Safety of the Zoster Vaccine Recombinant Adjuvanted in Rheumatoid Arthritis and Other Systemic Rheumatic Disease Patients: A Single Center's Experience With 400 Patients

Abstract

Objective. Patients with rheumatoid arthritis (RA) and other systemic rheumatic diseases (SRDs) are at increased risk of developing herpes zoster (HZ). Zoster recombinant adjuvanted (ZRA) is a recombinant vaccine approved by the Food and Drug Administration in 2018. Concern has been raised that the ZRA may trigger disease flares in rheumatology patients who are immunocompromised. We investigated the impact of the ZRA vaccine in patients with RA and SRD and measured the incidence of flares and side effects.Methods. A flare was defined as occurring within 12 weeks of vaccine administration by either 1) documentation of RA flare in office notes, telephone encounter, or patient portal communication or 2) new or increased dose of corticosteroids.Results. We identified 403 patients (239 patients with RA and 164 patients with SRD) who received the ZRA vaccine from February 1, 2018, to February 1, 2019. We measured a 6.7% (n = 27) incidence of flare. Side effects occurred in 12.7% (n = 51) of patients. All flares and side effects were regarded as mild. Three cases of HZ were reported as occurring 2, 10, and 11 months after the vaccination. Conclusion.In 403 patients who received the ZRA vaccine, the incidence of disease flares was 7% or less and that of side effects was 13% or less, both of which are less than the incidence rates observed in the pivotal trials.

Incidence of Disease Flare After BNT162b2 Coronavirus Disease 2019 Vaccination in Patients With Rheumatoid Arthritis in Remission

“…Our data show a very low flare rate after the BNT162b2 COVID‐19 vaccine in patients with RA in remission and are consistent with previous findings about Varicella‐zoster virus (6.7%) ( 4 ) and Hepatitis B virus (2.2%) ( 5 ) vaccinations. Because remission is not commonly obtained in the real world, we are aware that our findings may not be generalizable to all patients with RA receiving COVID‐19 vaccination.…”

Impact of disease-modifying antirheumatic drugs on vaccine immunogenicity in patients with inflammatory rheumatic and musculoskeletal diseases

“…The first retrospective review of 403 patients with rheumatic disease vaccinated with the RZV found a 7% incidence of disease flare within 12 weeks of receiving a vaccine dose; this incidence was considered to be similar to expected rates from clinical trials. 66 However, a second retrospective review of 359 patients with rheumatic diseases found that 16% had a flare of their disease within 12 on September 12, 2021 by guest. Protected by copyright.…”

A Decade of JAK Inhibitors: What Have We Learned and What May Be the Future?

“…Common side effects are infections, including serious and opportunistic infections and herpes zoster (45)(46)(47). Vaccination with recombinant adjuvanted herpes zoster subunit is generally safe in patients with autoimmune disease, although flares are not uncommon (48,49). Investigation of the serologic response to the recombinant vaccine in RA patients treated with jakinibs suggests satisfactory antibody responses and acceptable tolerability (50).…”