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001-es BibID:	BIBFORM120114
035-os BibID:	(Scopus)85159682435 (WoS)000961261800002
Első szerző:	Naveen, R.
Cím:	Systemic sclerosis and COVID-19 vaccine safety : short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey / Naveen R., Thakare Darpan R., Kuwana Masataka, Pauling John D., Day Jessica, Joshi Mrudula, Parodis Ioannis, Sen Parikshit, Jagtap Kshitij, Nikiphorou Elena, Saha Sreoshy, Agarwal Vishwesh, Chatterjee Tulika, Lilleker James B., Kardes Sinan, Milchert Marcin, Gheita Tamer, Salim Babur, Velikova Tsvetelina, Gracia-Ramos Abraham Edgar, Tan Ai Lyn, Nune Arvind, Cavagna Lorenzo, Saavedra Miguel A., Shinjo Samuel Katsuyuki, Ziade Nelly, Knitza Johannes, Distler Oliver, Chinoy, COVAD Study Group, Aggarwal Rohit, Gupta Latika, Agarwal Vikas, Makol Ashima
Dátum:	2023
ISSN:	0172-8172 1437-160X
Megjegyzések:	The safety profile of COVID-19 vaccines is understudied in patients with systemic sclerosis (SSc). We compared short-term adverse events (AEs) 7 days following vaccination in patients with SSc vs other rheumatic (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). The COVID-19 Vaccination in autoimmune diseases (COVAD) self-reporting e-survey was circulated by a group of > 110 collaborators in 94 countries from March to December 2021. AEs were analyzed between different groups using regression models. Of 10,679 complete respondents [73.8% females, mean age 43 years, 53% Caucasians], 478 had SSc. 83% had completed two vaccine doses, Pfizer-BioNTech (BNT162b2) (51%) was the most common. Minor and major AEs were reported by 81.2% and 3.3% SSc patients, respectively, and did not differ significantly with disease activity or different vaccine types, though with minor symptom differences. Frequencies of AEs were not affected by background immunosuppression, though SSc patients receiving hydroxychloroquine experienced fatigue less commonly (OR 0.4; 95% CI 0.2-0.8). Frequency of AEs and hospitalisations were similar to other AIRDs, nrAIDs, and HC except a higher risk of chills (OR 1.3; 95% CI 1.0-1.7) and fatigue (OR 1.3; 95% CI 1.0-1.6) compared to other AIRDs. COVID-19 vaccines were largely safe and well tolerated in SSc patients in the short term. Background immunosuppression and disease activity did not influence the vaccination-related short-term AEs.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Adverse events Autoimmune diseases COVID-19 Systemic sclerosis Vaccination
Megjelenés:	Rheumatology International. - 43 : 7 (2023), p. 1265-1275. -
További szerzők:	Thakare, Darpan R. Kuwana, Masataka Pauling, John D. Day, Jessica Joshi, Mrudula Parodis, Ioannis Sen, Parikshit Jagtap, Kshitij Nikiphorou, Elena (reumatológus) Saha, Sreoshy Agarwal, Vishwesh Chatterjee, Tulika Lilleker, James B. Kardes, Sinan Milchert, Marcin Gheita, Tamer A. Salim, Babur Velikova, Tsvetelina Gracia-Ramos, Abraham Edgar Tan, Ai Lyn Nune, Arvind Cavagna, Lorenzo Saavedra, Miguel A. Shinjo, Samuel Katsuyuki Ziade, Nelly Knitza, Johannes Distler, Oliver Aggarwal, Rohit Gupta, Latika Agarwal, Vikas Makol, Ashima Nagy-Vincze Melinda (1985-) (orvos) COVAD Study Group
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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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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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001-es BibID:	BIBFORM109287
Első szerző:	Sen, Parikshit
