scholarly journals 512. Does Time From COVID-19 Symptom Onset to Administration of Anti-spike Protein Monoclonal Antibody Predict Response?

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S358-S358
Author(s):  
Savanna SanFilippo ◽  
Brynna Crovetto ◽  
Marc Milano ◽  
John Bucek ◽  
Ronald G Nahass ◽  
...  

Abstract Background Casirivimab/imdevimab is a monoclonal antibody (mAb) cocktail with emergency use authorization for mild-to-moderate coronavirus disease 2019 (Covid-19) in patients at high risk for severe disease progression and/or hospitalization. Little is known about the importance of early administration of this product. The objective of this study was to determine if early administration (within 3 days of symptom onset) of casirivimab/imdevimab is associated with better outcomes. Methods Single-center, retrospective cohort study including all consecutive patients who received casirivimab/imdevimab at our institution through May 2021. The primary outcome was 30-day post-infusion hospital admission rate in patients who received mAb ≥ 3 days (later) or < 3 days (early) in relation to patient reported symptom onset. Secondary outcomes included any hospital revisit within 30-days. Adverse events were also captured. Chi-square and independent samples t-test were used to compare categorical and continuous data, respectively. Multivariable logistic regression was used to adjust for confounders. Results 270 patients met the inclusion criteria and were included in the analysis. There were 80 patients with early administration and 190 with later administration. Baseline characteristics for both groups were similar. Mean age was approximately 64 years and BMI 31 mg/m2. Table 1 provides a summary of patient characteristics. Late and early administration of casirivimab/imdevimab were similar in terms of hospital admission for any therapy related failure within 30 days of mAb administration after adjusting for age and Charlson comorbidity index (3.7% vs. 7.5%; adjusted odds ratio 0.69, 95% confidence interval, 0.20 – 2.39; p=0.561). Similarly, there were no significant differences in any hospital revisit. Conclusion We did not find any difference in outcomes between early and late administration of casirivimab/imdevimab. Disclosures Ronald G. Nahass, MD, Abbvie (Grant/Research Support, Speaker’s Bureau)Alkermes (Grant/Research Support)Gilead (Grant/Research Support, Speaker's Bureau)Merck (Grant/Research Support, Speaker's Bureau)

2019 ◽  
Vol 7 (1) ◽  
pp. e000809 ◽  
Author(s):  
Marion Fokkert ◽  
Peter van Dijk ◽  
Mireille Edens ◽  
Eglantine Barents ◽  
Jeanine Mollema ◽  
...  

IntroductionThe FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.MethodsProspective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.Results1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of −4 (95% CI −6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: −9 (95% CI −12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.ConclusionsReal world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jenny Liu ◽  
Therese Palmgren ◽  
Sari Ponzer ◽  
Italo Masiello ◽  
Nasim Farrokhnia

Abstract Background Emergency department (ED) care of older patients is often complex. Geriatric ED guidelines can help to meet this challenge. However, training requirements, the use of time-consuming tools for comprehensive geriatric assessment (CGA), a lack of golden standard to identify the frail patients, and the weak evidence of positive outcomes of using CGA in EDs pose barriers to introduce the guidelines. Dedicating an interprofessional team of regular ED medical and nursing staff and an older-friendly ED area can be another approach. Previous studies of geriatrician-led CGA in EDs have reported a reduced hospital admission rate. The aim of this study was to investigate whether a dedicated interprofessional emergency team also can reduce the hospital admission rate without the resources required by the formal use of CGA. Methods An observational pre-post study at a large adult ED, where all patients 80 years or older arriving on weekdays in the intervention period from 2016.09.26 to 2016.11.28 and the corresponding weekdays in the previous year from 2015.09.28 to 2015.11.30 were included. In the intervention period, older patients either received care in the geriatric module by the dedicated team or in the regular team modules for patients of mixed ages. In 2015, all patients received care in regular team modules. The primary outcome measure was the total hospital admission rate and the ED length of stay was the secondary outcome measure. Results We included 2377 arrivals in the intervention period, when 26.7% (N = 634) received care in the geriatric module, and 2207 arrivals in the 2015 period. The total hospital admission rate was 61.7% (N = 1466/2377) in the intervention period compared to 64.8% (N = 1431/2207) in 2015 (p = 0.03). The difference was larger for patients treated in the geriatric module, 51.1% compared to 62.1% (95% CI: 56.3 to 68.0%) for patients who would have been eligible in 2015. The ED length of stay was longer in the intervention period. Conclusions An interprofessional team and area dedicated to older patients was associated to a lower hospital admission rate. Further studies are needed to confirm the results.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 725.1-726
Author(s):  
T. Hunter ◽  
T. Blachley ◽  
W. Malatestinic ◽  
L. Harrold ◽  
B. Dube ◽  
...  

