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Article ; Online: Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. Reply.

Tuttle, Jay / Emery, Paul / Nirula, Ajay

2023 Volume 389, Issue 4, Page(s) 378–379

MeSH term(s)	Humans ; Adult ; Arthritis, Rheumatoid/drug therapy ; Severity of Illness Index
Language	English
Publishing date	2023-07-25
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2307020
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Article ; Online: Neutralizing Antibody LY-CoV555 for Outpatient Covid-19. Reply.

Nirula, Ajay / Shen, Lei / Skovronsky, Daniel M

The New England journal of medicine

2020 Volume 384, Issue 2, Page(s) 189

MeSH term(s)	Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 ; Humans ; Outpatients ; SARS-CoV-2
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral
Language	English
Publishing date	2020-12-30
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2033787
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Article ; Online: Bispecific antibodies: The next generation of targeted inflammatory bowel disease therapies.

Peyrin-Biroulet, Laurent / Demarest, Stephen / Nirula, Ajay

Autoimmunity reviews

2018 Volume 18, Issue 2, Page(s) 123–128

Abstract: Targeting various disease pathways using monoclonal antibodies (mAbs) has transformed the treatment paradigm for inflammatory bowel disease (IBD), with these agents exhibiting improved efficacy over corticosteroids or immunosuppressive therapies. ... ...

Abstract	Targeting various disease pathways using monoclonal antibodies (mAbs) has transformed the treatment paradigm for inflammatory bowel disease (IBD), with these agents exhibiting improved efficacy over corticosteroids or immunosuppressive therapies. Antibodies targeting tumor necrosis factor α (TNF-α) were the first approved biologics for IBD, followed by the more recent approval of antibodies targeting the α4β7 integrin heterodimer and ustekinumab, which targets the p40 subunit of interleukin-23. Current efforts are focused on the development of additional biologics targeting these known and other newly discovered pathways. Still significant unmet needs remain, as a large proportion of patients either fail to achieve remission or fail to respond altogether. Both Crohn's disease and ulcerative colitis are complex and heterogeneous diseases with several molecular pathways involved in disease pathophysiology. We propose an additional therapeutic approach to the treatment of IBD, bispecific antibodies (BsAbs), which combine two distinct binding specificities within a single biologic to allow the simultaneous targeting of multiple disease-causing cytokines or pathways. Although primarily used in oncology thus far, the unique combinatorial mechanism of action of BsAbs may provide new therapeutic options for a broad range of clinical applications, including autoimmune and inflammatory diseases. This review will discuss the current status of BsAb development in general and potentially therapeutic application in IBD.
MeSH term(s)	Antibodies, Bispecific/pharmacology ; Antibodies, Bispecific/therapeutic use ; Colitis, Ulcerative/drug therapy ; Colitis, Ulcerative/pathology ; Crohn Disease/drug therapy ; Crohn Disease/pathology ; Humans ; Inflammatory Bowel Diseases/pathology ; Inflammatory Bowel Diseases/therapy
Chemical Substances	Antibodies, Bispecific
Language	English
Publishing date	2018-12-17
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2144145-5
ISSN	1873-0183 ; 1568-9972
ISSN (online)	1873-0183
ISSN	1568-9972
DOI	10.1016/j.autrev.2018.07.014
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Article ; Online: Dietary Exposure to United States Food and Drug Administration-Approved Synthetic Food Colors in Children, Pregnant Women, and Women of Childbearing Age Living in the United States.

Bradman, Asa / Castorina, Rosemary / Thilakaratne, Ruwan / Gillan, Mayela / Pattabhiraman, Teja / Nirula, Anuroop / Marty, Melanie / Miller, Mark D

International journal of environmental research and public health

2022 Volume 19, Issue 15

Abstract: The Food and Drug Administration (FDA) regulates artificial food colors (AFCs) in the United States. Exposure to AFCs has raised concerns about adverse behavioral effects in children. We quantified AFC exposure in women of childbearing age, pregnant ... ...

