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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
Author(s) -
Calabrese Leonard H.,
AbudMendoza Carlos,
Lindsey Stephen M.,
Lee SangHeon,
Tatulych Svitlana,
Takiya Liza,
Iikuni Noriko,
Soma Koshika,
Luo Zhen,
Fleischmann Roy
Publication year - 2020
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.24010
Subject(s) - tofacitinib , medicine , rheumatoid arthritis , adalimumab , janus kinase inhibitor , adverse effect , methotrexate , erythema , randomized controlled trial , gastroenterology , surgery , dermatology
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.