Efficacy of tixagevimab-cilgavimab in preventing SARS-CoV-2 for patients with B-cell malignancies

Abstract

COVID-19 still represents a major issue for patients with lymphoid malignancies, especially those on therapy, because of immune suppression and suboptimal responses to vaccination. Davis et al report on their experience with double dose tixagevimab-cilgavimab preexposure prophylaxis in a cohort of 251 patients with chronic lymphocytic leukemia, B-cell lymphomas, multiple myeloma, or B-cell acute lymphoblastic leukemia, 63% of whom had received 3 doses of the SARS-CoV-2 vaccine. Breakthrough infections within 3 months occur despite passive immunization, affecting 11% in this series; however, hospitalization rates are low, and mortality was avoided, suggesting benefit from this strategy.

Efficacy and Safety of Tixagevimab/Cilgavimab to Prevent COVID-19 (Pre-Exposure Prophylaxis): A Systematic Review and Meta-Analysis

“…The full texts of the 76 remaining articles were reviewed, and 46 irrelevant articles were excluded (reasons: study with in vitro activity of TGM/CGM to prevent SARS-CoV-2 variants = 13, study with no relevant data = 13, review = 12, study with in silico activity of TGM/CGM to prevent SARS-CoV-2 variants = 4, study with no extractable data = 3, and editorial and commentary = 1). As a result, we identified 30 studies (total participants = 27,932) that met our inclusion criteria and were included in the systematic review and meta-analysis [ 6 , 9 , 10 , 11 , 12 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 ]. The PRISMA chart for the studies included is displayed in Figure 2 .…”

“…Among these, two articles were in preprint versions [ 26 , 35 ]. Most of the studies were cohorts ( n = 23) [ 6 , 10 , 11 , 12 , 20 , 21 , 22 , 23 , 26 , 27 , 30 , 31 , 33 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 ], however, there were one case report [ 24 ] and five case series studies [ 25 , 28 , 29 , 32 , 34 ]. These studies were conducted in United States ( n = 14), France ( n = 11), Israel ( n = 2), Germany ( n = 1), and Austria ( n = 1).…”

“…Only one study was conducted within several countries ( n = 1) [ 9 ]. The majority of the studies were single center [ 6 , 11 , 12 , 23 , 24 , 25 , 26 , 28 , 29 , 31 , 32 , 33 , 34 , 36 , 37 , 38 , 39 , 41 , 42 , 44 ], and only ten studies were multicenter [ 9 , 10 , 20 , 21 , 22 , 27 , 30 , 35 , 40 , 43 ]. Studies randomly assigned participants into a TGM/CGM therapy versus a placebo [ 9 , 10 , 12 , 35 ], a combination of casirivimab/imdevimab (CRM/IDM) [ 11 , 21 , 37 ], or no treatment (no mAbs) [ 11 , 25 , 27 , 29 , 31 , 37 , 40 ].…”

“…Few studies utilized a pre–post design (baseline) [ 6 , 23 , 26 , 36 ] and only one study utilized the design of randomized double-blind controlled trial [ 9 ]. Many studies compared TGM/CGM groups to no comparator groups [ 20 , 22 , 24 , 28 , 30 , 32 , 33 , 34 , 36 , 38 , 39 , 41 , 42 , 43 , 44 ] or patient groups that were infected previously with SARS-CoV-2 and recovered [ 21 ]. Only twelve studies reported on the safety of TGM/CGM in patients at high risk for breakthrough and severe SARS-CoV-2 infection [ 9 , 10 , 11 , 25 , 26 , 28 , 34 , 39 , 41 , 42 , 43 , 44 ].…”

“…Many studies compared TGM/CGM groups to no comparator groups [ 20 , 22 , 24 , 28 , 30 , 32 , 33 , 34 , 36 , 38 , 39 , 41 , 42 , 43 , 44 ] or patient groups that were infected previously with SARS-CoV-2 and recovered [ 21 ]. Only twelve studies reported on the safety of TGM/CGM in patients at high risk for breakthrough and severe SARS-CoV-2 infection [ 9 , 10 , 11 , 25 , 26 , 28 , 34 , 39 , 41 , 42 , 43 , 44 ]. Among the 30 included studies, 14 studies were moderate-quality studies (i.e., NOS scores were between 5 and 7 or based on the assessment for bias using the modified NOS) and 15 studies demonstrated relatively high quality (i.e., NOS scores > 7 or based on the assessment for bias using the modified NOS).…”