Effectiveness and safety of the recombinant zoster vaccine in individuals ≥50 years of age with rheumatoid arthritis: a matched cohort and self-controlled case series study.

Abstract

In an interim analysis, we evaluated vaccine effectiveness (VE) against herpes zoster (HZ) and postherpetic neuralgia (PHN) and safety of recombinant zoster vaccine (RZV) in adults aged ≥50 years with rheumatoid arthritis (RA). VE was assessed using a retrospective matched cohort analysis of Kaiser Permanente Southern California members aged ≥50 years with RA receiving 2 RZV doses (≥4 weeks apart) and matched up to 1:3 to RZV-unvaccinated individuals. Stratified Cox proportional hazards regression was used to estimate adjusted hazard ratios and VE against HZ and PHN. Safety was assessed using a self-controlled case series analysis of chart-confirmed RA flare within 30 days after any RZV vaccination versus comparison periods. The relative risk (RR) was estimated using conditional Poisson regression. In adults ≥50 years with RA (2-dose vaccinated: 1926; unvaccinated: 5746), the adjusted VE of 2 RZV doses against HZ was 60.7% (95% CI, 41.0%-73.8%); in a subgroup analysis among those who received 2 doses 4 weeks to 6 months apart, VE against HZ was 57.9% (95% CI, 34.4%-73.0%). Adjusted VE of 2 RZV doses against PHN was 88.7% (95% CI, 12.1%-98.5%). Among 2606 adults with RA who received ≥1 RZV dose, no increased risk of RA flares within 30 days after RZV vaccination was observed (RR, 1.02; 95% CI, 0.75-1.37). Among adults ≥50 years with RA, 2 RZV doses provided protection against HZ and PHN. The study did not observe an increased risk of RA flares within 30 days following RZV vaccination.