Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb–June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35–58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2–7.0, p < 0.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period.
Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study / Doskaliuk, Bohdana; Ravichandran, Naveen; Sen, Parikshit; Day, Jessica; Joshi, Mrudula; Nune, Arvind; Nikiphorou, Elena; Saha, Sreoshy; Lyn Tan, Ai; Katsuyuki Shinjo, Samuel; Ziade, Nelly; Velikova, Tsvetelina; Milchert, Marcin; Jagtap, Kshitij; Parodis, Ioannis; Edgar Gracia-Ramos, Abraham; Cavagna, Lorenzo; Kuwana, Masataka; Knitza, Johannes; Ming Chen, Yi; Makol, Ashima; Agarwal, Vishwesh; Patel, Aarat; D Pauling, John; Wincup, Chris; Barman, Bhupen; Adrian Zamora Tehozol, Erick; Rojas Serrano, Jorge; García-De La Torre, Ignacio; J Colunga-Pedraza, Iris; Merayo-Chalico, Javier; Celestine Chibuzo, Okwara; Katchamart, Wanruchada; Akarawatcharangura Goo, Phonpen; Shumnalieva, Russka; Santos Hoff, Leonardo; El Kibbi, Lina; Halabi, Hussein; Vaidya, Binit; Sazliyana Shaharir, Syahrul; M Tanveer Hasan, A T; Dey, Dzifa; Enrique Toro Gutiérrez, Carlos; V Caballero-Uribe, Carlo; B Lilleker, James; Salim, Babur; Gheita, Tamer; Chatterjee, Tulika; Distler, Oliver; A Saavedra, Miguel; Chinoy, Hector; Agarwal, Vikas; Aggarwal, Rohit; Gupta, Latika; Study Group, Covad; Kardes, Sinan; Andreoli, Laura; Lini, Daniele; Schreiber, Karen; Nagy Vince, Melinda; Preet Singh, Yogesh; Ranjan, Rajiv; Jain, Avinash; C Pandya, Sapan; Kumar Pilania, Rakesh; Sharma, Aman; M, Manesh Manoj; Gupta, Vikas; G Kavadichanda, Chengappa; Sekhar Patro, Pradeepta; Ajmani, Sajal; Phatak, Sanat; Prosad Goswami, Rudra; Chandra Chowdhury, Abhra; Jacob Mathew, Ashish; Shenoy, Padnamabha; Asranna, Ajay; Talari Bommakanti, Keerthi; Shukla, Anuj; R Pande, Arunkumar; Chandwar, Kunal; Ghodke, Akanksha; Boro, Hiya; Zahid Fazal, Zoha; Üsküdar Cansu, Döndü; Yıldırım, Reşit; Yuri Gasparyan, Armen; Del Papa, Nicoletta; Sambataro, Gianluca; Fabiola, Atzeni; Govoni Simone Parisi, Marcello; Bartoloni Bocci, Elena; Domenico Sebastiani, Gian; Fusaro, Enrico; Sebastiani Luca Quartuccio, Marco; Franceschini, Franco; Paolo Sainaghi Giovanni Orsolini, Pier; De Angelis, Rossella; Venerito, Vincenzo; Grignaschi, Silvia; Giollo, Alessandro; Alluno, Alessia; Ioannone, Florenzo; Fornaro, Marco; S Traboco, Lisa; Anggoro Kusumo Wibowo, Suryo; Loarce-Martos, Jesús; Prieto-González, Sergio; Aranega Gonzalez, Raquel; Yoshida, Akira; Nakashima, Ran; Sato, Shinji; Kimura, Naoki; Kaneko, Yuko; Gono, Takahisa; Tomaras, Stylianos; Nikolai Proft, Fabian; Holzer, Marie-Therese; Aleksandrovna Gromova, Margarita; Aharonov, Or; Griger, Zoltán; Hmamouchi, Ihsane; El Bouchti, Imane; Baba, Zineb; Giannini, Margherita; Maurier, François; Campagne, Julien; Meyer, Alain; Langguth, Daman; Limaye, Vidya; Needham, Merrilee; Srivastav, Nilesh; Hudson Océane Landon-Cardinal, Marie; Gerardo Rojas Zuleta, Wilmer; Arbeláez Javier Cajas, Álvaro; António Pereira Silva, José; Eurico Fonseca, João; Zimba Doskaliuk Bohdana, Olena; Ima-Edomwonyi, Uyi; Dedeke, Ibukunoluwa; Airenakho, Emorinken; Henry Madu, Nwankwo; Yerima, Abubakar; Olaosebikan, Hakeem; A, Becky; Devi Koussougbo, Oruma; Palalane, Elisa; So, Ho; Francisco Ugarte-Gil, Manuel; Chinchay, Lyn; Proaño Bernaola, José; Pimentel, Victorio; Mohammed Fathi, Hanan; A Mohammed, Reem Hamdy; Harifi, Ghita; Fuentes-Silva Karoll Cabriza, Yurilís; Losanto, Jonathan; Colaman, Nelly; Cachafeiro-Vilar, Antonio; Guerra Bautista, Generoso; Julio Giraldo Ho, Enrique; Stange Nunez, Lilith; M, Cristian Vergara; Then Báez, Jossiell; Alonzo, Hugo; Benito Santiago Pastelin, Carlos; García Salinas, Rodrigo; Quiñónez Obiols, Alejandro; Chávez, Nilmo; Bran Ordóñez, Andrea; Alberto Reyes Llerena, Gil; Sierra-Zorita, Radames; Arrieta, Dina; Romero Hidalgo, Eduardo; Saenz, Ricardo; M, Idania Escalante; Calapaqui, Wendy; Quezada, Ivonne; Arredondo, Gabriela. - In: RHEUMATOLOGY INTERNATIONAL. - ISSN 1437-160X. - 43:9(2023), pp. 1651-1664. [10.1007/s00296-023-05345-y]
Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study
Rossella De AngelisMembro del Collaboration Group
;
2023-01-01
Abstract
Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb–June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35–58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2–7.0, p < 0.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period.| File | Dimensione | Formato | |
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