Abstract	The Food and Drug Administration (FDA) regulates artificial food colors (AFCs) in the United States. Exposure to AFCs has raised concerns about adverse behavioral effects in children. We quantified AFC exposure in women of childbearing age, pregnant women, and children and compared them to FDA and World Health Organization acceptable daily intakes (ADIs). We estimated the “typical” and “high” single-day and two-day average dietary exposure to each AFC (mg/kg/day) based on laboratory measurements and food consumption data from the 2015−2016 National Health and Nutrition Examination Survey (NHANES). We also examined whether AFC intake differed by income, education, and ethnicity. Exposure tended to be higher in children and the highest AFC exposure was found for Red No. 40. Children’s mean and 95th percentile FD&C Red No. 3 estimated intakes exceeded the ADIs in some instances. Juice drinks, soft drinks, icings, and ice cream cones were major foods contributing to children’s (<16 years old) AFC exposure. AFC intake was higher in participants with lower incomes and education and of African American ethnicity. The findings indicate widespread AFC exposure including in very young children. Research is needed on the sociodemographic determinants of exposure and AFC toxicokinetics to better describe the absorption and organ-specific exposure.
MeSH term(s)	Adolescent ; Child ; Child, Preschool ; Color ; Diet ; Dietary Exposure ; Female ; Humans ; Nutrition Surveys ; Pregnancy ; Pregnant Women ; United States ; United States Food and Drug Administration
Language	English
Publishing date	2022-08-05
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2175195-X
ISSN	1660-4601 ; 1661-7827
ISSN (online)	1660-4601
ISSN	1661-7827
DOI	10.3390/ijerph19159661
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Article ; Online: A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis.

Tuttle, Jay / Drescher, Edit / Simón-Campos, Jesus Abraham / Emery, Paul / Greenwald, Maria / Kivitz, Alan / Rha, Hyungmin / Yachi, Pia / Kiley, Christina / Nirula, Ajay

The New England journal of medicine

2023 Volume 388, Issue 20, Page(s) 1853–1862

Abstract: Background: Peresolimab is a humanized IgG1 monoclonal antibody designed to stimulate the endogenous programmed cell death protein 1 (PD-1) inhibitory pathway. Stimulation of this pathway would be a novel approach to the treatment of patients with ... ...

Abstract	Background: Peresolimab is a humanized IgG1 monoclonal antibody designed to stimulate the endogenous programmed cell death protein 1 (PD-1) inhibitory pathway. Stimulation of this pathway would be a novel approach to the treatment of patients with autoimmune or autoinflammatory diseases. Methods: In this phase 2a, double-blind, randomized, placebo-controlled trial, we assigned, in a 2:1:1 ratio, adult patients with moderate-to-severe rheumatoid arthritis who had had an inadequate response to, a loss of response to, or unacceptable side effects with conventional synthetic disease-modifying antirheumatic drugs (DMARDs) or to biologic or targeted synthetic DMARDs to receive 700 mg of peresolimab, 300 mg of peresolimab, or placebo intravenously once every 4 weeks. The primary outcome was the change from baseline to week 12 in the Disease Activity Score for 28 joints based on the C-reactive protein level (DAS28-CRP). The DAS28-CRP ranges from 0 to 9.4, with higher scores indicating more severe disease. The primary comparison was between the 700-mg group and the placebo group. Secondary outcomes included the percentages of patients with American College of Rheumatology 20 (ACR20), ACR50, and ACR70 responses - defined as improvements from baseline of 20%, 50%, and 70% or more, respectively, in the numbers of tender and swollen joints and in at least three of five important domains - at week 12. Results: At week 12, the change from baseline in the DAS28-CRP was significantly greater in the 700-mg peresolimab group than in the placebo group (least-squares mean change [±SE], -2.09±0.18 vs. -0.99±0.26; difference in change, -1.09 [95% confidence interval, -1.73 to -0.46]; P<0.001). The results of the analyses of secondary outcomes favored the 700-mg dose over placebo with respect to the ACR20 response but not with respect to the ACR50 and ACR70 responses. Adverse events were similar in the peresolimab and placebo groups. Conclusions: Peresolimab showed efficacy in a phase 2a trial in patients with rheumatoid arthritis. These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis. (Funded by Eli Lilly; ClinicalTrials.gov number, NCT04634253.).
MeSH term(s)	Adult ; Humans ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Double-Blind Method ; Drug Therapy, Combination ; Severity of Illness Index ; Treatment Outcome ; Immunoglobulin G ; Administration, Intravenous ; Programmed Cell Death 1 Receptor/agonists
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; Immunoglobulin G ; PDCD1 protein, human ; Programmed Cell Death 1 Receptor
Language	English
Publishing date	2023-05-17
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa2209856
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Article ; Online: A Quantitative Modeling and Simulation Framework to Support Candidate and Dose Selection of Anti-SARS-CoV-2 Monoclonal Antibodies to Advance Bamlanivimab Into a First-in-Human Clinical Trial.

Chigutsa, Emmanuel / Jordie, Eric / Riggs, Matthew / Nirula, Ajay / Elmokadem, Ahmed / Knab, Tim / Chien, Jenny Y

Clinical pharmacology and therapeutics

2021 Volume 111, Issue 3, Page(s) 595–604

Abstract: Neutralizing monoclonal antibodies (mAb), novel therapeutics for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), have been urgently researched from the start of the pandemic. ... ...

