PMID- 36413073 OWN - NLM STAT- MEDLINE DCOM- 20230708 LR - 20240320 IS - 1462-0332 (Electronic) IS - 1462-0324 (Print) IS - 1462-0324 (Linking) VI - 62 IP - 7 DP - 2023 Jul 5 TI - Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study. PG - 2453-2463 LID - 10.1093/rheumatology/keac661 [doi] AB - 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. CI - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. FAU - Naveen, R AU - Naveen R AUID- ORCID: 0000-0003-2014-3925 AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. FAU - Nikiphorou, Elena AU - Nikiphorou E AD - Centre for Rheumatic Diseases, King's College London, London, UK. AD - Rheumatology Department, King's College Hospital, London, UK. FAU - Joshi, Mrudula AU - Joshi M AD - Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India. FAU - Sen, Parikshit AU - Sen P AD - Maulana Azad Medical College, New Delhi, Delhi, India. FAU - Lindblom, Julius AU - Lindblom J AD - Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. FAU - Agarwal, Vishwesh AU - Agarwal V AD - Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India. FAU - Lilleker, James B AU - Lilleker JB AUID- ORCID: 0000-0002-9230-4137 AD - Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK. AD - Neurology, Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK. FAU - Tan, Ai Lyn AU - Tan AL AUID- ORCID: 0000-0002-9158-7243 AD - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK. AD - Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. FAU - Salim, Babur AU - Salim B AD - Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan. FAU - Ziade, Nelly AU - Ziade N AUID- ORCID: 0000-0002-4479-7678 AD - Rheumatology Department, Saint-Joseph University, Beirut, Lebanon. AD - Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon. FAU - Velikova, Tsvetelina AU - Velikova T AD - Department of Clinical Immunology, Medical Faculty, University Hospital 'Lozenetz', Sofia University St. Kliment Ohridski, Sofia, Bulgaria. FAU - Gracia-Ramos, Abraham Edgar AU - Gracia-Ramos AE AUID- ORCID: 0000-0003-1842-2554 AD - Department of Internal Medicine, General Hospital, National Medical Center, 'La Raza', Instituto Mexicano del Seguro Social, Mexico City, Mexico. FAU - Kuwana, Masataka AU - Kuwana M AUID- ORCID: 0000-0001-8352-6136 AD - Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan. FAU - Day, Jessica AU - Day J AUID- ORCID: 0000-0001-8528-4361 AD - Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, Australia. AD - Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia. AD - Department of Medical Biology, University of Melbourne, Parkville, VIC, Australia. FAU - Makol, Ashima AU - Makol A AD - Division of Rheumatology, Mayo Clinic, Rochester, MN, USA. FAU - Distler, Oliver AU - Distler O AUID- ORCID: 0000-0002-0546-8310 AD - Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland. FAU - Chinoy, Hector AU - Chinoy H AUID- ORCID: 0000-0001-6492-1288 AD - Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK. AD - National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, The University of Manchester, Manchester, UK. AD - Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK. FAU - Traboco, Lisa S AU - Traboco LS AD - Department of Medicine, Section of Rheumatology, St. Luke's Medical Center-Global City, Taguig, Philippines. FAU - Wibowo, Suryo Anggoro Kusumo AU - Wibowo SAK AD - Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia/Dr Cipto Mangunkusumo General Hospital, Jakarta, Indonesia. FAU - Tehozol, Erick Adrian Zamora AU - Tehozol EAZ AD - Autoimmunity Division, Centro Medico Pensiones, Merida, Yucatan, Mexico. FAU - Serrano, Jorge Rojas AU - Serrano JR AD - Rheumatologist and Clinical Investigator, Interstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico. FAU - Garcia-De La Torre, Ignacio AU - Garcia-De La Torre I AD - Departamento de Inmunologia y Reumatologia, Hospital General de Occidente and University of Guadalajara, Guadalajara, Jalisco, Mexico. CN - COVAD Study Group FAU - Aggarwal, Rohit AU - Aggarwal R AD - Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. FAU - Gupta, Latika AU - Gupta L AUID- ORCID: 0000-0003-2753-2990 AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. AD - Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK. AD - Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK. AD - City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK. FAU - Agarwal, Vikas AU - Agarwal V AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. FAU - Parodis, Ioannis AU - Parodis I AUID- ORCID: 0000-0002-4875-5395 AD - Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. AD - Department of