In patients taking a tumor necrosis factor inhibitor (TNFi), the live attenuated varicella zoster vaccine (ZV) did not induce varicella infection or reactivation during the 6-week risk period following vaccination, according to results of a new study presented at the 2019 American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting. The findings suggest that live virus vaccines are safe in this possibly immunocompromised population.

“The trial is encouraging not only for results of live vaccination, but to perhaps challenge the notion that a live vaccine may not be given to people with autoimmune conditions, even those who are immunosuppressed,” study author Jeffrey Curtis, MD, MPH, a professor of medicine at the University of Alabama at Birmingham, said during a press conference at the ACR/ARP Annual Meeting.

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Dr Curtis and colleagues randomly assigned 617 participants from 33 centers who were taking a TNFi for various indications, the most common of which were rheumatoid arthritis (59.6%) and psoriatic arthritis (24.5%). All patients had no prior ZV.

Safety follow-up occurred over 6 weeks—the risk window for vaccine-related infection specified by the US Food and Drug Administration. Serum and peripheral blood mononuclear cells were collected at baseline and at week 6 to assess ZV-related immunity, with safety follow-up through 6 months.

Through week 6, no cases of confirmed disseminated or local varicella infection occurred, either wild-type or vaccine strain.

A total of 8 rashes were swabbed for varicella polymerase chain reaction testing, of which none were positive. The researchers did not observe any clinically diagnosed varicella infection or reactivation cases through week 6.

“This trial informs on any safety concerns of the use of live virus vaccines in this population,” Dr Curtis said.

—Melinda Stevens

Reference:

Curtis J, Bridges SL, Cofield SS, et al. Results from a randomized controlled trial of the safety of the live varicella vaccine in TNF-treated patients [abstract 824]. Arthritis Rheumatol. 2019;71(suppl 10). Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. https://acrabstracts.org/abstract/results-from-a-randomized-controlled-trial-of-the-safety-of-the-live-varicella-vaccine-in-tnf-treated-patients/. Accessed November 12, 2019.