Apremilast

In accordance with European guidelines: prior to commencement: complete blood count (CBC), AST, ALT, creatinine, pregnancy test; optional: Hepatitis B and C, HIV.

Initial titration for 5 days (titration pack containing 10/20/30 mg), followed by a maintenance dose of 30 mg twice daily, in the morning and in the evening (12-hour interval).

2–4 weeks for pruritus, 8 weeks for PASI50.

Optional every 3 months, recommended once a year: complete blood count, creatinine, liver function tests.

Absolute contraindications: pregnancy and breastfeeding, severe acute infections.

Relative contraindications: malignant tumours or lymphoproliferative disorders, severe renal impairment (eGFR < 30 mL/min), severe depression and suicidal ideation, galactosaemia, lactose intolerance, glucose-galactose malabsorption.

When used concomitantly with potent CYP3A4 inhibitors (rifampicin, phenobarbital, carbamazepine, phenytoin), a reduced clinical response to apremilast may occur. Anorexia. Depression/suicidal ideation – may be exacerbated by apremilast. In patients with severely impaired renal function, reduce the dose to a maximum of 30 mg daily. Do not use concomitantly with other immunosuppressants.

Nausea, diarrhoea (41%, particularly in the first 2 weeks), upper respiratory tract infections, headaches, nasopharyngitis, weight loss (not associated with diarrhoea, averaging 2 kg; 20% of all patients experienced weight loss of >5% of body weight).

No restrictions; for psoriasis/psoriatic arthritis: if no therapeutic benefit is evident in a patient after 24 weeks, the treatment should be changed; for Behçet's disease: if no therapeutic benefit is evident in a patient after 12 weeks, the treatment should be reviewed.