Infliximab is a chimeric monoclonal antibody that binds to and neutralises the endogenous inflammatory cytokine tumor necrosis factor alpha (TNF-α). Infliximab is used in the treatment of autoimmune conditions, including inflammatory bowel disease (IBD), inflammatory arthritis and plaque psoriasis.

 

Indications for measuring +

  • To guide dose-adjustment to optimise drug efficacy
    • Exposure-response relationship of intravenous infliximab is well established in patients with IBD and positive associations are observed in patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
    • Patients at risk of increased infliximab clearance may benefit the most from TDM.
  • Diagnosis
    • Differentiating disease refractory to infliximab versus inadequate drug exposure

How to measure

Assay detail

See Canterbury Health Labs TNF Biologic Drugs assay information.

Timing of concentration sample collection

  • Blood samples should be taken at the drug trough, within 24 hours prior to the next dose.

How to interpret

Disease Induction Maintenance
IBD 20-25 mg/L at week 2
15-20 mg/L at week 6
7-10 mg/L at week 14
5-10 mg/L after week 14
>10 mg/L in perianal fistulising Crohn’s disease and acute severe ulcerative colitis
Rheumatoid arthritis No recommendation 3-7 mg/L
Spondyloarthritis ≥6-7 mg/L
Plaque psoriasis >2-5 mg/L
Hidradenitis suppurativa No recommendation
Note: Evidence suggests that high concentrations do not lead to an increased risk of adverse effects

Factors affecting interpretation

Dose individualisation and adjustment

  • The presence of antibodies to infliximab (ATIs) can lead to high clearance and low concentrations of infliximab.  Some laboratories will do reflex testing of ATIs if infliximab is below a certain level (e.g. <2 mg/L).
  • Patients with active IBD activity may have a degree of protein losing enteropathy and/or bowel bleeding, which can lead to increased infliximab clearance by drug leaking into the bowel. Infliximab dose and/or dosing frequency may need to be increased to help attain adequate drug exposure.
  • Certain genetic variants can alter infliximab pharmacokinetics and treatment response. For instance, variants in the HLA-DQA105 allele are linked to increased risk of immunogenicity and loss of response. TDM can guide dosing escalations in patients carrying genetic variants.
  • Children typically exhibit higher infliximab clearance relative to body weight and require more frequent dosing optimisation.

Other dosing considerations

  • Some patients may have non-TNF-α driven disease, and therefore, may be unresponsive to infliximab despite high serum concentrations.
  • No dose adjustments are necessary for hepatic and renal impairment.
  • Dose adjustment may result in dosing outside of that which is Medsafe-approved and/or Pharmac funded.

Contacts for help with interpretation

Key References

  1. Alsoud D, Moes et. al . Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. Ther Drug Monit. 2024; 46:291-308.
  2. Barclay ML, Karim S, Helms ETJ, Keating PE, Hock B, Stamp LK, Schultz M. Infliximab and adalimumab concentrations and anti-drug antibodies in inflammatory bowel disease control using New Zealand assays. Intern Med J. 2019; 49:513-518

Last updated

October 2024