Safety of recombinant zoster vaccine: a retrospective study of 622 rheumatology patients

被引:29
作者
Lenfant, Tiphaine [1 ,2 ]
Jin, Yuxuan [3 ]
Kirchner, Elizabeth [1 ]
Hajj-Ali, Rula A. [1 ]
Calabrese, Leonard H. [1 ]
Calabrese, Cassandra [1 ,4 ]
机构
[1] Cleveland Clin Fdn, Orthoped & Rheumatol Inst, Dept Rheumatol & Immunol Dis, 9500 Euclid Ave, Cleveland, OH 44195 USA
[2] Univ Paris, Hop Europeen Georges Pomidou, AP HP, Dept Internal Med, Paris, France
[3] Cleveland Clin Fdn, Dept Quantitat Hlth Sci, Cleveland, OH 44195 USA
[4] Cleveland Clin Fdn, Dept Infect Dis, Cleveland, OH USA
关键词
Shingrix; recombinant zoster vaccine; herpes zoster; immune-mediated inflammatory disease; HERPES-ZOSTER; SUBUNIT VACCINE; AUTOIMMUNE; ARTHRITIS; EFFICACY; ADULTS; RISK;
D O I
10.1093/rheumatology/keab139
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives. To provide insight into the safety of recombinant zoster vaccine (RZV) in patients with immunemediated 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.
引用
收藏
页码:5149 / 5157
页数:9
相关论文
共 27 条
[1]   Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial [J].
Bastidas, Adriana ;
de la Serna, Javier ;
El Idrissi, Mohamed ;
Oostvogels, Lidia ;
Quittet, Philippe ;
Lopez-Jimenez, Javier ;
Vural, Filiz ;
Pohlreich, David ;
Zuckerman, Tsila ;
Issa, Nicolas C. ;
Gaidano, Gianluca ;
Lee, Je-Jung ;
Abhyankar, Sunil ;
Solano, Carlos ;
Perez de Oteyza, Jaime ;
Satlin, Michael J. ;
Schwartz, Stefan ;
Campins, Magda ;
Rocci, Alberto ;
Llamas, Carlos Vallejo ;
Lee, Dong-Gun ;
Tan, Sen Mui ;
Johnston, Anna M. ;
Grigg, Andrew ;
Boeckh, Michael J. ;
Campora, Laura ;
Lopez-Fauqued, Marta ;
Heineman, Thomas C. ;
Stadtmauer, Edward A. ;
Sullivan, Keith M. ;
Alonso Alonso, Aranzazu ;
Anagnostopoulos, Achilles ;
Andreadis, Charalambos ;
Angelopoulou, Maria ;
Anttila, Veli-Jukka ;
Aoun, Mickael ;
Barista, Ibrahim ;
Berkahn, Leanne ;
Bloor, Adrian J. C. ;
Broady, Raewyn ;
Brossart, Peter ;
Buadi, Francis K. ;
Bulabois, Claude-Eric ;
Cantin, Guy ;
Cellini, Claudia ;
Chandrasekar, Pranatharthi Haran ;
Chauncey, Thomas ;
Cuneo, Antonio ;
Dadwal, Sanjeet Singh ;
Dickinson, Michael .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2019, 322 (02) :123-133
[2]   A systematic review of herpes zoster incidence and consensus recommendations on vaccination in adult patients on systemic therapy for psoriasis or psoriatic arthritis: From the Medical Board of the National Psoriasis Foundation [J].
Baumrin, Emily ;
Van Voorhees, Abby ;
Garg, Amit ;
Feldman, Steven R. ;
Merola, Joseph F. .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2019, 81 (01) :102-110
[3]   Safety and Immunogenicity of an Adjuvanted Herpes Zoster Subunit Candidate Vaccine in HIV-Infected Adults: A Phase 1/2a Randomized, Placebo-Controlled Study [J].
Berkowitz, Elchonon M. ;
Moyle, Graeme ;
Stellbrink, Hans-Juergen ;
Schuermann, Dirk ;
Kegg, Stephen ;
Stoll, Matthias ;
El Idrissi, Mohamed ;
Oostvogels, Lidia ;
Heineman, Thomas C. .
JOURNAL OF INFECTIOUS DISEASES, 2015, 211 (08) :1279-1287
[4]   Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older [J].
