FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4380883905> ?p ?o ?g. }

• W4380883905 endingPage "139" @default.
• W4380883905 startingPage "137" @default.
• W4380883905 abstract "Patients with rheumatic diseases (RD) have a higher rate of poor outcomes of coronavirus disease 2019 (COVID-19) [[1]Álvarez-Troncoso J López-Caballero L Á Robles-Marhuend Soto-Abánades C Ríos-Blanco JJ Influence of vaccination and immunosuppressive treatments on the coronavirus disease 2019 outcomes in patients with systemic autoimmune diseases.Eur J Intern Med. 2023; 108: 114-116Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar]. The American College of Rheumatology (ACR) and the European League Against Rheumatism strongly recommended RD patients to receive the vaccination for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [[2]Curtis JR Johnson SR Anthony DD Arasaratnam RJ Baden LR Bass AR et al.American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 2.Arthritis Rheumatol. 2021; 73: e30-e45Crossref PubMed Google Scholar,[3]Landewé RBM Kroon FPB Alunno A Najm A Bijlsma JW Burmester GR et al.EULAR recommendations for the management and vaccination of people with rheumatic and musculoskeletal diseases in the context of SARS-CoV-2: the November 2021 update.Ann Rheum Dis. 2022; 81: 1628-1639Crossref PubMed Scopus (52) Google Scholar]. Unvaccinated patients are at an increased risk of not only infection, but also hospitalization and death [[1]Álvarez-Troncoso J López-Caballero L Á Robles-Marhuend Soto-Abánades C Ríos-Blanco JJ Influence of vaccination and immunosuppressive treatments on the coronavirus disease 2019 outcomes in patients with systemic autoimmune diseases.Eur J Intern Med. 2023; 108: 114-116Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar]. However, efficacy and safety data on vaccines for RD patients were initially unavailable because phase III clinical trials on these vaccines excluded patients receiving immunosuppressive agents. Therefore, some RD patients hesitate to be vaccinated because of concerns regarding adverse reactions, the effects of the vaccine itself on RD, and the effects of immunosuppressive therapy on the efficacy and safety of the vaccine [[4]Felten R Dubois M Ugarte-Gil MF Chaudier A Kawka L Bergier H et al.Vaccination against COVID-19: Expectations and concerns of patients with autoimmune and rheumatic diseases.Lancet Rheumatol. 2021; 3 (e243-e5)Abstract Full Text Full Text PDF Scopus (67) Google Scholar]. We recently reported that several immunosuppressants reduce the immunogenicity of vaccines and also discussed safety issues, but the small number of patients studied precluded statistical examination of adverse reactions [[5]Kawazoe M Aoki K Hirose W Masuoka S Nanki T. Influence of immunosuppressive therapy on longitudinal changes in anti-SARS-CoV-2 spike protein antibodies after two doses of mRNA vaccines in patients with rheumatic diseases.Eur J Intern Med. 2023; Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar]. We described here the result of a retrospective study of the effects of the SARS-CoV-2 mRNA vaccine on disease activity in a large number of RD patients and adverse reactions in RD and non-RD patients to clarify the safety of the vaccine for RD patients. We recruited non-RD patients (CG; control group) who were also attending our rheumatology outpatient clinics, who had diseases other than RD or malignancies, and who were not treated with glucocorticoids or immunosuppressants. Patients with RD were instructed to have a withholding period before and after the vaccination depending on the type of immunosuppressant administered, in accordance with the ACR guidance [[2]Curtis JR Johnson SR Anthony DD Arasaratnam RJ Baden LR Bass AR et al.American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 2.Arthritis Rheumatol. 2021; 73: e30-e45Crossref PubMed Google Scholar]. Participants received at least one dose of the BNT162b2 mRNA vaccine (Pfizer-BioNTech) or mRNA-1273 vaccine (Moderna), following the package inserts. Information was collected from the medical records on adverse reactions that appeared and their severity [rated on a 3-point scale; severe (interferes with daily activity), moderate (somewhat interferes with daily activity), or mild (does not interfere with daily activity)] up to 14 days after the first, second and third vaccinations, and disease activity in RD patients after the vaccination as well as treatment. A multivariate analysis of frequent adverse reactions was performed to establish whether they were related to immunosuppressive drugs. Present study was approved by the Ethics Committee of Toho University Omori Medical Center (M22067_21283). We analyzed 1380 patients; 193 (14.0%) CG