0177: COVID-19 Vaccination-related Short-term Adverse Events in Patients with Idiopathic Inflammatory Myositis and Autoimmune Multimorbidity: Results from the COVID-19 Vaccination in Autoimmune Diseases Survey

Mrinalini Dey¹, Naveen R², Elena Nikiphorou³, Parikshit Sen⁴, James B. Lilleker⁵, Vishwesh Agarwal⁶, Sinan Kardes⁷, Jessica Day⁸, Marcin Milchert⁹, Mrudula Joshi¹⁰, Tamer A Gheita¹¹, Babur Salim¹², Tsvetelina Velikova¹³, Abraham Edgar Gracia-Ramos¹⁴, Ioannis Parodis¹⁵, Albert Selva O’Callaghan¹⁶, Minchul Kim¹⁷, Tulika Chatterjee¹⁷, Ai Lyn Tan¹⁸, Ashima Makol¹⁹, Arvind Nune²⁰, Lorenzo Cavagna²¹, Miguel Angel Saavedra Salinas²², Samuel Shinjo²³, Nelly Ziade²⁴, Johannes Knitza²⁵, Masataka Kuwana²⁶, Oliver Distler²⁷, Hector Chinoy²⁸, John Pauling²⁹, Chris Wincup³⁰, Vikas Agarwal², Rohit Aggarwal³¹ and Latika Gupta³², ¹Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, United Kingdom, ²Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, ³Leiden University Medical Center & King's College London, London, United Kingdom, ⁴Maulana Azad Medical College, New Delhi, India, ⁵The University of Manchester, Manchester, United Kingdom, ⁶Mahatma Gandhi Missions Medical College, Lucknow, India, ⁷Istanbul University, Istanbul, Turkey, ⁸Walter and Eliza Hall Institute, Melbourne, Australia, ⁹Pomeranian Medical University in Szczecin, Szczecin, Poland, ¹⁰Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India, ¹¹Rheumatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt, ¹²Fauji foundation hospital Rawalpindi, Rawalpindi, Pakistan, ¹³Sofia University St. Kliment Ohridski, Sofia, Bulgaria, ¹⁴Instituto Mexicano del Seguro Social, Ciudad de México, Mexico, ¹⁵Karolinska Institutet, Stockholm, Sweden, ¹⁶Hospital Universitari Vall d'Hebron, Barcelona, Spain, ¹⁷University of Illinois College of Medicine Peoria, Peoria, IL, ¹⁸University of Leeds, Leeds, United Kingdom, ¹⁹Mayo Clinic, Rochester, MN, Rochester, MN, ²⁰Southport and Ormskirk Hospital NHS Trust, Southport, United Kingdom, ²¹Università di Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Pavia, Italy, ²²IMSS, Ciudad de México, Mexico, ²³Faculdade de Medicina FMUSP, Universidade de São Paulo, São Paulo, Brazil, ²⁴Saint-Joseph University, Beirut, Lebanon, ²⁵Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg and Universitätsklinikum Erlangen, 91054 Erlangen, Germany; Deutsches Zentrum Immuntherapie, Friedrich-Alexander-UniversityErlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany, ²⁶Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ²⁷Department of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland, ²⁸The University of Manchester, Sale, United Kingdom, ²⁹North Bristol NHS Trust, Bristol, United Kingdom, ³⁰Rayne Institute, University College London, London, United Kingdom, ³¹Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, ³²Royal Wolverhampton Trust, Wolverhampton/University of Manchester, United Kingdom

Background/Purpose: COVID-19 vaccines are safe and effective, though patients with rare rheumatic diseases like idiopathic inflammatory myositis (IIMs), and those with multiple comorbidities continue to be hesitant in taking the vaccine. Adverse events (AEs) after vaccination are not extensively studied in those with multiple coexisting autoimmune diseases. Patients with IIM often have multiple autoimmune rheumatic and autoimmune non-rheumatic comorbidities (IIM-AIDs), with potentially increased risk of AEs. The COVAD study aimed to assess COVID-19 vaccination-related adverse events (AEs) till seven days post-vaccination in IIM-AIDs compared to IIMs and healthy controls (HCs) group.

Methods: The COVAD study group comprised >110 collaborators across 94 countries. The study was conducted from March-December 2021. A survey monkey platform-based self-reported online survey captured data related to COVID-19 vaccination-related AEs in IIMs, AIDs, and HCs. IIM-AIDs patients comprised rheumatic AIDs like overlap syndromes, vasculitis, etc and non-rheumatic AIDs like inflammatory bowel disease, multiple sclerosis, hypothyroidism etc. We compared COVID-19 vaccination-related AEs among IIM-AID patients and IIM alone and HCs, adjusting for age, gender, ethnicity, COVID-19 vaccine type, immunosuppression received, and the numbers of AIDs, using binary logistic regression. Statistically significant results following multivariate regression are reported.

