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date: 2026-08-24T21:50:59
publisher: vivo
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label: RDF description of 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 - http://orbis.uaslp.mx/vivo/individual/scopus6351

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scopus6351
e iscopus: 2-s2.0-85079273131
page end: 359
has funding vehicle: Pfizer
volume: 72
type: Document
type: Article
related by: authorship_41340
date time value: article date 6352
freetext keyword: adalimumab; live vaccine; methotrexate; tofacitinib; varicella zoster vaccine; adalimumab; antirheumatic agent; Janus kinase inhibitor; methotrexate; piperidine derivative; pyrimidine derivative; pyrrole derivative; tofacitinib; varicella zoster vaccine; adult; Article; controlled study; drug efficacy; drug safety; drug tolerability; female; herpes zoster; human; incidence; injection site erythema; injection site reaction; male; middle aged; monotherapy; multicenter study (topic); opportunistic infection; phase 3 clinical trial (topic); phase 4 clinical trial (topic); randomized controlled trial (topic); rheumatoid arthritis; vaccination; aged; clinical trial; combination drug therapy; complication; herpes zoster; multicenter study; phase 3 clinical trial; phase 4 clinical trial; randomized controlled trial; rheumatoid arthritis; Adalimumab; Adult; Aged; Antirheumatic Agents; Arthritis, Rheumatoid; Drug Therapy, Combination; Female; Herpes Zoster; Herpes Zoster Vaccine; Humans; Incidence; Janus Kinase Inhibitors; Male; Methotrexate; Middle Aged; Piperidines; Pyrimidines; Pyrroles
related by: authorship_41339
related by: authorship_41345
label: 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
abstract: 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 (IRs; 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%25) received LZV. Overall, 18 patients (1.6%25) developed HZ (vaccinated: n = 3; nonvaccinated: n = 15). HZ IRs were 1.1 (95%25 confidence interval [95%25 CI] 0.3–2.9), 2.3 (95%25 CI 1.0–4.6), and 1.7 (95%25 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 IRs 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%25 of all patients were vaccinated. Furthermore, LZV has been shown to be effective only in ~50%25 of individuals. © 2019 Pfizer Inc. Arthritis Care %26 Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.
abstract: 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 (IRs; 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%25) received LZV. Overall, 18 patients (1.6%25) developed HZ (vaccinated: n = 3; nonvaccinated: n = 15). HZ IRs were 1.1 (95%25 confidence interval [95%25 CI] 0.3–2.9), 2.3 (95%25 CI 1.0–4.6), and 1.7 (95%25 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 IRs 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%25 of all patients were vaccinated. Furthermore, LZV has been shown to be effective only in ~50%25 of individuals. © 2019 Pfizer Inc. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.
accesstype: All Open Access, Hybrid Gold, Green
doi: 10.1002/acr.24010
related by: authorship_41337
most specific type: Document
related by: authorship_41343
type: Entity
type: Continuant
most specific type: Article
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has publication venue: Arthritis Care and Research
pmid: 31207152
chemicalscas: adalimumab, 331731-18-1, 1446410-95-2; methotrexate, 15475-56-6, 59-05-2, 7413-34-5; tofacitinib, 477600-75-2, 540737-29-9; Adalimumab; Antirheumatic Agents; Herpes Zoster Vaccine; Janus Kinase Inhibitors; Methotrexate; Piperidines; Pyrimidines; Pyrroles; tofacitinib
origen: scopus
type: Generically Dependent Continuant
issue: 3
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crisid: 6352
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page start: 353
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Arthritis Care and Research
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publication venue for: scopus6351
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Pfizer
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funding vehicle for: scopus6351