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IL-23 Inhibitor (IBD) Pregnancy: Avoid — limited human data. Animal studies show no reproductive toxicity but immunoglobulins cross placenta in third trimester. Use only if clearly needed; discontinue if pregnancy confirmed unless benefit outweighs risk.

Risankizumab

Brand names: Skyrizi

Adult dose

Dose: 600 mg IV induction (weeks 0, 4, 8), then 360 mg SC maintenance every 8 weeks
Route: IV (induction), Subcutaneous (maintenance)
Frequency: Every 4 weeks (induction ×3), then every 8 weeks (maintenance)
Max: 600 mg per IV infusion (induction); 360 mg per SC dose (maintenance)
Crohn's disease: IV induction 600 mg at weeks 0, 4, 8 (infused over ≥1 hour), followed by SC maintenance 360 mg every 8 weeks. UC: 1200 mg IV ×3 induction, then 360 mg SC every 8 weeks. Source: BNF 90.

Paediatric dose

Dose: Not licensed under 18 years N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed for paediatric IBD. Licensed for plaque psoriasis from 6 years — IBD indication adults only.

Dose adjustments

Renal

No dose adjustment required — renal excretion is minimal for monoclonal antibodies.

Hepatic

No dose adjustment required — not hepatically metabolised via CYP enzymes.

Paediatric weight-based calculator

Not licensed for paediatric IBD. Licensed for plaque psoriasis from 6 years — IBD indication adults only.

Clinical pearls

  • ADVANCE trial (NEJM 2022): CD induction — 45% clinical remission with risankizumab 600 mg IV vs 25% placebo at week 12. MOTIVATE trial confirmed. First IL-23p19 inhibitor approved for CD.
  • IL-23p19 selectivity advantage over older IL-12/23 blockers (ustekinumab): specifically targets the pathogenic Th17 pathway without suppressing Th1 immunity — theoretical safer infection profile, though not yet proven superior clinically.
  • Switch strategy: risankizumab is an option for patients who have failed anti-TNF therapy (secondary non-responders) or ustekinumab. NICE TA800 (CD) approved for adults whose disease has responded inadequately to TNF inhibitors.
  • IGRA mandatory pre-treatment: latent TB screening required. Reactivation risk lower than TNF inhibitors but screen mandatory.
  • Infusion administration: IV induction must be administered in a healthcare setting with resuscitation equipment. Premedication not routinely required but consider antihistamine for prior infusion reactions. Source: BNF 90; NICE TA800.

Contraindications

  • Active serious infection (screen for TB with IGRA before starting)
  • Hypersensitivity to risankizumab or excipients
  • Live vaccines during treatment

Side effects

  • Upper respiratory tract infection (most common ~15%)
  • Nasopharyngitis, headache, fatigue
  • Injection site reactions (SC maintenance phase)
  • Arthralgia
  • Infusion-related reactions (IV induction — mild, rate-related)

Interactions

  • Live vaccines: contraindicated — avoid during treatment and for at least 21 weeks after stopping
  • No significant CYP enzyme interactions — monoclonal antibody metabolism does not involve CYP system
  • Other biologics: do not combine — additive immunosuppression risk

Monitoring

  • Clinical response assessment at week 12 (induction) and week 52 (maintenance)
  • Signs of infection (monitor throughout)
  • Skin examination — malignancy (long-term immunosuppression)
  • Tuberculosis: monitor for symptoms throughout

Reference: BNFc; BNF 90; Ferrante et al. NEJM 2022 (ADVANCE); Loftus et al. NEJM 2022 (MOTIVATE); NICE TA800 (risankizumab for CD). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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