TNF-α Inhibitor (Human Monoclonal Antibody) Pregnancy: Available postmarketing data have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes. Monoclonal antibodies are transported across the placenta in the third trimester and may affect the infant's immune response.

Golimumab

Brand names: Simponi, Simponi I.V.

Golimumab is a subcutaneous (or intravenous) anti-tumour necrosis factor (TNF) monoclonal antibody used in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and ulcerative colitis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 2 mg/kg (intravenous infusion, SIMPONI ARIA)

Route: Intravenous infusion over 30 minutes

Frequency: At weeks 0 and 4, then every 8 weeks thereafter

US labelling (SIMPONI ARIA, IV formulation). Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS): 2 mg/kg IV over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. For RA, give in combination with methotrexate. Each 4 mL vial contains 50 mg golimumab; dilute total volume with 0.9% Sodium Chloride Injection (or 0.45%) to a final volume of 100 mL and infuse over 30 minutes using a 0.22 micron in-line filter. Prior to initiation and periodically, evaluate for active/latent tuberculosis and test for hepatitis B. Efficacy/safety of switching between IV and subcutaneous formulations/routes not established. Paediatric dosing is body-surface-area based (80 mg/m² IV at weeks 0 and 4, then every 8 weeks) for polyarticular juvenile idiopathic arthritis and PsA in patients 2 years and older — not a per-kg dose, verify against a current children's formulary.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None stated in US labelling (SIMPONI ARIA: 'None')

Side effects

Upper respiratory tract infection
Alanine aminotransferase increased / aspartate aminotransferase increased
Viral infection
Neutrophil count decreased
Bronchitis; hypertension; rash
Serious infections and malignancies (most serious reactions)

Interactions

Methotrexate — for RA, use SIMPONI ARIA with methotrexate; concomitant methotrexate decreases golimumab clearance (~9%) partly by reducing anti-golimumab antibody formation
Other biologic products (including abatacept, anakinra, rituximab) — not recommended; increased risk of serious infections with no added benefit
Live vaccines / therapeutic infectious agents — should not be given concurrently

Clinical monograph

How it works

It is a human monoclonal antibody that binds and neutralises soluble and transmembrane TNF-alpha, reducing the inflammatory cascade driving these conditions.

Prescribing in practice

As a TNF inhibitor it increases the risk of serious infection including reactivation of tuberculosis and hepatitis B, so screening before treatment is mandatory.
It is generally given with methotrexate in rheumatoid arthritis and should be avoided in active infection and moderate-to-severe heart failure.
Live vaccines should be avoided during treatment, and there is a small increased risk of certain malignancies including lymphoma.

Monitoring

Screen for latent tuberculosis and hepatitis before starting, and monitor for infection and disease response during treatment.

Counselling the patient

Report signs of infection such as persistent fever, cough or weight loss promptly.
Ensure vaccinations are up to date before starting and avoid live vaccines during treatment.
Store injections in the fridge and follow the technique taught for self-injection.

Evidence & guidelines

Efficacy across rheumatic indications was established in the GO-FORWARD, GO-RAISE and related randomised controlled trials.

Reference: NICE TA225; GO-FORWARD trial; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways