 3

    10 mg

    20 mg

    Day 4

    20 mg

    20 mg

    Day 5

    20 mg

    30 mg

    Day 6 and thereafter

    30 mg

    30 mg

    Source: Ref 5

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