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

Guselkumab

Brand names: Tremfya

Adult dose

Dose: 100 mg subcutaneous injection
Route: Subcutaneous
Frequency: Week 0, week 4, then every 8 weeks
Max: 100 mg every 8 weeks
No methotrexate co-administration required. Allow prefilled syringe to reach room temperature for 30 minutes before injection. Used for active 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

  • DISCOVER-1 and DISCOVER-2 trials: guselkumab demonstrated significant improvements in ACR20, ACR50, ACR70, and skin outcomes in psoriatic arthritis — DISCOVER-2 included biologic-naive patients only
  • IL-23 pathway selectivity: guselkumab targets the p19 subunit of IL-23 (shared with IL-39) — more specific than ustekinumab (which targets the p40 subunit shared by both IL-12 and IL-23)
  • Fungal infections: the IL-17/IL-23 axis is critical for mucocutaneous candidiasis and tinea defence — monitor for oral candidiasis and tinea; counsel patients
  • NICE TA596: approved for active psoriatic arthritis in adults after inadequate response to DMARDs
  • Once-every-8-weeks dosing (after initial loading) is an advantage for patient convenience versus biweekly biologics

Contraindications

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

Side effects

  • Upper respiratory tract infections (most common)
  • Tinea infections — IL-23 pathway important for fungal immunity
  • Headache
  • Injection site reactions
  • Arthralgia
  • Diarrhoea

Interactions

  • Live vaccines — contraindicated
  • Other immunosuppressants — limited data; use with caution
  • CYP450 substrates: IL-23 inhibition may alter CYP activity; monitor warfarin and ciclosporin levels

Monitoring

  • Signs of infection
  • TB testing before initiation
  • Fungal infection surveillance
  • Clinical response at 24 weeks

Reference: BNFc; BNF 90; NICE TA596; DISCOVER-1 Trial (Ann Rheum Dis 2020); DISCOVER-2 Trial (Lancet 2020); SPC Tremfya. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.