(Reuters Health) –, a clinical trial suggests.
Researchers randomized 617 participants receiving TNFis 1:1 to receive either the Zostavax live varicella-zoster vaccine or placebo. The study included individuals with a variety of different inflammatory conditions, including rheumatoid arthritis (57.6%) and psoriatic arthritis (24.1%).
After six weeks of follow-up, none of the participants in the intervention group experienced a case of vaccine-associated shingles or varicella infection. Similar proportions of patients who received the live vaccine (3.2%) and placebo (2.6%) experienced serious adverse events through 6 months of follow-up.
“The prohibition against live virus vaccines in patients receiving TNFi biologics may not be as inviolable as might have been thought,” said lead study author Dr. Jeffrey Curtis of the division of clinical immunology & rheumatology at the University of Alabama at Birmingham.
“I wouldn’t extrapolate that to severely immunocompromised patients such as organ transplant patients, nor patients receiving certain drugs known to increase zoster risk such as janus kinase inhibitors like Rinvoq or Xeljanz, but for people on cytokine inhibitors, this live virus vaccine would seem to be ok,” Dr. Curtis said by email.
The most commonly used TNFi medication in the study was adalimumab (32.7%), followed by infliximab (31.3%), etanercept (21.2%), golimumab (9.1%), and certolizumab (5.7%). Many patients were on concomitant therapies including methotrexate (48.0%) and oral glucocorticoids (10.5%).
Researchers assessed both humoral and cellular immune responses by gpELISA and ELISpot (IFN-gamma), respectively. From baseline to 6 weeks after vaccination, participants in the intervention group had mean geometric fold rises of 1.33 percentage points, and 1.39 percentage points, respectively.
Although the vaccine-induced immunogenicity responses were robust, the study also found that cell-mediated responses were variable and not sustained at one year after vaccination, according to the report in the Annals of Internal Medicine. This suggests that people on TNFIs might require evaluation for a booster vaccination, the researchers note.
Beyond its small size, one limitation of the study is that it only enrolled people over 50 years old, and immune responses may be superior in younger individuals, the study team notes. Another limitation is that the analysis only focused on a single type of immunomodulation therapy.
“Concerns regarding the safety of vaccinations reflects label contraindication of live vaccines,” said Dr. Kim Papp, a dermatologist at Probity Medical Research in Waterloo, Ontario, who wasn’t involved in the study.
The study results suggest that the broad contraindication on the label for TNFIs is unfounded, Dr. Papp said by email.
“The concern stems from occurrence of active and sometimes fatal infections developing in individuals who are profoundly immunosuppressed: marrow ablation, SCID patients, end stage leukemia or lymphoma, or patients receiving extreme doses of broad immunosuppressants or high-dose antimetabolites for the treatment of solid tumors,” Dr. Papp said.
SOURCE: https://bit.ly/3uq8FzF Annals of Internal Medicine, online September 27, 2021.
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