Citations 6
Characteristics of and risk factors for COVID-19 breakthrough infections in idiopathic inflammatory myopathies: results from the COVAD study
Ravichandran, Naveen , Day, Jessica , Nune, Arvind , Nikiphorou, Elena , Tan, Ai Lyn , Velikova, Tsvetelina , Milchert, Marcin , Parodis, Ioannis , Kuwana, Masataka , Patel, Aarat , Wincup, Chris , Tehozol, Erick Adrian Zamora , Chibuzo, Okwara Celestine , Katchamart, Wanruchada , Goo, Phonpen Akarawatcharangura , Kibbi, Lina El , Vaidya, Binit , Shaharir, Syahrul Sazliyana , Hasan, A T M Tanveer , Dey, Dzifa , Gutiérrez, Carlos Enrique Toro , Caballero‐Uribe, Carlo V. , Salim, Babur , Chinoy, Hector , Gupta, Latika, Group, COVAD Study, Ranjan, Rajiv , Jain, Avinash , Pandya, Sapan C , Sharma, Aman , M, Manesh Manoj, Patro, Pradeepta Sekhar , Ajmani, Sajal , Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Gaur, Prithvi Sanjeevkumar , Mamadapur, Mahabaleshwar , Ghodke, Akanksha, Kadam, Esha , Fazal, Zoha Zahid , Kardeş, Sinan , Yıldırım, Reşit, Maurier, F. , Meyer, Alain, Atzeni, Fabiola , Bocci, Elena Bartoloni, Orsolini, Giovanni , Angelis, Rossella De , Danielli, Maria Giovanna, Grignaschi, Silvia, Giollo, Alessandro, Lini, Daniele , Alluno, Alessia, Loarce‐Martos, Jesus , Aránega, Raquel, Nakashima, Ran , Sato, Shinji , Kaneko, Yuko , Gono, Takahisa, Tomaras, Stylianos , Aharonov, Mr Or, Nagy‐Vincze, Melinda , Schrieber, Karen, bouchti, Pr Imane El, Baba, Zineb, Ima-Edomwonyi, Uyi, Dedeke, Ibukunoluwa, Madu, Nwankwo Henry, Yerima, Abubakar , Olaosebikan, Hakeem , Becky, A, Koussougbo, Ouma Devi , Palalane, Elisa, Limaye, Vidya, Hudson, Marie , Landon‐Cardinal, Océane, Zuleta, Wilmer Gerardo Rojas, Cajas, Javier, Silva, José António Pereira, Doskaliuk, Bohdana , Chinchay, Lyn , Bernaola, José Proaño, Pimentel, Victorio, Harifi, Ghita, Fuentes-Silva, Yurilís , Cabriza, Karoll, Losanto, Jonathan, Colaman, Nelly, Cachafeiro-Vilar, Antonio , Bautista, Generoso Guerra , Ho, Enrique Julio Giraldo, González, Raúl, Nunez, Lilith Stange, Vergara, M Cristian, Báez, Jossiell Then , Alonzo, Hugo, Pastelin, Carlos Benito Santiago, Obiols, Alejandro Quiñónez, Chávez, Nilmo , Ordóñez, Andrea Bran , Argueta, Sandra, Quijivix, Daniel, Llerena, Gil Alberto Reyes, Sierra-Zorita, Radames, Arrieta, Dina , Hidalgo, Eduardo Romero, Saénz, Ricardo, M, Roberto Morales Idania Escalante, Calapaqui, Wendy, Quezada, Ivonne, Arredondo, Gabriela, Agarwal, Vikas , Giollo, Alessandro , Gupta, Latika , Naveen, R , Day, Jessica , Nune, Arvind , Tan, Ai Lyn , Ziade, Nelly , Milchert, Marcin , Parodis, Ioannis , Gracia-Ramos, Abraham Edgar , Kuwana, Masataka , Knitza, Johannes , Pauling, John D , Wincup, Chris , Colunga-Pedraza, Iris J , Merayo-Chalico, Javier , Lilleker, James B , Gheita, Tamer , Distler, Oliver , Chinoy, Hector , Agarwal, Vikas , Aggarwal, Rohit , Gupta, Latika , Agarwal, Vikas , Velikova, Tsvetelina , Zamora Tehozol, Erick Adrian , Dey, Dzifa , Caballero-Uribe, Carlo Vinicio , De Angelis, Rossella , Hoff, Leonardo Santos , Sen, Parikshit , Joshi, Mrudula , Saha, Sreoshy , Shinjo, Samuel Katsuyuki , Ziadé, Nelly , Jagtap, Kshitij , Gracia‐Ramos, Abraham Edgar , Cavagna, Lorenzo , Chen, Yi‐Ming , Makol, Ashima , Agarwal, Vishwesh , Pauling, John D , Barman, Bhupen , Rojas Serrano, Jorge , Torre, Ignacio García‐De La , Colunga-Pedraza, I. J. , Goo, Phonpen Akawatcharangura , Shumnalieva, Russka , Halabi, Hussein , Gheita, Tamer A. , Chatterjee, Tulika , Distler, Oliver , Saavedra, Miguel A , Aggarwal, Rohit , Group, COVAD Study, Singh, Yogesh Preet , Pilania, Rakesh Kumar , Gupta, Vikas , Kavadichanda, Chengappa G. , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Pande, Arun K. , Chandwar, Kunal , Cansu, Döndü Üsküdar , Gasparyan, Armen Yuri , Giannini, Margherita , Campagne, Julien , Meyer, Alain , Papa, Nicoletta Del , Sambataro, Gianluca , Govoni, Marcello , Parisi, Simone , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Sainaghi, Pier Paolo , Venerito, Vincenzo , Andréoli, Laura , Iannone, Florenzo , Fornaro, Marco , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Prieto‐González, Sergio , Yoshida, Akira , Kimura, Naoki, Proft, Fabian Nikolai , Holzer, Marie‐Therese , Gromova, Margarita Aleksandrovna , Griger, Zoltán , Hmamouchi, Ihsane , Emorinken, Airenakho , Langguth, Daman , Limaye, Vidya , Needham, Merrilee , Srivastav, Nilesh , Landon‐Cardinal, Océane , Arbeláez-Cortés, Álvaro , Silva, José António Pereira, Fonseca, João Eurico , Zimba, Olena , So, Ho , Ugarte‐Gil, Manuel F. , Fathi, Hanan Mohamed , Mohammed, Reem Hamdy A , Harifi, Ghita , Salinas, Rodrigo Nicolás Garcia
Rheumatology | March 2, 2024 | Volume: 64 | Issue: 2 | Pages: 597-606
Abstract Objectives The objective of this study was to explore the prevalence, characteristics and risk factors of COVID-19 breakthrough infections (BIs) in idiopathic inflammatory myopathies (IIMs) using data from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. Methods A validated patient self-reporting e-survey was circulated by the COVAD study group to collect data on COVID-19 infection and vaccination in 2022. BIs were defined as COVID-19 occurring ≥14 days after two vaccine doses. We compared BI characteristics and severity among patients with IIMs, patients with other autoimmune rheumatic and non-rheumatic diseases (AIRD, nrAID), and healthy controls (HCs). Multivariable Cox regression models were used to assess the risk factors for BI, severe BI ,and hospitalizations among patients with IIMs. Results Among the 9449 included responses, BIs occurred in 1447 respondents (15.3%). The median age was 44 years [interquartile range (IQR) 21], 77.4% were female, and 182 BIs (12.9%) occurred among the 1406 patients with IIMs. Multivariable Cox regression among the data for patients with IIMs showed increasing age to be a protective factor for BIs [hazard ratio (HR) = 0.98, 95% CI = 0.97–0.99], and HCQ and SSZ use were risk factors (HR = 1.81, 95% CI = 1.24–2.64, and HR = 3.79, 95% CI = 1.69–8.42, respectively). Glucocorticoid use was a risk factor for a severe BI (HR = 3.61, 95% CI = 1.09–11.8). Non-white ethnicity (HR = 2.61, 95% CI = 1.03–6.59) was a risk factor for hospitalization. Compared with other groups, patients with IIMs required more supplemental oxygen therapy (IIMs = 6.0% vs AIRDs = 1.8%, nrAIDs = 2.2% and HCs = 0.9%), intensive care unit admission (IIMs = 2.2% vs AIRDs = 0.6%, nrAIDs and HCs = 0%), advanced treatment with antiviral or monoclonal antibodies (IIMs = 34.1% vs AIRDs = 25.8%, nrAIDs = 14.6% and HCs = 12.8%) and had more hospitalization (IIMs = 7.7% vs AIRDs = 4.6%, nrAIDs = 1.1% and HCs = 1.5%). Conclusion Patients with IIMs are susceptible to severe COVID-19 BIs. Age and immunosuppressive treatments were related to the risk of BIs.
COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study
Andréoli, Laura , Lini, Daniele , Schreiber, Karen , Parodis, Ioannis , Sen, Parikshit , Ravichandran, Naveen , Day, Jessica , Joshi, Mrudula , Jagtap, Kshitij , Nune, Arvind , Nikiphorou, Elena , Tan, Ai Lyn , Velikova, Tsvetelina , Milchert, Marcin , Gracia‐Ramos, Abraham Edgar , Kuwana, Masataka , Patel, Aarat , Pauling, John D , Wincup, Chris , Tehozol, Erick Adrian Zamora , Colunga-Pedraza, I. J. , Chibuzo, Okwara Celestine , Katchamart, Wanruchada , Goo, Phonpen Akarawatcharangura , Shumnalieva, Russka , Kibbi, Lina El , Vaidya, Binit , Shaharir, Syahrul Sazliyana , Hasan, A T M Tanveer , Dey, Dzifa , Gutiérrez, Carlos Enrique Toro , Caballero‐Uribe, Carlo V. , Salim, Babur , Gheita, Tamer A. , Chinoy, Hector , Agarwal, Vikas , Gupta, Latika, Group, COVAD Study, Kardeş, Sinan , Vince, Melinda Nagy, Singh, Yogesh Preet , Ranjan, Rajiv , Jain, Avinash , Pandya, Sapan C , Sharma, Aman , Manoj, Manesh , Gupta, Vikas , Patro, Pradeepta Sekhar , Ajmani, Sajal , Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Ghodke, Akanksha, Fazal, Zoha Zahid , Yıldırım, Reşit, Sambataro, Gianluca , Atzeni, Fabiola , Parisi, Simone , Bocci, Elena Bartoloni, Sainaghi, Pier Paolo , Orsolini, Giovanni , Angelis, Rossella De , Danieli, Maria Giovanna , Giollo, Alessandro, Loarce‐Martos, Jesus , Prieto‐González, Sergio , Nakashima, Ran , Sato, Shinji, Kaneko, Yuko , Tomaras, Stylianos, Aharonov, Or, bouchti, Imane El, Baba, Zineb, Maurier, François, Meyer, Alain, Limaye, Vidya, Hudson, Marie , Landon‐Cardinal, Océane , Zuleta, Wilmer Gerardo Rojas, Cajas, Javier, Silva, José António Pereira, Doskaliuk, Bohdana , Ima-Edomwonyi, Uyi, Dedeke, Ibukunoluwa, Madu, Nwankwo Henry, Yerima, Abubakar , Olaosebikan, Hakeem , Becky, A, Koussougbo, Oruma Devi, Palalane, Elisa, Chinchay, Lyn , Bernaola, José Proaño, Pimentel, Victorio, Fathi, Hanan Mohammed, Harifi, Ghita , Fuentes-Silva, Yurilís , Cabriza, Karoll, Losanto, Jonathan, Colaman, Nelly, Cachafeiro-Vilar, Antonio , Bautista, Generoso Guerra , Ho, Enrique Julio Giraldo, Nunez, Lilith Stange, Vergara, M Cristian, Báez, Jossiell Then , Alonzo, Hugo, Pastelin, Carlos Benito Santiago, Obiols, Alejandro Quiñónez, Chávez, Nilmo , Ordóñez, Andrea Bran , Llerena, Gil Alberto Reyes, Sierra-Zorita, Radames, Arrieta, Dina , Hidalgo, Eduardo Romero, Saénz, Ricardo, Escalante, M Idania, Calapaqui, Wendy, Quezada, Ivonne, Arredondo, Gabriela, Giollo, Alessandro , Gupta, Latika , 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 , Pauling, John D , Wincup, Chris , Zamora Tehozol, Erick Adrian , Rojas Serrano, Jorge , García-De La Torre, Ignacio , Colunga-Pedraza, Iris J , Merayo-Chalico, Javier , Katchamart, Wanruchada , Shumnalieva, Russka , Chen, Yi-Ming , Hoff, Leonardo Santos , El Kibbi, Lina , Halabi, Hussein , Vaidya, Binit , Sazliyana Shaharir, Syahrul , Hasan, A T M Tanveer , Gutiérrez, Carlos Enrique Toro , Lilleker, James B , Salim, Babur , Gheita, Tamer , Chatterjee, Tulika , Saavedra, Miguel A , Distler, Oliver , Chinoy, Hector , Agarwal, Vikas , Aggarwal, Rohit , Gupta, Latika , Joshi, Mrudula , Day, Jessica , Parodis, Ioannis , Nune, Arvind , Naveen, R , Agarwal, Vikas , Dey, Dzifa , Caballero-Uribe, Carlo Vinicio , Sen, Parikshit , Andreoli, Laura , Jagtap, Kshitij , De Angelis, Rossella , Singh, Yogesh Preet , Agarwal, Vishwesh , Saha, Sreoshy , Shinjo, Samuel Katsuyuki , Ziadé, Nelly , Makol, Ashima , Barman, Bhupen , Torre, Ignacio García‐De La , Goo, Phonpen Akawatcharangura , Chen, Yi‐Ming , Halabi, Hussein , Chatterjee, Tulika , Distler, Oliver , Aggarwal, Rohit , Group, COVAD Study, Griger, Zoltán , Pilania, Rakesh Kumar , Kavadichanda, Chengappa G. , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Pande, Arun K. , Chandwar, Kunal , Boro, Hiya , Cansu, Döndü Üsküdar , Gasparyan, Armen Yuri , Papa, Nicoletta Del , Govoni, Marcello , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Venerito, Vincenzo , Grignaschi, Silvia , Alunno, Alessia , Iannone, Florenzo , Fornaro, Marco , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Gonzalez, Raquel Aranega, Yoshida, Akira, Kimura, Naoki, Gono, Takahisa , Tomaras, Stylianos , Proft, Fabian Nikolai , Holzer, Marie‐Therese , Gromova, Margarita Aleksandrovna , Hmamouchi, Ihsane , Giannini, Margherita , Maurier, F. , Campagne, Julien , Meyer, Alain , Langguth, Daman , Limaye, Vidya , Needham, Merrilee , Srivastav, Nilesh , Arbeláez-Cortés, Álvaro , Silva, José António Pereira, Fonseca, João Eurico , Zimba, Olena , Ima-Edomwonyi, Uyi, Emorinken, Airenakho , So, Ho , Ugarte‐Gil, Manuel F. , Mohammed, Reem Hamdy A , Salinas, Rodrigo Nicolás Garcia
Rheumatology | July 25, 2023 | Volume: 63 | Issue: 5 | Pages: 1341-1351
Abstract Objectives We investigated coronavirus disease 2019 (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 and AID-related treatment modifications were analysed upon diagnosis of AID vs 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 disease flares 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 disease flare 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 for the fetus by passive immunization appear to outweigh potential risks.