Background:Axial spondyloarthritis (axSpA) consists of ankylosing spondylitis (AS), also referred to as radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA). AxSpA can lead to reduced mobility, pain, fatigue, and impact quality of life. While bDMARDs are available for treatment, the literature lacks studies exploring their real-world effectiveness in clinical registry patients with axSpA.Table 1.Demographic characteristics and clinical response rates of AxSpA patientsTable 2.TNFi drug survival rate results of early and late disease courseObjectives:To describe patient characteristics of bDMARD initiators among the AS and nr-axSpA populations and the effectiveness of bDMARDs at the 6-month (± 3) post-initiation follow-up (FU) visit in the Corrona PsA/SpA Registry.Methods:This study included patients aged ≥ 18 years with AS per modified NY criteria and nr-axSpA per ASAS criteria enrolled between 3/2013 and 9/2019. Concurrently diagnosed patients with PsA were excluded. Baseline characteristics, such as demographic, clinical, disease activity, treatment, and patient-reported outcomes (PRO), were collected for those initiating a bDMARD at enrollment or during FU; response rates and mean change in disease activity and PRO between initiation and 6-month FU were calculated.Results:The AS (n=179) and nr-axSpA (n=32) bDMARD initiators groups were similar at initiation for mean age (AS: 49.1 yrs, nr-axSpA: 48.9 yrs), ASDAS scores (AS: 2.9, nr-axSpA: 2.8) and patient global assessment (AS: 59.6, nr-axSpA: 60.0). The two groups were different for time from disease duration (AS 8.5 yrs, nr-axSpA, 6.6 yrs), current NSAID use (AS: 64.2%, nr-axSpA: 46.9%) and naivete to cDMARDS (AS: 70.4%, nr-axSpA: 40.6%), TNFs (AS: 47.5%, nr-axSpA: 21.9%), non-TNFs (AS: 96.1%, nr-axSpA: 93.8%) and bDMARDs (AS: 46.9%, nr-axSpA: 21.9%). Patients were similarly impacted by their condition for BASDAI (AS: 5.0, nr-axSpA, 5.6), pain (AS: 55.8, nr-axSpA, 60.8) and fatigue (AS: 51.6, nr-axSpA, 59.9), but there was an imbalance in tender joint count (AS: 2.6, nr-axSpA, 13.4).At 6-month FU, both populations experienced minimal or no change in ASDAS scores (AS: -0.3, nr-axSpA: 0.0) remaining in a high state of disease activity (ASDAS, ≥2.2). A small percent of both groups achieved ASAS20 (AS: 20.1%; nr-axSpA: 21.9%) and ASAS40 (AS: 14 %, nr-axSpA: 15.6%). Further, bDMARD initiators had minimal decreases in BASDAI (AS: -0.6, nr-axSpA: -0.8), pain (AS: -8.5, nr-axSpA: -12.2), and fatigue (AS: -5.0, nr-axSpA: -7.9) scores.Conclusion:AS and nr-axSpA bDMARD initiators had a modest improvement in outcomes at six months. Twenty percent or fewer patients achieved ASAS20 or ASAS40, with many having residual impairment based on ASDAS, BASDAI, pain, and fatigue outcomes at six months. While patients are initiating biologic agents, room for improvement exists as many are not achieving optimal treatment response of inactive (ASDAS, <1.3) or low disease activity (ASDAS, <2.1).Disclosure of Interests:Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Taylor Blachley Employee of: Corrona, LLC, William Malatestinic Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Leslie Harrold Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Consultant of: AbbVie, BMS, Roche – consultant, Employee of: Corrona, LLC – employment, Blessing Dube Employee of: Corrona, LLC, Meghan Glynn Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Employee of: Corrona, LLC – employment, Jeffrey Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau


2010 ◽  
Vol 28 (8) ◽  
pp. 654-657 ◽  
Author(s):  
A. Newton ◽  
S. J. Sarker ◽  
A. Parfitt ◽  
K. Henderson ◽  
P. Jaye ◽  
...  

