Efficacy and Safety of Anti-SARS-CoV-2 Antiviral Agents and Monoclonal Antibodies in Patients with SLE: A Case-Control Study
Giuseppe A. Ramirez,
Maria Gerosa,
Chiara Bellocchi,
Daniel Arroyo-Sánchez,
Chiara Asperti,
Lorenza M. Argolini,
Gabriele Gallina,
Martina Cornalba,
Isabella Scotti,
Ilaria Suardi,
Luca Moroni,
Lorenzo Beretta,
Enrica P. Bozzolo,
Roberto Caporali,
Lorenzo Dagna
Affiliations
Giuseppe A. Ramirez
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy
Maria Gerosa
Department of Clinical Science of Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milan, Italy
Chiara Bellocchi
Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Via Francesco Sforza 35, 20122 Milan, Italy
Daniel Arroyo-Sánchez
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy
Chiara Asperti
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy
Lorenza M. Argolini
Department of Clinical Science of Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milan, Italy
Gabriele Gallina
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy
Martina Cornalba
Department of Clinical Science of Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milan, Italy
Isabella Scotti
Department of Clinical Science of Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milan, Italy
Ilaria Suardi
Department of Clinical Science of Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milan, Italy
Luca Moroni
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy
Lorenzo Beretta
Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Via Francesco Sforza 35, 20122 Milan, Italy
Enrica P. Bozzolo
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy
Roberto Caporali
Department of Clinical Science of Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milan, Italy
Lorenzo Dagna
Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Via Olgettina 60, 20132 Milan, Italy
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease (COVID-19) has spread pandemically with high rates of morbidity and mortality. COVID-19 has also posed unprecedented challenges in terms of rapid development of pharmacological countermeasures to prevent or contrast SARS-CoV-2 pathogenicity. Anti-SARS-CoV-2 antiviral agents and monoclonal antibodies have been specifically designed to attenuate COVID-19 morbidity and prevent mortality in vulnerable subjects, such as patients with immune-mediated diseases, but evidence for the safe and effective use of these drugs in this latter population group is scarce. Therefore, we designed a retrospective, multicentre, observational, case-control study to analyse the impact of these treatments in COVID-19 patients with systemic lupus erythematosus (SLE), a paradigmatic, multi-organ autoimmune disease. We identified 21 subjects treated with antivirals and/or monoclonal antibodies who were matched with 42 untreated patients by age, sex, SLE extension and duration. Treated patients had higher baseline SLE disease activity index 2000 scores [SLEDAI-2K median (interquartile range) = 4 (1–5) vs. 0 (0–2); p = 0.009], higher prednisone doses [5 (0–10) mg vs. 0 (0–3) mg; p = 0.002], and more severe COVID-19 symptoms by a five-point World Health Organisation-endorsed analogue scale [1 (0–1) vs. 0 (0–1); p < 0.010] compared to untreated patients. There was no difference between groups in terms of COVID-19 outcomes and sequelae, nor in terms of post-COVID-19 SLE exacerbations. Three subjects reported mild adverse events (two with monoclonal antibodies, one with nirmatrelvir/ritonavir). These data suggest that anti-SARS-CoV-2 antivirals and monoclonal antibodies might be safely and effectively used in patients with SLE, especially with active disease and more severe COVID-19 symptoms at presentation.
