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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.
Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey
R. Naveen;Darpan R. Thakare;Masataka Kuwana;John D. Pauling;Jessica Day;Mrudula Joshi;Ioannis Parodis;Parikshit Sen;Kshitij Jagtap;Elena Nikiphorou;Sreoshy Saha;Vishwesh Agarwal;Tulika Chatterjee;James B. Lilleker;Sinan Kardes;Marcin Milchert;Tamer Gheita;Babur Salim;Tsvetelina Velikova;Abraham Edgar Gracia‑Ramos;Ai Lyn Tan;Arvind Nune;Lorenzo Cavagna;Miguel A. Saavedra;Samuel Katsuyuki Shinjo;Nelly Ziade;Johannes Knitza;Oliver Distler;Hector Chinoy;COVAD Study Group authors: Bhupen Barman;Yogesh Preet Singh;Rajiv Ranjan;Avinash Jain;Sapan C Pandya;Rakesh Kumar Pilania;Aman Sharma;Manesh Manoj M;Vikas Gupta;Chengappa G Kavadichanda;Pradeepta Sekhar Patro;Sajal Ajmani;Sanat Phatak;Rudra Prosad Goswami;Abhra Chandra Chowdhury;Ashish Jacob Mathew;Padnamabha Shenoy;Ajay Asranna;Keerthi Talari Bommakanti;Anuj Shukla;Arunkumar R Pande;Kunal Chandwar;Döndü Üsküdar Cansu;John D Pauling;Chris Wincup;Ashima Makol;Nicoletta Del Papa;Gianluca Sambataro;Atzeni Fabiola;Marcello Govoni;Simone Parisi;Elena Bartoloni Bocci;Gian Domenico Sebastiani;Enrico Fusaro;Marco Sebastiani;Luca Quartuccio;Franco Franceschini;Pier Paolo Sainaghi;Giovanni Orsolini;Rossella De Angelis;Maria Giovanna Danielli;Vincenzo Venerito;Lisa S Traboco;Suryo Anggoro Kusumo Wibowo;Jorge Rojas Serrano;Ignacio García-De La Torre;Erick Adrian Zamora Tehozol;Jesús Loarce-Martos;Sergio Prieto-González;Raquel Aranega Gonzalez;Akira Yoshida;Ran Nakashima;Shinji Sato;Naoki Kimura;Yuko Kaneko;Stylianos Tomaras;Margarita Aleksandrovna Gromova;Or Aharonov;Ihsane Hmamouchi;Leonardo Santos Hoff;Margherita Giannini;François Maurier;Julien Campagne;Alain Meyer;Melinda Nagy-Vincze;Daman Langguth;Vidya Limaye;Merrilee Needham;Nilesh Srivastav;Marie Hudson;Océane Landon-Cardinal;Syahrul Sazliyana Shaharir;Wilmer Gerardo Rojas Zuleta;José António Pereira Silva;João Eurico Fonseca;Olena Zimba;Rohit Aggarwal;Latika Gupta;Vikas Agarwal;Ashima Makol.
2023-01-01
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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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11379/573365
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.