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Biologic DMARD — IL-23 Inhibitor (Anti-p19) Pregnancy: Avoid — insufficient data; animal studies show no teratogenicity

Risankizumab (Rheumatology)

Brand names: Skyrizi

Adult dose

Dose: 150 mg subcutaneous injection
Route: Subcutaneous
Frequency: Week 0, week 4, then every 12 weeks
Max: 150 mg every 12 weeks
Every-12-weeks maintenance dosing (after initial two doses) is the longest maintenance interval among approved IL-23 inhibitors — convenience advantage. Used for psoriatic arthritis and plaque psoriasis.

Paediatric dose

Route:
Not licensed for paediatric use — seek specialist opinion

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment required

Clinical pearls

  • KEEPsAKE 1 and KEEPsAKE 2 trials: risankizumab demonstrated ACR20 response rates of 57% vs 34% placebo in PsA at week 24; improvements in skin, enthesitis, and dactylitis
  • Longest maintenance interval of approved IL-23 inhibitors: guselkumab every 8 weeks vs risankizumab every 12 weeks — most convenient injection schedule among biologics for PsA
  • Like guselkumab, targets p19 subunit of IL-23 specifically — does not block IL-12 (unlike ustekinumab); IL-12 preservation theoretically maintains Th1-mediated antimicrobial immunity
  • NICE TA775: approved for active psoriatic arthritis in adults after inadequate response to ≥1 DMARD
  • Fungal infection risk: IL-23/Th17 axis critical for candida and dermatophyte defence — monitor for tinea unguium, tinea corporis, and oral candidiasis

Contraindications

  • Active serious infection including TB
  • Clinically significant hypersensitivity to risankizumab
  • Live vaccines

Side effects

  • Upper respiratory tract infections (most common)
  • Tinea and candidal infections — IL-23 pathway
  • Headache
  • Injection site reactions
  • Fatigue

Interactions

  • Live vaccines — contraindicated during treatment
  • Other immunosuppressants — limited evidence; infection risk
  • CYP450 substrates — potential minor interaction via IL-23 axis effects on CYP enzymes

Monitoring

  • TB screening before starting
  • Signs of infection
  • Fungal infection surveillance
  • Clinical response at 24 weeks — discontinue if inadequate

Reference: BNFc; BNF 90; NICE TA775; KEEPsAKE 1 Trial (Lancet 2021); KEEPsAKE 2 Trial (Ann Rheum Dis 2021); SPC Skyrizi. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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