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001-es BibID:BIBFORM117878
035-os BibID:(WOS)001051657500001
Első szerző:Andreoli, Laura
Cím:COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases : results from the COVAD study / Andreoli Laura, Lini Daniele, Schreiber Karen, Parodis Ioannis, Sen Parikshit, Ravichandran Naveen, Day Jessica, Joshi Mrudula, Jagtap Kshitij, Nune Arvind, Nikiphorou Elena, Agarwal Vishwesh, Saha Sreoshy, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Ziade Nelly, Velikova Tsvetelina, Milchert Marcin, Gracia-Ramos, Abraham Edgar, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Makol Ashima, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Zamora Tehozol Erick Adrian, Serrano Jorge Rojas, De La Torre Ignacio García, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Akarawatcharangura Goo Phonpen, Shumnalieva Russka, Chen Yi-Ming, Hoff Leonardo Santos, El Kibbi Lina, Halabi Hussein, Vaidya Binit, Shaharir Syahrul Sazliyana, Hasan A. T. M. Tanveer, Dey Dzifa, Toro Gutiérrez Carlos Enrique, Caballero-Uribe Carlo V., Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Saavedra Miguel A., Distler Oliver, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika, COVAD Study Group
Dátum:2023
ISSN:1462-0324 1462-0332
Megjegyzések:Objectives: We investigated COVID-19 vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. Methods: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares (DF), and AID-related treatment modifications were analyzed upon diagnosis of AID versus healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine. Results: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, p= 0.01; minor AE 40% vs 25.9%, p= 0.03; major AE 17.5% vs 4.6%, p< 0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC with respect to AE. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18.3% of age- and disease-matched non-pregnant and non-breastfeeding patients (n = 262). All pregnant/breastfeeding patients who experienced a DF were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively. Conclusion: This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods, helping overcome hesitant attitudes, as the benefits for the mother and the fetus by passive immunization appear to outweigh potential risks.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
COVID-19 vaccination
adverse events
autoimmune diseases
breastfeeding
disease flare
pregnancy
treatment
Megjelenés:Rheumatology. - [Epub ahead of print] (2023). -
További szerzők:Lini, Daniele Schreiber, Karen Parodis, Ioannis Sen, Parikshit Ravichandran, Naveen Day, Jessica Joshi, Mrudula Jagtap, Kshitij Nune, Arvind Nikiphorou, Elena (reumatológus) Agarwal, Vishwesh Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Makol, Ashima Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Zamora Tehozol, Erick Adrian Serrano, Jorge Rojas De La Torre, Ignacio García Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Chen, Yi-Ming Hoff, Leonardo Santos El Kibbi, Lina Halabi, Hussein Vaidya, Binit Shaharir, Syahrul Sazliyana Hasan, A. T. M. Tanveer Dey, Dzifa Toro Gutiérrez, Carlos Enrique Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Saavedra, Miguel A. Distler, Oliver Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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2.

001-es BibID:BIBFORM117879
035-os BibID:(scopus)85162972096 (wos)001014747300001
Első szerző:Doskaliuk, Bohdana
Cím:Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies : results from the COVAD study / Doskaliuk Bohdana, Ravichandran Naveen, Sen Parikshit, Day Jessica, Joshi Mrudula, Nune Arvind, Nikiphorou Elena, Saha Sreoshy, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Ziade Nelly, Velikova Tsvetelina, Milchert Marcin, Jagtap Kshitij, Parodis Ioannis, Gracia-Ramos Abraham Edgar, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Chen Yi Ming, Makol Ashima, Agarwal Vishwesh, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Tehozol Erick Adrian Zamora, Serrano Jorge Rojas, La Torre Ignacio García-De, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Goo Phonpen Akarawatcharangura, Shumnalieva Russka, Hoff Leonardo Santos, Kibbi Lina El, Halabi Hussein, Vaidya Binit, Shaharir Syahrul Sazliyana, Hasan A. T. M. Tanveer, Dey Dzifa, Gutiérrez Carlos Enrique Toro, Caballero-Uribe Carlo V., Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Distler Oliver, Saavedra Miguel A., COVAD study group, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika
Dátum:2023
ISSN:0172-8172 1437-160X
Megjegyzések:Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb-June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35-58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2-7.0, p < 0.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Adverse event
Autoimmunity
COVID-19
Myositis
Surveys and questionnaires
Vaccination
Megjelenés:Rheumatology International. - 43 : 9 (2023), p. 1651-1664. -
További szerzők:Ravichandran, Naveen Sen, Parikshit Day, Jessica Joshi, Mrudula Nune, Arvind Nikiphorou, Elena (reumatológus) Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Jagtap, Kshitij Parodis, Ioannis Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Chen, Yi Ming Makol, Ashima Agarwal, Vishwesh Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Tehozol, Erick Adrian Zamora Serrano, Jorge Rojas La Torre, Ignacio García-De Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Hoff, Leonardo Santos Kibbi, Lina El Halabi, Hussein Vaidya, Binit Shaharir, Syahrul Sazliyana Hasan, A. T. M. Tanveer Dey, Dzifa Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Distler, Oliver Saavedra, Miguel A. Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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3.

