Technologies to Maintain Biological Diversity. Volume 2, Part C: Natural Systems-United States; Part D: Natural Systems-International.

1989 ◽  
Vol 64 (4) ◽  
pp. 516-516
Author(s):  
Herbert A. Raffaele
Keyword(s):  
United States ◽  
Biological Diversity ◽  
Part D ◽  
Natural Systems ◽  
Part C

scholarly journals SAT0172 UTILIZATION OF HYDROXYCHLOROQUINE AND CORTICOSTEROIDS AMONG LUPUS PATIENTS WITH INCIDENT END-STAGE RENAL DISEASE (ESRD) ONSET: A LONGITUDINAL STUDY USING USRDS REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1027.2-1027
Author(s):  
A. R. Broder ◽  
W. Mowrey ◽  
A. Valle ◽  
B. Goilav ◽  
K. Yoshida ◽  
...  
Keyword(s):  
United States ◽  
Lupus Nephritis ◽  
Renal Disease ◽  
International Classification Of Diseases ◽  
The United States ◽  
Diagnostic Code ◽  
Prescribing Practices ◽  
Part D ◽  
Stage Renal Disease

Background:The development of ESRD due to lupus nephritis is one of the most common and serious complications of SLE. Mortality among SLE ESRD patients is 4-fold higher compared to lupus nephritis patients with preserved renal function1Mortality in SLE ESRD is also twice as high compared with non-SLE ESRD, even though SLE patients develop ESRD at a significantly younger age. In the absence of ESRD specific guidelines, medication utilization in SLE ESRD is unknown.Objectives:The objective of this study was to investigate the real-world current US-wide patterns of medication prescribing among lupus nephritis patients with new onset ESRD enrolled in the United States Renal Disease Systems (USRDS) registry. We specifically focused on HCQ and corticosteroids (CS) as the most used medications to treat SLE.Methods:Inclusion: USRDS patients 18 years and above with SLE as a primary cause of ESRD (International Classification of Diseases, 9thRevision (ICD9) diagnostic code 710.0, previously validated2). who developed ESRD between January 1st, 2006 and July 31, 2011 (to ensure at least 6 months of follow-up in the USRDS). Patients had to be enrolled in Medicare Part D (to capture pharmacy claims). The last follow-up date was defined as either the last date of continuous part D coverage or the end of the study period, Dec 31, 2013.Results:Of the 2579 patients included, 1708 (66%) were HCQ- at baseline, and 871 (34%) were HCQ+ at baseline. HCQ+ patients at baseline had a slightly lower duration of follow-up compared to HCQ- patients at baseline, median (IQR) of 2.32 (1.33, 3.97) years and 2.55 (1.44, 4.25) years, respectively, p= 0.02. During follow-up period, only 778 (30%) continued HCQ either intermittently or continuously to the last follow-up date, 1306 (51%) were never prescribed HCQ after baseline, and 495 (19%) discontinued HCQ before the last follow-up date. Of the 1801 patients who were either never prescribed or discontinued HCQ early after ESRD onset, 713 (40%) were prescribed CS to the end of the follow-up period: 55% were receiving a low dose <10mg/daily, and 43 were receiving moderate dose (10-20mg daily)Conclusion:HCQ may be underprescribed and CS may be overprescribed in SLE ESRD. Changing the current prescribing practices may improve outcomes in SLE ESRDReferences:[1]Yap DY et al., NDT 2012.[2]Broder A et al., AC&R 2016.Acknowledgments :The data reported here have been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government.Funding: :NIH/NIAMS K23 AR068441 (A Broder), NIH/NIAMS R01 AR 057327 and K24 AR 066109 (KH Costenbader)Disclosure of Interests: :Anna R. Broder: None declared, Wenzhu Mowrey: None declared, Anna Valle: None declared, Beatrice Goilav: None declared, Kazuki Yoshida: None declared, Karen Costenbader Grant/research support from: Merck, Consultant of: Astra-Zeneca

