bDMARDs Quick Reference Guide

Golimumab

Active ingredient

Golimumab

Mechanism of action

Tumour necrosis factor (TNF) – alpha inhibitor

Molecule type

Human monoclonal antibody

PBS listed indications

RheumatologyAxial spondyloarthritis

  • Ankylosing spondylitis
  • Non-radiographic axial spondyloarthritis

Severe psoriatic arthritis

Severe active rheumatoid arthritis

GastroenterologyModerate to severe ulcerative colitis

Reference product (brand)

Simponi

Biosimilar brands

None

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Pre-filled syringe 50mg/0.5mL

Pre-filled pen (Smartject®) 50mg/0.5mL, 100mg/mL

Instructions for patient self-administration are included with the product.

Frequency of administration

Once a month

Storage

Store at 2-8oC (refrigerate do not freeze).

Keep pre-filled syringes and pens in the outer carton until time of use to protect from light.

Golimumab may be stored at temperatures of up to 25oC for a single period of up to 30 days in the original carton; after which it should not be refrigerated again. Should be discarded if exposed to temperatures >25oC or if not used within 30 days of initial removal from refrigeration.

Standard dosing

Axial spondyloarthritis, psoriatic arthritis and rheumatoid arthritis: 50mg once a month

Ulcerative colitis: Initially 200mg, followed by 100mg after 2 weeks, then 100mg every 4 weeks thereafter.

Treatment with csDMARDs (e.g., methotrexate) may continue during treatment with golimumab.

Dose variations

Axial spondyloarthritis, psoriatic arthritis and rheumatoid arthritis: For patients >100kg, the European Medicines Agency suggests that if response is inadequate after 12-14 weeks, the dose may be increased to 100mg once a month taking into consideration the increased risk of adverse reactions.

This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways. 

 

Patients with rheumatoid arthritis who are in remission or have low disease activity may have their dose of golimumab down-titrated by their rheumatologist.

  • Dose reduction - 50% reduction in standard dose
  • Dose interval increase  - stepwise increase in dose interval every year (up to 3 years with complete stop at third step)

Special notes

Therapeutic drug level monitoring of golimumab can be used to guide management of ulcerative colitis. A steady state trough level of ≥2.5microgram/mL is commonly used with higher levels targeted in certain situations.

 

Golimumab is not recommended for patients within serious or untreated infection, e.g. sepsis, abscess, hepatitis B, active TB (before completing TB treatment).
May reactivate inactive hepatitis B and latent TB (begin TB treatment before starting a TNF-alpha inhibitor).
Patients with suspected latent or active TB should be treated in consultation with an Infectious Diseases physician.

Treatment with another cytokine modulator (e.g. TNF-alpha inhibitor, abatacept, anakinra, rituximab, tocilizumab) is not recommended due to increased risk of infection.

 

TNF-alpha inhibitors like golimumab are contraindicated with anakinra.

 

Golimumab is contraindicated in moderate or severe heart failure (NYHA class III–IV) and left ventricular ejection fraction <50%; use cautiously in mild disease as TNF-alpha inhibitors may worsen heart failure.

 

Rare cases of serious blood dyscrasias (some fatal) have been reported in patients taking golimumab. Monitor full blood count regularly.

 

A drug-induced lupus is rarely seen following administration of any TNF-alpha inhibitor. Patients presenting with a new rash or joint pain should be referred to their prescriber. This does not represent a class effect, and patients may be successfully rechallenged with a different TNF-alpha inhibitor without recurrence of a drug-induced lupus.

 

Live vaccines should not be given concurrently with golimumab.

References

Pharmaceutical benefits Scheme (PBS) listing. Available from https:///www.pbs.gov.au/pbs/search?term=golimumab&analyse=false&search-type=medicines [accessed 8/10/21]

Product information. Available from https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2011-PI-03025-3&d=202105111016933 [accessed 8/10/2021]

Australian Medicines Handbook 2020 (online). Adelaide: Australian Medicines Handbook Pty Ltd; 2020 July. Available from: https://amhonline.amh.net.au/

Summary of Product Characteristics. Available online: https://www.ema.europa.eu/en/documents/product-information/simponi-epar-product-information_en.pdf [accessed 10/6/21]

NPS Medicinewise. Down-titration strategies. Available from https://www.nps.org.au/bdmards/rheumatology-conditions/titration-strategies [accessed 11/5/2021]

Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases. Gastroenterology. 2017;153:835-857.e836

Papamichael K, Cheifetz AS, Melmed GY, et al. Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases. Clinical Gastroenterology and Hepatology. 2019;17:1655-1668.e1653

Vande Casteele N, Feagan BG, Wolf DC, et al. Therapeutic Drug Monitoring of Tumor Necrosis Factor Antagonists in Crohn Disease: A Theoretical Construct to Apply Pharmacokinetics and Guidelines to Clinical Practice. Inflamm Bowel Dis. 2020.