Risk of SARS-CoV-2 infection and severe COVID-19 in hematological patients who received or not pre-exposure prophylaxis with tixagevimab/cilgavimab: a target trial emulation

Leuk Lymphoma. 2024 Oct;65(10):1474-1481. doi: 10.1080/10428194.2024.2361099. Epub 2024 Jun 4.

Abstract

We emulated a hypothetical target trial in which hematological subjects cared at the University Hospital of Pisa (Italy) received or not SARS-CoV-2 prophylaxis with tixagevimab/cilgavimab. Subjects who received prophylaxis (cases) were compared to those who did not (controls). The main outcome was SARS-CoV-2 infection in the subsequent 6 months. Inverse probability weighting (IPW) was used to adjust for confounders. A multivariable analysis was performed to identify variables associated with SARS-CoV-2 infection. We recruited 462 patients: 228 received prophylaxis, 234 were controls. COVID-19 was lower in cases compared to controls (16.7% vs 24.8%, p = 0.03, after IPW 14.3% vs 24.6%, p = 0.01). On multivariable analysis, B-cell depleting therapies (HR 2.09, 95%CI 1.05-4.18, p = 0.037) were associated with increased risk of COVID-19, while tixagevimab/cilgavimab prophylaxis (HR 0.45, 95%CI 0.27-0.73, p = 0.001) and previous SARS-CoV-2 infection (HR 0.27, 95%CI 0.14-0.51, p < 0.001) were protective. In conclusion, prophylaxis with monoclonal antibodies may reduce the risk of COVID-19 in hematological patients.

Keywords: B-cell depletion; COVID-19; monoclonal antibodies; prophylaxis; tixagevimab/cilgavimab.

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • COVID-19* / complications
  • COVID-19* / prevention & control
  • Female
  • Hematologic Neoplasms* / complications
  • Hematologic Neoplasms* / therapy
  • Humans
  • Italy / epidemiology
  • Male
  • Middle Aged
  • Pre-Exposure Prophylaxis* / methods
  • Risk Factors
  • SARS-CoV-2*
  • Severity of Illness Index

Substances

  • Antibodies, Monoclonal, Humanized