PMID- 36315075 OWN - NLM STAT- MEDLINE DCOM- 20230708 LR - 20240320 IS - 1462-0332 (Electronic) IS - 1462-0324 (Linking) VI - 62 IP - 7 DP - 2023 Jul 5 TI - COVID-19 vaccination in autoimmune diseases (COVAD) study: vaccine safety and tolerance in rheumatoid arthritis. PG - 2366-2376 LID - 10.1093/rheumatology/keac624 [doi] AB - OBJECTIVES: The COVID-19 vaccination in autoimmune diseases (COVAD) study aimed to assess short-term COVID-19 vaccination-related adverse events (AEs) in RA patients. METHODS: An online self-reported questionnaire (March-December 2021) was used to capture data related to COVID-19 vaccination-related AEs in RA, other autoimmune rheumatic diseases (AIRDs) (excluding RA and inflammatory myositis), non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs). Descriptive and multivariable regression analyses were performed. RESULTS: Of the 9462 complete respondents, 14.2% (n = 1347) had been diagnosed with RA; they had a mean (s.d.) age of 50.7 (13.7) years, 74.2% were women and 49.3% were Caucasian. In total, 76.9% and 4.2% of patients with RA reported minor and major AEs, respectively. Patients with active and inactive RA had similar AE and hospitalization frequencies. Overall, AEs were reported more frequently by BNT162b2 and mRNA-1273 recipients and less frequently by BBV152 recipients compared with the rest. Major AE and hospitalization frequencies were similar across recipients of different vaccines. Patients receiving methotrexate and hydroxychloroquine reported fewer minor AEs than those patients not on them. Compared with HCs and patients with other AIRDs, patients with RA reported similar total AEs, overall minor AEs, and hospitalizations. Compared with nrAIDs, patients with RA reported lower frequencies of overall AEs, minor AEs (both odds ratio [OR] = 0.7; 95% CI: 0.5, 0.9), and injection site pain (OR = 0.6; 95% CI: 0.5, 0.8) with similar major AE and hospitalization frequencies. CONCLUSION: Despite the differences in AE frequency across different COVID-19 vaccines, all were well tolerated in patients with RA and were comparable to HCs, providing reassurance as to the safety of COVID-19 vaccination. CI - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 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 - 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. FAU - Joshi, Mrudula AU - Joshi M AUID- ORCID: 0000-0001-7312-351X AD - Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India. FAU - Sen, Parikshit AU - Sen P AUID- ORCID: 0000-0002-1630-6026 AD - Maulana Azad Medical College, New 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 AUID- ORCID: 0000-0002-0986-8354 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 - Nune, Arvind AU - Nune A AUID- ORCID: 0000-0002-3849-614X AD - Southport and Ormskirk Hospital NHS Trust, Southport, UK. FAU - Shinjo, Samuel Katsuyuki AU - Shinjo SK AUID- ORCID: 0000-0002-3682-4517 AD - Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Salim, Babur AU - Salim B AUID- ORCID: 0000-0001-8430-9299 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 AUID- ORCID: 0000-0002-0593-1272 AD - Department of Clinical Immunology, Medical Faculty, University Hospital 'Lozenetz', Sofia University St. Kliment Ohridski, Sofia, Bulgaria. FAU - Edgar Gracia-Ramos, Abraham AU - Edgar Gracia-Ramos A 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 - Saavedra, Miguel A AU - Saavedra MA AUID- ORCID: 0000-0003-0687-9944 AD - Departamento de Reumatologia Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Medico Nacional La Raza, IMSS, Mexico City, Mexico. 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 AUID- ORCID: 0000-0002-8748-898X 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 - Agarwal, Vikas AU - Agarwal V AUID- ORCID: 0000-0002-2089-027X AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. FAU - Aggarwal, Rohit AU - Aggarwal R AUID- ORCID: 0000-0001-7531-8038 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 Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK. AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. AD - City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK. 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. FAU - Nikiphorou, Elena AU - Nikiphorou E AUID- ORCID: 0000-0001-6847-3726 AD - Centre for Rheumatic Diseases, King's College London, London, UK. AD - Rheumatology Department, King's College Hospital, London, UK. CN - COVAD Study Group 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 - 76JZE5DSN6 (BBV152 COVID-19 vaccine) RN - 0 (BNT162 Vaccine) RN - 0 (COVID-19 Vaccines) SB - IM MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Arthritis, Rheumatoid/drug therapy MH - *Autoimmune Diseases/epidemiology MH - BNT162 Vaccine MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - *Rheumatic Diseases MH - Vaccination/adverse effects OTO - NOTNLM OT - Adverse effects OT - COVID-19 OT - RA OT - autoimmune diseases OT - vaccination 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 - M, Manoj IR - M 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, Dr Marcin IR - Milchert DM 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 - De La Torre, Ignacio Garcia IR - De La Torre IG 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- 2022/11/01 06:00 MHDA- 2023/07/07 06:42 CRDT- 2022/10/31 11:13 PHST- 2022/09/09 00:00 [received] PHST- 2022/10/13 00:00 [accepted] PHST- 2023/07/07 06:42 [medline] PHST- 2022/11/01 06:00 [pubmed] PHST- 2022/10/31 11:13 [entrez] AID - 6782953 [pii] AID - 10.1093/rheumatology/keac624 [doi] PST - ppublish SO - Rheumatology (Oxford). 2023 Jul 5;62(7):2366-2376. doi: 10.1093/rheumatology/keac624.