Exposure to obinutuzumab does not affect outcomes of SARS-CoV-2 infection in vaccinated patients with newly diagnosed advanced-stage follicular lymphoma.

Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 0372544 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2141 (Electronic) Linking ISSN: 00071048 NLM ISO Abbreviation: Br J Haematol Subsets: MEDLINE

Publication: Oxford : Wiley-Blackwell
Original Publication: Oxford : Blackwell Scientific Publications

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; 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

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.)

Hemasphere. 2021 Jun 28;5(7):e603. (PMID: 34235400)
Br J Haematol. 2022 Sep;198(5):826-829. (PMID: 35718461)
Stat Methods Appt. 2022;31(1):181-195. (PMID: 34035795)
Br J Haematol. 2024 May;204(5):1617-1634. (PMID: 38532527)
Influenza Other Respir Viruses. 2023 Aug 16;17(8):e13181. (PMID: 37599801)
Ann Hematol. 2023 Jun;102(6):1421-1431. (PMID: 37041299)
Haematologica. 2019 Jun;104(6):1202-1208. (PMID: 30573503)
RMD Open. 2022 Feb;8(1):. (PMID: 35115385)
Infect Agent Cancer. 2021 Jun 2;16(1):38. (PMID: 34078415)
Blood. 2022 Mar 17;139(11):1684-1693. (PMID: 34614146)
Haematologica. 2022 Jan 01;107(1):7-18. (PMID: 34985230)
Clin Infect Dis. 2022 May 30;74(10):1786-1794. (PMID: 34383032)
Nat Cancer. 2022 May;3(5):526-527. (PMID: 35624336)
Blood Adv. 2021 Aug 24;5(16):3053-3061. (PMID: 34387648)
J Clin Oncol. 1997 Mar;15(3):1110-7. (PMID: 9060552)
Hemasphere. 2022 Nov 15;6(12):e807. (PMID: 36407092)
Am J Hematol. 2023 Jan;98(1):131-139. (PMID: 35607995)
Ann Hematol. 2020 Jul;99(7):1595-1604. (PMID: 32417940)
Blood. 2022 Jan 6;139(1):142-147. (PMID: 34669919)
Vaccines (Basel). 2022 Jun 26;10(7):. (PMID: 35891185)
Br J Haematol. 2020 Jul;190(2):185-188. (PMID: 32557623)
Br J Haematol. 2024 Mar;204(3):805-814. (PMID: 37886835)
Eur J Cancer. 2020 Sep;136:4-6. (PMID: 32619884)
Clin Lymphoma Myeloma Leuk. 2020 Nov;20(11):774-776. (PMID: 32933879)
Oncol Res Treat. 2015;38(4):185-92. (PMID: 25877943)
Nat Cancer. 2022 May;3(5):552-564. (PMID: 35332334)
J Clin Oncol. 2018 Aug 10;36(23):2395-2404. (PMID: 29856692)
Br J Haematol. 2024 Dec;205(6):2219-2227. (PMID: 39039666)
N Engl J Med. 2017 Oct 5;377(14):1331-1344. (PMID: 28976863)
Viruses. 2023 Mar 07;15(3):. (PMID: 36992402)
Haematologica. 2022 Mar 01;107(3):572-573. (PMID: 34320792)
Front Public Health. 2022 Nov 01;10:986743. (PMID: 36388357)
Blood Cancer J. 2021 Sep 14;11(9):151. (PMID: 34521813)
Nat Rev Microbiol. 2023 Jun;21(6):361-379. (PMID: 37020110)
Infection. 2023 Oct;51(5):1577-1581. (PMID: 37076752)
Blood Adv. 2021 Jun 21;5(12):2624-2643. (PMID: 34152403)
Adv Clin Exp Med. 2023 Jan;32(1):131-136. (PMID: 36603138)
Am J Hematol. 2021 Aug 1;96(8):934-944. (PMID: 33909916)

Roche; Mattioli Health

Keywords: SARS‐CoV‐2 infection; follicular lymphoma; maintenance; obinutuzumab; vaccination

ClinicalTrials.gov NCT04034056

O43472U9X8 (obinutuzumab)
0 (Antibodies, Monoclonal, Humanized)
0 (COVID-19 Vaccines)
0 (Antineoplastic Agents, Immunological)

Date Created: 20240723 Date Completed: 20241212 Latest Revision: 20241230

20241230

PMC11637738

10.1111/bjh.19661

39039666