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Multicenter Study
. 2024 Dec;205(6):2219-2227.
doi: 10.1111/bjh.19661. Epub 2024 Jul 22.

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

A Pinto  1 , M Caltagirone  2 , M Battista  3 , G C Gazzoli  4 , C Patti  5 , E Pennese  6 , S De Lorenzo  7 , V Pavone  8 , M Merli  9 , A Chiarenza  10 , A G Gorgone  11 , F Piazza  12 , B Puccini  13 , A Noto  9 , L Arcaini  14   15 , R De Filippi  16 , P L Zinzani  17   18 , A J M Ferreri  19 , M Ladetto  20 , S Ferrari  21 , G Gritti  21
Affiliations
Multicenter Study

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

A Pinto et al. Br J Haematol. 2024 Dec.

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.

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

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Conflict of interest statement

A.P. received honoraria from Roche, Beigene, Incyte, Eli‐Lilly, Sobi, MSD, BMS for educational lectures, speaker bureau and advisory board activities. M.C. is employed by and has equity ownership interest in Roche S.p.A. M.C. is employed by Roche S.p.A. G.C.G. is employed by Roche S.p.A. F.P. received honoraria for Roche, Janssen, Kite‐GIlead, Abbvie and received funding from Kite‐Gilead. P.L.Z. received honoraria from EUSA Pharma, Roche, Janssen‐Cilag, Incyte, Kite/Gilead, ADC Therapeutics. L.A. received Honoraria from EUSA Pharma, Novartis, Roche, Janssen‐Cilag, Verastem, Incyte, Celgene/Bristol Myers Squibb, Kite/Gilead, ADC Therapeutics. M.L. received honoraria from AbbVie, Acerta, Amgen, ADC Therapeutics, BeiGene, Celgene/BMS, Eusapharma, GSKI, Gentili, Gilead/Kite, Lilly, Novartis, Incyte, J&J, Jazz, Regeneron, Roche, Sandoz. G.G. received honoraria from Roche, Takeda, Kite‐Gilead, Italfarmaco. The remaining authors declare no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Timeline of events for the URBAN study: Enrolment, pandemic waves and prevalent SARS‐CoV‐2 variants in Italy.
FIGURE 2
FIGURE 2
Treatment discontinuations and application of obinutuzumab maintenance.
See this image and copyright information in PMC

References

    1. Markov PV, Ghafari M, Beer M, Lythgoe K, Simmonds P, Stilianakis NI, et al. The evolution of SARS‐CoV‐2. Nat Rev Microbiol. 2023;21:361–379. - PubMed
    1. Calderón‐Parra J, Múñez‐Rubio E, Fernández‐Cruz A, García‐Sánchez MC, Maderuelo‐González E, López‐Dosil M, et al. Incidence, clinical presentation, relapses and outcome of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection in patients treated with anti‐CD20 monoclonal antibodies. Clin Infect Dis. 2022;74:1786–1794. - PubMed
    1. Ishio T, Tsukamoto S, Yokoyama E, Izumiyama K, Saito M, Muraki H, et al. Anti‐CD20 antibodies and bendamustine attenuate humoral immunity to COVID‐19 vaccination in patients with B‐cell non‐Hodgkin lymphoma. Ann Hematol. 2023;102:1421–1431. - PMC - PubMed
    1. Schietzel S, Anderegg M, Limacher A, Born A, Horn MP, Maurer B, et al. Humoral and cellular immune responses on SARS‐CoV‐2 vaccines in patients with anti‐CD20 therapies: a systematic review and meta‐analysis of 1342 patients. RMD Open. 2022;8:e002036. - PMC - PubMed
    1. Marcacci G, Fiorentino G, Volzone F, Falcone U, Parrella R, Donnarumma D, et al. Atypical COVID‐19 dynamics in a patient with mantle cell lymphoma exposed to rituximab. Infect Agent Cancer. 2021;16:38. - PMC - PubMed

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