Makindo Medical Notes

💊 About

Golimumab (Simponi®) is a fully human monoclonal antibody that targets tumour necrosis factor-alpha (TNF-α). It is a biological disease-modifying antirheumatic drug (bDMARD) used for autoimmune inflammatory conditions refractory to conventional DMARDs. Always 🔗 check the BNF entry here for current guidance, monitoring, and dosing advice.

🧬 Mode of Action

• Binds to TNF-α, a key pro-inflammatory cytokine, preventing its interaction with TNF receptors on cell surfaces.
• This reduces synovial inflammation, pannus formation, and joint destruction.
• By modulating immune signalling, it also decreases systemic inflammation in skin, spine, and entheses.

📋 Indications

• Rheumatoid arthritis — in combination with methotrexate if response to DMARDs is inadequate.
• Psoriatic arthritis — improves peripheral and axial joint disease, enthesitis, and dactylitis.
• Ankylosing spondylitis — for active disease unresponsive to NSAIDs.
• Ulcerative colitis — moderate to severe active disease (specialist use).

💉 Dose & Administration

• Rheumatoid arthritis: 50 mg subcutaneously once monthly (with methotrexate).
• If weight > 100 kg and response inadequate after 3–4 doses → increase to 100 mg monthly.
• Psoriatic arthritis / Ankylosing spondylitis: 50 mg SC monthly.
• Usually given in combination with methotrexate; monotherapy may be used if intolerant.
• Administered via pre-filled pen or syringe into the thigh or abdomen.

⚠️ Interactions

• Do not combine with other biologics targeting TNF or IL-1 (e.g. etanercept, anakinra).
• Concurrent live vaccines should be avoided during and for 6 months after treatment.
• Review in the BNF for immunisation and drug-interaction specifics.

🚧 Cautions

• Screen for hepatitis B virus (reactivation risk) before starting therapy.
• Exclude both active and latent tuberculosis via CXR and interferon-gamma release assay (IGRA).
• Use with caution in chronic or recurrent infections, demyelinating disorders, or mild heart failure (NYHA I–II).
• Monitor for malignancy (especially lymphoma and skin cancers) in long-term use.

⛔ Contraindications

• Moderate-to-severe heart failure (NYHA III–IV).
• Active tuberculosis or other severe infections.
• Known hypersensitivity to golimumab or excipients.
• Rare hereditary fructose intolerance (contains sorbitol).

💥 Side Effects

• 🌡️ Infections: nasopharyngitis, pharyngitis, sinusitis, pneumonia.
• 🩸 Injection-site reactions, rash, urticaria.
• 🧠 Headache, fatigue, dizziness.
• ⚡ Possible autoantibody formation, lupus-like reaction, or demyelination (rare).
• 📈 Mild liver enzyme elevation, cytopenias (monitor FBC, LFTs).

📚 References

• BNF: Golimumab
• NICE Technology Appraisal (TA225)
• British Society for Rheumatology (BSR) Biologic DMARD Safety Guidelines, 2023.