Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease
Article first published online: 3 MAY 2011
© 2011 Blackwell Publishing Ltd
Alimentary Pharmacology & Therapeutics
Volume 34, Issue 1, pages 51–58, July 2011
How to Cite
Steenholdt, C., Svenson, M., Bendtzen, K., Thomsen, O. Ø., Brynskov, J. and Ainsworth, M. A. (2011), Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Alimentary Pharmacology & Therapeutics, 34: 51–58. doi: 10.1111/j.1365-2036.2011.04682.x
- Issue published online: 2 JUN 2011
- Article first published online: 3 MAY 2011
- Publication data Submitted 11 March 2011 First decision 29 March 2011 Resubmitted 12 April 2011 Accepted 14 April 2011 EV Pub Online 3 May 2011
Aliment Pharmacol Ther 2011; 34: 51–58
Background Infliximab (IFX) elicits acute severe infusion reactions in about 5% of patients with inflammatory bowel disease (IBD).
Aim To investigate the role of anti-IFX antibodies (Ab) and other risk factors.
Methods The study included all IBD patients treated with IFX at a Danish university hospital until 2010 either continuously (IFX every 4–12 weeks) or episodically (reinitiation after >12 weeks). Anti-IFX Ab were measured using radioimmunoassay.
Results Twenty-five (8%) of 315 patients experienced acute severe infusion reactions. Univariate analysis showed that patients who reacted were younger at the time of diagnosis (19 vs. 26 years, P = 0.013) and at first IFX infusion (28 vs. 35 years, P = 0.012). Furthermore, they more often received episodic therapy (72% vs. 31%, P < 0.001) and logistic regression revealed this as the only significant predictor of reactions (OR 5 [2–13]; P < 0.001). IFX reinitiation after 6 months intermission further increased the risk (OR 8 [3–20], P < 0.001). Most reactions (n = 14, 88%) occurred at 2nd infusion in the 2nd treatment series (P = 0.006). Anti-IFX IgG Ab were highly positive in 19 of 20 patients (95%) shortly after the reactions (median 84 U/mL). Anti-IFX IgG Ab measured prior to the retreatment series were negative in 7 of 11 patients tested (64%). Anti-IFX IgE Ab were negative in all patients with reactions.
Conclusions Acute severe infusion reactions were strongly associated with development of anti-IFX IgG Ab, but not with anti-IFX IgE Ab. The risk was particularly high at the 2nd infusion in retreatment series. Negative anti-IFX Ab before reinitiation did not rule out reactions.