Abstract	Neutralizing monoclonal antibodies (mAb), novel therapeutics for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), have been urgently researched from the start of the pandemic. The selection of the optimal mAb candidate and therapeutic dose were expedited using open-access in silico models. The maximally effective therapeutic mAb dose was determined through two approaches; both expanded on innovative, open-science initiatives. A physiologically-based pharmacokinetic (PBPK) model, incorporating physicochemical properties predictive of mAb clearance and tissue distribution, was used to estimate mAb exposure that maintained concentrations above 90% inhibitory concentration of in vitro neutralization in lung tissue for up to 4 weeks in 90% of patients. To achieve fastest viral clearance following onset of symptoms, a longitudinal SARS-CoV-2 viral dynamic model was applied to estimate viral clearance as a function of drug concentration and dose. The PBPK model-based approach suggested that a clinical dose between 175 and 500 mg of bamlanivimab would maintain target mAb concentrations in the lung tissue over 28 days in 90% of patients. The viral dynamic model suggested a 700 mg dose would achieve maximum viral elimination. Taken together, the first-in-human trial (NCT04411628) conservatively proceeded with a starting therapeutic dose of 700 mg and escalated to higher doses to evaluate the upper limit of safety and tolerability. Availability of open-access codes and application of novel in silico model-based approaches supported the selection of bamlanivimab and identified the lowest dose evaluated in this study that was expected to result in the maximum therapeutic effect before the first-in-human clinical trial.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/pharmacokinetics ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Neutralizing/administration & dosage ; Antiviral Agents/administration & dosage ; Antiviral Agents/pharmacokinetics ; Clinical Trials as Topic ; Computer Simulation ; Dose-Response Relationship, Drug ; Dose-Response Relationship, Immunologic ; Humans ; Models, Biological ; SARS-CoV-2/drug effects ; SARS-CoV-2/immunology
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Antibodies, Neutralizing ; Antiviral Agents ; bamlanivimab (45I6OFJ8QH)
Language	English
Publishing date	2021-11-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2459
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Article ; Online: COVID-19 symptom relationship to antibody response and ACE2 neutralization in recovered health systems employees before and after mRNA BNT162b2 COVID-19 vaccine.

Huhn, Gregory / Poorbaugh, Josh / Zhang, Lin / Beasley, Stephanie / Nirula, Ajay / Brothers, Jennifer / Welbel, Sharon / Wilson, James / Gillani, Sheena / Weber, Kathleen M / Morack, Ralph / Keckler, Kody / Benschop, Robert J

PloS one

2022 Volume 17, Issue 9, Page(s) e0273323

Abstract: Background: The humoral response to SARS-CoV-2 can provide immunity and prevent reinfection. However, less is known about how the diversity, magnitude, and length of the antibody response after a primary infection is associated with symptoms, post- ... ...

Abstract	Background: The humoral response to SARS-CoV-2 can provide immunity and prevent reinfection. However, less is known about how the diversity, magnitude, and length of the antibody response after a primary infection is associated with symptoms, post-infection immunity, and post-vaccinated immunity. Methods: Cook County Health employees provided blood samples and completed an online survey 8-10 weeks after a PCR-confirmed positive SARS-CoV-2 test (pre-vaccinated, N = 41) and again, 1-4 weeks after completion of a 2-dose series mRNA BNT162b2 COVID-19 vaccine (post-vaccinated, N = 27). Associations were evaluated between SARS-CoV-2 antibody titers, participant demographics, and clinical characteristics. Antibody titers and angiotensin-converting enzyme 2 (ACE2) neutralization were compared before and after the mRNA BNT162b2 COVID-19 vaccine. Results: Antibody titers to the spike protein (ST4), receptor binding domain (RBD), and RBD mutant D614G were significantly associated with anosmia and ageusia, cough, and fever. Spike protein antibody titers and ACE2 neutralization were significantly higher in participants that presented with these symptoms. Antibody titers to the spike protein N-terminal domain (NTD), RBD, and ST4, and ACE2 IC50 were significantly higher in all post-vaccinated participant samples compared to pre-vaccinated participant sample, and not dependent on previously reported symptoms. Conclusions: Spike protein antibody titers and ACE2 neutralization are associated with the presentation of anosmia and ageusia, cough, and fever after SARS-CoV-2 infection. Symptom response to previous SARS-CoV-2 infection did not influence the antibody response from subsequent vaccination. These results suggest a relationship between infection severity and the magnitude of the immune response and provide meaningful insights into COVID-19 immunity according to discrete symptom presentation.
MeSH term(s)	Ageusia ; Angiotensin-Converting Enzyme 2 ; Anosmia ; Antibodies, Viral ; Antibody Formation ; BNT162 Vaccine ; COVID-19/diagnosis ; COVID-19/prevention & control ; COVID-19 Vaccines ; Cough ; Humans ; RNA, Messenger/genetics ; SARS-CoV-2 ; Spike Glycoprotein, Coronavirus
Chemical Substances	Antibodies, Viral ; COVID-19 Vaccines ; RNA, Messenger ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2 ; Angiotensin-Converting Enzyme 2 (EC 3.4.17.23) ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2022-09-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0273323
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Article ; Online: Exposures to FD&C synthetic color additives from over-the-counter medications and vitamins in United States children and pregnant women.

