In:
Arthritis Care & Research, Wiley, Vol. 72, No. 3 ( 2020-03), p. 353-359
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
2151-464X
,
2151-4658
Language:
English
Publisher:
Wiley
Publication Date:
2020
detail.hit.zdb_id:
2016713-1
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