PMID- 37000295 OWN - NLM STAT- MEDLINE DCOM- 20230517 LR - 20240320 IS - 1437-160X (Electronic) IS - 0172-8172 (Print) IS - 0172-8172 (Linking) VI - 43 IP - 7 DP - 2023 Jul TI - Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey. PG - 1265-1275 LID - 10.1007/s00296-023-05310-9 [doi] AB - 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. CI - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. 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 - Thakare, Darpan R AU - Thakare DR AUID- ORCID: 0000-0002-6852-4869 AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. 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 - Pauling, John D AU - Pauling JD AUID- ORCID: 0000-0002-2793-2364 AD - Bristol Medical School Translational Health Sciences, University of Bristol, Bristol, UK. AD - Department of Rheumatology, North Bristol NHS Trust, Bristol, UK. FAU - Day, Jessica AU - Day J AUID- ORCID: 0000-0001-8528-4361 AD - Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia. AD - Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, 3052, Australia. AD - Department of Medical Biology, University of Melbourne, Parkville, VIC, 3052, Australia. 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 - 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 - Sen, Parikshit AU - Sen P AUID- ORCID: 0000-0002-1630-6026 AD - Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India. FAU - Jagtap, Kshitij AU - Jagtap K AUID- ORCID: 0000-0003-2729-737X AD - Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India. 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. FAU - Saha, Sreoshy AU - Saha S AUID- ORCID: 0000-0001-6745-9770 AD - Mymensingh Medical College, Mymensingh, Bangladesh. FAU - Agarwal, Vishwesh AU - Agarwal V AUID- ORCID: 0000-0002-0986-8354 AD - Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India. FAU - Chatterjee, Tulika AU - Chatterjee T AUID- ORCID: 0000-0001-8844-851X AD - Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Peoria, IL, USA. 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 - Kardes, Sinan AU - Kardes S AUID- ORCID: 0000-0002-6311-8634 AD - Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Capa-Fatih, 34093, Istanbul, Turkey. FAU - Milchert, Marcin AU - Milchert M AUID- ORCID: 0000-0002-0943-8768 AD - Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Ul Unii Lubelskiej 1, 71-252, Szczecin, Poland. FAU - Gheita, Tamer AU - Gheita T AUID- ORCID: 0000-0002-1155-9729 AD - Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt. FAU - Salim, Babur AU - Salim B AUID- ORCID: 0000-0001-8430-9299 AD - Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan. 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, 1 Kozyak Str, 1407, 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, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P. 02990, Mexico City, Mexico. 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, PR8 6PN, UK. FAU - Cavagna, Lorenzo AU - Cavagna L AUID- ORCID: 0000-0003-3292-1528 AD - Department of Rheumatology, Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy. AD - Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Universita degli Studi di Pavia, Pavia, Lombardy, Italy. 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 - 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 - 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 - Knitza, Johannes AU - Knitza J AUID- ORCID: 0000-0001-9695-0657 AD - Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitatsklinikum Erlangen, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Ulmenweg 18, 91054, Erlangen, Deutschland. 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. CN - COVAD Study Group 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 - 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. FAU - Agarwal, Vikas AU - Agarwal V AUID- ORCID: 0000-0002-4508-1233 AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. FAU - Makol, Ashima AU - Makol A AUID- ORCID: 0000-0002-8748-898X AD - Division of Rheumatology, Mayo Clinic, 200 1st St. SW, Rochester, MN, 55905, USA. Makol.ashima@mayo.edu. LA - eng GR - 21992/VAC_/Versus Arthritis/United Kingdom PT - Journal Article DEP - 20230331 PL - Germany TA - Rheumatol Int JT - Rheumatology international JID - 8206885 RN - 0 (COVID-19 Vaccines) RN - 0 (BNT162 Vaccine) SB - IM MH - Female MH - Humans MH - Adult MH - Male MH - COVID-19 Vaccines/adverse effects MH - BNT162 Vaccine MH - *COVID-19/prevention & control MH - *Autoimmune Diseases/epidemiology MH - *Scleroderma, Systemic MH - Vaccination/adverse effects MH - Self Report MH - Fatigue MH - *Rheumatic Diseases/drug therapy PMC - PMC10064600 OTO - NOTNLM OT - Adverse events OT - Autoimmune diseases OT - COVID-19 OT - Systemic sclerosis OT - Vaccination COIS- ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB. EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from Pfizer and Lilly. HC has received grant support from Eli Lilly and UCB, consulting fees from Novartis, Eli Lilly, Orphazyme, Astra Zeneca, speaker for UCB, and Biogen. IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG. JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript. JD has received research funding from CSL Limited. NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre; none are related to this manuscript. OD has/had consultancy relationship with and/or has received research funding from and/or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years: 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi and Topadur. Patent issued "mir-29 for the treatment of systemic sclerosis" (US8247389, EP2331143). RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio. Rest of the authors have no conflict of interest relevant to this manuscript. 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, Manesh Manoj IR - M MM 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 - Pande, Arunkumar R IR - Pande AR FIR - Chandwar, Kunal IR - Chandwar K FIR - Cansu, Dondu Uskudar IR - Cansu DU FIR - Pauling, John D IR - Pauling JD FIR - Wincup, Chris IR - Wincup C FIR - Makol, Ashima IR - Makol A 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 - Traboco, Lisa S IR - Traboco LS FIR - Wibowo, Suryo Anggoro Kusumo IR - Wibowo SAK FIR - Serrano, Jorge Rojas IR - Serrano JR FIR - La Torre, Ignacio Garcia-De IR - La Torre IG FIR - Tehozol, Erick Adrian Zamora IR - Tehozol EAZ FIR - Loarce-Martos, Jesus IR - Loarce-Martos J FIR - Prieto-Gonzalez, Sergio IR - Prieto-Gonzalez S FIR - Gonzalez, Raquel Aranega IR - Gonzalez RA 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 - Tomaras, Stylianos IR - Tomaras S FIR - Gromova, Margarita Aleksandrovna IR - Gromova MA FIR - Aharonov, Or IR - Aharonov O 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- 2023/04/01 06:00 MHDA- 2023/05/17 06:42 PMCR- 2023/03/31 CRDT- 2023/03/31 11:17 PHST- 2023/01/17 00:00 [received] PHST- 2023/03/07 00:00 [accepted] PHST- 2023/05/17 06:42 [medline] PHST- 2023/04/01 06:00 [pubmed] PHST- 2023/03/31 11:17 [entrez] PHST- 2023/03/31 00:00 [pmc-release] AID - 10.1007/s00296-023-05310-9 [pii] AID - 5310 [pii] AID - 10.1007/s00296-023-05310-9 [doi] PST - ppublish SO - Rheumatol Int. 2023 Jul;43(7):1265-1275. doi: 10.1007/s00296-023-05310-9. Epub 2023 Mar 31.