Cunningham, A. L. ;
Lal, H. ;
Kovac, M. ;
Chlibek, R. ;
Hwang, S. -J. ;
Diez-Domingo, J. ;
Godeaux, O. ;
Levin, M. J. ;
McElhaney, J. E. ;
Puig-Barbera, J. ;
Abeele, C. Vanden ;
Vesikari, T. ;
Watanabe, D. ;
Zahaf, T. ;
Ahonen, A. ;
Athan, E. ;
Barba-Gomez, J. F. ;
Campora, L. ;
de Looze, F. ;
Downey, H. J. ;
Ghesquiere, W. ;
Gorfinkel, I. ;
Korhonen, T. ;
Leung, E. ;
McNeil, S. A. ;
Oostvogels, L. ;
Rombo, L. ;
Smetana, J. ;
Weckx, L. ;
Yeo, W. ;
Heineman, T. C. .
NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (11) :1019-1032
[5]   Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older [J].
Cunningham, Anthony L. ;
Heineman, Thomas C. ;
Lal, Himal ;
Godeaux, Olivier ;
Chlibek, Roman ;
Hwang, Shinn-Jang ;
McElhaney, Janet E. ;
Vesikari, Timo ;
Andrews, Charles ;
Choi, Won Suk ;
Esen, Meral ;
Ikematsu, Hideyuki ;
Choma, Martina Kovac ;
Pauksens, Karlis ;
Ravault, Stephanie ;
Salaun, Bruno ;
Schwarz, Tino F. ;
Smetana, Jan ;
Vanden Abeele, Carline ;
Van den Steen, Peter ;
Vastiau, Ilse ;
Weckx, Lily Yin ;
Levin, Myron J. .
JOURNAL OF INFECTIOUS DISEASES, 2018, 217 (11) :1750-1760
[6]   Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials [J].
Dagnew, Alemnew F. ;
Rausch, Debora ;
Herve, Caroline ;
Zahaf, Toufik ;
Levin, Myron J. ;
Schuind, Anne .
RHEUMATOLOGY, 2021, 60 (03) :1226-1233
[7]   Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis [J].
Dagnew, Alemnew F. ;
Ilhan, Osman ;
Lee, Won-Sik ;
Woszczyk, Dariusz ;
Kwak, Jae-Yong ;
Bowcock, Stella ;
Sohn, Sang Kyun ;
Rodriguez Macias, Gabriela ;
Chiou, Tzeon-Jye ;
Quiel, Dimas ;
Aoun, Mickael ;
Navarro Matilla, Maria Belen ;
de la Serna, Javier ;
Milliken, Samuel ;
Murphy, John ;
McNeil, Shelly A. ;
Salaun, Bruno ;
Di Paolo, Emmanuel ;
Campora, Laura ;
Lopez-Fauqued, Marta ;
El Idrissi, Mohamed ;
Schuind, Anne ;
Heineman, Thomas C. ;
Van den Steen, Peter ;
Oostvogels, Lidia .
LANCET INFECTIOUS DISEASES, 2019, 19 (09) :988-1000
[8]   Principal Controversies in Vaccine Safety in the United States [J].
DeStefano, Frank ;
Bodenstab, Heather Monk ;
Offit, Paul A. .
CLINICAL INFECTIOUS DISEASES, 2019, 69 (04) :726-731
[9]   2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases [J].
Furer, Victoria ;
Rondaan, Christien ;
Heijstek, Marloes W. ;
Agmon-Levin, Nancy ;
van Assen, Sander ;
Bijl, Marc ;
Breedveld, Ferry C. ;
D'Amelio, Raffaele ;
Dougados, Maxime ;
Kapetanovic, Meliha Crnkic ;
van Laar, Jacob M. ;
de Thurah, A. ;
Landewe, Robert B. M. ;
Molto, Anna ;
Mueller-Ladner, Ulf ;
Schreiber, Karen ;
Smolar, Leo ;
Walker, Jim ;
Warnatz, Klaus ;
Wulffraat, Nico M. ;
Elkayam, Ori .
ANNALS OF THE RHEUMATIC DISEASES, 2020, 79 (01) :39-52
[10]   The REDCap consortium: Building an international community of software platform partners [J].
Harris, Paul A. ;
Taylor, Robert ;
Minor, Brenda L. ;
Elliott, Veida ;
Fernandez, Michelle ;
O'Neal, Lindsay ;
McLeod, Laura ;
Delacqua, Giovanni ;
Delacqua, Francesco ;
Kirby, Jacqueline ;
Duda, Stephany N. .
JOURNAL OF BIOMEDICAL INFORMATICS, 2019, 95