and 1032 (74.8%) RD patients received the BNT162b2 mRNA vaccine, while 19 (1.4%) CG and 136 (9.9%) RD patients received the mRNA-1273 vaccine as the first dose. The second and third doses are shown in eTable 1, Supplementary material. The mean age of BNT162b2 mRNA vaccinators was significantly higher than that of mRNA-1273 vaccinators, whereas no significant difference was observed between CG and RD patients (eTable 1, Supplementary material). The diagnosis and treatment of RD patients are shown in eTable 2, Supplementary material. A number of adverse reactions were observed, the most common of which was pain at the injection site, which occurred in more than 20% of patients in both groups (eTable 3, Supplementary material). A comparison of CG and RD patients after each dose of the BNT162b2 mRNA and mRNA-1273 vaccines revealed that the frequencies of most adverse reactions did not significantly differ between CG and RD patients, except for swelling at the injection site being more common and chills being less common in RD patients after the third dose of the BNT162b2 mRNA vaccine. A comparison of the first and second doses of the vaccine in RD patients showed that fever was significantly more common after the second dose of the BNT162b2 mRNA and mRNA-1273 vaccines. A comparison of the second and third doses revealed that swelling at the injection site and fever were significantly more common after the second dose of the mRNA-1273 vaccine. A comparison of the BNT162b2 mRNA and mRNA-1273 vaccines showed that fever was significantly more common after each dose of the mRNA-1273 vaccine. Also, swelling at the injection site was significantly more common after the first and second doses, while fatigue was significantly more common after the second and third doses in the mRNA-1273 vaccine. We then examined the severities of the four most frequent adverse reactions, pain and swelling at the injection site, fever, and fatigue (Figure 1A). Although the severity of these adverse reactions of the mRNA-1273 vaccine appeared to partially differ between CG and RD, the number of patients who received the first and second doses of the mRNA-1273 vaccine was small, particularly among CG (n=19). No significant differences were observed in the severity of each adverse reaction between CG and RD. We also compared the frequencies of adverse reactions between male and female. The frequency of swelling at the injection site and fever were higher in female, while the frequencies of pain at the injection site and fatigue were comparable (eTable 4, Supplementary material). Persistent arthralgia and/or arthritis, evaluated as disease flare by physicians based on the clinical course, after the vaccination occurred in 19 patients (1.8%) with rheumatoid arthritis (RA) (16 patients), polymyalgia rheumatica (1 patient), scleroderma (1 patient), and Behçet's disease (BD) (1 patient), with the onset of flare in 3 patients after the first dose of vaccine, 13 after 2 doses, and 3 after 3 doses. Among these patients, only four (0.4%) required intensified treatment: an increased dose of methotrexate for one RA patient, a change in biologic agents for two RA patients, and the initiation of colchicine for the BD patient. No other disease flares were induced by the vaccines. Factors related to adverse reactions were examined using a multivariate analysis with a generalized linear mixed model constructed by performing a variable reduction method based on Akaike's information criterion, taking into account effects over time and individual differences among RD patients (Figure 1B). The results obtained showed that pain at the injection site was more common in patients receiving hydroxychloroquine (HCQ) and at the third dose of the vaccine. Fever was more common in HCQ-treated patients, and after the second and third doses of the vaccine, and was less common in patients receiving prednisolone (PSL), tacrolimus/cyclosporine, and interleukin-6 inhibitors. Fatigue was less common in patients receiving PSL, and more common in those receiving cytotoxic T lymphocyte-associated antigen 4-immunoglobulin (CTLA4-Ig), and after the second and third doses of the vaccine. Swelling at the injection site in Janus kinase inhibitor (JAKi)-treated patients and fever in CTLA4-Ig- and JAKi-treated patients were slightly less common. These four adverse reactions were less common in BNT162b2 mRNA vaccinators compared with mRNA-1273 vaccinators. In the present study, we compared adverse reactions after the SARS-CoV-2 mRNA vaccination in RD and non-RD patients, and showed that the frequency and severity of each symptom were similar in CG and RD patients. Disease flare by the vaccines only developed for arthralgia/arthritis in 1.8% of RD patients. We also investigated the effects of immunosuppressive drugs on adverse reactions in RD patients. To the best of our knowledge, this is the first study to report a relationship between adverse reactions after the SARS-CoV-2 mRNA vaccination and treatment with immunosuppressants in RD patients. Several immunosuppressants increase or decrease adverse reactions. Adverse reactions, such as pain at the injection site and fatigue, were found to be more frequent in RD patients than in healthy subjects [[6]Furer V Eviatar T Zisman D Peleg H Paran D Levartovsky D et al.Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study.Ann Rheum Dis. 2021; 80: 1330-1338Crossref PubMed Scopus (360) Google Scholar,[7]Sattui SE Liew JW Kennedy K Sirotich E Putman M Moni TT et al.Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey.RMD Open. 2021; 7Crossref PubMed Scopus (85) Google Scholar]. We herein showed no significant difference of the adverse reactions between RD and non-RD patients. Although the frequency of adverse reactions was previously reported to be similar regardless of the type of vaccine [[7]Sattui SE Liew JW Kennedy K Sirotich E Putman M Moni TT et al.Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey.RMD Open. 2021; 7Crossref PubMed Scopus (85) Google Scholar], the present study found that their frequency was higher after the mRNA-1273 vaccine. We already demonstrated that anti-SARS-CoV-2 spike protein antibody values were higher after the mRNA-1273 vaccine [[5]Kawazoe M Aoki K Hirose W Masuoka S Nanki T. Influence of immunosuppressive therapy on longitudinal changes in anti-SARS-CoV-2 spike protein antibodies after two doses of mRNA vaccines in patients with rheumatic diseases.Eur J Intern Med. 2023; Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar], suggesting the higher efficacy, but also more frequent adverse reactions of the mRNA-1273 vaccine. Theoretically, the relapse of RD may be an exacerbation of the disease due to the adjuvant effects of the mRNA vaccine; however, this has not yet been confirmed. Regarding the rate of RD flares after the SARS-CoV-2 mRNA vaccination, values as high as 10-20% have been reported [[6]Furer V Eviatar T Zisman D Peleg H Paran D Levartovsky D et al.Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study.Ann Rheum Dis. 2021; 80: 1330-1338Crossref PubMed Scopus (360) Google Scholar,[8]Connolly CM Ruddy JA Boyarsky BJ Barbur I Werbel WA Geetha D et al.Disease Flare and Reactogenicity in Patients With Rheumatic and Musculoskeletal Diseases Following Two-Dose SARS-CoV-2 Messenger RNA Vaccination.Arthritis Rheumatol. 2022; 74: 28-32Crossref PubMed Scopus (57) Google Scholar]; however, the majority of studies conducted in the early pandemic period were based on telephone or online surveys, which were self-reported and may have been affected by patient bias. A physician-reported-based study showed a rate of 4% [[9]Machado PM Lawson-Tovey S Strangfeld A Mateus EF Hyrich KL Gossec L et al.Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry.Ann Rheum Dis. 2022; 81: 695-709Crossref PubMed Scopus (75) Google Scholar], which was even lower (1.8%) in this study, and only 0.4% of patients required a change in treatment. Regarding disease flares, an analysis of 27 episodes in SLE patients revealed a lower risk if they were taking HCQ and had a history of renal involvement [[10]Zavala-Flores E Salcedo-Matienzo J Quiroz-Alva A Berrocal-Kasay A. Side effects and flares risk after SARS-CoV-2 vaccination in patients with systemic lupus erythematosus.Clin Rheumatol. 2022; 41: 1349-1357Crossref PubMed Scopus (19) Google Scholar]. In this study, the number of flared patients was too small to analyze the risk of disease flare. The limitation of this study is its retrospective nature, whereas its strengths are the large sample size of RD patients and the judgment of flare being based on a physician's evaluation. The present results indicate that the frequency and severity of each symptom of adverse reactions after the SARS-CoV-2 mRNA vaccination in RD patients were similar to those in non-RD patients, and disease flares were rare, indicating the safety of the vaccine for RD patients. Furthermore, several immunosuppressive drugs exerted positive or negative effects on the development of adverse reactions. The present results may alleviate the concerns of RD patients about SARS-CoV-2 mRNA vaccines and increase their willingness to be vaccinated as well as booster vaccination rates. Download .docx (.04 MB) Help with docx files" @default.
• W4380883905 created "2023-06-17" @default.
• W4380883905 creator A5024304758 @default.
• W4380883905 creator A5025672222 @default.
• W4380883905 creator A5047064501 @default.
