Initial romiplostim dosing and time to platelet response in patients with treatment refractory immune thrombocytopenia

2018 ◽  
Vol 25 (3) ◽  
pp. 567-576 ◽  
Author(s):  
Ryan K DasGupta ◽  
Lauren Levine ◽  
Tracy Wiczer ◽  
Spero Cataland
Keyword(s):  
Length Of Stay ◽  
Intravenous Immunoglobulin ◽  
Initial Dose ◽  
Immune Thrombocytopenia ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Bleeding Complications ◽  
Severe Thrombocytopenia ◽  
Platelet Response ◽  
Treatment Refractory

Background/rationale Romiplostim is a thrombopoietin receptor agonist recommended as a second-line therapy for immune thrombocytopenia. An initial dose of 1 mcg/kg/week subcutaneously with weekly 1 mcg/kg dose escalation is recommended per package labeling. Optimizing romiplostim dosing for hospitalized, corticosteroid- and intravenous immunoglobulin-refractory patients with severe thrombocytopenia secondary to immune thrombocytopenia may be critical for improving platelet responses, reducing the risk of bleeding, and decreasing hospital length of stay. Limited data are available evaluating the efficacy and safety of higher initial doses. Objective The primary objective of this study was to compare the time to platelet ≥ 10 × 109/L between patients who received an initial romiplostim dose of ≥2 mcg/kg/week compared to the standard initial dose of 1 mcg/kg/week. Secondary objectives included time to platelet response ≥ 30 × 109/L and ≥50 × 109/L, percentage of patients achieving platelet responses, hospital length of stay, and incidence of adverse events and bleeding complications. Methods This was a retrospective, single-center, cohort study including hospitalized adults with corticosteroid- and intravenous immunoglobulin-refractory immune thrombocytopenia. A baseline platelet < 10 × 109/L was required. Patients were stratified by their initial romiplostim dose into Cohort 1 (1 mcg/kg/week) and Cohort 2 (≥2 mcg/kg/week). A review of electronic medical records and descriptive statistics generated findings. Results A total of 18 patients were included, 4 in Cohort 1 and 14 in Cohort 2. Patients in Cohort 2 had a median initial dose of 4.5 mcg/kg/week. Patients in Cohort 2 achieved a platelet ≥ 10 × 109/L in a median of 2 days versus 4.5 days for Cohort 1. More patients in Cohort 2 achieved a platelet ≥ 30 × 109/L (42.9% vs. 25%) and platelet ≥ 50 × 109/L (28.6% vs. 25%). The median hospital length of stay was shorter in Cohort 2 (13.5 vs. 20 days). Clinically relevant nonmajor bleeding was noted less frequently in Cohort 2 (28.6% vs. 75%), while major bleeding was more frequent in Cohort 2 (14.3% vs. 0%). No thrombotic events occurred. Conclusion Our study suggests that higher initial romiplostim doses may be safe for hospitalized patients with treatment-refractory immune thrombocytopenia. Compared to Food and Drug Administration-approved dosing, higher initial doses may shorten time to platelet responses and hospital length of stay. Further large-scale studies are needed to confirm these findings.

scholarly journals 71. Use of Intravenous Immunoglobulin Therapy Reduces Progression to Mechanical Ventilation in COVID-19 Patients with Moderate to Severe Hypoxia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S166-S166
Author(s):  
George Sakoulas ◽  
Matthew Geriak ◽  
Ravina Kullar ◽  
Kris Greenwood ◽  
Mackenzie Habib ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Length Of Stay ◽  
Intravenous Immunoglobulin ◽  
Group Versus ◽  
Composite Endpoint ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Fisher Exact Test ◽  
Intravenous Immunoglobulin Therapy ◽  
Exact Test

