{
  "abstract": "Objective To evaluate the immunogenicity of adjuvanted recombinant zoster vaccine (RZV) in patients with rheumatoid arthritis receiving upadacitinib 15 mg once daily (QD) with background methotrexate.Methods Eligible patients in SELECT-COMPARE ( NCT02629159) receiving upadacitinib 15 mg QD and background methotrexate received RZV at weeks 0 and 12. Antibody titres were collected at weeks 0, 4, 16 and 60 (prevaccination, 4 weeks after first dose, and 4 and 48 weeks after second dose). The primary endpoint was the proportion of patients achieving a satisfactory humoral response to RZV at week 16 (≥ 4-fold increase in prevaccination anti-glycoprotein E (gE) antibody titres). Cell-mediated immune (CMI) response to RZV (≥ 2-fold increase in prevaccination gE-specific CD4+ [2+] T-cell frequency) was assessed at each time point in a subcohort of 38 patients. Safety was assessed for 30 days after each vaccination.Results Overall, 93 patients received both RZV doses (78.5% female; mean age, 62.4 years). At baseline, 49.5% used concomitant corticosteroids (median daily dose, 5.0 mg). Satisfactory humoral responses to RZV were observed in 87.8% (95% CI 81.0 to 94.5) of patients at week 16. Age and concomitant corticosteroid use did not affect RZV antibody response. Over 60% of patients achieved a CMI response to RZV at all time points. No serious adverse events were reported. One patient developed herpes zoster 4 months after the second RZV dose.Conclusions Most patients receiving upadacitinib 15 mg QD with background methotrexate achieved satisfactory humoral and CMI responses 4 weeks after the second RZV vaccination (week 16).",
  "authors": [
    {
      "affiliations": [
        "Schools of Medicine and Public Health, Oregon Health & Science University School of Medicine, Portland, Oregon, USA"
      ],
      "name": "Kevin L Winthrop"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Justin Klaff"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Sara K Penn"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Yanxi Liu"
    },
    {
      "affiliations": [
        "Rheumatology Unit, Hospital General de México Dr Eduardo Liceaga, Mexico City, Mexico"
      ],
      "name": "Conrado García"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Organización Médica de Investigación SA, Buenos Aires, Argentina"
      ],
      "name": "Eduardo Mysler"
    },
    {
      "affiliations": [
        "Department of Rheumatology, American Medical Group, Destin, Florida, USA"
      ],
      "name": "Alvin F Wells"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Xianwei Bu"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Irina Fish"
    },
    {
      "affiliations": [
        "AbbVie Inc, North Chicago, Illinois, USA"
      ],
      "name": "Michael Chen"
    },
    {
      "affiliations": [
        "Centre for Virus Research, The Westmead Institute for Medical Research, Sydney ID, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia"
      ],
      "name": "Anthony L Cunningham"
    }
  ],
  "title": "Immunogenicity of adjuvanted recombinant zoster vaccine in patients with rheumatoid arthritis treated with upadacitinib: 60-week results from a randomised controlled trial substudy",
  "uid": "9c84e63c-cb94-5c43-adfd-7314da4e9a25"
}