PMID- 36441656
OWN - NLM
STAT- MEDLINE
DCOM- 20221223
LR  - 20221223
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 40
IP  - 12
DP  - 2022 Dec
TI  - Safety and efficacy of SARS-CoV-2 vaccination in 1237 patients with primary 
      Sjogren syndrome.
PG  - 2290-2297
LID - 10.55563/clinexprheumatol/dt6klo [doi]
AB  - OBJECTIVES: To investigate the safety and efficacy of SARS-Cov-2 vaccination in 
      patients with primary Sjogren syndrome (pSS) due to scarcity of data in this 
      population. METHODS: By the first week of May 2021, all Big Data SS Consortium 
      centres patients who had received at least one dose of any SARS-CoV-2 vaccine 
      were included in the study. The in-charge physician asked patients about local 
      and systemic reactogenicity to collect SARS-CoV-2 vaccination data. RESULTS: The 
      vaccination data of 1237 patients were received. A total of 835 patients (67%) 
      reported any adverse events (AEs), including local (53%) and systemic (50%) AEs. 
      Subjective symptoms (63%) were the most common local AEs, followed by objective 
      signs at the injection site (16%), and general symptoms were the most commonly 
      reported systemic AEs (46%), followed by musculoskeletal (25%), gastrointestinal 
      (9%), cardiopulmonary (3%), and neurological (2%). In addition, 141 (11%) 
      patients reported a significant worsening/exacerbation of their pre-vaccination 
      sicca symptoms and fifteen (1.2%) patients reported active involvement in the 
      glandular (n=7), articular (n=7), cutaneous (n=6), pulmonary (n=2), and 
      peripheral nervous system (n=1) domains due to post-vaccination SS flares. In 
      terms of vaccination efficacy, breakthrough SARS-CoV-2 infection was confirmed 
      after vaccination in three (0.24 %) patients, and positive anti-SARS-Cov-2 
      antibodies were detected in approximately 95% of vaccinated SS patients, 
      according to data available. CONCLUSIONS: Our data suggest that patients with pSS 
      develop adequate humoral response and no severe AEs after SARS-CoV-2 vaccination 
      and therefore raise no concerns about the vaccine's efficacy or safety profile in 
      this population.
FAU - Inanc, Nevsun
AU  - Inanc N
AD  - Marmara University, School of Medicine, Istanbul, Turkey.
FAU - Kostov, Belchin
AU  - Kostov B
AD  - Primary Care Centre Les Corts, Consorci d'Atencio Primaria de Salut Barcelona 
      Esquerra (CAPSBE), Barcelona, Spain.
FAU - Priori, Roberta
AU  - Priori R
AD  - Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, 
      Sapienza University of Rome, and Saint Camillus International University of 
      Health Science, UniCamillus, Rome, Italy.
FAU - Flores-Chavez, Alejandra
AU  - Flores-Chavez A
AD  - Department of Autoimmune Diseases, ICMiD, Hospital Clinic, Barcelona, Spain, and 
      Consejo Nacional de Ciencia y Tecnologia (CONACYT), Mexico.
FAU - Carubbi, Francesco
AU  - Carubbi F
AD  - Department of Life, Health & Environmental Sciences, University of L'Aquila and 
      Internal Medicine and Nephrology Unit, Department of Medicine, ASL 
      Avezzano-Sulmona-L'Aquila, San Salvatore Hospital, L'Aquila, Italy.
FAU - Szanto, Antonia
AU  - Szanto A
AD  - Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, 
      Hungary.
FAU - Valim, Valeria
AU  - Valim V
AD  - Department of Medicine, Federal University of Espirito Santo, Vitoria, Brazil.
FAU - Bootsma, Hendrika
AU  - Bootsma H
AD  - Department of Rheumatology and Clinical Immunology, University of Groningen, 
      University Medical Centre Groningen, the Netherlands.
FAU - Praprotnik, Sonja
AU  - Praprotnik S
AD  - Department of Rheumatology, University Medical Centre, Ljubljana, Slovenia.
FAU - Fernandes Moca Trevisani, Virginia
AU  - Fernandes Moca Trevisani V
AD  - Federal University of Sao Paulo, and Santo Amaro University, Sao Paulo, Brazil.
FAU - Hernandez-Molina, Gabriela
AU  - Hernandez-Molina G
AD  - Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Medicas 
      y Nutricion Salvador Zubiran, Mexico City, Mexico.
FAU - Hofauer, Benedikt
AU  - Hofauer B
AD  - Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Technical 
      University of Munich, Germany.
FAU - Pasoto, Sandra G
AU  - Pasoto SG
AD  - Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina da 
      Universidade de Sao Paulo, Brazil.
FAU - Lopez-Dupla, Miguel
AU  - Lopez-Dupla M
AD  - Department of Internal Medicine, Hospital Universitari Joan XXIII, Tarragona, 
      Spain.
FAU - Bartoloni, Elena
AU  - Bartoloni E
AD  - Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, 
      Italy.