Thilakaratne, Ruwan / Castorina, Rosemary / Gillan, Mayela / Han, Dorothy / Pattabhiraman, Teja / Nirula, Anuroop / Miller, Mark D / Marty, Melanie / Lehmkuhler, Arlie / Mitchell, Alyson / Bradman, Asa

Journal of exposure science & environmental epidemiology

2022 Volume 33, Issue 5, Page(s) 787–793

Abstract: Background: Food and Drug Administration (FDA) Food Drug and Cosmetic (FD&C) synthetic color additives (SCAs) have been associated with attentional and behavioral problems in children. Efforts to quantify exposure have focused on foods, while the ... ...

Abstract	Background: Food and Drug Administration (FDA) Food Drug and Cosmetic (FD&C) synthetic color additives (SCAs) have been associated with attentional and behavioral problems in children. Efforts to quantify exposure have focused on foods, while the contribution of medications and supplements remains unknown. Objective: To estimate exposures to SCAs in children (2-16 years) and pregnant women from intake of common over-the-counter (OTC) medications and vitamins. Methods: We estimated single-day exposure (mg/kg/day) to FD&C SCAs based on measurements of 25 different products and recommended dosages on product labels. Exposures were compared to SCA exposure estimates from food we previously developed and acceptable daily intakes (ADIs) established by FDA and the World Health Organization. Results: The highest exposure was found for FD&C Red No. 40 in a children's cold/cough/allergy syrup. A child aged 12-16 years consuming the maximum daily dosage would have an exposure of 0.221 mg/kg/day, which is twice this age group's typical exposure to this additive from food. No estimated exposures exceeded the ADIs. Significance: Some children's OTC medications and vitamins may cause daily SCA exposures comparable to those from foods. OTC medications and vitamins should be considered in efforts to quantify population exposure to FD&C SCAs. Impact: Exposure to synthetic color additives (SCAs) from foods has been associated with behavioral problems in children. Exposures from over-the-counter (OTC) medications and vitamins remain unquantified despite widespread use. We estimated exposures in children and pregnant women for 25 different OTC medication and vitamin products sold in the United States. While exposures were below acceptable daily intakes (ADIs) established by the US Food and Drug Administration and the World Health Organization, some were comparable to typical daily exposures from foods. This work critically informs future SCA exposure assessments and provides valuable information for parents concerned about the health effects of SCAs.
MeSH term(s)	Child ; Humans ; Female ; Pregnancy ; United States ; Vitamins/analysis ; Pharmaceutical Preparations ; Pregnant Women ; Food Additives ; Dietary Supplements/adverse effects ; Vitamin A ; Vitamin K
Chemical Substances	Vitamins ; Pharmaceutical Preparations ; Food Additives ; Vitamin A (11103-57-4) ; Vitamin K (12001-79-5)
Language	English
Publishing date	2022-03-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2218551-3
ISSN	1559-064X ; 1559-0631
ISSN (online)	1559-064X
ISSN	1559-0631
DOI	10.1038/s41370-022-00418-9
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Article ; Online: The anti-SARS-CoV-2 monoclonal antibody bamlanivimab minimally affects the endogenous immune response to COVID-19 vaccination.

Benschop, Robert J / Tuttle, Jay L / Zhang, Lin / Poorbaugh, Josh / Kallewaard, Nicole L / Vaillancourt, Peter / Crisp, Melissa / Trinh, Thi Ngoc Vy / Freitas, Joshua J / Beasley, Stephanie / Daniels, Montanea / Haustrup, Natalie / Higgs, Richard E / Nirula, Ajay / Cohen, Myron S / Marovich, Mary

Science translational medicine

2022 Volume 14, Issue 655, Page(s) eabn3041

Abstract: As the coronavirus disease 2019 (COVID-19) pandemic evolves and vaccine rollout progresses, the availability and demand for monoclonal antibodies for the prevention and treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ... ...

