scholarly journals Establishing a Distribution Network for COVID-19 Monoclonal Antibody Therapy Across a Large Health System During a Global Pandemic

2021 ◽  
Author(s):  
J Ryan Bariola ◽  
Erin K McCreary ◽  
Tina Khadem ◽  
Graham M Snyder ◽  
Richard J Wadas ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Health System ◽  
Distribution Network ◽  
Antibody Therapy ◽  
Lessons Learned ◽  
Monoclonal Antibody Therapy ◽  
Global Pandemic

Abstract Emergency authorized COVID-19 neutralizing monoclonal antibodies can aid outpatients with mild to moderate COVID-19 infection. Many report barriers to adequate distribution and uptake. We present our model for distribution in a large health system as well as early lessons learned.

scholarly journals Monoclonal Antibody Therapy in Neuromyelitis Optica Spectrum Disorders: a Meta-analysis of Randomized Control Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Fanxin Kong ◽  
Jianjun Wang ◽  
Haotao Zheng ◽  
Haobin Cai ◽  
Jun Hua ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Neuromyelitis Optica ◽  
Antibody Therapy ◽  
Cochrane Library ◽  
Control Group ◽  
Monoclonal Antibody Therapy ◽  
Neuromyelitis Optica Spectrum Disorders ◽  
Spectrum Disorders

Background: To update the efficacy and safety data of monoclonal antibodies for the treatment of neuromyelitis optica spectrum disorders (NMOSD) and explore the differences in the effect of treatment between patients seropositive and seronegative for AQP4-IgG. Methods: PubMed, Embase, and the Cochrane Library published up to July 2020 were searched for randomized controlled trials (RCTs) of monoclonal antibodies treatment (mAb) in patients with NMOSD. The primary outcome was the hazard ratio (HR) for relapse. The secondary outcomes included Expanded Disability Status Scale (EDSS) changes from baseline, adverse events (AEs), and serious adverse events (SAEs). A random-effects model was applied for the effect of heterogeneity among trials. Results: We included 603 patients (monoclonal antibody group, n=382, and control group, n=221) from seven RCTs. There were fewer relapses in the mAb group (HR=0.32, 95% CI: 0.23-0.46, p<0.001), as well as in the AQP4-IgG-seropositive patients (HR=0.18, 95% CI: 0.10–0.32, p<0.001), but not in AQP4-IgG-seronegative NMOSD. Similar results were observed when considering satralizumab only. The mAb had no impact on the changes in EDSS scores from baseline (WMD=−0.21, 95% CI: −0.50-0.09, p=0.176). The mAb did not lead to a higher frequency of AEs (OR=1.18, 95% CI: 0.70–1.98, p=0.529) or SAEs (OR=0.99, 95% CI: 0.63–1.56, p=0.975) compared with the control group. Conclusions: Compared to the control arm, monoclonal antibody therapy showed a significantly better outcome in restraining the HR for relapse among patients with NMOSD but insignificant effects in NMOSD patients with seronegative APQ4-IgG. The safety profile in each arm had no significant difference.

scholarly journals B.1.526 SARS-CoV-2 Variants Identified in New York City are Neutralized by Vaccine-Elicited and Therapeutic Monoclonal Antibodies

mBio ◽  
2021 ◽  
Author(s):  
Hao Zhou ◽  
Belinda M. Dcosta ◽  
Marie I. Samanovic ◽  
Mark J. Mulligan ◽  
Nathaniel R. Landau ◽  
...  
Keyword(s):  
New York ◽  
Monoclonal Antibody ◽  
New York City ◽  
Monoclonal Antibodies ◽  
York City ◽  
Antibody Therapy ◽  
Spike Protein ◽  
Monoclonal Antibody Therapy ◽  
Therapeutic Monoclonal Antibodies

A novel SARS-CoV-2 variant termed B.1.526 was recently identified in New York City and has been found to be spreading at an alarming rate. The variant has mutations in its spike protein that might allow it to escape neutralization by vaccine-elicited antibodies and might cause monoclonal antibody therapy for COVID-19 to be less successful.

scholarly journals Monoclonal Antibody Therapy for COVID-19: A Public Health Perspective From Arkansas

2022 ◽  
Vol 9 (1) ◽  
Author(s):  
Atul Kothari ◽  
Elizabeth Woodland Borella ◽  
Michelle R Smith
Keyword(s):  
Public Health ◽  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Antibody Therapy ◽  
Ambulatory Setting ◽  
Short Report ◽  
Monoclonal Antibody Therapy ◽  
Public Health Perspective

Abstract COVID-19 monoclonal antibodies revolutionized the treatment for eligible patients who have tested positive for SARS CoV-2 infection in an ambulatory setting. In this short report, we describe our experience assisting in the distribution of monoclonal antibodies in Arkansas during the summer surge of the delta variant.

scholarly journals Different Targets of Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders: A Meta-Analysis Evidenced From Randomized Controlled Trials