Results: Among 6099 participants, 1387 (22.7%) IIM, 4712 (77.2%) HC, 66.3% females, were included from a total of 18,882 respondents: 573 (41.0%) people with IIM-AIDs; 814 (59.0%) with IIM without other AIDs; and 4712 HCs (Figure 1). People with IIM were older [median age 54 (45-66) IIM-AIDs, 64 (50-73) IIM, 34 (26-47) HC years, p< 0.001]. BNT162b2 (Pfizer)(37.5%) and ChAdOx1 nCoV-19 (Oxford) (11.1%) were the most common vaccines received.

When compared to IIM alone patients, IIM-AID patients reported higher overall AEs [OR 1.5 (1.1-2.1)], minor AE [OR 1.5 (1.1-2.1)] and major AE [OR 3 (1.5-5.8)]. IIM-AIDs patients also reported higher body ache, nausea, headache, and fatigue (OR ranging 1.3-2.3, Table 2). After adjusting for the number of AIDs, the major AEs equalized but overall AEs, and minor AEs, such as fatigue remained higher in IIM-AIDs (Table 2).

When compared to HCs, IIM-AIDs patients reported similar overall AEs, minor AEs but higher major AEs [OR 2 (1.2-3.3)] nausea/vomiting [OR 1.4 (1.01-2)], headache [OR 1.2 (1.01-1.6)], and fatigue [OR 1.3 (1.03-1.6)].

Dermatomyositis (DM) patients with AIDs (n=183) reported higher major AEs [OR 4.3 (1.5-12)] compared to DM alone (n=293).

Active IIM with AIDs (n=482) reported higher overall AEs [OR 1.5 (1.1-2.2)], minor AEs [OR 1.5 (1.1-2.2)] and major AEs [OR 2.6 (1.2-5.2)] compared to active IIM alone (n=643).>

Conclusion: COVID-19 vaccination is safe with minimal to no risks of short-term AEs in patients with IIM without other concomitant autoimmune diseases. The presence of autoimmune multimorbidity conferred higher self-reported short-term risks of overall, major, and minor COVID-19 vaccination-related AEs seven days post-vaccination in IIM patients, particularly in those with active IIM.
Figure 1: Summary of respondents to COVAD survey

Table 1: Basic demographics and characteristics of cohort

Table 2. Comparison of vaccine related AE among IIM-AIDs and IIM alone
Disclosures: M. Dey, None; N. R, None; E. Nikiphorou, Pfizer, Celltrion, Sanofi, Gilead, Galapagos, AbbVie, Lilly, Fresenius; P. Sen, None; J. Lilleker, None; V. Agarwal, None; S. Kardes, None; J. Day, CSL; M. Milchert, None; M. Joshi, None; T. Gheita, None; B. Salim, None; T. Velikova, None; A. Gracia-Ramos, None; I. Parodis, GlaxoSmithKlein(GSK), Amgen, AstraZeneca, Aurinia Pharmaceuticals, Eli Lilly, Gilead, Janssen, Novartis, Roche; A. O’Callaghan, None; M. Kim, None; T. Chatterjee, None; A. Tan, None; A. Makol, Boehringer-Ingelheim; A. Nune, None; L. Cavagna, None; M. Saavedra Salinas, GlaxoSmithKlein(GSK), AbbVie/Abbott; S. Shinjo, None; N. Ziade, Pfizer, Roche, AbbVie/Abbott, Eli Lilly, Boehringer-Ingelheim, Janssen; J. Knitza, AbbVie, Novartis, ThermoFisher, UCB, ABATON, Sanofi, Medac, Lilly, BMS, Gilead, GSK, Werfen, Vila Health, Böhringer Ingelheim, Janssen, Galapagos, Chugai; M. Kuwana, Boehringer-Ingelheim, Ono pharmaceuticals, Mochida, AbbVie/Abbott, Astellas, Janssen, Bayer, Corbus, Horizon; O. Distler, AbbVie/Abbott, Amgen, GlaxoSmithKlein(GSK), Novartis, Roche, UCB, Kymera, Mitsubishi Tanabe, Boehringer Ingelheim, 4P-Pharma, Acceleron, Alcimed, Altavant Sciences, AnaMar, Arxx, AstraZeneca, Blade Therapeutics, Bayer, Corbus Pharmaceuticals, CSL Behring, Galapagos, Glenmark, Horizon, Inventiva, Lupin, Miltenyi Biotec, Merck/MSD, Prometheus Biosciences, Redx Pharma, Roivant, Sanofi, Topadur, Pfizer, Janssen, Medscape, Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143), FOREUM Foundation, ERS/EULAR Guidelines, EUSTAR, SCQM (Swiss Clinical Quality Management in Rheumatic Diseases), Swiss Academy of Medical Sciences (SAMW), Hartmann Müller Foundation; H. Chinoy, Eli Lilly, UCB; J. Pauling, None; C. Wincup, None; V. Agarwal, None; R. Aggarwal, Mallinckrodt, Bristol Myers Squibb, EMD Serono, Pfizer, Octapharma, CSL Behring, Q32, Kezar, AstraZeneca, Alexion, Argenx, Boehringer Ingelheim, Corbus, Janssen, Kyverna, Roivant, AbbVie, Jubilant, Orphazyme, Genentech; L. Gupta, None.