Study challenges safety concerns over live vaccine use in rheumatic disease patients
medwireNews: Trial findings reported at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, refute concerns that patients with rheumatic diseases taking tumor necrosis factor (TNF) inhibitors should not be given the live varicella virus vaccine.
“The concern is a theoretical risk that with any live virus vaccine, including zoster vaccine, that you would give people the very infection that you are trying to prevent long term,” explained presenter Jeffrey Curtis, from the University of Alabama at Birmingham in the USA.
This concern has resulted in “a general prohibition” to giving the varicella zoster vaccine to immunocompromised patients, such as those with rheumatoid arthritis or psoriatic arthritis, he noted.
This is despite them having “double or even triple” the risk for herpes zoster reactivation, or shingles. A risk that Curtis pointed out is increased further for those taking treatments commonly used to treat the inflammatory disorders.
For their blinded study – the Varicella Zoster Vaccine (VERVE) study – Curtis and colleagues randomly assigned 617 patients taking TNF inhibitors, most commonly for rheumatoid arthritis (59.6%), followed by psoriatic arthritis (24.5%), to receive live attenuated zoster vaccine or a saline placebo. The patients were all at least 50 years of age.
“All these people would be considered not eligible to get this or any other live virus vaccine,” Curtis stressed.
The TNF inhibitors taken by the participants included adalimumab, infliximab, etanercept, golimumab, and certolizumab in conjunction with background methotrexate and oral glucocorticoids.
Curtis reported that through 6 weeks of study there were no cases of disseminated or local varicella infection and no cases of herpes zoster reactivation.
This gave an upper bound of the 95% confidence interval for vaccine-related varicella infection of less than 1%.
“The nice thing about this pragmatic trial is that you can answer the safety question within 6 weeks,” so you only need two in-person visits, Curtis commented.
“If you are going to give someone an infection related to a live vaccine it’s going to happen quite quickly; it’s going to happen within 4 weeks and 6 is a good margin that the FDA acknowledges.”
He described the findings as “exceedingly heartening as a result,” adding that there were also no incidences of disease flare.
The researchers also looked at the potential for immunogenicity based on lab tests, so see whether “the immune system is changing in a way that suggests people are probably protected,” Curtis explained.
“And that was the case – the immune parameters that were measured and some of the blood work – that’s both humoral and cell-mediated immunity – both of those parameters changed in a way that was expected to suggest that the vaccine actually had effectiveness.”
He concluded: “The trial is encouraging not only for its result with the live zoster vaccine in TNF-treated patients but also to perhaps challenge the notion that, if you need to, a live virus vaccine may in fact be able to be safely given to people with autoimmune and inflammatory diseases, even those treated with biologics like TNF inhibitors.”
By Lucy Piper
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