Is it safe for patients with congestive heart failure to receive infliximab?

This one is hard to answer – best synthesis is probably yes, though not at high doses, and not if NYHA Class III/IV. When these biologics were first introduced, in the early 2000s, there were reports of increased adverse events in patients with HF as well as concern that the drug was inducing failure. Subsequently we saw a drop-off in that observation, but that may have been because it was prescribed less in this patient population. The attached Circ letter goes through the underlying pathophysiology nicely.

A 2011 Cochrane review found infliximab did increase adverse events and result in drug withdrawal, but as best I can tell, the adverse events were mostly related to infectious concerns. The review overall concludes the rate of congestive heart failure was not significantly different between groups who received biologic therapies and groups who didn’t, but the dataset is quite small, limiting interpretation. There’s not good literature that is more recent.

The issue is confusing because separately, TNF-alpha inhibitors have been tested as a treatment modality for heart failure. Both the RENEWAL (eternacept) and ATTACH (infliximab) trials showed no benefit, and the latter showed increased mortality in the 10 mg/kg dose group.

The infliximab label does include a note of caution regarding its use in HF patients and concern for new HF. If you have to use it for your patient, the UpToDate article on this topic suggests a baseline echo, close f/u, avoiding a dose higher than 3 mg/kg of infliximab, and stopping the drug if the heart failure gets worse (obviously).


de’ Clari F, Salani I, Safwan E, Giannacco A. Sudden Death in a Patient Without Heart Failure After a Single Infusion of 200 mg Infliximab: Does TNF-α Have Protective Effects on the Failing Heart, or Does Infliximab Have Direct Harmful Cardiovascular Effects? Circulation. 2002;105(21). doi:https://doi.org/10.1161/01.cir.0000017216.41471.df

Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database of Systematic Reviews. Published online February 16, 2011. doi:https://doi.org/10.1002/14651858.cd008794.pub2

UpToDate. www.uptodate.com. https://www.uptodate.com/contents/tumor-necrosis-factor-alpha-inhibitors-an-overview-of-adverse-effects

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