EARLY TREATMENT WITH BAMLANIVIMAB ALONE DOES NOT PREVENT COVID-19 HOSPITALIZATION AND ITS POST-ACUTE SEQUELAE. A REAL EXPERIENCE IN UMBRIA, ITALY.

Background and Objective The use of monoclonal antibodies to the SARS-Cov-2 spike protein for early treatment of COVID-19 disease is being evaluated, with only phase 2 studies available, to date. Emergency authorization of bamlanivimab monotherapy was get in November 2020 by the FDA and in March 2021 by italian agency AIFA. Its use was then revoked in April 2021 by both. This study reports the results of bamlanivimab utilization in monotherapy in Umbria (Italian region), in order to verify whether, in a population with multiple risk factors, comparable results to phase 2 BLAZE1 trial had been obtained. Methods Retrospective observational study, between March and April 2021, in patients treated with bamlanivimab was performed. Demographic and clinical characteristics before and after infusion were evaluated. Moreover, a telephone interview about 30 days after the infusion was carried out to evaluate the overall course. Results All patients had an early infection (mean 4±1.73 days), almost all by alpha variant (97%). No adverse events to treatment were observed. Altogether within 30 days, the hospitalization rate was 20%, 15% for COVID-19 related pathologies , versus 4% at 11 days in BLAZE1 phase 2 study. Worsening of some symptoms observed at baseline such as asthenia (77 vs 51.3%), shortness of breath (38 vs 23%) was registered, as well as the onset of non-restorative sleep (41%). Conclusions The clinical outcome after bamlanivimab monotherapy was far below the expectation despite the patients had been infected by a theoretically sensitive viral variant.

Download Full-text

Abstract 16955: Effects of Evolocumab (AMG 145) as a Monotherapy or in Combination with Statins on Lipoprotein Particles and Subclasses

Circulation ◽

10.1161/circ.130.suppl_2.16955 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Ren Xu ◽

Matt Peach ◽

Michael Tracy ◽

Lisa Hamilton ◽

Stephen Djedjos ◽

...

Keyword(s):

Clinical Studies ◽

Dependent Manner ◽

Phase 2 ◽

P Values ◽

Lipoprotein Particles ◽

Treatment Regimens ◽

Phase 2 Study ◽

Before And After ◽

Phase 1B ◽

Dose Dependent

Background: Evolocumab (AMG 145) reduces LDL-C alone or in combination with statins. We evaluated the effect of evolocumab on lipoprotein particles from subjects receiving evolocumab as monotherapy or combined with statins using biomarker samples collected from 2 clinical studies. Methods: Exploratory biomarker samples, taken before and after evolocumab treatment from a phase 1b study evaluating evolocumab combined with statins in hypercholesterolemic (HCL) subjects and from a phase 2 study evaluating evolocumab as a monotherapy in HCL subjects, were analyzed by NMR at LipoScience, Inc. Lipoprotein particle concentrations and size were determined using the LP-3 module. Results: Evolocumab alone or in combination with statins significantly reduced total, small, and large LDL-P in a dose-dependent manner. As shown in the table, evolocumab monotherapy reduced total LDL-P by 45% and 54%, small LDL-P by 36% and 35%, and large LDL-P by 68% and 84%, after 140 mg and 420 mg doses, respectively. LDL-P values were reduced slightly less than LDL-C (52% at 140 mg and 62% at 420 mg), but LDL-P reductions were similar to those seen for ApoB. IDL-P, total VLDL-P, and small VLDL-P were also reduced. Total HDL-P increased, primarily due to increases in large HDL-P. Similar results were obtained when evolocumab was given combined with statins, but with greater reductions in total, small, and large LDL-P. Notably, greater reductions in LDL-P or LDL-C were correlated with higher concentrations of total LDL-P, small LDL-P, triglycerides, smaller LDL size, and lower HDL-C at baseline. Conclusion: Evolocumab either alone or in combination with statins affected lipoprotein particles similarly. In both treatment regimens, LDL-C and total LDL-P were significantly reduced and large LDL-P were reduced, on average, to a greater extent than small LDL-P. Total LDL-P was reduced to a lesser extent than LDL-C. Additionally, reductions in VLDL-P and IDL-P were observed along with increases in HDL-P.

Download Full-text