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3667-3667
Author(s):  
Brian Bolwell ◽  
Lisa Rybicki ◽  
Matt Kalaycio ◽  
Brad Pohlman ◽  
Steven Andresen ◽  
...  

Abstract One of the theoretic advantages of non-myeloablative (“mini”) preparative regimens such as fludarabine and low dose total body irradiation (TBI) is that the transplant can be performed as an outpatient. Data is surprisingly sparse concerning the later hospital admission rate of such transplanted patients. We transplanted 71 patients from 1/1/00 to 6/15/05 using a “mini” preparative regimen of fludarabine and TBI (200cGy, n=53, 400cGy, n=18) and examined the rates of admission after transplant. All transplants and preparative regimens were delivered as an outpatient. The admission rate was similar between those receiving 200cGy and 400cGy, and the two groups were combined for this analysis. Median patient age was 52 (range, 15–65). Diagnoses included NHL (n=16 [23%]), AML (n=13, [18%]), myeloma (n=7, [10%)]), CML (n=7, [10%]), MDS (n=7, [10%], myelofibrosis (n=6, [8%]), CLL (n=4, [6%]), other (n=11, [15%]). Approximately 40% had resistant or untreated disease at transplant. 63 of 71 patients (89%) were admitted within 1 year of their original transplant. Rates of admissions were similar for related donor transplants (41/47, 33%) and unrelated donor transplants (22/24, 92%). Of 63 patients admitted to the hospital after their outpatient transplant, 52 (83%) were admitted within 3 months of the transplant. The most common reason for admission was fever (n=30, [58%]). Four patients were admitted for cardiac events (chest pain, tachycardia, possible MI and atrial fibrillation) and 7 patients were admitted for acute graft vs host disease. Of the 30 patients with fever at the time of transplant, the absolute neutrophil count was 0.94 k/μL (range, 0–16.49), and 9 had an absolute neutrophil count &lt;500 k/μL. 11 patients were admitted to the hospital between 3 and 12 months after their initial transplant, most commonly because of either acute graft vs host disease or infection. The median number of all post-transplant hospitalizations for matched related transplants was 2 (range, 0–8) and for matched unrelated transplants was 3 (range, 0–11). The median time from transplant to the first admission to the hospital was Day +22 for matched related transplants, and Day +6 for matched unrelated transplants. Median length of stay for the admissions was 6 days for the entire group. 32/71 (45%) of patients were admitted to the hospital at least 3 or more times within 18 months of their original transplant. Patients admitted to the hospital 0 or 1 time had a superior survival than those admitted 2 or more times, (overall survival 54% vs 24%, p value = 0.022) In conclusion, while the delivery of a “mini” transplant preparative regimen and the infusion of hematopoietic stem cells may safely be given as an outpatient, our experience suggests that the vast majority of patients have at least one hospital admission for various complications within 3 months of the transplant. This data does not support the concept that non-myeloablative allogeneic transplants can be performed as an outpatient in their entirety.


2020 ◽  
Vol 49 (4) ◽  
pp. E20 ◽  
Author(s):  
Michael D. Cusimano ◽  
Olli Saarela ◽  
Kirsten Hart ◽  
Shudong Zhang ◽  
Steven R. McFaull

OBJECTIVEThe purpose of this study was to examine the population-based trends and factors associated with hospitalization of patients with traumatic brain injury (TBI) treated in the Emergency Department (ED) among those 65 years and older. The implications of these trends for neurosurgery and the broader society are discussed.METHODWith a national, mandatory reporting system of ED visits, the authors used Poisson regression controlling for age and sex to analyze trends in fall-related TBI of those aged 65 years and older between 2002 and 2017.RESULTSThe overall rate of ED visits for TBI increased by 78%—from 689.51 per 100,000 (95% CI 676.5–702.8) to 1229 per 100,000 (95% CI 1215–1243) between 2002 and 2017. Females consistently experienced higher rates of fall-related TBI than did males. All age groups 65 years and older experienced significant increases in fall-related TBI rate over the study period; however, the highest rates occurred among the oldest individuals (90+ and 85–89 years). The hospital admission rate increased with age and Charlson Comorbidity Index. Males experienced both a higher admission rate and a greater percentage change in admission rate than females.CONCLUSIONSRates of ED visits for fall-related TBI, hospitalization, and in-ED mortality in those aged 65 years and older are increasing for both sexes. The increasing hospital admission rate is related to more advanced comorbidities, male sex, and increasing age. These findings have significant implications for neurosurgical resources; they emphasize that health professionals should work proactively with patients, families, and caregivers to clarify goals of care, and they also outline the need for more high-level and, preferably, randomized evidence to support outcomes-based decisions. Additionally, the findings highlight the urgent need for improved population-based measures for prevention in not only this age demographic but in younger ones, and the need for changes in the planning of health service delivery and long-term care.