Abstract	As the coronavirus disease 2019 (COVID-19) pandemic evolves and vaccine rollout progresses, the availability and demand for monoclonal antibodies for the prevention and treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are also accelerating. This longitudinal serological study evaluated the magnitude and potency of the endogenous antibody response to COVID-19 vaccination in participants who first received a COVID-19 monoclonal antibody in a prevention study. Over the course of 6 months, serum samples were collected from a population of nursing home residents and staff enrolled in a clinical trial who were randomized to either bamlanivimab treatment or placebo. In an unplanned component of this trial, a subset of these participants was subsequently fully vaccinated with two doses of either SpikeVax (Moderna) or Comirnaty (BioNTech/Pfizer) COVID-19 mRNA vaccines. This post hoc analysis assessed the immune response to vaccination for 135 participants without prior SARS-CoV-2 infection. Antibody titers and potency were assessed using three assays against SARS-CoV-2 proteins that bamlanivimab does not efficiently bind to, thereby reflecting the endogenous antibody response. All bamlanivimab and placebo recipients mounted a robust immune response to full COVID-19 vaccination, irrespective of age, risk category, and vaccine type with any observed differences of uncertain clinical importance. These findings are pertinent for informing public health policy with results that suggest that the benefit of receiving COVID-19 vaccination at the earliest opportunity outweighs the minimal effect on the endogenous immune response due to prior prophylactic COVID-19 monoclonal antibody infusion.
MeSH term(s)	Antibodies, Monoclonal, Humanized/therapeutic use ; Antibodies, Neutralizing ; Antibodies, Viral ; Antibody Formation ; COVID-19 ; COVID-19 Vaccines ; Humans ; SARS-CoV-2 ; Vaccination ; Viral Vaccines
Chemical Substances	Antibodies, Monoclonal, Humanized ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Viral Vaccines ; bamlanivimab (45I6OFJ8QH)
Language	English
Publishing date	2022-07-27
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2518854-9
ISSN	1946-6242 ; 1946-6234
ISSN (online)	1946-6242
ISSN	1946-6234
DOI	10.1126/scitranslmed.abn3041
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Article ; Online: Characterization of the Cytokine Storm Reflects Hyperinflammatory Endothelial Dysfunction in COVID-19

Sims, JT / Krishnan, V / Chang, C-Y / Eagle, SM / Casalini, G / Rodgers, GH / Bivi, N / Nickoloff, BJ / Konrad, RJ / De Bono, S / Higgs, RE / Benschop, RJ / Ottaviani, S / Cardosa, A / Nirula, A / Corbellino, M / Stebbing, J

2020

Abstract: Background Physicians treating COVID-19 patients increasingly believe that the hyperinflammatory acute stage of COVID-19 results in a cytokine storm. The circulating biomarkers seen across the spectrum of COVID-19 have not been characterized compared to ... ...

Abstract	Background Physicians treating COVID-19 patients increasingly believe that the hyperinflammatory acute stage of COVID-19 results in a cytokine storm. The circulating biomarkers seen across the spectrum of COVID-19 have not been characterized compared to healthy controls, but such analyses are likely to yield insights into the pursuit of interventions that adequately reduce the burden of these cytokine storms. Objective To identify and characterize the host inflammatory response to SARS-CoV-2 infection, we assessed levels of proteins related to immune responses and cardiovascular disease, in patients stratified as mild, moderate, and severe, versus matched healthy controls. Methods Blood samples from adult patients hospitalized with COVID-19 were analyzed using high-throughput and ultrasensitive proteomic platforms and compared with age- and sex-matched healthy controls to provide insights into differential regulation of 185 markers. Results Results indicate a dominant hyperinflammatory milieu in the circulation and vascular endothelial damage markers within COVID-19 patients, and strong biomarker association with patient response as measured by Ordinal scale. As patients progress, we observe statistically significant dysregulation of IFNγ, IL-1RA, IL-6, IL-10, IL-19, MCP-1, -2, -3, CXCL9, CXCL10, CXCL5, ENRAGE and PARP-1. Furthermore, in a limited series of patients who were sampled frequently confirming reliability and reproducibility of our assays, we demonstrate that intervention with baricitinib attenuates these circulating biomarkers associated with the cytokine storm. Conclusion These wide-ranging circulating biomarkers show an association with increased disease severity and may help stratify patients and selection of therapeutic options. They also provide insights into mechanisms of SARS-CoV-2 pathogenesis and the host response.
Keywords	1107 Immunology ; Allergy ; covid19
Publishing date	2020-08-12
Publisher	Elsevier
Publishing country	uk
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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