AB1312 MYOSITIS PATIENTS WITHOUT AUTOIMMUNE MULTIMORBIDITY AT LOWER RISK OF DELAYED ONSET COVID-19 VACCINE ADVERSE EVENTS THAN OTHER AUTOIMMUNE DISEASES: RESULTS FROM THE COVAD STUDY

Abstract

BackgroundLimited data on the delayed onset effects of COVID-19 vaccination in patients with idiopathic inflammatory myopathies (IIMs) continues to be a significant cause of hesitancy in this vulnerable group.ObjectivesTo analyze the delayed onset adverse events (ADEs) of COVID-19 vaccination in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the ongoing 2nd COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.MethodsA validated patient self-reporting e-survey was circulated by the international COVAD study group (157 collaborators, 106 countries) from Feb to June 2022, collecting respondent demographics, comorbidities, IIM/SAID details, COVID-19 infection history and outcomes, and vaccination details including ADEs. Delayed onset (> 7 day) ADEs (including minor and major ADEs and hospitalizations) were analyzed in patients with IIMs, SAIDs, and HCs, using various regression models.Results15,165 total respondents completed the survey, of whom 8759 complete responses from vaccinated individuals [median age 46 (35-58) years, 74.4% females, 45.4% Caucasians] were included in the analysis. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% were HCs.16.3% of IIMs patients reported minor ADEs, and 10.2% experienced major ADEs, and 2.9% required hospitalization. Patients with IIMs had a lower risk of minor ADEs than other SAIDs, though a higher risk of rashes compared to HCs [OR 4.0 (2.2-7.0), p<0.001]. In the IIMs subgroup, patients with active disease, overlap myositis, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients were at a higher risk of ADEs, while those with inclusion body myositis, and BNT162b2 (Pfizer) vaccine recipients were comparatively protected.Patients with IIMs with co-existing SAIDs were at a higher risk of minor [OR 5.2 (3.3-8.2), p<0.001] and major ADEs [OR 2.1 (1.2-3.8), p<0.05] compared to those with IIMs alone.ConclusionPatients with IIMs were at a lower risk of delayed onset COVID-19 vaccine ADEs compared to other SAIDs, though within this patient group, those with active disease, overlap myositis and autoimmune multimorbidity were vulnerable, and warrant close monitoring and long term follow up post COVID-19 vaccination.Reference[1]Furer V, Eviatar T, Zisman D, Peleg H, Paran D, Levartovsky D, et al. Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study. Ann Rheum Dis. 2021 Oct;80(10):1330–8.AcknowledgementsCOVAD Study Team.Disclosure of InterestsSyahrul Sazliyana Shaharir Speakers bureau: Pfizer, Novartis, Bohdana Doskaliuk: None declared, Naveen Ravichandran: None declared, Jessica Day Grant/research support from: CSL Limited, Parikshit Sen: None declared, Samuel Katsuyuki Shinjo: None declared, Mrudula Joshi: None declared, Nelly Ziade Speakers bureau: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre, Consultant of: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre, Grant/research support from: Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre, Tsvetelina Velikova Speakers bureau: Pfizer and AstraZeneca, Marcin Milchert: None declared, Sreoshy Saha: None declared, Johannes Knitza: None declared, Ashima Makol: None declared, Kshitij Jagtap: None declared, Vishwesh Agarwal: None declared, Dzifa Dey: None declared, Carlos Enrique Toro Gutierrez: None declared, Carlo Vinicio Caballero: None declared, Vikas Agarwal: None declared, Rohit Aggarwal Consultant of: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therapeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio., Grant/research support from: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therapeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio., Latika Gupta: None declared.