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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, Hector; Aggarwal, Rohit; Gupta, Latika; Agarwal, Vikas; Makol, Ashima.
  • Naveen R; Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
  • Thakare DR; Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
  • Kuwana M; Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
  • Pauling JD; Bristol Medical School Translational Health Sciences, University of Bristol, Bristol, UK.
  • Day J; Department of Rheumatology, North Bristol NHS Trust, Bristol, UK.
  • Joshi M; Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia.
  • Parodis I; Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, 3052, Australia.
  • Sen P; Department of Medical Biology, University of Melbourne, Parkville, VIC, 3052, Australia.
  • Jagtap K; Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
  • Nikiphorou E; Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
  • Saha S; Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
  • Agarwal V; Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India.
  • Chatterjee T; Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India.
  • Lilleker JB; Centre for Rheumatic Diseases, King's College London, London, UK.
  • Kardes S; Rheumatology Department, King's College Hospital, London, UK.
  • Milchert M; Mymensingh Medical College, Mymensingh, Bangladesh.
  • Gheita T; Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
  • Salim B; Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Peoria, IL, USA.
  • Velikova T; 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.
  • Gracia-Ramos AE; Neurology, Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK.
  • Tan AL; Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Capa-Fatih, 34093, Istanbul, Turkey.
  • Nune A; Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Ul Unii Lubelskiej 1, 71-252, Szczecin, Poland.
  • Cavagna L; Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
  • Saavedra MA; Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
  • Shinjo SK; Department of Clinical Immunology, Medical Faculty, University Hospital "Lozenetz", Sofia University St. Kliment Ohridski, 1 Kozyak Str, 1407, Sofia, Bulgaria.
  • Ziade N; 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.
  • Knitza J; NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK.
  • Distler O; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
  • Chinoy H; Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK.
  • Aggarwal R; Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli Studi di Pavia, Pavia, Lombardy, Italy.
  • Gupta L; Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.
  • Agarwal V; Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
  • Makol A; Rheumatology Department, Saint-Joseph University, Beirut, Lebanon.
Rheumatol Int ; 43(7): 1265-1275, 2023 07.
Article in English | MEDLINE | ID: covidwho-2273811
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Scleroderma, Systemic / Autoimmune Diseases / Rheumatic Diseases / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male Language: English Journal: Rheumatol Int Year: 2023 Document Type: Article Affiliation country: S00296-023-05310-9

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Scleroderma, Systemic / Autoimmune Diseases / Rheumatic Diseases / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Female / Humans / Male Language: English Journal: Rheumatol Int Year: 2023 Document Type: Article Affiliation country: S00296-023-05310-9