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 , Ziadé, Nelly , Velikova, Tsvetelina , Milchert, Marcin , Jagtap, Kshitij , Parodis, Ioannis , Kuwana, Masataka , Patel, Aarat , Pauling, John D , Wincup, Chris , Tehozol, Erick Adrian Zamora , Chibuzo, Okwara Celestine , Katchamart, Wanruchada , Goo, Phonpen Akarawatcharangura , Shumnalieva, Russka , 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. , Salim, Babur , Chinoy, Hector , Agarwal, Vikas , Gupta, Latika, Group, COVAD Study, Kardeş, Sinan , Lini, Daniele , Screiber, Karen, Vince, Melinda Nagy, Singh, Yogesh Preet , Jain, Avinash , Pandya, Sapan C , Sharma, Aman , Manoj, Manesh , Patro, Pradeepta Sekhar , Ajmani, Sajal , Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Ghodke, Akanksha, Fazal, Zoha Zahid , Yıldırım, Reşit, Sambataro, Gianluca , Atzeni, Fabiola , Parisi, Simone , Bocci, Elena Bartoloni, Sainaghi, Pier Paolo , Orsolini, Giovanni , Angelis, Rossella De , Danielli, Maria Giovanna, Giollo, Alessandro, Alluno, Alessia, Ioannone, Florenzo, Loarce‐Martos, Jesus , Prieto‐González, Sergio , Nakashima, Ran , Sato, Shinji , Kaneko, Yuko , Gono, Takahisa, Tomaras, Stylianos, Aharonov, Or, Bouchti, I. El , Baba, Zineb, Maurier, François, Meyer, Alain, Limaye, Vidya, Hudson, Marie , Landon‐Cardinal, Océane , Zuleta, Wilmer Gerardo Rojas, Cajas, Javier, Silva, José António Pereira, Doskaliuk, Bohdana , Ima-Edomwonyi, Uyi, Dedeke, Ibukunoluwa, Madu, Nwankwo Henry, Yerima, Abubakar , Olaosebikan, Hakeem , Becky, A, Koussougbo, Oruma Devi, Palalane, Elisa, So, Ho, Chinchay, Lyn , Bernaola, José Proaño, Pimentel, Victorio, Fathi, Hanan Mohammed, Mohammed, Reem Hamdy A , Harifi, Ghita, Fuentes-Silva, Yurilís , Cabriza, Karoll, Losanto, Jonathan, Colaman, Nelly, Cachafeiro-Vilar, Antonio , Bautista, Generoso Guerra , Ho, Enrique Julio Giraldo, González, Raúl, Nunez, Lilith Stange, Vergara, M Cristian, Báez, Jossiell Then , Alonzo, Hugo, Pastelin, Carlos Benito Santiago, Obiols, Alejandro Quiñónez, Chávez, Nilmo , Ordóñez, Andrea Bran , Llerena, Gil Alberto Reyes, Sierra-Zorita, Radames, Arrieta, Dina , Hidalgo, Eduardo Romero, Saénz, Ricardo, Escalante, M Idania, Calapaqui, Wendy, Quezada, Ivonne, Arredondo, Gabriela, Ravichandran, Naveen , Giollo, Alessandro , Schreiber, Karen , Gupta, Latika , Naveen, R , Gracia-Ramos, Abraham Edgar , Cavagna, Lorenzo , Kuwana, Masataka , Knitza, Johannes , Chen, Yi-Ming , Makol, Ashima , Agarwal, Vishwesh , Pauling, John D , Wincup, Chris , Zamora Tehozol, Erick Adrian , Rojas Serrano, Jorge , García-De La Torre, Ignacio , Colunga-Pedraza, Iris J , Merayo-Chalico, Javier , Katchamart, Wanruchada , Shumnalieva, Russka , Hoff, Leonardo Santos , El Kibbi, Lina , Halabi, Hussein , Vaidya, Binit , Sazliyana Shaharir, Syahrul , Hasan, A T M Tanveer , Gutiérrez, Carlos Enrique Toro , Lilleker, James B , Salim, Babur , Gheita, Tamer , Chatterjee, Tulika , Distler, Oliver , Saavedra, Miguel A , Chinoy, Hector , Agarwal, Vikas , Aggarwal, Rohit , Gupta, Latika , Milchert, Marcin , Joshi, Mrudula , Day, Jessica , Velikova, Tsvetelina , Parodis, Ioannis , Tan, Ai Lyn , Shinjo, Samuel Katsuyuki , Ziade, Nelly , Nune, Arvind , Dey, Dzifa , Caballero-Uribe, Carlo Vinicio , Sen, Parikshit , Saha, Sreoshy , Griger, Zoltan , Jagtap, Kshitij , De Angelis, Rossella , Singh, Yogesh Preet , Gracia‐Ramos, Abraham Edgar , Chen, Yi‐Ming , Makol, Ashima , Agarwal, Vishwesh , Barman, Bhupen , Torre, Ignacio García‐De La , Colunga-Pedraza, I. J. , Goo, Phonpen Akawatcharangura , Gheita, Tamer A. , Chatterjee, Tulika , Distler, Oliver , Aggarwal, Rohit , Group, COVAD Study, Andréoli, Laura , Ranjan, Rajiv , Pilania, Rakesh Kumar , Gupta, Vikas , Kavadichanda, Chengappa G. , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Pande, Arun K. , Chandwar, Kunal , Boro, Hiya , Cansu, Döndü Üsküdar , Gasparyan, Armen Yuri , Papa, Nicoletta Del , Govoni, Marcello , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Venerito, Vincenzo , Grignaschi, Silvia , Giollo, Alessandro, Fornaro, Marco , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Gonzalez, Raquel Aranega, Yoshida, Akira , Kimura, Naoki, Tomaras, Stylianos , Proft, Fabian Nikolai , Holzer, Marie‐Therese , Gromova, Margarita Aleksandrovna , Hmamouchi, Ihsane , Giannini, Margherita , Maurier, F. , Campagne, Julien , Meyer, Alain , Langguth, Daman , Limaye, Vidya , Needham, Merrilee , Srivastav, Nilesh , Arbeláez-Cortés, Álvaro , Cajas, Javier, Silva, José António Pereira, Fonseca, João Eurico , Zimba, Olena , Emorinken, Airenakho , Ugarte‐Gil, Manuel F. , Harifi, Ghita , Salinas, Rodrigo Nicolás Garcia
