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Objective  To explore herpes zoster ( HZ ) rates and live zoster vaccine ( LZV ) safety in a subset of patients with rheumatoid arthritis who received  LZV  before tofacitinib ± methotrexate ( MTX ), or adalimumab ( ADA ) plus  MTX  in the ORAL Strategy.    Methods   ORAL  Strategy was a 1‐year, phase IIIb/IV, randomized, triple‐dummy, active‐comparator–controlled study.  MTX ‐inadequate responder patients received tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID plus  MTX , or  ADA  40 mg every other week plus  MTX  (1:1:1 randomization). Eligible patients age ≥50 years could opt to receive  LZV  28 days before initiating study treatment.  HZ  incidence rates ( IR s; patients with events per 100 patient‐years) were calculated. Opportunistic  HZ  infections (multidermatomal/disseminated), serious  HZ  events, and  LZV ‐related adverse events were monitored.    Results  In  ORAL  Strategy, 216 of 1,146 patients (18.8%) received  LZV . Overall, 18 patients (1.6%) developed  HZ  (vaccinated: n = 3; nonvaccinated: n = 15).  HZ IR s were 1.1 (95% confidence interval [95%  CI ] 0.3–2.9), 2.3 (95%  CI  1.0–4.6), and 1.7 (95%  CI  0.6–3.7) for tofacitinib monotherapy, tofacitinib plus  MTX , and  ADA  plus  MTX , respectively, and were generally similar between vaccinated and nonvaccinated patients. Three multidermatomal, 1 disseminated, and 2 serious  HZ  events occurred. No vaccinated patients had zoster‐like lesions within 42 days of vaccination; 1 patient had vaccination‐site erythema.    Conclusion   LZV  was well tolerated, and  HZ IR s were generally similar between treatment groups and vaccinated versus nonvaccinated patients. However,  ORAL  Strategy was not powered for comparisons between vaccinated and nonvaccinated patients because <20% of all patients were vaccinated. Furthermore,  LZV  has been shown to be effective only in ~50% of individuals.

arthritis care and research

Live Zoster Vaccine in Patients With Rheumatoid Arthritis Treated With Tofacitinib With or Without Methotrexate, or Adalimumab With Methotrexate: A Post Hoc Analysis of Data From a Phase IIIb/IV Randomized Study