Immunogenicity of adjuvanted recombinant zoster vaccine in patients with rheumatoid arthritis treated with upadacitinib: 60-week results from a randomised controlled trial substudy
Authors' conclusion
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).
Study context
- Population
- Patients with RA receiving upadacitinib 15 mg QD with background MTX in SELECT-COMPAREreceived both recombinant zoster vaccine (RZV) doses
- Participants
- 93 patients
- Primary endpoint
- Proportion achieving satisfactory humoral response to RZV (≥ 4-fold increase in prevaccination anti-gE antibody titres)
- Follow-up
- Week 16
Methodological detailssingle-group vaccine substudy
- Single-group vaccine substudy
Primary result
As reported in the abstract
Satisfactory humoral response to RZV (≥ 4-fold increase in prevaccination anti-gE antibody titres)
Proportion of patients with satisfactory humoral response to RZV
87.8%
95% CI 81.0 to 94.5
Further findings
Effect of age and concomitant GC use on RZV antibody response
- Age and concomitant corticosteroid use did not affect RZV antibody response
Cell-mediated immune (CMI) response to RZV (≥ 2-fold increase in gE-specific CD4+ [2+] T-cell frequency), subcohort of 38 · all time points
- Over 60% of patients achieved a CMI response
Safety
Serious adverse events · 30 days after each vaccination
- No serious adverse events were reported
Herpes zoster · 4 months after the second RZV dose
- Patients who developed herpes zoster
- 1
Original publication
Immunogenicity of adjuvanted recombinant zoster vaccine in patients with rheumatoid arthritis treated with upadacitinib: 60-week results from a randomised controlled trial substudy. RMD Open. Published 12 August 2025. doi:10.
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