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S807-S808
Author(s):  
Teresa H Evering ◽  
Mark Giganti ◽  
Kara W Chew ◽  
Michael Hughes ◽  
Carlee Moser ◽  
...  

Abstract Background SARS-CoV-2 continues to spread and the development of safe and effective therapeutics for the prevention of severe disease remains a priority. BRII-196 and BRII-198 are non-competing anti-SARS-CoV-2 mAbs with YTE triple amino acid substitution in Fc to extend half-life and reduce receptor binding, that are being studied for treatment of COVID-19 in the ACTIV-2 Trial, sponsored by NIAID and led by ACTG. Methods ACTIV-2 evaluates safety/efficacy of investigational agents for treatment of non-hospitalized adults with mild-moderate COVID-19 under a randomized, blinded, controlled adaptive platform. BRII-196/BRII-198 (1000 mg each) as a single dose given as sequential infusions, or placebo to those at high risk of clinical progression (i.e., age ≥ 60 years or presence of other medical conditions) within 10 days of symptom onset and positive test for SARS-CoV-2. The primary endpoint was hospitalization and/or death through day 28. We report Phase 3 BRII-196/BRII-198 trial results per DSMB recommendation following an interim analysis. Results Between January and July 2021, 837 participants (418 active, 419 placebo) from sites in the US (66%), Brazil, South Africa, Mexico, Argentina and the Philippines were randomized and received study product at time of emerging variants. Median age 49 years (Q1, Q3: 39, 58), 51% female, 17% Black/African-American and 49% Hispanic/Latino, with median 6 days from symptom onset. At interim analysis 71% and 97% had a day 28 and 7 visit, respectively. For all available data at interim review, BRII-196/BRII-198 compared to placebo had fewer hospitalizations (12 vs. 45) and deaths (1 vs. 9). At day 28 of follow-up, there was an estimated 78% reduction in hospitalization and/or death (2.4 vs. 11.1%), relative risk 0.22 (95% CI: 0.05, 0.86), P=0.00001 (nominal one-sided). Grade 3 or higher adverse events (AEs) were observed less frequently among BRII-196/BRII-198 participants than placebo (3.8% vs. 13.4%) with no severe infusion reactions or drug related serious AEs. Conclusion BRII-196/BRII-198 was safe, well-tolerated, and demonstrated significant reduction compared to placebo in the risk of hospitalization and/or death among adults with mild-moderate COVID-19 at high risk for progression to severe disease. Disclosures Kara W. Chew, MD, MS, Amgen (Individual(s) Involved: Self): Grant/Research Support; Merck Sharp & Dohme (Individual(s) Involved: Self): Grant/Research Support David Alain Wohl, MD, Gilead Sciences (Individual(s) Involved: Self): Advisor or Review Panel member, Consultant, Research Grant or Support, Scientific Research Study Investigator; Janssen (Individual(s) Involved: Self): Advisor or Review Panel member; Merck (Individual(s) Involved: Self): Advisor or Review Panel member, Research Grant or Support; ViiV (Individual(s) Involved: Self): Advisor or Review Panel member, Research Grant or Support Joseph J. Eron, MD, Gilead Sciences (Consultant, Research Grant or Support)Janssen (Consultant, Research Grant or Support)Merck (Consultant)ViiV (Consultant, Research Grant or Support) David A. Margolis, MD MPH, Brii Biosciences (Employee) Courtney Fletcher, Pharm.D., National Institute of Allergy and Infectious Diseases, NIH (Grant/Research Support) Davey Smith, M.D., Linear Therapies, Matrix Biomed, Bayer (Consultant, Shareholder) Eric Daar, Gilead (Consultant, Grant/Research Support)Merck (Consultant)ViiV (Consultant, Grant/Research Support)


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