001-es BibID:BIBFORM120113
Első szerző:Naveen, R.
Cím:Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus : results from the COVAD study / Naveen R., Nikiphorou Elena, Joshi Mrudula, Sen Parikshit, Lindblom Julius, Agarwal Vishwesh, Lilleker James B., Tan Ai Lyn, Salim Babur, Ziade Nelly, Velikova Tsvetelina, Gracia-Ramos Abraham Edgar, Kuwana Masataka, Day Jessica, Makol Ashima, Distler Oliver, Chinoy Hector, Traboco Lisa S., Wibowo Suryo Anggoro Kusumo, Tehozol Erick Adrian Zamora, Serrano Jorge Rojas, García-De La Torre Ignacio, COVAD Study Group, Aggarwal Rohit, Gupta Latika, Agarwal Vikas, Parodis Ioannis
Dátum:2023
ISSN:1462-0324 1462-0332
Megjegyzések:Objective: To determine COVID-19 vaccine-related adverse events (AEs) in the seven-day post-vaccination period in patients with SLE vs autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HC). Methods: Data were captured through the COVID-19 Vaccination in Autoimmune Diseases (COVAD) questionnaire (March-December 2021). Multivariable regression models accounted for age, gender, ethnicity, vaccine type and background treatment. Results: Among 9462 complete respondents, 583 (6.2%) were SLE patients (mean age: 40.1 years; 94.5% females; 40.5% Asian; 42.9% Pfizer-recipients). Minor AEs were reported by 83.0% of SLE patients, major by 2.6%, hospitalization by 0.2%. AE and hospitalization frequencies were similar between patients with active and inactive SLE. Rashes were more frequent in SLE patients vs HC (OR; 95% CI: 1.2; 1.0, 1.5), chills less frequent in SLE vs AIRDs (0.6; 0.4, 0.8) and nrAIDs (0.5; 0.3, 0.8), and fatigue less frequent in SLE vs nrAIDs (0.6; 0.4, 0.9). Pfizer-recipients reported higher overall AE (2.2; 1.1, 4.2) and injection site pain (2.9; 1.6, 5.0) frequencies than recipients of other vaccines, Oxford/AstraZeneca-recipients more body ache, fever, chills (OR: 2.5, 3.0), Moderna-recipients more body ache, fever, chills, rashes (OR: 2.6, 4.3). Hospitalization frequencies were similar across vaccine types. AE frequencies were similar across treatment groups, although chills were less frequent in antimalarial users vs non-users (0.5; 0.3, 0.9). Conclusion: While COVID-19 vaccination-related AEs were reported by four-fifths of SLE patients, those were mostly minor and comparable to AEs reported by healthy individuals, providing reassurance regarding COVID-19 vaccination safety in SLE.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
COVID-19
adverse events
rheumatology
systemic lupus erythematosus
vaccine
Megjelenés:Rheumatology. - 62 : 7 (2023), p. 2453-2463. -
További szerzők:Nikiphorou, Elena (reumatológus) Joshi, Mrudula Sen, Parikshit Lindblom, Julius Agarwal, Vishwesh Lilleker, James B. Tan, Ai Lyn Salim, Babur Ziade, Nelly Velikova, Tsvetelina Gracia-Ramos, Abraham Edgar Kuwana, Masataka Day, Jessica Makol, Ashima Distler, Oliver Chinoy, Hector Traboco, Lisa S. Wibowo, Suryo Anggoro Kusumo Tehozol, Erick Adrian Zamora Serrano, Jorge Rojas García-De La Torre, Ignacio Aggarwal, Rohit Gupta, Latika Agarwal, Vikas Parodis, Ioannis Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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4.