FAU - Rischmueller, Maureen
AU  - Rischmueller M
AD  - Department of Rheumatology, The Queen Elizabeth Hospital, Discipline of Medicine, 
      University of Adelaide, SA, Australia.
FAU - Devauchelle-Pensec, Valerie
AU  - Devauchelle-Pensec V
AD  - Department of Rheumatology, Centre Hospitalier Universitaire de la Cavale 
      Blanche, Brest, France.
FAU - Abacar, Kerem
AU  - Abacar K
AD  - Marmara University, School of Medicine, Istanbul, Turkey.
FAU - Giardina, Federico
AU  - Giardina F
AD  - Department of Internal Medicine and Medical Specialties, Rheumatology Clinic, 
      Sapienza University of Rome, and Saint Camillus International University of 
      Health Science, UniCamillus, Rome, Italy.
FAU - Alunno, Alessia
AU  - Alunno A
AD  - Department of Life, Health & Environmental Sciences, University of L'Aquila and 
      Internal Medicine and Nephrology Unit, Department of Medicine, ASL 
      Avezzano-Sulmona-L'Aquila, San Salvatore Hospital, L'Aquila, Italy.
FAU - Fanny Horvath, Ildiko
AU  - Fanny Horvath I
AD  - Division of Clinical Immunology, Faculty of Medicine, University of Debrecen, 
      Hungary.
FAU - de Wolff, Liseth
AU  - de Wolff L
AD  - Department of Rheumatology and Clinical Immunology, University of Groningen, 
      University Medical Centre Groningen, the Netherlands.
FAU - Caldas, Laura
AU  - Caldas L
AD  - Federal University of Sao Paulo, Brazil.
FAU - Retamozo, Soledad
AU  - Retamozo S
AD  - Grup de Recerca Consolidat en la Sindrome de Sjogren (GRESS), Agencia de Gestio 
      d'Ajuts Universitaris i de Recerca (AGAUR), Generalitat de Catalunya, Spain.
FAU - Ramos-Casals, Manuel
AU  - Ramos-Casals M
AD  - Department of Autoimmune Diseases, ICMiD, Hospital Clinic, Barcelona; Grup de 
      Recerca Consolidat en la Sindrome de Sjogren (GRESS), Agencia de Gestio d'Ajuts 
      Universitaris i de Recerca (AGAUR), Generalitat de Catalunya, Spain; and 
      Department of Medicine, University of Barcelona, Spain. mramos@clinic.cat.
FAU - Brito-Zeron, Pilar
AU  - Brito-Zeron P
AD  - Grup de Recerca Consolidat en la Sindrome de Sjogren (GRESS), Agencia de Gestio 
      d'Ajuts Universitaris i deRecerca (AGAUR), Generalitat de Catalunya, and Research 
      and Innovation Group in Autoimmune Diseases, Sanitas Digital Hospital, 
      Hospital-CIMA-Centre Medic Milenium Balmes Sanitas, Barcelona, Spain.
CN  - Sjogren Big Data Consortium
LA  - eng
PT  - Journal Article
DEP - 20221117
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - Humans
MH  - *COVID-19/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - SARS-CoV-2
MH  - *Sjogren's Syndrome
MH  - Vaccination/adverse effects
FIR - Xu, Bei
IR  - Xu B
FIR - Li, Xiaomei
IR  - Li X
FIR - Gheita, Tamer A
IR  - Gheita TA
FIR - Gattamelata, Angelica
IR  - Gattamelata A
FIR - Saraux, Alain
IR  - Saraux A
FIR - Jezequel, Marie
IR  - Jezequel M
FIR - Nagy, Bela
IR  - Nagy B
FIR - Sanchez-Guerrero, Jorge
IR  - Sanchez-Guerrero J
FIR - Downie-Doyle, Sarah
IR  - Downie-Doyle S
FIR - Kirana, Chandra
IR  - Kirana C
FIR - Verstappen, Gwenny M P J
IR  - Verstappen GMPJ
FIR - Vissink, Arjan
IR  - Vissink A
FIR - Akasbi, Miriam
IR  - Akasbi M
FIR - Rojas, Richard Alberto
IR  - Rojas RA
FIR - Nafria, Anna Maria Febrer
IR  - Nafria AMF
FIR - Siso-Almirall, Antoni
IR  - Siso-Almirall A
EDAT- 2022/11/29 06:00
MHDA- 2022/12/23 06:00
CRDT- 2022/11/28 12:53
PHST- 2022/05/31 00:00 [received]
PHST- 2022/08/02 00:00 [accepted]
PHST- 2022/11/29 06:00 [pubmed]
PHST- 2022/12/23 06:00 [medline]
PHST- 2022/11/28 12:53 [entrez]
AID - 18827 [pii]
AID - 10.55563/clinexprheumatol/dt6klo [doi]
PST - ppublish
SO  - Clin Exp Rheumatol. 2022 Dec;40(12):2290-2297. doi: 
      10.55563/clinexprheumatol/dt6klo. Epub 2022 Nov 17.