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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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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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001-es BibID:	BIBFORM105749
035-os BibID:	(scopus)85139571711 (wos)000840395200001
Első szerző:	Fazal, Zoha Zahid
Cím:	COVAD survey 2 long-term outcomes : unmet need and protocol / Fazal Zoha Zahid, Sen Parikshit, Joshi Mrudula, Ravichandran Naveen, Lilleker James B., Agarwal Vishwesh, Kardes Sinan, Kim Minchul, Day Jessica, Makol Ashima, Milchert Marcin, Gheita Tamer, Salim Babur, Velikova Tsvetelina, Gracia-Ramos Abraham Edgar, Parodis Ioannis, Nikiphorou Elena, Tan Ai Lyn, Chatterjee Tulika, Cavagna Lorenzo, Saavedra Miguel A., Shinjo Samuel Katsuyuki, Ziade Nelly, Selva-O'Callaghan Albert, Nune Arvind, Knitza Johannes, Kuwana Masataka, Gutiérrez Carlos-Enrique Toro, Caballero-Uribe Carlo Vinicio, Dey Dzifa, Distler Oliver, Chinoy Hector, Agarwal Vikas, Aggarwal Rohit, Gupta Latika, COVAD Study Group
Dátum:	2022
ISSN:	0172-8172 1437-160X
Megjegyzések:	Vaccine hesitancy is considered a major barrier to achieving herd immunity against COVID-19. While multiple alternative and synergistic approaches including heterologous vaccination, booster doses, and antiviral drugs have been developed, equitable vaccine uptake remains the foremost strategy to manage pandemic. Although none of the currently approved vaccines are live-attenuated, several reports of disease flares, waning protection, and acute-onset syndromes have emerged as short-term adverse events after vaccination. Hence, scientific literature falls short when discussing potential long-term effects in vulnerable cohorts. The COVAD-2 survey follows on from the baseline COVAD-1 survey with the aim to collect patient-reported data on the long-term safety and tolerability of COVID-19 vaccines in immune modulation. The e-survey has been extensively pilot-tested and validated with translations into multiple languages. Anticipated results will help improve vaccination efforts and reduce the imminent risks of COVID-19 infection, especially in understudied vulnerable groups.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Autoimmune diseases COVID-19 Long-term adverse effects Registries Vaccination
Megjelenés:	Rheumatology International. - 42 : 12 (2022), p. 2151-2158. -
További szerzők:	Sen, Parikshit Joshi, Mrudula Ravichandran, Naveen Lilleker, James B. Agarwal, Vishwesh Kardes, Sinan Kim, Minchul Day, Jessica Makol, Ashima Milchert, Marcin Gheita, Tamer A. Salim, Babur Velikova, Tsvetelina Gracia-Ramos, Abraham Edgar Parodis, Ioannis Nikiphorou, Elena (reumatológus) Tan, Ai Lyn Chatterjee, Tulika Cavagna, Lorenzo Saavedra, Miguel A. Shinjo, Samuel Katsuyuki Ziade, Nelly Selva-O'Callaghan, Albert Nune, Arvind Knitza, Johannes Kuwana, Masataka Gutiérrez, Carlos-Enrique Toro Caballero-Uribe, Carlo Vinicio Dey, Dzifa Distler, Oliver Chinoy, Hector Agarwal, Vikas Aggarwal, Rohit Gupta, Latika Nagy-Vincze Melinda (1985-) (orvos) Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) COVAD Study Group
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001-es BibID:	BIBFORM117880
035-os BibID:	(WOS)001116143800001 (Scopus)85181481512
Első szerző:	Panchawagh, Suhrud
Cím:	COVID-19 breakthrough infections in type 1 diabetes mellitus : a cross-sectional study by the COVID-19 Vaccination in Autoimmune Diseases (COVAD) Group / Panchawagh Suhrud, Ravichandran Naveen, Barman Bhupen, Nune Arvind, Javaid Mahnoor, Gracia-Ramos Abraham Edgar, Day Jessica, Joshi Mrudula, Kuwana Masataka, Saha Sreoshy, Pande Arunkumar R., Caballero-Uribe Carlo Vinicio, Velikova Tsvetelina, Parodis Ioannis, Knitza Johannes, Kadam Esha, Tan Ai Lyn, Shinjo Samuel Katsuyuki, Boro Hiya, COVAD Study Group, Aggarwal Rohit, Agarwal Vikas, Chatterjee Tulika, Gupta Latika
Dátum:	2023
ISSN:	0172-8172 1437-160X
Megjegyzések:	To investigate the frequency, profile, and severity of COVID-19 breakthrough infections (BI) in patients with type I diabetes mellitus (T1DM) compared to healthy controls (HC) after vaccination. The second COVID-19 Vaccination in Autoimmune Diseases (COVAD-2) survey is a multinational cross-sectional electronic survey which has collected data on patients suffering from various autoimmune diseases including T1DM. We performed a subgroup analysis on this cohort to investigate COVID-19 BI characteristics in patients with T1DM. Logistic regression with propensity score matching analysis was performed. A total of 9595 individuals were included in the analysis, with 100 patients having T1DM. Among the fully vaccinated cohort, 16 (16%) T1DM patients had one BI and 2 (2%) had two BIs. No morbidities or deaths were reported, except for one patient who required hospitalization with oxygen without admission to intensive care. The frequency, clinical features, and severity of BIs were not significantly different between T1DM patients and HCs after adjustment for confounding factors. Our study did not show any statistically significant differences in the frequency, symptoms, duration, or critical care requirements between T1DM and HCs after COVID-19 vaccination. Further research is needed to identify factors associated with inadequate vaccine response in patients with BIs, especially in patients with autoimmune diseases.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Breakthrough infections COVID-19 Survey Type 1 diabetes mellitus Vaccine
Megjelenés:	Rheumatology International. - 44 : 1 (2023), p. 73-80. -
További szerzők:	Ravichandran, Naveen Barman, Bhupen Nune, Arvind Javaid, Mahnoor Gracia-Ramos, Abraham Edgar Day, Jessica Joshi, Mrudula Kuwana, Masataka Saha, Sreoshy Pande, Arunkumar R. Caballero-Uribe, Carlo Vinicio Velikova, Tsvetelina Parodis, Ioannis Knitza, Johannes Kadam, Esha Tan, Ai Lyn Shinjo, Samuel Katsuyuki Boro, Hiya Aggarwal, Rohit Agarwal, Vikas Chatterjee, Tulika Gupta, Latika Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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