What is the indication for Otezla (apremilast)?

From the Guidelines

Otezla (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet's disease. The medication is beneficial as monotherapy due to its oral administration and lack of requirement for laboratory monitoring, making it an appropriate choice for patients who prefer to avoid frequent injections and laboratory monitoring 1.

Key Considerations

• The typical dosing regimen begins with a 5-day titration period to reduce gastrointestinal side effects, starting at 10 mg on day 1 and gradually increasing to the maintenance dose of 30 mg twice daily by day 6 1.
• Patients with severe renal impairment (creatinine clearance less than 30 mL/min) should receive a reduced maintenance dose of 30 mg once daily 1.
• Common side effects include diarrhea, nausea, upper respiratory tract infection, headache, and weight loss, with patients 65 and older being prone to experience dehydration and its complications 1.
• Apremilast may be associated with the emergence or worsening of depression, and patients should be discussed about this risk in advance of therapy 1.

Important Interactions and Precautions

• Apremilast is metabolized in the liver by cytochrome P450 and should not be used with strong inducers of cytochrome P450 (e.g., rifampin, phenobarbital, carbamazepine, and phenytoin) as it may result in decreased efficacy 1.
• Pregnancy should only be used in pregnancy if benefit justifies potential risk to fetus 1.

From the FDA Drug Label

Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The indication for Otezla (apremilast) is for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy 2, 2.

• The main use is for patients with plaque psoriasis.
• Key points to consider are the patient's candidacy for phototherapy or systemic therapy.

From the Research

Indication for Otezla

• Otezla (apremilast) is indicated for the treatment of:
  • Adults with psoriasis 3, 4, 5
  • Adults with psoriatic arthritis (PsA) 3, 4, 6, 5
  • Oral ulcers associated with Behcet's disease (BD) 5
• Apremilast is an orally administered, small molecule inhibitor of phosphodiesterase 4 (PDE4) 3, 4
• The recommended dose is 30 mg twice daily 3, 4

Approved Uses

• Otezla was first approved on March 21,2014 for the treatment of psoriatic arthritis 5
• On September 23,2014 for moderate to severe plaque psoriasis 5
• On July 19,2019 for the treatment of oral ulcers associated with Behcet's disease (BD) 5

Clinical Efficacy

• Apremilast reduced the severity of moderate to severe plaque psoriasis in the phase 3 ESTEEM trials 3
• Improved signs and symptoms in both disease-modifying antirheumatic drug (DMARD)-naïve and DMARD-experienced patients with active psoriatic arthritis in the phase 3 PALACE trials 3
• Enthesitis, dactylitis, physical function and fatigue were also improved with apremilast 3