001-es BibID:BIBFORM110887
035-os BibID:(WoS)000999243100001 (Scopus)85180733005
Első szerző:Naveen, R.
Cím:Flares in IIMs and the timeline following COVID-19 vaccination : a combined analysis of the COVAD-1 and 2 surveys / Naveen R., Sen Parikshit, Griger Zoltán, Day Jessica, Joshi Mrudula, Nune Arvind, Nikiphorou Elena, Saha Sreoshy, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Ziade Nelly, Velikova Tsvetelina, Milchert Marcin, Jagtap Kshitij, Parodis Ioannis, Edgar Gracia-Ramos Abraham, Cavagna Lorenzo, Kuwana Masataka, Knitza Johannes, Chen Yi Ming, Makol Ashima, Agarwal Vishwesh, Patel Aarat, Pauling John D., Wincup Chris, Barman Bhupen, Zamora Tehozol Erick Adrian, Serrano Jorge Rojas, García-De La Torre Ignacio, Colunga-Pedraza Iris J., Merayo-Chalico Javier, Chibuzo Okwara Celestine, Katchamart Wanruchada, Goo Phonpen Akawatcharangura, Shumnalieva Russka, Hoff Leonardo Santos, Kibbi El Lina, Halabi Hussein, Vaidya Binit, Shaharir Syahrul Sazliyana, Hasan A. T. M. Tanveer, Dey Dzifa, Gutiérrez Carlos Enrique Toro, Caballero-Uribe Carlo Vinicio, Lilleker James B., Salim Babur, Gheita Tamer, Chatterjee Tulika, Distler Oliver, Saavedra Miguel A., COVAD study group, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika
Dátum:2024
ISSN:1462-0324 1462-0332
Megjegyzések:Objectives: Disease flares in the post COVID-19 vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs). Methods: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022 respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history, and vaccination details.Flares of IIMs were defined as a. patient self-reported, b. immunosuppression (IS) denoted, c. clinical sign directed, and d. with >7.9-point MCID worsening of PROMISPF10a score. Risk factors of flares were analyzed using regression models. Results: Of 15165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians), and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7%, and 19.6% patients by definitions a-d respectively with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR:1.2; 95%CI:1.03-1.6, p = 0.025) were prone to flares, while those receiving Rituximab (OR:0.3; 95%CI:0.1-0.7, p = 0.010) and Azathioprine (OR:0.3, 95%CI:0.1-0.8, p = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in immunosuppression. Asthma (OR: 1.62; 95%CI: 1.05-2.50, p = 0.028) and higher pain VAS (OR: 1.19; 95%CI: 1.11-1.27, p < 0.001) were associated with disparity between self-reported and IS-denoted flares. Conclusion: A diagnosis of IIMs confers an equal risk of flares in the post COVID-19 vaccination period to AIRDs, with active disease, female gender, and comorbidities conferring a higher risk. Disparity between patient and physician reported outcomes represents a future avenue for exploration.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
COVID-19 Vaccines
Disease Exacerbation
Idiopathic Inflammatory Myopathies
Patient Reported Outcomes
Megjelenés:Rheumatology. - 63 : 1 (2024), p. 127-139. -
További szerzők:Sen, Parikshit Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Day, Jessica Joshi, Mrudula Nune, Arvind Nikiphorou, Elena (reumatológus) Saha, Sreoshy Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Jagtap, Kshitij Parodis, Ioannis Gracia-Ramos, Abraham Edgar Cavagna, Lorenzo Kuwana, Masataka Knitza, Johannes Chen, Yi Ming Makol, Ashima Agarwal, Vishwesh Patel, Aarat Pauling, John D. Wincup, Chris Barman, Bhupen Zamora Tehozol, Erick Adrian Serrano, Jorge Rojas García-De La Torre, Ignacio Colunga-Pedraza, Iris J. Merayo-Chalico, Javier Chibuzo, Okwara Celestine Katchamart, Wanruchada Akawatcharangura Goo, Phonpen Shumnalieva, Russka Hoff, Leonardo Santos El Kibbi, Lina Halabi, Hussein Vaidya, Binit Shaharir, Syahrul Sazliyana Hasan, A. T. M. Tanveer Dey, Dzifa Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Lilleker, James B. Salim, Babur Gheita, Tamer A. Chatterjee, Tulika Distler, Oliver Saavedra, Miguel A. Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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