AB0079 NO FLARE AFTER PRE-EXPOSURE PROPHYLAXIS WITH MONOCLONAL ANTIBODIES AGAINST SARS-COV-2 IN 82 PATIENTS WITH SYSTEMIC AUTOIMMUNE RHEUMATIC DISEASES: A SINGLE CENTER EXPERIENCE
Authors: M. Fernanda Zacarin, R. Suwa Marques, R. Da Rocha Jorge, V. De Castro Grotti, C. W. Menuzzo, D. P. De Souza, T. J. Trevisan, L. T. Hirata, M. Paula Souza Dos Santos, J. G. Borghi, A. P. Del Rio, L. Tereza Lavras Costallat, Z. Sachetto, M. B. Bertolo, A. Pugliesi
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> SARS-CoV-2 infection is associated with greater morbidity and mortality in patients with systemic autoimmune rheumatic diseases (SARDs), not only because of the immunosuppression to which these patients are subject, but also because of their low vaccine response. Therefore, along with other risk groups, they are considered to be patients who could benefit from pre-exposure preventive therapies. Although tixagevimab+cilgavimab is no longer available, other monoclonal antibodies against SARS-COV-2 are in development and will have an indication in the immunosuppressed population. Not adequately represented in trials, little is known about the particularities of this drug in SARD patients: few publications on its effectiveness and safety and, to the authors' knowledge, no information to date on the risk of post-application flares. <h3>Objectives:</h3> To evaluate the incidence of flare of the underlying disease one month after the application of tixagevimab +cilgavimab in patients with SARDs. We will also evaluate other post-application side effects and the frequency of patients with COVID infection over a six-month period. <h3>Methods:</h3> This was a retrospective, single-center study based on interviews and a review of the medical records of patients with SARDs who underwent pre-exposure prophylaxis with tixagevimab/cilgavimab. In a descriptive manner, a series of characteristics of these patients were assessed and the three main objectives were evaluated after application: the presence of flare of the disease four weeks after application of the medication (defined by the increase in the dose of glucocorticoids or adjustment in the immunosuppressive medication regimen), the incidence of adverse events associated with the product, characterized as serious in the case of anaphylaxis or other life-threatening situations assessed for a period of one hour after application or mild effects within one week after being informed through contact made available to the patient by the health team, and the number of confirmed cases of COVID-19 infection in a period of 6 months. <h3>Results:</h3> Between December 12 and 20, 2022, 82 patients with SARDs received tixagevimab/cilgavimab at a dose of 300 + 300 mg. The baseline characteristics of the patients are summarized in Table 1. None of the patients experienced a flare of the underlying disease after the four-week period considered and no serious adverse events were detected after the application. Of the 3 patients known to have had COVID infection, none had a severe form of the disease (Table 2). <h3>Conclusion:</h3> Our study, the first to objectively assess the risk of disease reactivation in patients undergoing pre-COVID19 prophylaxis with monoclonal antibodies, showed that no patient presented with a flare of the underlying disease after the application period, as well as a low and non-serious incidence of adverse events. Although the lack of comparators makes it impossible to assess the effectiveness against SARS COV2 infection, our data indicate safety in this specific population. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> Maria Fernanda Zacarin: None declared, Regis Suwa Marques: None declared, Rodrigo da Rocha Jorge: None declared, Vitor de Castro Grotti: None declared, Carolina Wonhnrath Menuzzo: None declared, Debora Pessoa De Souza: None declared, Thiago Junqueira Trevisan: None declared, Lilian Tiemi Hirata: None declared, Marília Paula Souza dos Santos: None declared, Juliana Gaino Borghi: None declared, Ana Paula del Rio: None declared, Lilian Tereza Lavras Costallat: None declared, Zoraida Sachetto: None declared, Manoel Barros Bertolo: None declared, Alisson Pugliesi Abbvie, Janssen, Lilly, UCB, Pfizer, Boehringer, Aztra Zeneca, Boehringer, UCB.