2020 ◽  
Vol 11 ◽  
Author(s):  
Tao Xue ◽  
Jiahao Yu ◽  
Shujun Chen ◽  
Zilan Wang ◽  
Yanbo Yang ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Neuromyelitis Optica ◽  
Meta Analysis ◽  
Antibody Therapy ◽  
Controlled Trials ◽  
Monoclonal Antibody Therapy ◽  
Randomized Controlled

Background: Neuromyelitis optica spectrum disorder (NMOSD), an autoimmune inflammatory disorder of the central nervous system, often leads to vision loss or paralysis. This meta-analysis focused on the assessment of the monoclonal antibody therapy in NMOSD and compared different targets of monoclonal antibodies with each other in terms of efficacy and safety outcomes.Method: We searched through the databases of MEDLINE, EMBASE, Central Register of Controlled Trials (CENTRAL), and clinicaltrials.gov for randomized controlled trials (RCTs) evaluating monoclonal antibody therapy in NMOSD up to April 2020.Results: We identified seven randomized controlled trials (RCTs), including 775 patients (monoclonal antibody group, n = 485 and placebo group, n = 290). Monoclonal antibody therapy decreased relapse risk (RR 0.33, 95% CI 0.21–0.52, P < 0.00001), annualized relapse rate (ARR) (mean −0.28, 95% CI −0.35−0.20, P < 0.00001), expanded disability status scale score (EDSS) (mean −0.19, 95% CI −0.32−0.07, P = 0.002) and serious adverse events (RR 0.78, 95% CI 0.61–1.00, P = 0.05). However, we did not observe any significant difference in terms of adverse events or mortality. Further, the subgroup analysis demonstrated that the anti-complement protein C5 monoclonal antibody (eculizumab) might have a lower relapse risk (RR 0.07, 95% CI 0.02–0.23, P < 0.0001) in the AQP4 seropositive patients, and anti-interleukin-6 receptor monoclonal antibodies (satralizumab and tocilizumab) showed decreased EDSS score (mean −0.17, 95% CI −0.31−0.02, P = 0.02) more effectively than other monoclonal antibodies.Conclusions: Monoclonal antibodies were effective and safe in NMOSD. Different targets of monoclonal antibodies might have their own advantages.

Update on Targeted Therapy—Focus on Monoclonal Antibodies

2008 ◽  
Vol 21 (1) ◽  
pp. 4-16 ◽  
Author(s):  
Meredith B. Toma ◽  
Patrick J. Medina
Keyword(s):  
Monoclonal Antibody ◽  
Cell Death ◽  
Monoclonal Antibodies ◽  
Targeted Therapy ◽  
Antibody Therapy ◽  
Therapeutic Agents ◽  
Monoclonal Antibody Therapy ◽  
Effective Management ◽  
Cellular Targets ◽  
Common Structure

Monoclonal antibodies represent a diverse class of therapeutic agents frequently used in the treatment of various malignancies. Monoclonal antibodies have a common structure with varying amounts of human and nonhuman components. These agents have been developed to identify and to interact with specific cellular targets or signaling pathways, leading to cell death by various mechanisms. Adverse effects associated with monoclonal antibodies are related to their structure (human vs nonhuman content) and to their cellular targets. Pharmacists should be familiar with this class of therapeutic agents to provide effective management and to monitor patients receiving monoclonal antibody therapy.

scholarly journals THE USE OF MONOCLONAL ANTIBODIES IN THE TREATMENT OF AUTOIMMUNE COMPLICATIONS OF CHRONIC LYMPHOCYTIC LEUKEMIA

2013 ◽  
Vol 5 (1) ◽  
pp. e2013027 ◽  
Author(s):  
Luca Laurenti
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Malignant Disease ◽  
Randomized Trials ◽  
Antibody Therapy ◽  
Lymphocytic Leukemia ◽  
Monoclonal Antibody Therapy ◽  
Future Studies ◽  
Autoimmune Cytopenias ◽  
Common Manifestation

Autoimmune cytopenias are a frequent complication in CLL, occuring in approximately 5-10% of the patients. The most common manifestation is autoimmune haemolytic anaemia, followed by immune thrombocytopaenia and only rarely pure red blood cell aplasia or autoimmune granulocytopaenia. Initial treatment is as for the idiopathic autoimmune cytopenias, with most patients responding to conventional corticosteroid therapy. Patients not responding after 4–6 weeks of conventional therapy should be considered for alternative immunosuppression, monoclonal antibody therapy or splenectomy.   While randomized trials demonstrating the benefit of rituximab in CLL-related autoimmune diseases are still lacking, there are considerable data in the literature that provide evidence for its effectiveness.The monoclonal antibody alemtuzumab also displays considerable activity against both the malignant disease and the autoimmune complication in patients with CLL, although at the expense of greater toxicity. A number of new monoclonal antibodies, such as ofatumumab, GA-101, lumiliximab, TRU-016, epratuzumab, and galiximab, are currently investigated in CLL and their activity in CLL-related autoimmune cytopenias should be evaluated in future studies.

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