CheckMate 8KX: Phase 1/2 multitumor preliminary analyses of a subcutaneous formulation of nivolumab (± rHuPH20).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2575-2575
Author(s):  
Sara Lonardi ◽  
Iwona Lugowska ◽  
Christopher G. C. A. Jackson ◽  
Anne O'Donnell ◽  
Rastilav Bahleda ◽  
...  
Keyword(s):  
De Novo ◽  
Phase 1 ◽  
Geometric Mean ◽  
Primary Objective ◽  
Tumor Type ◽  
Part D ◽  
Part C ◽  
Local Site ◽  
Survival Expectations ◽  
Grade 3

2575 Background: Immunotherapy has transformed cancer survival expectations. Nivolumab (NIVO), a programmed death-1 inhibitor, is approved for intravenous (IV) administration across multiple cancers. BMS is developing a subcutaneous (SC) NIVO formulation with a permeation enhancer, recombinant human hyaluronidase PH20 enzyme (rHuPH20), to allow for more rapid delivery and the potential to decrease treatment burden. We report the first data on pharmacokinetics (PK), pharmacodynamics, safety, and immunogenicity for SC NIVO + rHuPH20. Methods: CheckMate 8KX is a phase 1/2 study in checkpoint inhibitor-naïve patients (pts) who were ≥ 18 years of age, ECOG PS 0–1, with metastatic/unresectable solid tumors and measurable disease. The primary objective was to describe SC NIVO PK; secondary objectives were safety and immunogenicity. Additional analyses compared exposures to historical IV NIVO (Zhao X, et al. J Clin Oncol 2020;31:302–309). In cycle 1, pts in Part A received SC NIVO 720 mg + rHuPH20, and pts in Part B received SC NIVO 720 mg, SC NIVO 960 mg + rHuPH20, or SC NIVO 960 mg. For cycles 2+, pts in Parts A and B received IV NIVO 480 mg every 4 weeks (Q4W). Pts still on study switched to Part C, SC NIVO 1200 mg + rHuPH20 until end of therapy. In Part D, pts received de novo SC NIVO 1200 mg + rHuPH20 Q4W. Results: Patient characteristics varied by age, weight, tumor type, and prior treatment. NIVO exposures increased with increasing SC dose (Table). For 960 mg and 1200 mg NIVO + rHuPH20, Cavg and Ctau were above geometric mean exposures for IV NIVO 3 mg/kg every 2 weeks (Q2W), and Cmax was below IV NIVO 10 mg/kg Q2W. In Part C (n = 28), 13 (46.4%) pts experienced any-grade TRAEs with no new/worsening grade 3+ TRAEs or TRAEs leading to discontinuation/death; 7 (25.0%) reported grade 1 local site reactions. In Part D (n = 36), 27 (75.0%) pts experienced any-grade TRAEs, 4 (11.1%) grade 3/4 TRAEs, 2 (5.6%) serious grade 3/4 TRAEs with 1 leading to discontinuation, and no treatment-related deaths; 10 (27.8%) reported grade 1 local site reactions. Anti-NIVO antibodies (Ab) were observed with SC NIVO but not associated with altered PK/safety, or neutralizing Ab. Exploratory biomarker data found increased CD8+ tumor-infiltrating lymphocytes and PD-L1 tumor expression in post-treatment biopsies, similar to IV NIVO. Conclusions: Exposures associated with SC NIVO + rHuPH20 doses investigated in CheckMate 8KX were well tolerated, with a safety profile consistent with IV NIVO. Data support evaluation of SC NIVO + rHuPH20 in a phase 3 study. Clinical trial information: NCT03656718. [Table: see text]

The Right to an Effective Remedy Pursuant to Article II-107 Paragraph 1 of the Constitutional Treaty

