PMID- 37851412
OWN - NLM
STAT- Publisher
LR  - 20231018
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
DP  - 2023 Oct 18
TI  - Serologic immunogenicity and safety of Herpes Zoster subunit vaccine in patients 
      with Rheumatoid Arthritis receiving Janus Kinase inhibitors.
LID - kead552 [pii]
LID - 10.1093/rheumatology/kead552 [doi]
AB  - OBJECTIVE: Patients with rheumatoid arthritis (RA) treated with Janus Kinase 
      inhibitors (JAKi) are at increased risk of Herpes Zoster (HZ). The objective of 
      this study was to investigate serological immunogenicity and safety of the HZ 
      subunit (HZ/su) vaccine in RA patients treated with JAKi, for which little is 
      known. METHODS: RA patients treated with JAKi (n = 82) at the Department of 
      Rheumatology, Skane University Hospital, Sweden, and healthy controls (n = 51) 
      received two doses of the HZ/su vaccine (Shingrix). Vaccine-specific antibody 
      responses were analysed using indirect enzyme-linked immunosorbent assay (ELISA). 
      Post-vaccination antibody levels were compared between patients and controls 
      using analysis of covariance. Potential predictors for vaccine response were 
      investigated using a multivariable linear regression analysis. Self-reported 
      adverse events (AEs) and changes in RA disease activity were analysed. RESULTS: 
      Following vaccination, vaccine-specific antibody levels increased significantly 
      in both patients and controls (p< 0.0001). 80.5% of patients and 98.0% of 
      controls achieved a >/= 4-fold increase in antibody levels. Post-vaccination 
      antibody levels were lower in patients than controls (ratio 0.44, 95% CI 
      0.31-0.63), and lower in patients receiving JAKi+Methotrexate than JAKi 
      monotherapy (ratio 0.43, 95% CI 0.24-0.79). AEs, mostly mild/moderate, were 
      common. One patient developed HZ and six patients (6.5%) had increased RA disease 
      activity following vaccination. CONCLUSION: The HZ/su vaccine was serologically 
      immunogenic in most RA patients treated with JAKi. Moreover, the vaccine had an 
      acceptable safety profile. These results support recommendations for usage of the 
      HZ/su vaccine in this vulnerable population. TRIAL REGISTRATION: 
      ClinicalTrials.gov, https://clinicaltrials.gov, NCT03886038.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of the 
      British Society for Rheumatology.
FAU - Kallmark, Hanna
AU  - Kallmark H
AUID- ORCID: 0000-0003-3092-5074
AD  - Department of Clinical Sciences Lund, Section of Rheumatology, Lund University 
      and Skane University Hospital, Lund and Malmo, Sweden.
FAU - Bergstrom, Tomas
AU  - Bergstrom T
AD  - Department of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, 
      University of Gothenburg, Gothenburg, Sweden.
FAU - Nagel, Johanna
AU  - Nagel J
AD  - Department of Clinical Sciences Lund, Section of Rheumatology, Lund University 
      and Skane University Hospital, Lund and Malmo, Sweden.
FAU - Gullstrand, Birgitta
AU  - Gullstrand B
AD  - Department of Clinical Sciences Lund, Section of Rheumatology, Lund University 
      and Skane University Hospital, Lund and Malmo, Sweden.
FAU - Einarsson, Jon T
AU  - Einarsson JT
AD  - Department of Clinical Sciences Lund, Section of Rheumatology, Lund University 
      and Skane University Hospital, Lund and Malmo, Sweden.
FAU - Bengtsson, Anders A
AU  - Bengtsson AA
AD  - Department of Clinical Sciences Lund, Section of Rheumatology, Lund University 
      and Skane University Hospital, Lund and Malmo, Sweden.
FAU - Kapetanovic, Meliha C
AU  - Kapetanovic MC
AD  - Department of Clinical Sciences Lund, Section of Rheumatology, Lund University 
      and Skane University Hospital, Lund and Malmo, Sweden.
LA  - eng
SI  - ClinicalTrials.gov/NCT03886038
PT  - Journal Article
DEP - 20231018
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
SB  - IM
OTO - NOTNLM
OT  - Herpes Zoster
OT  - Janus Kinase inhibitors
OT  - Rheumatoid Arthritis
OT  - Vaccination
OT  - Vaccine immunogenicity
EDAT- 2023/10/18 12:42
MHDA- 2023/10/18 12:42
CRDT- 2023/10/18 11:25
PHST- 2023/08/16 00:00 [received]
PHST- 2023/09/12 00:00 [revised]
PHST- 2023/09/21 00:00 [accepted]
PHST- 2023/10/18 12:42 [medline]
PHST- 2023/10/18 12:42 [pubmed]
PHST- 2023/10/18 11:25 [entrez]
AID - 7321123 [pii]
AID - 10.1093/rheumatology/kead552 [doi]
PST - aheadofprint
SO  - Rheumatology (Oxford). 2023 Oct 18:kead552. doi: 10.1093/rheumatology/kead552.