Abstract and Introduction
Abstract
Objectives: Recombinant zoster vaccine (RZV) is Food and Drug Administration approved for the prevention of herpes zoster (shingles) in adults 50 years old and older. Immunocompromised subjects were excluded from the pivotal vaccine trials. We studied the safety of this vaccine in our university-affiliated rheumatology practice.
Methods: This was a single-center, retrospective study focusing on subjects who received RZV during 2018. We collected the demographic data, any self-reported adverse events after vaccination, C-reactive protein, Routine Assessment of Patient Index Data 3 (RAPID3) scores for subjects with rheumatoid arthritis, and available RAPID3 scores for all study subjects before and after the vaccination.
Results: Comparision of C-reactive protein (n = 40), RAPID3 scores for subjects with rheumatoid arthritis (n = 16), and available RAPID3 scores for all subjects (n = 21) using the paired t test, did not show significant differences before and after the administration of RZV. A total of 6.4% of patients reported adverse events after vaccination. The adverse events were mild and did not lead to hospitalization, end organ damage, or change in treatment plan.
Conclusions: The RZV was safe and well tolerated among our study population.
Introduction
Herpes zoster (HZ) affects 1 in every 3 human beings during his or her lifetime; the incidence seems to be higher in the older adult population.[1] The complications of HZ, the most common being postherpetic neuralgia, tend to be more frequent and severe in immunocompromised subjects.[2,3] Certain immunosuppressive medications such as mycophenolate mofetil may be associated with greater risk, as observed in a study involving solid organ transplant patients,[4] and individuals with T cell immunodeficiency, either congenital or acquired, are at increased risk of developing HZ.[5] Patients with rheumatic diseases are found to be at higher risk of HZ. A meta-analysis showed a particularly high risk of HZ with rheumatoid arthritis (RA) (pooled risk ratio 1.67) and systemic lupus erythematosus (SLE) (pooled risk ratio 2.10).[6] HZ appears to be more common in patients with RA treated with tofacitinib, certain nontumor necrosis factor-α biologics, and corticosteroids (in particular with doses >10 mg/day).[7,8]
RZV is a Food and Drug Administration–approved vaccine for the prevention of HZ in adults 50 years old and older. In the two Phase III trials involving individuals older than 50 and 70 years, the vaccine efficacy against HZ was 97.2% and 89.8%, respectively.[9,10] Both of these trials excluded immunocompromised subjects. RZV is a subunit vaccine containing recombinant varicella-zoster virus glycoprotein E formulated with AS01B adjuvant.[11] The reactogenicity of all gE/AS01B formulations is greater when compared with other formulations.[12] In a Phase III trial of RZV involving adults 50 years or older, solicited reports of systemic reactions were present in 66.1% of vaccine receivers compared with 29.5% of placebo. The reactions included myalgia, fatigue, headache, shivering, and fever.[9] Some of these systemic reactions can mimic the worsening of underlying rheumatic disease. Because of the high immunogenicity and reactogenicity of the RZV vaccine, there has been concern for the potential worsening of underlying disease among clinicians treating patients with rheumatic diseases.[13] Our understanding of both the efficacy and safety of RZV remains significantly limited in patients with inflammatory diseases mediated by aberrations of the immune system, with only a few small studies[14,15] published to date. The present study aimed to evaluate the safety of RZV in rheumatic disease patients from a single center.