In a letter to healthcare professionals, the manufacturer of apremilast has advised that the drug should be used with caution in patients with a history of psychiatric symptoms or in those taking medications that may cause psychiatric symptoms.
Patients and carers should be advised to report any changes in behaviour or mood or any signs of suicidal ideation. Treatment should be discontinued if new or worsening psychiatric symptoms occur, or suicidal ideation or attempts are identified.
Analysis of postmarketing data for apremilast up to 20th March 2016 revealed 65 cases of suicidal ideation and behaviour (in patients with or without a history of depression), including five completed suicides.
Apremilast is indicated for the treatment of moderate to severe chronic plaque psoriasis in adults who have failed to respond to, have a contraindication to, or are intolerant to, other systemic therapy including ciclosporin, methotrexate or PUVA.
Apremilast can also be used, alone or in combination with DMARDs, to treat active psoriatic arthritis in patients with an inadequate response or intolerance to DMARDs.