PMID- 33560302 OWN - NLM STAT- MEDLINE DCOM- 20211228 LR - 20211228 IS - 1462-0332 (Electronic) IS - 1462-0324 (Linking) VI - 60 IP - 11 DP - 2021 Nov 3 TI - Safety of recombinant zoster vaccine: a retrospective study of 622 rheumatology patients. PG - 5149-5157 LID - 10.1093/rheumatology/keab139 [doi] AB - OBJECTIVES: To provide insight into the safety of recombinant zoster vaccine (RZV) in patients with immune-mediated inflammatory diseases (IMID). METHODS: Patients who received RZV in a single-centre rheumatology department were retrospectively included. An IMID flare was defined as (i) a documentation of flare in the office notes or patient portal communication or (ii) new prednisone prescription, in the 12 weeks after each dose. RESULTS: Six-hundred and twenty-two patients were included (67% female, median age 67 years), 8.5% of them experienced adverse events (AEs) and herpes zoster (HZ) incidence was 0.6% after median follow-up of 36 weeks. Of 359 IMID patients: 88 had RA (25%), 50 vasculitis (14%) and 29 PMR (8%). At vaccination, 35% were on glucocorticoids (GC). Fifty-nine patients (16%) experienced a flare, 18 flares occurred in temporal relation to a treatment change (31%). RA patients had the highest flare rate (n = 21, 24%), 25% of patients who flared required adjustment of immunosuppression. In a multivariate analysis, use of GC at time of vaccination was associated with flare after vaccination [odds ratio (OR) 2.31 (1.3-4.1), P =0.004]. A time-to-flare survival analysis (Cox-model) showed that GC was a significant predictor of IMID flare after first RZV dose [hazard ratio (HR) 2.4 (1.3-4.5), P =0.0039] and that a flare after the first dose was associated with flaring after the second RZV dose [HR 3.9 (1.7-9), P =0.0015]. CONCLUSION: RZV administration in patients with IMIDs was generally well-tolerated, though mild flares were not uncommon in the first 12 weeks after vaccination. These data may provide useful information for patient education when considering RZV administration. CI - (c) The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com. FAU - Lenfant, Tiphaine AU - Lenfant T AD - Department of Rheumatologic and Immunologic Diseases, Orthopedic & Rheumatologic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. AD - Department of Internal Medicine, Hopital Europeen Georges Pomidou, AP-HP, Universite de Paris, Paris, France. FAU - Jin, Yuxuan AU - Jin Y AD - Department of Quantitative Health Sciences. FAU - Kirchner, Elizabeth AU - Kirchner E AD - Department of Rheumatologic and Immunologic Diseases, Orthopedic & Rheumatologic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. FAU - Hajj-Ali, Rula A AU - Hajj-Ali RA AD - Department of Rheumatologic and Immunologic Diseases, Orthopedic & Rheumatologic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. FAU - Calabrese, Leonard H AU - Calabrese LH AD - Department of Rheumatologic and Immunologic Diseases, Orthopedic & Rheumatologic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. FAU - Calabrese, Cassandra AU - Calabrese C AUID- ORCID: 0000-0002-8773-7739 AD - Department of Rheumatologic and Immunologic Diseases, Orthopedic & Rheumatologic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. AD - Department of Infectious Diseases, Cleveland Clinic Foundation, Cleveland, OH, USA. LA - eng PT - Journal Article PL - England TA - Rheumatology (Oxford) JT - Rheumatology (Oxford, England) JID - 100883501 RN - 0 (Herpes Zoster Vaccine) SB - IM MH - Aged MH - Female MH - Herpes Zoster Vaccine/*adverse effects MH - Humans MH - Male MH - Retrospective Studies MH - *Rheumatic Diseases MH - *Symptom Flare Up OTO - NOTNLM OT - Shingrix OT - herpes zoster OT - immune-mediated inflammatory disease OT - recombinant zoster vaccine EDAT- 2021/02/10 06:00 MHDA- 2021/12/29 06:00 CRDT- 2021/02/09 12:10 PHST- 2020/10/01 00:00 [received] PHST- 2021/01/18 00:00 [revised] PHST- 2021/02/10 06:00 [pubmed] PHST- 2021/12/29 06:00 [medline] PHST- 2021/02/09 12:10 [entrez] AID - 6131690 [pii] AID - 10.1093/rheumatology/keab139 [doi] PST - ppublish SO - Rheumatology (Oxford). 2021 Nov 3;60(11):5149-5157. doi: 10.1093/rheumatology/keab139.