Live Zoster Vaccine in Patients with Rheumatoid Arthritis Treated with Tofacitinib with or without Methotrexate, or Adalimumab with Methotrexate

Arthritis Care and Research 2019 DOI: 10.1002/acr.24010

Live zoster vaccine (LZV) was well tolerated, and herpes zoster (HZ) incidence rates were generally similar between treatment groups in vaccinated versus non-vaccinated patients in a subset of RA who received LZV before TOF ± MTX, or ADA + MTX, in ORAL Strategy. It is known that patient with RA are at increased risk of developing HZ though the mechanisms behind this are currently not well understood though therapies, such as TOF, are thought to increase the risk. ACR and EULAR recommend using LZV, although efficacy is limited and reduces with age. This analysis of ORAL Strategy explores LZV safety and HZ events by treatment arm.In ORAL Strategy, 1146 patients were randomised to receive TOF monotherapy, TOF + MTX, or ADA + MTX. HZ incidence rates and 95% CIs were calculated for each treatment group and for vaccinated versus non-vaccinated patients. Crude HZ incidence rates were also calculated for vaccinated and non-vaccinated patients, stratified by age ≥50 years. Overall, 1.6% of patients receiving study treatment developed HZ. All patients who developed HZ that received TOF monotherapy also received corticosteroids at baseline. Incidence rates of HZ were 1.1, 2.3, and 1.7 for TOF monotherapy, TOF + MTX, and ADA + MTX, respectively, and were similar between vaccinated and non-vaccinated patients. HZ incidence rates for vaccinated and non-vaccinated patients aged ≥50 years were 1.6 & 0.9 in TOF Mono, 3.1 & 4.0 for TOF +MTX and 0 & 2.4 ADA + MTX.In this post hoc analysis of ORAL Strategy, HZ incidence rates were generally similar across treatment groups, and between vaccinated and non-vaccinated patients, with wide and overlapping 95% CIs. It should be noted that ORAL Strategy was not designed for comparisons between vaccinated and non-vaccinated patients, with <20% of patients vaccinated. With this in mind, the authors concluded that further studies are necessary to fully compare LZV efficacy in RA patients versus the general population, and to identify potential modifiable factors to achieve maximal HZ prevention. Safety findings were consistent with previous reports.