Rheumatology | April 21, 2023 | Volume: 63 | Issue: 1 | Pages: 127-139
Abstract Objectives Disease flares in the post–coronavirus disease 2019 (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 minimal clinically significant improvement difference worsening of Patient-Reported Outcomes Measurement Information System (PROMIS) PROMISPF10a score. Risk factors of flares were analysed using regression models. Results Of 15 165 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) to (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 AZA (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 IS. Asthma (OR 1.62; 95% CI 1.05, 2.50, P = 0.028) and higher pain visual analogue score (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.
Flares after COVID-19 infection in patients with idiopathic inflammatory myopathies: results from the COVAD study
Ali, Sasha Saadia, Naveen, R, Sen, Parikshit , Day, Jessica , Joshi, Mrudula , Nune, Arvind , Nikiphorou, Elena , Saha, Sreoshy , Tan, Ai Lyn , Shinjo, Samuel Katsuyuki , Ziadé, Nelly , Velikova, Tsvetelina , Milchert, Marcin , Jagtap, Kshitij , Parodis, Ioannis , Kuwana, Masataka , Makol, Ashima , Patel, Aarat , Pauling, John D , Wincup, Chris , Tehozol, Erick Adrian Zamora , Chibuzo, Okwara Celestine , Katchamart, Wanruchada , Goo, Phonpen Akawatcharangura , Shumnalieva, Russka , 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. , Salim, Babur , Gheita, Tamer A. , Chinoy, Hector , Agarwal, Vikas , Gupta, Latika, Group, for the COVAD Study, Kardeş, Sinan , Lini, Daniele , Schreiber, Karen, Vince, Melinda Nagy, Singh, Yogesh Preet , Jain, Avinash , Pandya, Sapan C , Manoj, Manesh , Patro, Pradeepta Sekhar , Ajmani, Sajal, Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Ghodke, Akanksha, Fazal, Zoha Zahid , Yıldırım, Reşit , Sambataro, Gianluca , Atzeni, Fabiola , Parisi, Simone , Bocci, Elena Bartoloni, Sainaghi, Pier Paolo , Orsolini, Giovanni , Angelis, Rossella De , Danielli, Maria Giovanna, Giollo, Alessandro , Alluno, Alessia, Ioannone, Florenzo, Fornaro, Marco, Loarce‐Martos, Jesus , Prieto‐González, Sergio , Nakashima, Ran , Sato, Shinji, Kaneko, Yuko , Tomaras, Stylianos , Aharonov, Or, Bouchti, I. El , Baba, Zineb, Maurier, François, Meyer, Alain , Limaye, Vidya , Hudson, Marie , Landon‐Cardinal, Océane, Zuleta, Wilmer Gerardo Rojas, Cajas, Javier, Silva, José António Pereira, Doskaliuk, Bohdana , Ima-Edomwonyi, Uyi, Dedeke, Ibukunoluwa, Madu, Nwankwo Henry, Yerima, Abubakar , Olaosebikan, Hakeem , Becky, A, Koussougbo, Oruma Devi, Palalane, Elisa, Chinchay, Lyn , Bernaola, José Proaño, Pimentel, Victorio, Fathi, Hanan Mohammed, Mohammed, Reem Hamdy A , Harifi, Ghita , Fuentes-Silva, Yurilís , Cabriza, Karoll, Losanto, Jonathan, Colaman, Nelly, Cachafeiro-Vilar, Antonio , Bautista, Generoso Guerra , Ho, Enrique Julio Giraldo, Nunez, Lilith Stange, Vergara, M Cristian, Báez, Jossiell Then , Alonzo, Hugo, Pastelin, Carlos Benito Santiago, Obiols, Alejandro Quiñónez, Chávez, Nilmo , Ordóñez, Andrea Bran , Llerena, Gil Alberto Reyes, Sierra-Zorita, Radames, Arrieta, Dina , Hidalgo, Eduardo Romero, Saénz, Ricardo, Escalante, M Idania, Calapaqui, Wendy, Quezada, Ivonne, Arredondo, Gabriela, Ravichandran, Naveen , Schreiber, Karen , Gupta, Latika , Naveen, R , Gracia-Ramos, Abraham Edgar , Cavagna, Lorenzo , Kuwana, Masataka , Knitza, Johannes , Chen, Yi-Ming , Makol, Ashima , Agarwal, Vishwesh , 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 , Katchamart, Wanruchada , Shumnalieva, Russka , 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 , Chatterjee, Tulika , Distler, Oliver , Saavedra, Miguel A , Chinoy, Hector , Agarwal, Vikas , Aggarwal, Rohit , Gupta, Latika , Milchert, Marcin , Joshi, Mrudula , Day, Jessica , Velikova, Tsvetelina , Parodis, Ioannis , Tan, Ai Lyn , Shinjo, Samuel Katsuyuki , Ziade, Nelly , Nune, Arvind , Sen, Parikshit , Saha, Sreoshy , Jagtap, Kshitij , De Angelis, Rossella , Singh, Yogesh Preet , Gracia‐Ramos, Abraham Edgar , Chen, Yi‐Ming , Agarwal, Vishwesh , Torre, Ignacio García‐De La , Colunga-Pedraza, I. J. , Chatterjee, Tulika , Distler, Oliver , Aggarwal, Rohit , Group, for the COVAD Study, Andréoli, Laura , Ranjan, Rajiv , Pilania, Rakesh Kumar , Sharma, Aman , Gupta, Vikas , Kavadichanda, Chengappa G. , Ajmani, Sajal , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Pande, Arun K. , Chandwar, Kunal , Boro, Hiya , Cansu, Döndü Üsküdar , Gasparyan, Armen Yuri , Papa, Nicoletta Del , Govoni, Marcello , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Venerito, Vincenzo , Grignaschi, Silvia , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Gonzalez, Raquel Aranega, Yoshida, Akira, Kimura, Naoki, Gono, Takahisa , Proft, Fabian Nikolai , Holzer, Marie‐Therese , Gromova, Margarita Aleksandrovna , Griger, Zoltán , Hmamouchi, Ihsane , Baba, Zineb, Giannini, Margherita , Maurier, F. , Campagne, Julien , Langguth, Daman , Needham, Merrilee , Srivastav, Nilesh , Landon‐Cardinal, Océane , Arbeláez-Cortés, Álvaro , Cajas, Javier, Fonseca, João Eurico , Zimba, Olena , Ima-Edomwonyi, Uyi, Emorinken, Airenakho , So, Ho , Ugarte‐Gil, Manuel F. , Salinas, Rodrigo Nicolás Garcia
Rheumatology | April 2, 2023 | Volume: 62 | Issue: 9 | Pages: e263-e268
Flares in autoimmune rheumatic diseases in the post-COVID-19 vaccination period—a cross-sequential study based on COVAD surveys
Jagtap, Kshitij , Naveen, R, Day, Jessica , Sen, Parikshit , Vaidya, Binit , Nune, Arvind , Nikiphorou, Elena , Tan, Ai Lyn , Agarwal, Vishwesh , Saha, Sreoshy , Ziadé, Nelly , Velikova, Tsvetelina , Milchert, Marcin , Parodis, Ioannis , Kuwana, Masataka , Makol, Ashima , Patel, Aarat , Pauling, John D , Wincup, Chris , Tehozol, Erick Adrian Zamora , Chibuzo, Okwara Celestine , Katchamart, Wanruchada , Goo, Phonpen Akawatcharangura , Shumnalieva, Russka , Kibbi, Lina El , Halabi, Hussein , Shaharir, Syahrul Sazliyana , Hasan, A T M Tanveer , Dey, Dzifa , Gutiérrez, Carlos Enrique Toro , Caballero‐Uribe, Carlo V. , Salim, Babur , Gheita, Tamer A. , Group, COVAD Study, Kardeş, Sinan , Schreiber, Karen, Vince, Melinda Nagy, Singh, Yogesh Preet , Ranjan, Rajiv , Jain, Avinash , Pandya, Sapan C , Sharma, Aman , Manoj, Manesh , Patro, Pradeepta Sekhar , Ajmani, Sajal , Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Ghodke, Akanksha, Fazal, Zoha Zahid , Yıldırım, Reşit , Atzeni, Fabiola , Bocci, Elena Bartoloni, Sebastiani, Marco, Orsolini, Giovanni , Angelis, Rossella De , Danielli, Maria Giovanna, Grignaschi, Silvia, Alluno, Alessia, Ioannone, Florenzo, Prieto‐González, Sergio , Nakashima, Ran , Sato, Shinji , Kaneko, Yuko , Gono, Takahisa, Tomaras, Stylianos , Aharonov, Or, Bouchti, I. El , Baba, Zineb, Maurier, François, Meyer, Alain , Limaye, Vidya , Hudson, Marie , Landon‐Cardinal, Océane , Zuleta, Wilmer Gerardo Rojas, Cajas, Javier, Silva, José António Pereira, Ima-Edomwonyi, Uyi, Dedeke, Ibukunoluwa, Madu, Nwankwo Henry, Yerima, Abubakar , Becky, A, Koussougbo, Oruma Devi, Palalane, Elisa, Chinchay, Lyn , Bernaola, José Proaño, Pimentel, Victorio, Fathi, Hanan Mohammed, Harifi, Ghita, Cabriza, Karoll, Losanto, Jonathan, Colaman, Nelly, Cachafeiro-Vilar, Antonio , Bautista, Generoso Guerra , Ho, Enrique Julio Giraldo, Nunez, Lilith Stange, Vergara, M Cristian, Báez, Jossiell Then , Alonzo, Hugo, Pastelin, Carlos Benito Santiago, Obiols, Alejandro Quiñónez, Chávez, Nilmo , Ordóñez, Andrea Bran , Argueta, Sandra, Llerena, Gil Alberto Reyes, Sierra-Zorita, Radames, Arrieta, Dina , Hidalgo, Eduardo Romero, Saénz, Ricardo, Escalante, Miguel , Calapaqui, Wendy, Quezada, Ivonne, Arredondo, Gabriela, Chinoy, Hector , Agarwal, Vikas , Gupta, Latika, Ravichandran, Naveen , Gupta, Latika , Naveen, R , Shinjo, Samuel Katsuyuki , Ziade, Nelly , Joshi, Mrudula , Velikova, Tsvetelina , Milchert, Marcin , Parodis, Ioannis , Gracia-Ramos, Abraham Edgar , Cavagna, Lorenzo , Kuwana, Masataka , Knitza, Johannes , Makol, Ashima , 