Cím:	Vaccine hesitancy decreases in rheumatic diseases, long-term concerns remain in myositis : a comparative analysis of the COVAD surveys / Parikshit Sen, Naveen R., Nazanin Houshmand, Siamak Moghadam Kia, Mrudula Joshi, Sreoshy Saha, Kshitij Jagtap, Vishwesh Agarwal, Arvind Nune, Elena Nikiphorou, Ai Lyn Tan, Samuel Katsuyuki Shinjo, Nelly Ziade, Tsvetelina Velikova, Marcin Milchert, Ioannis Parodis, Abraham Edgar Gracia-Ramos, Lorenzo Cavagna, Masataka Kuwana, Johannes Knitza, Ashima Makol, Aarat Patel, John D. Pauling, Chris Wincup, Bhupen Barman, Erick Adrian Zamora Tehozol, Jorge Rojas Serrano, Ignacio Garcia-De La Torre, Iris J. Colunga-Pedraza, Javier Merayo-Chalico, Okwara Celestine Chibuzo, Wanruchada Katchamart, Phonpen Akawatcharangura Goo, Russka Shumnalieva, Yi-Ming Chen, Leonardo Santos Hoff, Lina El Kibbi, Hussein Halabi, Binit Vaidya, Syahrul Sazliyana Shaharir, A. T. M. Tanveer Hasan, Dzifa Dey, Carlos Enrique Toro Gutièrrez, Carlo Vinicio Caballero-Uribe, James B. Lilleker, Babur Salim, Tamer Gheita, Tulika Chatterjee, Oliver Distler, Miguel A. Saavedra, Jessica Day, Hector Chinoy, COVAD Study Group
Dátum:	2023
ISSN:	1462-0324 1462-0332
Megjegyzések:	Objective: COVID-19 vaccines have a favorable safety profile in patients with autoimmune rheumatic diseases (AIRDs) such as idiopathic inflammatory myopathies (IIMs), however hesitancy continues to persist among these patients.Therefore, we studied the prevalence, predictors, and reasons for hesitancy in patients with IIMs, other AIRDs, non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs), using data from the two international COVID-19 Vaccination in Autoimmune Diseases (COVAD) e-surveys. Methods: The 1st and 2nd COVAD patient self-reported e-surveys were circulated from March to December 2021, and February to June 2022 (ongoing). We collected data on demographics, comorbidities, COVID-19 infection and vaccination history, reasons for hesitancy, and patient reported outcomes. Predictors of hesitancy were analyzed using regression models in different groups. Results: We analyzed data from 18,882 (COVAD-1) and 7666 (COVAD-2) respondents. Reassuringly, hesitancy decreased from 2021 (16.5%) to 2022 (5.1%) [OR 0.26; 95%CI: 0.24-0.30, p < 0.001]. However, concerns/fear over long-term safety had increased [OR 3.6;95% CI:2.9-4.6, p < 0.01].We noted with concern greater skepticism over vaccine science among patients with IIMs than AIRDs [OR:1.8; 95%CI: 1.08-3.2, p = 0.023] and HCs [OR: 4; 95%CI: 1.9-8.1, p < 0.001], as well as more long-term safety concerns/fear [IIMs vs AIRDs; OR: 1.9; 95%CI: 1.2-2.9, p = 0.001; IIMs vs HCs; OR: 5.4 95%CI: 3-9.6), p < 0.001].Caucasians [OR 4.2 (1.7-10.3)] were likely to be more hesitant, while those with better PROMIS physical health score were less hesitant [OR 0.9 (0.8-0.97)]. Conclusion: Vaccine hesitancy has decreased from 2021 to 2022, long-term safety concerns remain among patients with IIMs, particularly in Caucasians and those with poor physical function.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk COVID-19 vaccines Idiopathic Inflammatory Myopathies autoimmune disease registries vaccine hesitancy
Megjelenés:	Rheumatology. - 62 : 10 (2023), p. 3291-3301. -
További szerzők:	Naveen, R. Houshmand, Nazanin Moghadam Kia, Siamak Joshi, Mrudula Saha, Sreoshy Jagtap, Kshitij Agarwal, Vishwesh Nune, Arvind Nikiphorou, Elena (reumatológus) Tan, Ai Lyn Shinjo, Samuel Katsuyuki Ziade, Nelly Velikova, Tsvetelina Milchert, Marcin Parodis, Ioannis 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 Rojas Serrano, Jorge García-De La Torre, Ignacio 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 Sazliyana Shaharir, Syahrul 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. Day, Jessica Chinoy, Hector Nagy-Vincze Melinda (1985-) (orvos) Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) COVAD Study Group
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