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.
Calculators
- SMART Risk Score for Recurrent CVD · Cardiovascular Risk
- PCSK9 Inhibitor Eligibility Assessment · Lipid Management
- PASI Score (Psoriasis Area and Severity Index) · Psoriasis
- DLQI (Dermatology Life Quality Index) · Quality of Life
- Revised Original International Autoimmune Hepatitis Score (IAIHG) · Autoimmune Liver Disease
- Immune-Related Adverse Events (irAE) -- GI Toxicity Colitis Grading · Oncology-Related GI
Pathways
- Cutaneous Lupus Erythematosus · BAD; EULAR
- Osteoporosis / Fragility Fracture · NOGG 2021; NICE NG147; NG224
- Arteritic AION (Giant Cell Arteritis) · RCOphth; BSR
- Osteoarthritis Hip / Knee Management · NICE NG226 (2022)
- Lupus Nephritis · EULAR/ERA-EDTA 2019; KDIGO 2024
- Rheumatoid Arthritis Management · NICE CG79 2018 / EULAR 2022