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 , Shumnalieva, Russka , Chen, Yi-Ming , Hoff, Leonardo Santos , El Kibbi, Lina , Halabi, Hussein , 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 , Chatterjee, Tulika , Saavedra, Miguel A , Distler, Oliver , Chinoy, Hector , Agarwal, Vikas , Aggarwal, Rohit , Gupta, Latika , Agarwal, Vishwesh , Day, Jessica , Tan, Ai Lyn , Nune, Arvind , Sen, Parikshit , Saha, Sreoshy , Jagtap, Kshitij , De Angelis, Rossella , Singh, Yogesh Preet , Shinjo, Samuel Katsuyuki , Joshi, Mrudula , Gracia‐Ramos, Abraham Edgar , Torre, Ignacio García‐De La , Colunga-Pedraza, I. J. , Chen, Yi‐Ming , Chatterjee, Tulika , Distler, Oliver , Group, COVAD Study, Griger, Zoltán , Andréoli, Laura , Lini, Daniele , Schreiber, Karen , Pilania, Rakesh Kumar , Gupta, Vikas , Kavadichanda, Chengappa G. , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Pande, Arun K. , Chandwar, Kunal , Boro, Hiya , Cansu, Döndü Üsküdar , Gasparyan, Armen Yuri , Papa, Nicoletta Del , Sambataro, Gianluca , Govoni, Marcello , Parisi, Simone , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco, Quartuccio, Luca , Franceschini, Franco , Sainaghi, Pier Paolo , Venerito, Vincenzo , Giollo, Alessandro , Fornaro, Marco , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Loarce‐Martos, Jesus , Gonzalez, Raquel Aranega, Yoshida, Akira , Kimura, Naoki, Proft, Fabian Nikolai , Holzer, Marie‐Therese , Gromova, Margarita Aleksandrovna , Hmamouchi, Ihsane , Baba, Zineb, Giannini, Margherita , Maurier, F. , Campagne, Julien , Langguth, Daman , Needham, Merrilee , Srivastav, Nilesh , Arbeláez-Cortés, Álvaro , Cajas, Javier, Silva, José António Pereira, Fonseca, João Eurico , Zimba, Olena , Doskaliuk, Bohdana , Ima-Edomwonyi, Uyi, Emorinken, Airenakho , Olaosebikan, Hakeem , So, Ho , Ugarte‐Gil, Manuel F. , Mohammed, Reem Hamdy A , Harifi, Ghita , Fuentes-Silva, Yurilís , Salinas, Rodrigo Nicolás Garcia , Aggarwal, Rohit
Rheumatology | March 24, 2023 | Volume: 62 | Issue: 12 | Pages: 3838-3848
Abstract Objective Flares of autoimmune rheumatic diseases (AIRDs) following COVID-19 vaccination are a particular concern in vaccine-hesitant individuals. Therefore, we investigated the incidence, predictors and patterns of flares following vaccination in individuals living with AIRDs, using global COVID-19 Vaccination in Autoimmune Diseases (COVAD) surveys. Methods The COVAD surveys were used to extract data on flare demographics, comorbidities, COVID-19 history, and vaccination details for patients with AIRDs. Flares following vaccination were identified as patient-reported (a), increased immunosuppression (b), clinical exacerbations (c) and worsening of PROMIS scores (d). We studied flare characteristics and used regression models to differentiate flares among various AIRDs. Results Of 15 165 total responses, the incidence of flares in 3453 patients with AIRDs was 11.3%, 14.8%, 9.5% and 26.7% by definitions a–d, respectively. There was moderate agreement between patient-reported and immunosuppression-defined flares (K = 0.403, P = 0.022). Arthritis (61.6%) and fatigue (58.8%) were the most commonly reported symptoms. Self-reported flares were associated with higher comorbidities (P = 0.013), mental health disorders (MHDs) (P < 0.001) and autoimmune disease multimorbidity (AIDm) (P < 0.001). In regression analysis, the presence of AIDm [odds ratio (OR) = 1.4; 95% CI: 1.1, 1.7; P = 0.003), or a MHD (OR = 1.7; 95% CI: 1.1, 2.6; P = 0.007), or being a Moderna vaccine recipient (OR = 1.5; 95% CI: 1.09, 2.2; P = 0.014) were predictors of flares. Use of MMF (OR = 0.5; 95% CI: 0.3, 0.8; P = 0.009) and glucocorticoids (OR = 0.6; 95% CI: 0.5, 0.8; P = 0.003) were protective. A higher frequency of patients with AIRDs reported overall active disease post-vaccination compared with before vaccination (OR = 1.3; 95% CI: 1.1, 1.5; P < 0.001). Conclusion Flares occur in nearly 1 in 10 individuals with AIRDs after COVID vaccination; people with comorbidities (especially AIDm), MHDs and those receiving the Moderna vaccine are particularly vulnerable. Future avenues include exploring flare profiles and optimizing vaccine strategies for this group.
