PMID- 34358147
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210809
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 9
IP  - 7
DP  - 2021 Jul 2
TI  - Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic 
      Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease 
      Subtypes, and Immunosuppressive Therapies: A Two-Centers Study.
LID - 10.3390/vaccines9070730 [doi]
LID - 730
AB  - An increased risk of developing severe infections has been evidenced in rheumatic 
      disease (RD) patients, and anti-COVID-19 vaccination is strictly recommended for 
      RD patients. However, up to now, no data are available on safety, immunogenicity 
      and efficacy of COVID-19 vaccinations in RD patients. The possible development of 
      adverse events (AEs), including the flare-up of underlying RD, represents a 
      matter of growing importance. The aim of our study is to assess, in RD patients, 
      the safety profile of different types of approved vaccines and the possible 
      influence of immunosuppressive therapies and clinical or demographic 
      characteristics of RD patients on development of AEs. Participants (n = 185; 
      30.7%) received anti-COVID-19 vaccinations, 137 with autoimmune/chronic 
      inflammatory RD (Au/cIn-RD) and 48 with nonautoimmune/chronic inflammatory RD 
      (no-Au/cIn-RD). AEs were recorded in 42% of patients after the first dose of 
      vaccine, and in 26% of patients after the second dose. The most common reported 
      AEs after anti-COVID 19 vaccines were site injection pain (17%), headache (12%), 
      fever (12%), myalgia (10%) and fatigue (10%). Relapses of the underlying 
      Au/c-In-RD were recorded in 2.2% of patients after the first dose of vaccine. In 
      Au/c-In-RD the risk of developing AEs after the first dose of vaccine was lower 
      in older patients (OR = 0.95; p = 0.001), and in the group of patients with 
      complete control of RD (OR: 0.2; p = 0.010). A lower percentage of AEs was 
      observed in patients with complete control of their Au/cIn-RD (29%) compared to 
      those with low (57%) or moderate-high disease activity (63%) (p = 0.002 and p = 
      0.006 respectively). In this study all types of COVID-19 vaccines in use in Italy 
      seemed safe in RD patients. The results of this study might provide reassuring 
      information for Au/cIn RD patients and clinicians and could strengthen the data 
      on vaccine safety to guide the use of COVID-19 vaccines in Au/cIn-RD on 
      immunosuppressive agents.
FAU - Rotondo, Cinzia
AU  - Rotondo C
AUID- ORCID: 0000-0003-1356-8423
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Cantatore, Francesco Paolo
AU  - Cantatore FP
AUID- ORCID: 0000-0001-9929-9177
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Fornaro, Marco
AU  - Fornaro M
AUID- ORCID: 0000-0003-1716-7432
AD  - Rheumatology Unit, Department of Emergency and Organ Transplantations, 
      Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy.
FAU - Colia, Ripalta
AU  - Colia R
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Busto, Giuseppe
AU  - Busto G
AUID- ORCID: 0000-0002-6412-2256
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Rella, Valeria
AU  - Rella V
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Sciacca, Stefania
AU  - Sciacca S
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Lops, Lucia
AU  - Lops L
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Cici, Daniela
AU  - Cici D
AUID- ORCID: 0000-0002-3532-5791
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Maruotti, Nicola
AU  - Maruotti N
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - D'Onofrio, Francesca
AU  - D'Onofrio F
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
FAU - Iannone, Florenzo
AU  - Iannone F
AD  - Rheumatology Unit, Department of Emergency and Organ Transplantations, 
      Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy.
FAU - Corrado, Addolorata
AU  - Corrado A
AD  - Rheumatology Unit, Department of Medical and Surgical Sciences, Ospedali Riuniti 
      di Foggia, Viale Luigi Pinto 1, 71122 Foggia, Italy.
LA  - eng
PT  - Journal Article
DEP - 20210702
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC8310114
OTO - NOTNLM
OT  - DMARDs
OT  - SARs-COV-2
OT  - anti-COVID-19 vaccine
OT  - biologic drugs
OT  - comirnaty
OT  - disease activity
OT  - efficacy
OT  - flare
OT  - relapse
OT  - rheumatic diseases
OT  - safety
OT  - vaxzevria
COIS- The authors declare no conflict of interest.
EDAT- 2021/08/07 06:00
MHDA- 2021/08/07 06:01
PMCR- 2021/07/02
CRDT- 2021/08/06 17:18
PHST- 2021/04/26 00:00 [received]
PHST- 2021/06/20 00:00 [revised]
PHST- 2021/06/24 00:00 [accepted]
PHST- 2021/08/06 17:18 [entrez]
PHST- 2021/08/07 06:00 [pubmed]
PHST- 2021/08/07 06:01 [medline]
PHST- 2021/07/02 00:00 [pmc-release]
AID - vaccines9070730 [pii]
AID - vaccines-09-00730 [pii]
AID - 10.3390/vaccines9070730 [doi]
PST - epublish
SO  - Vaccines (Basel). 2021 Jul 2;9(7):730. doi: 10.3390/vaccines9070730.