Rheumatology, Faculty of Medicine and Health, Orebro University, Orebro, Sweden. LA - eng GR - 21992/VAC_/Versus Arthritis/United Kingdom PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - Rheumatology (Oxford) JT - Rheumatology (Oxford, England) JID - 100883501 RN - 0 (COVID-19 Vaccines) RN - 0 (Vaccines) SB - IM MH - Adult MH - Female MH - Humans MH - Male MH - *Autoimmune Diseases MH - Chills MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - *Exanthema MH - *Lupus Erythematosus, Systemic MH - SARS-CoV-2 MH - Vaccination/adverse effects MH - *Vaccines PMC - PMC10321116 OTO - NOTNLM OT - COVID-19 OT - adverse events OT - rheumatology OT - systemic lupus erythematosus OT - vaccine FIR - Barman, Bhupen IR - Barman B FIR - Singh, Yogesh Preet IR - Singh YP FIR - Ranjan, Rajiv IR - Ranjan R FIR - Jain, Avinash IR - Jain A FIR - Pandya, Sapan C IR - Pandya SC FIR - Pilania, Rakesh Kumar IR - Pilania RK FIR - Sharma, Aman IR - Sharma A FIR - Manesh Manoj, M IR - Manesh Manoj M FIR - Gupta, Vikas IR - Gupta V FIR - Kavadichanda, Chengappa G IR - Kavadichanda CG FIR - Patro, Pradeepta Sekhar IR - Patro PS FIR - Ajmani, Sajal IR - Ajmani S FIR - Phatak, Sanat IR - Phatak S FIR - Goswami, Rudra Prosad IR - Goswami RP FIR - Chowdhury, Abhra Chandra IR - Chowdhury AC FIR - Mathew, Ashish Jacob IR - Mathew AJ FIR - Shenoy, Padnamabha IR - Shenoy P FIR - Asranna, Ajay IR - Asranna A FIR - Bommakanti, Keerthi Talari IR - Bommakanti KT FIR - Shukla, Anuj IR - Shukla A FIR - Pandey, Arun Kumar R IR - Pandey AKR FIR - Chandwar, Kunal IR - Chandwar K FIR - Kardes, Sinan IR - Kardes S FIR - Cansu, Dondu Uskudar IR - Cansu DU FIR - Kim, Minchul IR - Kim M FIR - Makol, Ashima IR - Makol A FIR - Chatterjee, Tulika IR - Chatterjee T FIR - Pauling, John D IR - Pauling JD FIR - Wincup, Chris IR - Wincup C FIR - Cavagna, Lorenzo IR - Cavagna L FIR - Del Papa, Nicoletta IR - Del Papa N FIR - Sambataro, Gianluca IR - Sambataro G FIR - Fabiola, Atzeni IR - Fabiola A FIR - Govoni, Marcello IR - Govoni M FIR - Parisi, Simone IR - Parisi S FIR - Bocci, Elena Bartoloni IR - Bocci EB FIR - Sebastiani, Gian Domenico IR - Sebastiani GD FIR - Fusaro, Enrico IR - Fusaro E FIR - Sebastiani, Marco IR - Sebastiani M FIR - Quartuccio, Luca IR - Quartuccio L FIR - Franceschini, Franco IR - Franceschini F FIR - Sainaghi, Pier Paolo IR - Sainaghi PP FIR - Orsolini, Giovanni IR - Orsolini G FIR - De Angelis, Rossella IR - De Angelis R FIR - Danielli, Maria Giovanna IR - Danielli MG FIR - Venerito, Vincenzo IR - Venerito V FIR - Milchert, Marcin IR - Milchert M FIR - Traboco, Lisa S IR - Traboco LS FIR - Wibowo, Suryo Anggoro Kusumo IR - Wibowo SAK FIR - Tehozol, Erick Adrian Zamora IR - Tehozol EAZ FIR - Serrano, Jorge Rojas IR - Serrano JR FIR - Garcia-De La Torre, Ignacio IR - Garcia-De La Torre I FIR - Loarce-Martos, Jesus IR - Loarce-Martos J FIR - Prieto-Gonzalez, Sergio IR - Prieto-Gonzalez S FIR - Gil-Vila, Albert IR - Gil-Vila A FIR - Gonzalez, Raquel Aranega IR - Gonzalez RA FIR - Kuwana, Masataka IR - Kuwana M FIR - Yoshida, Akira IR - Yoshida A FIR - Nakashima, Ran IR - Nakashima R FIR - Sato, Shinji IR - Sato S FIR - Kimura, Naoki IR - Kimura N FIR - Kaneko, Yuko IR - Kaneko Y FIR - Knitza, Johannes IR - Knitza J FIR - Tomaras, Stylianos IR - Tomaras S FIR - Gromova, Margarita Aleksandrovna IR - Gromova MA FIR - Aharonov, Or IR - Aharonov O FIR - Gheita, Tamer A IR - Gheita TA FIR - Hmamouchi, Ihsane IR - Hmamouchi I FIR - Hoff, Leonardo Santos IR - Hoff LS FIR - Giannini, Margherita IR - Giannini M FIR - Maurier, Francois IR - Maurier F FIR - Campagne, Julien IR - Campagne J FIR - Meyer, Alain IR - Meyer A FIR - Nagy-Vincze, Melinda IR - Nagy-Vincze M FIR - Langguth, Daman IR - Langguth D FIR - Limaye, Vidya IR - Limaye V FIR - Needham, Merrilee IR - Needham M FIR - Srivastav, Nilesh IR - Srivastav N FIR - Hudson, Marie IR - Hudson M FIR - Landon-Cardinal, Oceane IR - Landon-Cardinal O FIR - Shaharir, Syahrul Sazliyana IR - Shaharir SS FIR - Zuleta, Wilmer Gerardo Rojas IR - Zuleta WGR FIR - Silva, Jose Antonio Pereira IR - Silva JAP FIR - Fonseca, Joao Eurico IR - Fonseca JE FIR - Zimba, Olena IR - Zimba O EDAT- 2022/11/23 06:00 MHDA- 2023/07/07 06:42 PMCR- 2022/11/22 CRDT- 2022/11/22 09:23 PHST- 2022/09/16 00:00 [received] PHST- 2022/11/10 00:00 [accepted] PHST- 2023/07/07 06:42 [medline] PHST- 2022/11/23 06:00 [pubmed] PHST- 2022/11/22 09:23 [entrez] PHST- 2022/11/22 00:00 [pmc-release] AID - 6839954 [pii] AID - keac661 [pii] AID - 10.1093/rheumatology/keac661 [doi] PST - ppublish SO - Rheumatology (Oxford). 2023 Jul 5;62(7):2453-2463. doi: 10.1093/rheumatology/keac661.