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 , Tan, Ai Lyn , Salim, Babur , Ziadé, Nelly , Velikova, Tsvetelina , Gracia‐Ramos, Abraham Edgar , Kuwana, Masataka , Chinoy, Hector , Tehozol, Erick Adrian Zamora , Torre, Ignacio García-De La, Group, COVAD Study, Singh, Yogesh Preet , Ranjan, Rajiv , Pandya, Sapan C , Sharma, Aman , Manoj, Manesh , Patro, Pradeepta Sekhar , Ajmani, Sajal , Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Pandey, Arun Kumar R, Kardeş, Sinan , Kim, Minchul , Pauling, John D , Wincup, Chris , Sambataro, Gianluca , Atzeni, Fabiola , Parisi, Simone , Bocci, Elena Bartoloni, Sainaghi, Pier Paolo , Orsolini, Giovanni , Angelis, Rossella De , Danielli, Maria Giovanna, Milchert, Marcin , Serrano, Jorge Rojas, Torre, Ignacio García-De La, Loarce‐Martos, Jesus , Prieto‐González, Sergio , Kuwana, Masataka, Nakashima, Ran , Sato, Shinji , Kimura, Naoki , Kaneko, Yuko , Tomaras, Stylianos, Aharonov, Or, Maurier, F. , Meyer, Alain , Nagy‐Vincze, Melinda , Limaye, Vidya, Needham, Merrilee , Srivastav, Nilesh , Hudson, Marie, Landon‐Cardinal, Océane , Shaharir, Syahrul Sazliyana , Zuleta, Wilmer Gerardo Rojas, Silva, José António Pereira, Gupta, Latika, Agarwal, Vikas , Parodis, Ioannis , Ravichandran, Naveen , Danieli, Maria Giovanna , Gupta, Latika , Naveen, R , Lilleker, James B , Tan, Ai Lyn , Ziade, Nelly , Gracia-Ramos, Abraham Edgar , Kuwana, Masataka , Day, Jessica , Distler, Oliver , Chinoy, Hector , Gupta, Latika , Parodis, Ioannis , Milchert, Marcin , Agarwal, Vikas , Joshi, Mrudula , Agarwal, Vishwesh , Salim, Babur , Velikova, Tsvetelina , Pauling, John D , Wincup, Chris , Zamora Tehozol, Erick Adrian , Sen, Parikshit , De Angelis, Rossella , Singh, Yogesh Preet , Day, Jessica , Makol, Ashima , Distler, Oliver , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Rojas Serrano, Jorge , Torre, Ignacio García-De La, Group, COVAD Study, Barman, Bhupen , Jain, Avinash , Pilania, Rakesh Kumar , Gupta, Vikas , Kavadichanda, Chengappa G. , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Chandwar, Kunal , Cansu, Döndü Üsküdar , Chatterjee, Tulika , Cavagna, Lorenzo , Papa, Nicoletta Del , Govoni, Marcello , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Venerito, Vincenzo , Serrano, Jorge Rojas, Torre, Ignacio García-De La, Gil‐Vila, Albert , Gonzalez, Raquel Aranega, Kuwana, Masataka, Yoshida, Akira, Knitza, Johannes , Tomaras, Stylianos , Gromova, Margarita Aleksandrovna , Gheita, Tamer A. , Hmamouchi, Ihsane , Hoff, Leonardo Santos , Giannini, Margherita , Campagne, Julien , Langguth, Daman , Limaye, Vidya , Silva, José António Pereira, Fonseca, João Eurico , Zimba, Olena , Aggarwal, Rohit
Rheumatology | November 21, 2022 | Volume: 62 | Issue: 7 | Pages: 2453-2463
Abstract 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.