Infection risks with anti-TNFs highlight need for vaccinations

IBD

By Michael Woodhead

12 Jul 2018

While malignancy may be the most feared adverse event of anti-TNF therapy, real world experience shows patients are up to 50 times more likely to develop a serious infection than cancer.

A French study of almost 200,000 patients with IBD treated with anti-TNFs and/or thiopurines has shown the annual incidence of serious infections requiring hospitalisation to be 1.1% (1 in 91) for patients receiving thiopurine monotherapy, 1.9% (1 in 53), for anti-TNF monotherapy and 2.2% (1 in 45) for combination therapy. Serious infections had a 3.9% mortality rate at three months.

By comparison, the population-based study, published in Gastroenterology, found a  0.8% (1 in 125) incidence of serious infections among patients not exposed to the drugs.

The risk of adverse outcomes with anti-TNFs and thiopurines was especially high in patients over 65, among whom the annual incidence of serious infections was 2.7% (1 in 37) for thiopurine, 5.3% (1 in 19) for anti-TNF–exposed patients, and 5.1% (1 in 20) in the combination therapy group.

The annual incidence of opportunistic infections was 0.17% (1 in 588) in thiopurine-exposed patients, 0.21% (1 in 476) in anti-TNF–treated patients, and 0.41% (1 in 244) for the combination therapy group. The 3-month mortality rate for opportunistic infections was 3% for all patients.

An accompanying commentary by Dr Amanda Lynn and Professor Edward Loftus of the Mayo Clinic, Minnesota, notes that the rates of serious infections seen in the French real world study were adjusted for disease severity and reflected similar rates seen in the TREAT registry of safety data for IBD drugs.

And with lymphoma incidence rates of around 0.1% with combination thiopurine/anti-TNF therapy the latest findings show that patients with IBD are 20 to 50 times more likely to suffer from a serious infection than develop lymphoma, the authors say.

“Although malignancy is often the more feared complication of thiopurine and anti-TNF therapy, the current study  …highlights the fact that serious infectious complications are exceedingly more common than malignancy in this population,” they write.

The infection rates found in the study show the risks of IBD treatment should be considered on an individual patient basis before starting biologic treatment, they suggest.

“This caveat is particularly true in the elderly population, in whom the absolute risk of serious and opportunistic infections is increased by two- to three-fold compared with their younger counterparts.”

In addition, they recommend gastroenterologists play an active role in ensuring that IBD patients have vaccinations for infections such as hepatitis A, B, influenza, pneumococcal disease and meningococcal disease. Live vaccines against infections such as varicella and zoster should also be urged in non-immunosuppressed patients.

GESA guidelines on the use of biologics in IBD state that most serious infectious complications in IBD patients on an anti-TNF agent occur early in their treatment, and TREAT registry data show they are usually associated with steroid and opiate co-therapy.

“These data emphasise the need for a thorough initial assessment for septic foci pre biologic therapy, minimising steroid and opiate co-therapy and close supervision when using biologics (and indeed all immunosuppressants),” they advise.

Already a member?

Login to keep reading.

OR
Email me a login link