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. 2022 Oct;66(4):426-437.
doi: 10.1002/mus.27681. Epub 2022 Aug 8.

COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies

Albert Gil-Vila  1 , Naveen Ravichandran  2 , Albert Selva-O'Callaghan  1 , Parikshit Sen  3 , Arvind Nune  4 , Prithvi Sanjeevkumar Gaur  5 , Raquel Arànega Gonzalez  6 , James B Lilleker  7   8 , Mrudula Joshi  9 , Vishwesh Agarwal  10 , Sinan Kardes  11 , Minchul Kim  12 , Jessica Day  13   14   15 , Ashima Makol  16 , Marcin Milchert  17 , Tamer Gheita  18 , Babur Salim  19 , Tsvetelina Velikova  20 , Abraham Edgar Gracia-Ramos  21 , Ioannis Parodis  22   23 , Elena Nikiphorou  24   25 , Ai Lyn Tan  26   27 , Tulika Chatterjee  12 , Lorenzo Cavagna  28   29 , Miguel A Saavedra  30 , Samuel Katsuyuki Shinjo  31 , Nelly Ziade  32   33 , Johannes Knitza  34 , Masataka Kuwana  35 , Oliver Distler  36 , Hector Chinoy  7   37   38 , Vikas Agarwal  2 , Rohit Aggarwal  39 , Latika Gupta  2   7   40   41 ; COVAD Study Group
Affiliations

COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies

Albert Gil-Vila et al. Muscle Nerve. 2022 Oct.

Abstract

Introduction/aims: In this study we investigated COVID-19 vaccination-related adverse events (ADEs) 7 days postvaccination in patients with idiopathic inflammatory myopathies (IIMs) and other systemic autoimmune and inflammatory disorders (SAIDs).

Methods: Seven-day vaccine ADEs were collected in an international patient self-reported e-survey. Descriptive statistics were obtained and multivariable regression was performed.

Results: Ten thousand nine hundred respondents were analyzed (1227 IIM cases, 4640 SAID cases, and 5033 healthy controls [HCs]; median age, 42 [interquartile range, 30-455] years; 74% female; 45% Caucasian; 69% completely vaccinated). Major ADEs were reported by 76.3% of the IIM patients and 4.6% reported major ADEs. Patients with active IIMs reported more frequent major (odds ratio [OR], 2.7; interquartile range [IQR], 1.04-7.3) and minor (OR, 1.5; IQR, 1.1-2.2) ADEs than patients with inactive IIMs. Rashes were more frequent in IIMs (OR, 2.3; IQR, 1.2-4.2) than HCs. ADEs were not impacted by steroid dose, although hydroxychloroquine and intravenous/subcutaneous immunoglobulins were associated with a higher risk of minor ADEs (OR, 1.9; IQR, 1.1-3.3; and OR, 2.2; IQR, 1.1-4.3, respectively). Overall, ADEs were less frequent in inclusion-body myositis (IBM) and BNT162b2 (Pfizer) vaccine recipients.

Discussion: Seven-day postvaccination ADEs were comparable in patients with IIMs, SAIDs, and HCs, except for a higher risk of rash in IIMs. Patients with dermatomyositis with active disease may be at higher risk, and IBM patients may be at lower risk of specific ADEs. Overall, the benefit of preventing severe COVID-19 through vaccination likely outweighs the risk of vaccine-related ADEs. Our results may inform future guidelines regarding COVID-19 vaccination in patients with SAIDs, specifically in those with IIMs. Studies to evaluate long-term outcomes and disease flares are needed to shed more light on developing future COVID-19 vaccination guidelines.

Keywords: COVID-19; dermatomyositis; myositis; rheumatology; vaccination.

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Conflict of interest statement

J.D. has received research funding from CSL, Ltd. A.L.T. has received honoraria for advisory boards and speaking for AbbVie, Gilead, Janssen, Lilly, Novartis, BNT162b2 (Pfizer), and UCB. E.N. has received speaker honoraria or participated on advisory boards for Celltrion, BNT162b2 (Pfizer), Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from BNT162b2 (Pfizer) and Lilly. H.C. has received grant support from Eli Lilly and UCB, consulting fees from Novartis, Eli Lilly, Orphazyme, and AstraZeneca, and speaker fees from UCB and Biogen. I.P. has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, and Hoffmann‐La Roche. N.Z. has received speaker fees, advisory board fees, and research grants from BNT162b2 (Pfizer), Roche, AbbVie, Eli Lilly, NewBridge, Sanofi‐Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre (none related to this work). O.D. has/had consultancy relationship with and/or has received research funding from or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the past 3 years: AbbVie, Acceleron, Alcimed, Amgen, AnaMar, Arxx, Baecon, Blade, Bayer, Boehringer Ingelheim, ChemomAb, Corbus, CSL Behring, Galapagos, Glenmark, GSK, Horizon (Curzion), Inventiva, iQvia, Kymera, Lupin, Medac, Medscape, Mitsubishi Tanabe, Novartis, Roche, Roivant, Sanofi, Serodapharm, Topadur, and UCB. O.D. has also issued a patent “mir‐29 for the Treatment of Systemic Sclerosis” (US8247389, EP2331143). R.A. has/had a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers‐Squibb, BNT162b2 (Pfizer), Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, AbbVie, Janssen, Alexion, Argenx, Q32, EMD‐Serono, Boehringer Ingelheim, and Roivant. The remaining authors declare no conflicts of interest.

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References

    1. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid‐19 vaccine. N Engl J Med. 2020;383:2603‐2615. doi: 10.1056/NEJMoa2034577. - DOI - PMC - PubMed
    1. Tariq J, Gupta L. Safety and efficacy of COVID‐19 vaccines in pregnant women with rheumatic diseases: an immunologic perspective. Rheumatol Int. 2021;41:1545‐1547. doi: 10.1007/s00296-021-04918-z. - DOI - PMC - PubMed
    1. Wack S, Patton T, Ferris LK. COVID‐19 vaccine safety and efficacy in patients with immune‐mediated inflammatory disease: review of available evidence. J Am Acad Dermatol. 2021;85:1274‐1284. doi: 10.1016/j.jaad.2021.07.054. - DOI - PMC - PubMed
    1. Sattui SE, Liew JW, Kennedy K, et al. Early experience of COVID‐19 vaccination in adults with systemic rheumatic diseases: results from the COVID‐19 Global Rheumatology Alliance Vaccine Survey. RMD Open. 2021;7:e001814. doi: 10.1136/rmdopen-2021-001814. - DOI - PMC - PubMed
    1. Medeiros‐Ribeiro AC, Aikawa NE, Saad CGS, et al. Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. Nat Med. 2021;27:1744‐1751. doi: 10.1038/s41591-021-01469-5. - DOI - PubMed

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