Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study

Doskaliuk B, Ravichandran N, Sen P, Day J, Joshi M, Nune A, Nikiphorou E, Saha S, Tan AL, Shinjo SK, Ziade N, Velikova T, Milchert M, Jagtap K, Parodis I, Gracia-Ramos AE, Cavagna L, Kuwana M, Knitza J, Chen YM, Makol A, Agarwal V, Patel A, Pauling JD, Wincup C, Barman B, Tehozol EAZ, Serrano JR, La Torre IGD, Colunga-Pedraza IJ, Merayo-Chalico J, Chibuzo OC, Katchamart W, Goo PA, Shumnalieva R, Hoff LS, Kibbi LE, Halabi H, Vaidya B, Shaharir SS, Hasan AT, Dey D, Gutiérrez CET, Caballero-Uribe CV, Lilleker JB, Salim B, Gheita T, Chatterjee T, Distler O, Saavedra MA, Kardes S, Andreoli L, Lini D, Schreiber K, Vince MN, Singh YP, Ranjan R, Jain A, Pandya SC, Pilania RK, Sharma A, Manesh Manoj M, Gupta V, Kavadichanda CG, Patro PS, Ajmani S, Phatak S, Goswami RP, Chowdhury AC, Mathew AJ, Shenoy P, Asranna A, Bommakanti KT, Shukla A, Pande AR, Chandwar K, Ghodke A, Boro H, Fazal ZZ, Cansu DÜ, Yıldırım R, Del PapaSambataro AYGNG, Fabiola A, Parisi MGS, Bocci EB, Sebastiani GD, Fusaro E, Quartuccio MSL, Franceschini F, Orsolini PPSG, De AngelisVenerito RMGDV, Grignaschi S, Giollo A, Alluno A, Ioannone F, Fornaro M, Traboco LS, Wibowo SAK, Loarce-Martos J, Prieto-González S, Gonzalez RA, Yoshida A, Nakashima R, Sato S, Kimura N, Kaneko Y, Gono T, Tomaras S, Proft FN, Holzer MT, Gromova MA, Aharonov O, Griger Z, Hmamouchi I, bouchti IE, Baba Z, Giannini M, Maurier F, Campagne J, Meyer A, Langguth D, Limaye V, Needham M, Srivastav N, Landon-Cardinal MHO, Zuleta WGR, Cajas ÁAJ, Silva JAP, Fonseca JE, Bohdana OZD, Ima-Edomwonyi U, Dedeke I, Airenakho E, Madu NH, Yerima A, Olaosebikan H, Becky A, Koussougbo OD, Palalane E, So H, Ugarte-Gil MF, Chinchay L, Bernaola JP, Pimentel V, Fathi HM, Mohammed RHA, Harifi G, Cabriza YFSK, Losanto J, Colaman N, Cachafeiro-Vilar A, Bautista GG, Ho EJG, Nunez LS, Cristian Vergara M, Báez JT, Alonzo H, Pastelin CBS, Salinas RG, Obiols AQ, Chávez N, Ordóñez AB, Llerena GAR, Sierra-Zorita R, Arrieta D, Hidalgo ER, Saenz R, Idania Escalante M, Calapaqui W, Quezada I, Arredondo G, Chinoy H, Agarwal V, Aggarwal R, Gupta L (2023)

Publication Type: Journal article

Publication year: 2023

Journal

DOI: 10.1007/s00296-023-05345-y

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.

Authors with CRIS profile

Involved external institutions

Ivano-Frankivsk National Medical University (IFNMU) / Івано-Франківський національний медичний університет Ukraine (UA) Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) India (IN) Maulana Azad Medical College (MAMC) India (IN) Royal Melbourne Hospital (RMH) Australia (AU) Byramjee Jeejeebhoy Government Medical College & Sassoon General Hospital India (IN) Southport and Ormskirk Hospital NHS Trust United Kingdom (GB) King’s College London United Kingdom (GB) Mymensingh Medical College / ময়মনসিংহ মেডিকেল কলেজ Bangladesh (BD) NIHR Leeds Musculoskeletal Biomedical Research Unit (LMBRU) United Kingdom (GB) University of São Paulo / Universidade de São Paulo (USP) Brazil (BR) Université Saint-Joseph (USJ) / جامعة القديس يوسف / Սուրբ Ժոզեֆի համալսարան Lebanon (LB) Sofia University "St. Kliment Ohridski" / Софийски университет "Св. Климент Охридски" Bulgaria (BG) Pomeranian Medical University / Pomorski Uniwersytet Medyczny w Szczecinie (PMU) Poland (PL) King Edward Memorial Hospital and Seth G.S. Medical College / கிங் எட்வர்ட் நினைவு மருத்துவமனை,राजा एड्वर्ड स्मारक रुग्णालय व सेठ गोवर्धनदास सुंदरदास वैद्यकीय महाविद्यालय India (IN) Karolinska University Hospital / Karolinska Universitetssjukhuset Sweden (SE) Instituto Mexicano del Seguro Social Mexico (MX) Università degli Studi di Pavia Italy (IT) Taichung Veterans General Hospital Taiwan (TW) Mayo Clinic United States (USA) (US) Mahatma Gandhi Mission Medical College and Hospital India (IN) University of Virginia (UVA) United States (USA) (US) University of Bristol United Kingdom (GB) University College London (UCL) United Kingdom (GB) Instituto Nacional de Enfermedades Respiratorias Mexico (MX) Hospital General de Occidente (HGO) Mexico (MX) Hospital Universitario Dr José Eleuterio Gonzalez Mexico (MX) Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Mexico (MX) University of Nigeria Nigeria (NG) Siriraj Hospital Thailand (TH) Queen Savang Vadhana Memorial Hospital / โรงพยาบาลสมเด็จพระบรมราชเทวี ณ ศรีราชา Thailand (TH) University Hospital St. Ivan Rilski Bulgaria (BG) Universidade Potiguar (UnP) Brazil (BR) King Faisal Specialist Hospital & Research Centre Saudi Arabia (SA) National Center for Rheumatic Diseases (NCRD) Nepal (NP) University of Malaya (UM) / Universiti Malaya Malaysia (MY) Enam Medical College & Hospital (EMCH) / এনাম মেডিকেল কলেজ ও হাসপাতাল Bangladesh (BD) University of Ghana Ghana (GH) Pontifical Xavierian University / Pontificia Universidad Javeriana Colombia (CO) Universidad del Norte Colombia (CO) University of Manchester United Kingdom (GB) Fauji Foundation Hospital Pakistan (PK) University of Illinois at Chicago United States (USA) (US) Universitätsspital Zürich (USZ) Switzerland (CH) Centro Medico Nacional Siglo XXI Mexico (MX) University of Pittsburgh United States (USA) (US)

How to cite

APA:

Doskaliuk, B., Ravichandran, N., Sen, P., Day, J., Joshi, M., Nune, A.,... Gupta, L. (2023). Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study. Rheumatology International. https://dx.doi.org/10.1007/s00296-023-05345-y

MLA:

Doskaliuk, Bohdana, et al. "Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study." Rheumatology International (2023).

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