• W4380883905 creator A5073403230 @default.
• W4380883905 creator A5081181665 @default.
• W4380883905 date "2023-09-01" @default.
• W4380883905 modified "2023-10-18" @default.
• W4380883905 title "Safety of SARS-CoV-2 mRNA vaccines and effects of immunosuppressive drugs on adverse reactions in patients with rheumatic diseases" @default.
• W4380883905 cites W3133272057 @default.
• W4380883905 cites W3164069651 @default.
• W4380883905 cites W3173109173 @default.
• W4380883905 cites W3192715231 @default.
• W4380883905 cites W3196332529 @default.
• W4380883905 cites W3213516711 @default.
• W4380883905 cites W4207076468 @default.
• W4380883905 cites W4213451248 @default.
• W4380883905 cites W4307053055 @default.
• W4380883905 cites W4363674489 @default.
• W4380883905 doi "https://doi.org/10.1016/j.ejim.2023.06.014" @default.
• W4380883905 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37339924" @default.
• W4380883905 hasPublicationYear "2023" @default.
• W4380883905 type Work @default.
• W4380883905 citedByCount "0" @default.
• W4380883905 crossrefType "journal-article" @default.
• W4380883905 hasAuthorship W4380883905A5024304758 @default.
• W4380883905 hasAuthorship W4380883905A5025672222 @default.
• W4380883905 hasAuthorship W4380883905A5047064501 @default.
• W4380883905 hasAuthorship W4380883905A5073403230 @default.
• W4380883905 hasAuthorship W4380883905A5081181665 @default.
• W4380883905 hasBestOaLocation W43808839051 @default.
• W4380883905 hasConcept C116675565 @default.
• W4380883905 hasConcept C126322002 @default.
• W4380883905 hasConcept C159047783 @default.
• W4380883905 hasConcept C177713679 @default.
• W4380883905 hasConcept C197934379 @default.
• W4380883905 hasConcept C203014093 @default.
• W4380883905 hasConcept C2779134260 @default.
• W4380883905 hasConcept C3006700255 @default.
• W4380883905 hasConcept C3007834351 @default.
• W4380883905 hasConcept C3008058167 @default.
• W4380883905 hasConcept C524204448 @default.
• W4380883905 hasConcept C71924100 @default.
• W4380883905 hasConcept C98274493 @default.
• W4380883905 hasConceptScore W4380883905C116675565 @default.
• W4380883905 hasConceptScore W4380883905C126322002 @default.
• W4380883905 hasConceptScore W4380883905C159047783 @default.
• W4380883905 hasConceptScore W4380883905C177713679 @default.
• W4380883905 hasConceptScore W4380883905C197934379 @default.
• W4380883905 hasConceptScore W4380883905C203014093 @default.
• W4380883905 hasConceptScore W4380883905C2779134260 @default.
• W4380883905 hasConceptScore W4380883905C3006700255 @default.
• W4380883905 hasConceptScore W4380883905C3007834351 @default.
• W4380883905 hasConceptScore W4380883905C3008058167 @default.
• W4380883905 hasConceptScore W4380883905C524204448 @default.
• W4380883905 hasConceptScore W4380883905C71924100 @default.
• W4380883905 hasConceptScore W4380883905C98274493 @default.
• W4380883905 hasLocation W43808839051 @default.
• W4380883905 hasLocation W43808839052 @default.
• W4380883905 hasLocation W43808839053 @default.
• W4380883905 hasOpenAccess W4380883905 @default.
• W4380883905 hasPrimaryLocation W43808839051 @default.
• W4380883905 hasRelatedWork W3009669391 @default.
• W4380883905 hasRelatedWork W3036314732 @default.
• W4380883905 hasRelatedWork W3127693599 @default.
• W4380883905 hasRelatedWork W3198183218 @default.
• W4380883905 hasRelatedWork W4200329650 @default.
• W4380883905 hasRelatedWork W4205317059 @default.
• W4380883905 hasRelatedWork W4206669628 @default.
• W4380883905 hasRelatedWork W4210401150 @default.
• W4380883905 hasRelatedWork W4382894326 @default.
• W4380883905 hasRelatedWork W3127156785 @default.
• W4380883905 hasVolume "115" @default.
• W4380883905 isParatext "false" @default.
• W4380883905 isRetracted "false" @default.
• W4380883905 workType "article" @default.