2005 ◽  
Vol 6 (11) ◽  
pp. 1601-1616
Author(s):  
Katharina Pabel
Keyword(s):  
European Union ◽  
Legal Protection ◽  
The European Union ◽  
Constitutional Treaty ◽  
Part D ◽  
Binding Effect ◽  
Part C ◽  
Effective Remedy ◽  
The Right

The fundamental right to an effective remedy as guaranteed in Art. II-107(1) of the ‘Treaty establishing a Constitution for Europe’ (CT) is part of a comprehensive guarantee of effective legal protection and procedural guarantees. In the following, this fundamental right and how it relates to Parts I and III of the CT will be investigated in detail. First, the scope of Art. II-107(1) CT will be identified in Part B. Part C comments on the binding effect of this right. Finally, in Part D, some aspects of the Union's system of legal protection will be investigated in the light of Art. II-107(1) CT, and it will be discussed whether this right could be an instrument to close gaps in the legal protection of individuals against measures of the European Union.

Private Property Rights: The Development of Takings in the United States

2002 ◽  
Vol 17 (2) ◽  
pp. 195-233 ◽  
Author(s):  
Gerard J. Mangone
Keyword(s):  
United States ◽  
Biological Diversity ◽  
Private Property ◽  
The United States ◽  
Individual Property ◽  
Clean Environment ◽  
Public Nuisance ◽  
The 1960S ◽  
Regulatory Powers ◽  
The 19Th Century

AbstractConstraints upon the uses of private property in the United States have increased very far beyond the doctrines of Grotius, Locke, Blackstone, and the framers of the Constitution. In the 19th century, both public nuisance limitations and eminent domain takings were applied to particular holdings, with the latter requiring compensation under the Fifth Amendment. The New Deal of the 1930s and the envirommental movement of the 1960s radically changed the relationship of government to private property. Sweeping economic reforms and the exercise of broad regulatory powers by public agencies for a clean environment and biological diversity led to a wholesale "taking" of private property without compensation. Recent cases of the Supreme Court involving wetlands and coastal property reveal the tensions that exist between sovereign power for the public good and the protection of individual property as a bulwark against arbitrary government.

scholarly journals Recurrent bridgehead effects accelerate global alien ant spread

2018 ◽  
Vol 115 (21) ◽  
pp. 5486-5491 ◽  
Author(s):  
Cleo Bertelsmeier ◽  
Sébastien Ollier ◽  
Andrew M. Liebhold ◽  
Eckehard G. Brockerhoff ◽  
Darren Ward ◽  
...  
Keyword(s):  
United States ◽  
Latin America ◽  
New Zealand ◽  
Feedback Loop ◽  
Biological Diversity ◽  
The United States ◽  
Invasion Process ◽  
Positive Feedback Loop ◽  
Major Threat ◽  
Successful Establishment

Biological invasions are a major threat to biological diversity, agriculture, and human health. To predict and prevent new invasions, it is crucial to develop a better understanding of the drivers of the invasion process. The analysis of 4,533 border interception events revealed that at least 51 different alien ant species were intercepted at US ports over a period of 70 years (1914–1984), and 45 alien species were intercepted entering New Zealand over a period of 68 years (1955–2013). Most of the interceptions did not originate from species’ native ranges but instead came from invaded areas. In the United States, 75.7% of the interceptions came from a country where the intercepted ant species had been previously introduced. In New Zealand, this value was even higher, at 87.8%. There was an overrepresentation of interceptions from nearby locations (Latin America for species intercepted in the United States and Oceania for species intercepted in New Zealand). The probability of a species’ successful establishment in both the United States and New Zealand was positively related to the number of interceptions of the species in these countries. Moreover, species that have spread to more continents are also more likely to be intercepted and to make secondary introductions. This creates a positive feedback loop between the introduction and establishment stages of the invasion process, in which initial establishments promote secondary introductions. Overall, these results reveal that secondary introductions act as a critical driver of increasing global rates of invasions.

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