TITLE

DEVELOPMENT OF HUMAN ANTI-MURINE ANTIBODIES IN PATIENTS FOLLOWING TREATMENT WITH INFLIXIMAB

AUTHOR(S)
Maiden, L.P.; Lawson, G.J.; Harris, A.W.
PUB. DATE
April 2003
SOURCE
Gut;Apr2003 Supplement 1, Vol. 52, pA62
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Introduction: Infliximab is a 75% human and 25% murine antibody directed against tumour necrosis factor-alpha. Human anti-mouse antibody (HAMA) directed against the murine component of this antibody could develop in patients given infliximab. The estimated prevalence of HAMAs varies widely from <1-80%. Many biochemical immuno-assays involve the use of mouse antibodies, eg. thyroid function tests (TFTs). If present, HAMAs could interfere with these assays giving rise to misleading results with clinical consequences. The aim of this pilot study was to assess whether patients receiving infliximab for Crohn's disease or Rheumatoid arthritis subsequently developed abnormal TFTs. If so, this could be due to the development of HAMAs as a result of exposure to infliximab. Method: Patients who had received infliximab at the Kent and Sussex or Homeopathic Hospitals as treatment for Crohn's disease or Rheumatoid arthritis between March 2000 and August 2001 subsequently had the r TFTs assessed using the standard hospital assay If any results were abnormal the assay could be confirmed using "blocking agents" which filter out the HAMAs by binding to them. Results: 19 patients (15 female; mean age=50 years, range 21-70), with either Crohn's disease (n=3) or Rheumatoid arthritis (n=16), received infliximab (mean dose=3 infusions at 5mg/kg, range 1-7 infusions). TFTs were assessed between 3 and 15 months (mean=7 months) after the last infusion. One patient had abnormal TFTs. This patient was already known to be hypothyroid and was regularly taking thyroxine. No patients required repeat assays with blocking agents. Conclusion: This pilot study has failed to show that HAMAs develop following, at least, a single infusion of infliximab. HAMAs may persist for up to 30 months after exposure. HAMAs may have developed but subsequently disappeared prior to the TFT assay, given that 3 patients had assays up to 15 months after their last infusions. Larger studies are needed to confirm...
ACCESSION #
9747707

 

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