1. Exposure to obinutuzumab does not affect outcomes of SARS-CoV-2 infection in vaccinated patients with newly diagnosed advanced-stage follicular lymphoma.
- Author
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Pinto A, Caltagirone M, Battista M, Gazzoli GC, Patti C, Pennese E, De Lorenzo S, Pavone V, Merli M, Chiarenza A, Gorgone AG, Piazza F, Puccini B, Noto A, Arcaini L, De Filippi R, Zinzani PL, Ferreri AJM, Ladetto M, Ferrari S, and Gritti G
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Italy epidemiology, Adult, Vaccination, Aged, 80 and over, Hospitalization statistics & numerical data, Neoplasm Staging, Antineoplastic Agents, Immunological therapeutic use, Antineoplastic Agents, Immunological adverse effects, Antineoplastic Agents, Immunological administration & dosage, Treatment Outcome, COVID-19 prevention & control, COVID-19 mortality, Lymphoma, Follicular drug therapy, Lymphoma, Follicular mortality, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized administration & dosage, SARS-CoV-2, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage
- Abstract
URBAN is a multicentric, ambispective study evaluating the effectiveness and safety of obinutuzumab-based immuno-chemotherapy and maintenance in patients with untreated advanced follicular lymphoma (FL). The study began before the COVID-19 emergency declaration in Italy. It is currently ongoing for follow-up, and the enrolment timeline encompassed different stages of the pandemic, various vaccination roll-out phases and prevalence of SARS-CoV-2 variants. Outcomes of interest of the present sub-analysis included SARS-CoV-2 infection rates and COVID-19-related hospitalizations/deaths. At data cut-off, 86 (28.8%) and 213 patients (71.2%) were treated before and during/after the COVID-19 outbreak respectively; 294 (98.3%) completed the induction, 31 (10.4%) completed maintenance and 170 (56.9%) were still on maintenance. Overall, 245 patients (81.9%) received at least one SARS-CoV-2 vaccine dose: 13.5%, 31.4% and 55.1% received one, two and three doses respectively. We observed a substantial decrease in COVID-19-related mortality rates in pre- versus post-vaccination phases, along with a reduction in COVID-19-related outcomes due to the shift from alpha/delta to omicron variant predominance. No differences emerged between patients given maintenance or not, although the schedule was modified in 65% of cases. To our knowledge, URBAN represents the largest dataset of COVID-19-related outcomes in FL patients extensively exposed to obinutuzumab. ClinicalTrials.gov identifier: NCT04034056., (© 2024 The Author(s). British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
- Published
- 2024
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