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Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2015.
Apremilast (Otezla®; Celgene, New Jersey, USA) is an oral small-molecule inhibitor of the enzyme phosphodiesterase 4, which plays an important role in chronic inflammation associated with psoriasis.
In September 2014, the US Food and Drug Administration (FDA) approved the use of apremilast in patients with plaque psoriasis. It was approved for use in New Zealand in psoriasis in November 2016.
Apremilast was approved for the treatment of plaque psoriasis in patients:
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for apremilast for:
It has been reported to be particularly effective in palmoplantar psoriasis.
Apremilast was also shown to be effective for the treatment of oral ulceration in Behçet disease.
The recommended dose of apremilast is 30 mg twice daily. To reduce the risk of gastrointestinal symptoms the recommended dose is titrated according to the following schedule:
Day 1: 10 mg in the morning
Day 2: 10 mg in the morning and 10 mg in the evening
Day 3: 10 mg in the morning and 20 mg in the evening
Day 4: 20 mg in the morning and 20 mg in the evening
Day 5: 20 mg in the morning and 30 mg in the evening
Day 6 and thereafter: 30 mg twice daily
For patients with severe renal impairment, the recommended dose is 30 mg once daily, titrated using the morning schedule only, as listed above.
Apremilast is well tolerated. No monitoring or testing is required.
It is not known whether apremilast or its metabolites are present in human milk.
The safety and effectiveness of apremilast have not been established in patients less than 18 years of age.
No overall differences were observed in the efficacy and safety of apremilast in elderly subjects ≥65 years of age compared with those <65 years of age in clinical trials involving 1257 plaque psoriasis patients.
The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute).
No dose adjustments of apremilast are necessary for patients with moderate and severe hepatic impairment.
Apremilast is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.
Treatment with apremilast is associated with an increase in depression. Patients, their 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 if such changes occur to contact their healthcare provider.
Patients treated with apremilast should have their body weight monitored regularly. In clinical trials in psoriasis, weight decrease between 5%-10% of body weight occurred in 12% (96/784) of subjects treated with apremilast compared to 5% (19/382) treated with placebo.
If unexplained or clinically significant weight loss occurs, discontinuation of apremilast should be considered.
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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