ATLANTA — Data from the Varicella Zoster Vaccine study demonstrate that administering live, attenuated varicella vaccine to patients taking TNF inhibitors did not result in any safety events or disease flare after 6 weeks. In addition, there were no cases of varicella infection — either wild or vaccine type.
“I’m very excited about the results of this long-planned and long in coming study,” Jeffrey Curtis, MD, a rheumatologist and clinical researcher at the University of Alabama at Birmingham, and Healio Rheumatology Peer Perspective Board member, said during a press conference. “The goal of the trial was to mitigate the risk of herpes zoster reactivation, which is also known as shingles.”
“Everyone over the age of about 30 in the United States harbors this virus; it’s actually in your body and the lifetime risk of reactivating the virus and the painful rash that we call shingles is about one in three,” he added. “However, if you have rheumatoid arthritis or psoriatic arthritis or inflammatory bowel, your risk of having shingles is about double if not closer to triple. So, it would be really important, if you could, to lower the risk of shingles and reactivation of herpes zoster virus.”
In 2006, a zoster vaccine live (Zostavax, Merck) was approved; however, according to Curtis, it’s rarely administered to patients with immunosuppressed conditions or those on immunomodulating or immunosuppressive drugs. “The concern is that there is a theoretical risk with any live virus vaccine, including Zostavax, that you would give people the very infection that you are trying to prevent long-term,” he said.
To test the hypothesis that administering the live varicella vaccine to these patients is effective and does not result in safety concerns, Curtis and colleagues conducted the blinded, 1:1 randomized, placebo-controlled Varicella Zoster Vaccine (VERVE) study at 33 centers in the U.S. Participants were eligible if they were without cancer and vaccine-naive.
The study included 617 patients; mean age was 62.4 years and 66.9% were female. The most common reasons for taking a TNF inhibitor were rheumatoid arthritis (59.6%) and psoriatic arthritis (24.5%), and the most common agents used were adalimumab (Humira, Abbvie; 32.7%), infliximab (Remicade, Janssen; 31.3%), etanercept (Enbrel, Amgen; 21.2%), golimumab (Simponi, Janssen; 9.1%) and certolizumab (Cimzia, UCB; 5.7%). Half of patients were assigned to zoster vaccine and the other half to placebo (saline).
After 6 weeks there were no confirmed cases of disseminated or local varicella, either wild or vaccine type; this resulted in an upper bound of the 95% CI for vaccine-related infection of < 1%. Additionally, the immune parameters and blood work, including humoral and cell-mediated immunity, changed as expected and suggested the vaccine was effective, according to Curtis. Lastly, he reported there were no cases of disease flare after vaccination.
“This 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 tumor necrosis factor inhibitors.” – by Stacey L. Adams
Curtis J, et al. Abstract #824. Presented at ACR/ARP Annual Meeting, Nov. 8-13, 2019; Atlanta.
Disclosure: Curtis reports research grants and consulting fees from AbbVie, Amgen, BMS, Corrona, Janssen, Lilly, Myriad, Pfizer, Roche and UCB.