Safety of Live Zoster Vaccination in Rheumatoid Arthritis

In patients with rheumatoid arthritis (RA) undergoing treatment with tofacitinib, methotrexate (MTX), or adalimumab (ADA), the rates of herpes zoster are similar in vaccinated and unvaccinated patients, according to study results published in Arthritis Care & Research.

The results also indicated that the live zoster vaccine (LZV) was well-tolerated in this patient population.

Patients from the Oral Rheumatoid Arthritis triaL study who had an inadequate response to MTX were randomly assigned 1:1:1 to receive tofacitinib 5 mg twice daily, tofacitinib 5 mg twice daily plus MTX, or ADA 40 mg every other week plus MTX. Patients age ≥50 years could opt to receive LZV 28 days before initiating study treatment.

The researchers calculated herpes zoster incidence rates (IR) (participants with events per 100 patient-years). They monitored opportunistic herpes zoster infections (multidermatomal/disseminated), serious herpes zoster events, and LZV-related adverse events.

Of 1146 participants, 18.8% (n=216) received LZV. Of all participants, 1.6% developed herpes zoster (n=18, 3 vaccinated and 15 non-vaccinated).

The researchers found that tofacitinib monotherapy had a herpes zoster IR of 1.1 (95% CI, 0.3-2.9), tofacitinib plus MTX had a herpes zoster IR of 2.3 (95% CI, 1.0-4.6), and ADA plus MTX had a herpes zoster IR of 1.7 (95% CI, 0.6-). The IRs were generally similar in  vaccinated and unvaccinated patients.

During the study, 3 multidermatomal, 1 disseminated, and 2 serious herpes zoster events occurred. No vaccinated patients presented with zoster type lesions within 42 days of vaccination, while 1 participant had vaccination-site erythema.

“Further studies are necessary to fully compare LZV efficacy in patients with RA versus the general population, and to identify potential modifiable factors, such as concomitant medications, to achieve maximal [herpes zoster] HZ prevention,” the researchers wrote.

Disclosure

This study was funded by Pfizer Inc.

Reference

Calabrese LH, Abud-Mendoza C, Lindsey SM, et al. Live zoster vaccine in patients with rheumatoid arthritis treated with tofacitinib with or without methotrexate, or adalimumab with methotrexate: post hoc analysis of data from a phase 3b/4 randomized study (ORAL Strategy) [published online June 17, 2019]. Arthritis Care Res. doi:10.1002/acr.24010