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Targeted Synthetic DMARD — Phosphodiesterase-4 (PDE4) Inhibitor Pregnancy: Avoid — animal studies showed embryotoxicity; effective contraception required

Apremilast

Brand names: Otezla

Adult dose

Dose: 30 mg twice daily (after titration)
Route: Oral
Frequency: Twice daily
Max: 30 mg twice daily
Titration over first 5 days to reduce GI side effects: Day 1: 10 mg morning; Day 2: 10 mg morning + 10 mg evening; Day 3: 10 mg morning + 20 mg evening; Day 4: 20 mg morning + 20 mg evening; Day 5: 30 mg morning + 30 mg evening. Not an immunosuppressant — no routine blood monitoring required.

Paediatric dose

Route:
Not licensed in patients under 18 years — seek specialist opinion

Dose adjustments

Renal

eGFR <30 mL/min: reduce dose to 30 mg once daily (morning)

Hepatic

No dose adjustment required

Clinical pearls

  • PALACE 1–4 trials: demonstrated efficacy in psoriatic arthritis across patient populations including those biologic-naive and biologic-experienced
  • MHRA 2019: Reports of depression, suicidal ideation, and completed suicide — screen for psychiatric history before initiating; review at each visit; advise patients to report mood changes
  • No routine blood monitoring required unlike conventional DMARDs and biologics — an advantage for patients with needle phobia or in primary care settings
  • Weight loss averaging 1–2 kg at 52 weeks — monitor BMI in underweight patients
  • Not recommended in patients with pre-existing severe depression — screen carefully
  • Also licensed for moderate-to-severe plaque psoriasis

Contraindications

  • Pregnancy
  • Hypersensitivity to apremilast or excipients

Side effects

  • Diarrhoea — very common; usually resolves within 4 weeks
  • Nausea — common
  • Upper respiratory tract infections
  • Headache
  • Weight loss — significant in some patients; monitor BMI
  • Depression and suicidal ideation — MHRA safety warning

Interactions

  • Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin) — significantly reduce apremilast levels; avoid combination
  • No major interactions with other DMARDs or biologics

Monitoring

  • Weight/BMI at baseline and periodically
  • Mental health assessment — depression and suicidal ideation
  • Clinical response at 16 weeks to assess continuation

Reference: BNFc; BNF 90; NICE TA433; PALACE 1–4 Trials; MHRA Drug Safety Update (depression/suicidality 2019). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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