POS1212 SARS-CoV-2 VACCINE SAFETY IN ADOLESCENTS WITH INFLAMMATORY RHEUMATIC AND MUSCULOSKELETAL DISEASES AND ADULTS WITH JUVENILE IDIOPATHIC ARTHRITIS

Abstract

BackgroundThere is a lack of data on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs.ObjectivesTo describe the characteristics and outcomes of adolescents with inflammatory RMDs and adults with juvenile idiopathic arthritis (JIA) vaccinated against SARS-CoV-2.MethodsWe described patient characteristics, flares, and adverse events in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology (EULAR) COVAX registry.ResultsThirty-six adolescent cases were reported from 4 countries, the most frequent diagnosis was JIA (42%). Over half (56%) reported early reactogenic-like adverse events (AEs) experienced within 7 days of vaccination. One mild polyarthralgia flare and one serious AE (malaise) were reported. No CYP reported SARS-CoV-2 infection post-vaccination.In addition to the adolescent cases, eleven countries reported 74 adult JIA cases. Among these, 62% reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three 20-30 year old females were diagnosed with SARS-CoV-2 post-vaccination; all fully recovered.ConclusionIn this observational registry dataset, SARS-CoV-2 vaccines appeared safe in adolescents with RMDs and adults with JIA, with a low frequency of disease flares, serious AEs, and SARS-CoV-2 re-infection seen in both populations.Table 1.Characteristics of adolescents with RMDs and adults with JIA reported to the EULAR COVAX registryAdolescents with RMDs (N=36)Adults with JIA (N=74)SexFemale21 (58)54 (73)Male15 (42)20 (27)Age (median [IQR])15 [14.5, 17]26 [23, 31]Primary RMD diagnosisNon-systemic JIA10 (28)63 (85)Systemic JIA5 (14)11 (15)Systemic lupus erythematosus5 (14)Spondyloarthritis/psoriatic arthritis5 (14)Vasculitis/other RMD #11 (30)RMD disease activityRemission23 (64)33 (45)Minimal8 (22)21 (28)Moderate2 (6)12 (16)Severe1 (3)1 (1)Not applicable/missing2 (6)7 (10)RMD medicationNone9 (25)3 (4)b-DMARD9 (25)50 (68)cs-DMARD21 (58)25 (34)ts-DMARD5 (14)2 (3)Systemic glucocorticoids5 (14)1 (1)Colchicine7 (10)Other immunosuppressant *COVAX typePfizer/BioNTech33 (92)50 (68)Moderna2 (6)10 (14)AstraZeneca/Oxford1 (3)10 (14)Janssen1 (1)CoronaVac2 (3)UNK1 (1)COVAX doses111 (31)8 (11)22 (24)61 (82)31 (3)5 (7)RMD flareYes1 (3)2 (3)AEYes20 (56)46 (62)Early AEInjection site pain8 (22)16 (22)Redness6 (17)2 (3)Muscle pain1 (3)9 (12)Joint pain4 (11)3 (4)Headache9 (25)10 (14)Fever1 (3)26 (35)Chills2 (6)5 (7)Fatigue1 (3)13 (18)VomitingAE of special interestNon-serious1 (3)1 (1)Serious – important medical event1 (3)All data are N(%) of the column unless stated otherwise.# Other RMD includes Sjogren’s syndrome, systemic sclerosis, undifferentiated connective tissue disease, non-monogenic auto-inflammatory syndrome, chronic recurrent multifocal osteomyelitis, and other inflammatory arthritis* Other immunosuppressant includes ciclosporin, mycophenolate mofetil/mycophenolic acid.RMD, rheumatic and musculoskeletal disease; JIA, juvenile idiopathic arthritis; EULAR, European Alliance of Associations for Rheumatology; ANCA-associated vasculitis, anti-neutrophil cytoplasmic antibody-associated vasculitis; cs-, conventional synthetic; b-, biological; ts-, targeted synthetic; DMARD, disease-modifying anti-rheumatic drug; COVAX, Coronavirus vaccine; AE, adverse event.AcknowledgementsWe wish to thank all healthcare providers who entered data into the registry.Disclosure of InterestsSaskia Lawson-Tovey: None declared, Anja Strangfeld Speakers bureau: AbbVie, MSD, Roche, BMS, Pfizer, Elsa Mateus: None declared, Laure Gossec Consultant of: AbbVie, Amgen, BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Lilly, Pfizer, Sandoz, Loreto Carmona: None declared, Pedro Machado Speakers bureau: AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, UCB, Consultant of: AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, UCB, BERND RAFFEINER: None declared, Inita Bulina Speakers bureau: AbbVie, Pfizer, Janssen, Boehringer Ingelheim, Daniel Clemente Speakers bureau: Novartis, GSK, Julija Zepa Speakers bureau: AbbVie, Novartis, Janssen/Johnson & Johnson, Ana Maria Rodrigues Speakers bureau: Amgen, AbbVie, Grant/research support from: Amgen, Pfizer, AstraZeneca, Xavier Mariette Consultant of: BMS, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sanofi-Aventis, UCB, Grant/research support from: Ose, Kimme Hyrich Speakers bureau: AbbVie, Grant/research support from: Pfizer, BMS, UCB