Monoclonal antibodies against SARS-CoV-2 to prevent COVID-19 worsening in a large multicenter cohort.

Autor:	Soria A; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy., Graziano F; Biostatistics and Clinical Epidemiology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; Bicocca Bioinformatics, Biostatistics and Bioimaging Centre (B4), School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Ghilardi G; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; School of Medicine, University of Milano-Bicocca, Monza, Italy., Lapadula G; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; School of Medicine, University of Milano-Bicocca, Monza, Italy., Gasperina DD; Department of Medicine and Technological Innovation, University of Insubria, ASST Sette Laghi, Varese, Italy., Benatti SV; Unit of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy.; Clinic of Infectious Diseases, ASST Santi Paolo e Carlo, Milan, Italy., Quiros-Roldan E; Clinic of Infectious Diseases, University of Brescia, Brescia, Italy., Milesi M; Unit of Infectious Diseases, ASST Cremona, Cremona, Italy., Bai F; Clinic of Infectious Diseases, ASST Santi Paolo e Carlo, Milan, Italy.; Department of Health Sciences, University of Milan, Milan, Italy., Merli M; Clinic of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy., Minisci D; Clinic of Infectious Diseases, University of Brescia, Brescia, Italy.; Unit of Infectious Diseases, ASST Mantova, Mantova, Italy., Franzetti M; Unit of Infectious Diseases, ASST Ovest Milano, Legnano, Italy., Asperges E; Clinic of Infectious Diseases, University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Chiabrando F; Università Vita-Salute San Raffaele, Milan, Italy., Pocaterra D; IRCCS Humanitas Research Hospital, Rozzano, Italy., Pandolfo A; Unit of Infectious Diseases, ASST Lecco, Italy., Zanini F; ASST Nord Milano, Cinisello Balsamo, Italy., Lombardi D; Unit of Infectious Diseases, ASST Lariana, Como, Italy., Cappelletti A; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy., Rugova A; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy., Borghesi ML; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy., Squillace N; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy., Pusterla L; Unit of Infectious Diseases, ASST Lariana, Como, Italy., Piconi S; Unit of Infectious Diseases, ASST Lecco, Italy., Morelli P; IRCCS Humanitas Research Hospital, Rozzano, Italy., Querini PR; Università Vita-Salute San Raffaele, Milan, Italy.; IRCCS Ospedale San Raffaele, Milan, Italy., Bruno R; Clinic of Infectious Diseases, University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Rusconi S; Unit of Infectious Diseases, ASST Ovest Milano, Legnano, Italy.; University of Milano, Milan, Italy., Casari S; Unit of Infectious Diseases, ASST Mantova, Mantova, Italy., Bandera A; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.; Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy., Franzetti F; Unit of Infectious Diseases, ASST Valle Olona, Busto Arsizio, Italy., Travi G; Clinic of Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy., D'Arminio Monforte A; Clinic of Infectious Diseases, ASST Santi Paolo e Carlo, Milan, Italy.; Department of Health Sciences, University of Milan, Milan, Italy., Marchetti G; Clinic of Infectious Diseases, ASST Santi Paolo e Carlo, Milan, Italy.; Department of Health Sciences, University of Milan, Milan, Italy., Pan A; Unit of Infectious Diseases, ASST Cremona, Cremona, Italy., Castelli F; Clinic of Infectious Diseases, University of Brescia, Brescia, Italy., Rizzi M; Unit of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy., Dentali F; Department of Medicine and Technological Innovation, University of Insubria, ASST Sette Laghi, Varese, Italy., Mallardo M; Bicocca Bioinformatics, Biostatistics and Bioimaging Centre (B4), School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Rossi E; Bicocca Bioinformatics, Biostatistics and Bioimaging Centre (B4), School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Valsecchi MG; Biostatistics and Clinical Epidemiology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; Bicocca Bioinformatics, Biostatistics and Bioimaging Centre (B4), School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Galimberti S; Biostatistics and Clinical Epidemiology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; Bicocca Bioinformatics, Biostatistics and Bioimaging Centre (B4), School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Bonfanti P; Clinic of Infectious Diseases, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; School of Medicine, University of Milano-Bicocca, Monza, Italy.
Jazyk:	angličtina
Zdroj:	Heliyon [Heliyon] 2024 Aug 13; Vol. 10 (16), pp. e36102. Date of Electronic Publication: 2024 Aug 13 (Print Publication: 2024).
DOI:	10.1016/j.heliyon.2024.e36102
Abstrakt:	Objective: Monoclonal antibodies (mAbs) against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) reduced Coronavirus Disease 2019 (COVID-19) hospitalizations in people at risk of clinical worsening. Real-world descriptions are limited. Methods: CONDIVIDIAMO, a two-year multicenter observational study, consecutively enrolled SARS-CoV-2 outpatients with ≥1 risk factor for COVID-19 progression receiving mAbs. Demographic data, underlying medical condition, type of mAbs combination received, duration of symptoms before mAbs administration, COVID-19 vaccination history, were collected upon enrolment and centrally recorded. Data on outcomes (hospitalizations, reasons of hospitalization, deaths) were prospectively collected. The primary endpoint was the rate of hospitalization or death in a 28-day follow-up, whichever occurred first; subjects were censored at the day of last follow-up or up to 28 days. The Kaplan-Meier method was used to estimate the incidence rate curve in time. The Cox regression model was used to assess potential risk factors for unfavorable outcome. Results were shown as hazard ratio (HR) along with the corresponding 95 % Confidence Interval (95%CI). Results: Among 1534 subjects (median [interquartile range, IQR] age 66.5 [52.4-74.9] years, 693 [45.2 %] women), 632 (41.2 %) received bamlanivimab ± etesevimab, 209 (13.6 %) casirivimab/imdevimab, 586 (38.2 %) sotrovimab, 107 (7.0 %) tixagevimab/cilgavimab. After 28-day follow-up, 87/1534 (5.6 %, 95%CI: 4.4%-6.8 %) met the primary outcome (85 hospitalizations, 2 deaths). Hospitalizations for COVID-19 (52, 3.4 %) occurred earlier than for other reasons (33, 2.1 %), after a median (IQR) of 3.5 (1-7) versus 8 (3-15) days (p = 0.006) from mAbs administration.In a multivariable Cox regression model, factors independently associated with increased hospitalization risk were age (hazard ratio [HR] 1.02, 95%CI 1.00-1.03, p = 0.021), immunodeficiency (HR 1.78, 95%CI 1.11-2.85, p = 0.017), pre-Omicron calendar period (HR 1.66, 95%CI 1.02-2.69, p = 0.041). Conclusions: MAbs real-world data over a 2-year changing pandemic landscape showed the feasibility of the intervention, although the hospitalization rate was not negligible. Immunosuppressed subjects remain more at risk of clinical worsening. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2024 The Authors.)
Databáze:	MEDLINE
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