COVID-19 BOOSTER VACCINATION, EITHER MRNA OR PROTEIN SUBUNIT VACCINES, APPEARS SAFE IN RITUXIMAB-TREATED PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS, RHEUMATOID ARTHRITIS AND VASCULITIS

PV144 / #585 Poster Topic: AS17 - Miscellaneous Background/Purpose People living with systemic autoimmune rheumatic diseases (SARD) on B cell depletion agents have impaired immunogenicity and increased vulnerability to severe COVID-19. We assessed the 7-day solicited reactogenicity and safety of booster doses following COVID-19 vaccine primary series. Methods We recruited adults with SARDs on rituximab post-third or fourth dose of a messenger RNA (mRNA) COVID-19 vaccine in an open-label, non-randomized, comparative trial. Participants chose to receive either a fourth dose of mRNA Spikevax ® or Nuvaxovid TM , a protein subunit vaccine (PSV). Patients who had already received a fourth dose of mRNA vaccine were offered the PSV as their fifth dose. From study entry, up to 180 days post-booster, subjects self-reported solicited 7-days reactogenicity, and unsolicited adverse events, adverse events of special interest (AESI) (defined as medically confirmed flares of the underlying SARD), new COVID-19 infections, and serious adverse events (SAEs) (requiring hospitalization). We used descriptive statistics for demographics and Chi-square tests to report reactogenicity and adverse events. Results We recruited 86 participants with rheumatoid arthritis (39%), ANCA vasculitis (32%), idiopathic inflammatory myositis (9%), systemic lupus erythematosus (8%), systemic sclerosis (7%), and undifferentiated SARDs (4%). Mean (SD) age was 57.3 (15.3); 73% were female; 91% White; 23% were on prednisone, 21% on antimalarials, and 42% on other immunosuppressors. The most significant reactogenicity manifestations were fever, erythrema, swelling and pain. The proportion of side effects for all types of AEs were similar comparing the fourth-dose mRNA vs the fourth-dose PSV, and the fourth-dose PSV vs the fifth-dose PSV. Fever was only present in the fourth-dose mRNA group; erythema and swelling were reported more often in fifth-dose PSV vs fourth-dose mRNA; and pain significantly more in fourth-dose mRNA vs 5 th -dose PSV. Disease flares (N=3, occurring at 14, 92, and 131 days) are presented in Table 1, along with COVID-19 and other infections (N=6). Including infections, there were 9 SAEs experienced by 8 participants (Table 1). There were no deaths. Table 1. Adverse Events of Special Interest and Serious Adverse Events. Conclusions Three of 86 patients experienced a disease flare and 9 others required hospitalization, most for COVID-19/other infections. A fourth or fifth booster dose of either an mRNA or a PSV vaccine were not clearly associated with unexpected vaccine reactions in rituximab-treated SARD patients. Revaccination of patients on rituximab with either mRNA or PSV vaccines appears safe.

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