Study Suggests Zoster Vaccine Safe in Patients Receiving TNF Inhibitors

New data from a University of Alabama-Birmingham-led study comes as a relief to patients receiving anti-tumor necrosis factor(TNF) inhibitors and their care providers.

Results of the study, which included more than 600 individuals from the US receiving TNF inhibitor therapies, revealed the live zoster vaccine was safe for people currently receiving the biologic therapies for various conditions.

In an effort to determine the safety and efficacy of the live zoster vaccine, investigators conducted the Varicella Zoster Vaccine (VERVE) trial. The VERVE trial, which was designed as a randomized, placebo-controlled blinded trial, included 617 patients from 33 centers.

To be included in the study, patients must have been 50 years of age or older, be current users of TNF inhibitor therapies for any disease indication, and have no prior zoster vaccination. Of the 617 included in the study, the mean age was 62 years, women made up 66% of the group, and 87% of participants were white.

Investigators noted rheumatoid arthritis accounted for 59% of the TNF inhibitor indications while psoriatic arthritis accounted for an additional 24.5% of indications.

TNF inhibitors used by study participants included adalimumab (32.7%), infliximab (31.3%), etanercept (21.2%), golimumab (9.1%), and certolizumab (5.7%). Concomitant therapy use was common among study participants, with 48% using background methotrexate and 10.5% using oral glucocorticoids.

Patients included in the study received the vaccine and were followed for 6 weeks to assess safety. Investigators noted patients with suspected cases of varicella infection or shingles underwent clinical assessment, polymerase chain reaction collection, and digital photographs.

Additionally, investigators also collected serum and peripheral blood mononuclear cell (PBMC) samples at baseline and week 6 to assess zoster-related immunity. Investigators conducted another safety follow-up through 6 months after vaccination there patients were unmasked to the treatment arm.

At 6 weeks, there were no causes of confirmed disseminated or local varicella infection. In total 8 rashes were swabbed for varicella polymerase chain reaction and zero came back positive. Furthermore, no clinically adjudicated varicella or shingles reactivation vases were observed through week 6.

For more on the clinical impact of the VERVE trial, MD Magazine® sat down with Curtis at the 2019 American College of Rheumatology annual meeting in Atlanta, GA for his takeaways on the data.