Abstract Background The majority of COVID-19 morbidity and mortality occurs in patients who progress to mechanical ventilation. Therefore, therapeutic interventions targeting the mitigation of this complication would markedly improve outcomes and reduce healthcare utilization. Methods Patients with COVID-19 from two hospitals in San Diego, California were randomized at a 1:1 ratio to receive standard of care (SOC) plus intravenous immunoglobulin (IVIG) at 0.5 g/kg/day x 3 days with solumedrol 40 mg 30 minutes before infusion (IVIG group) versus SOC alone. The primary composite endpoint was receipt of mechanical ventilation or death before receiving ventilation. Patients were followed until discharge to home or up to 30 days from time of enrollment. Results Sixteen patients received IVIG plus SOC and 17 SOC alone. The median age was 54 years for SOC and 57 years for IVIG. Median time from hospital admission to study enrollment was 1 day (range 0–4) for SOC and 2 days (range 0–8) for IVIG. APACHE II scores and Charlson comorbidity indices were similar for IVIG and SOC (median 8 vs 7 and 2 for both, respectively). Seven SOC patients achieved the composite endpoint (6 ventilated, 1 death) versus 2 IVIG patients (2 ventilated), p=0.12, Fisher exact test. Among the subgroup with an estimated A-a gradient of &gt;200 mm Hg at time of enrollment, the IVIG group showed a lower rate of progression to the composite endpoint (2/14 vs 7/12, p=0.04 Fisher exact test), shorter median hospital length (11 vs 24 days, p=0.001 Mann Whitney U), and shorter median intensive care unit (ICU) stay (3 vs 13 days, p=0.005 Mann Whitey U). Conclusion This small, prospective, randomized, open-label study showed that when administered to hypoxic non-ventilated COVID-19 patients with an A-a gradient of &gt;200 mm Hg (corresponding to a requirement of 6 liters O2 via nasal cannula to achieve an SpO2 of 92%), IVIG significantly decreased the rates of progression to mechanical ventilation, ICU length of stay, and total hospital length of stay. A Phase 3 prospective, randomized, placebo-controlled, multicenter trial is underway to further validate these findings. Disclosures George Sakoulas, MD, Octapharma (Grant/Research Support, Scientific Research Study Investigator)

scholarly journals A Case of Immune Thrombocytopenia After COVID-19 Vaccination: Coincidental or Causal Effect? Running Title: ITP After COVID-19 Vaccination

2021 ◽  
Author(s):  
Ernesto Vigna ◽  
Daniele Caracciolo ◽  
Enrica Martino ◽  
Francesco Mendicino ◽  
Eugenio Lucia ◽  
...  
Keyword(s):  
Platelet Count ◽  
Side Effects ◽  
Intravenous Immunoglobulin ◽  
Vaccine Efficacy ◽  
Immune Thrombocytopenia ◽  
Causal Effect ◽  
High Dose ◽  
Severe Thrombocytopenia ◽  
Platelet Response ◽  
Normal Range

Abstract The discovery and the introduction of different vaccines in the therapeutic armamentarium against SARS-CoV-2 represents a big hope in the fight against the pandemic. However, safety of SARS-CoV-2 vaccination is continuously monitored for the emergence of potential new side effects, such as recently reported thrombotic events, after the use of certain types of vaccines. In this context, we report a case of 31-year-old woman who developed immune thrombocytopenia (ITP) after 3 weeks from receiving SARS-CoV-2 vaccine. She developed significant widespread petechiae and gum bleeding, with severe thrombocytopenia documented at her hemogram. Over a 10-day period, thrombocytopenia was treated first with high dose corticosteroids, intravenous immunoglobulin and platelet transfusions, without a platelet response. Two days later, she received the TPO-mimetic and after three days, his platelet count began to rise reaching the normal range 18 days from her admission to our Hematology department. These findings cannot actually elucidate if vaccination was causal or coincidental effect of ITP, but further highlights the need of additional pharmacovigilance studies to empower SARS-CoV2 vaccine efficacy.

scholarly journals Intravenous Immunoglobulin (IVIG) Significantly Reduces Respiratory Morbidity in COVID-19 Pneumonia: A Prospective Randomized Trial

2020 ◽  
Author(s):  
George Sakoulas ◽  
Matthew Geriak ◽  
Ravina Kullar ◽  
Kristina Greenwood ◽  
MacKenzie Habib ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Length Of Stay ◽  
Intravenous Immunoglobulin ◽  
Randomized Study ◽  
Length Of Hospital Stay ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Respiratory Morbidity ◽  
Fisher Exact Test ◽  
Exact Test

Background. Interventions mitigating progression to mechanical ventilation in COVID-19 would markedly improve outcome and reduce healthcare utilization. We hypothesized that immunomodulation with IVIG would improve oxygenation and reduce length of hospital stay and progression to mechanical ventilation in COVID-19 pneumonia. Methods. Patients with COVID-19 were randomized 1:1 to prospectively receive standard of care (SOC) plus intravenous immunoglobulin (IVIG) 0.5 g/kg/day x 3 days with methylprednisolone 40 mg 30 minutes before infusion versus SOC alone. Results. 16 subjects received IVIG plus SOC and 17 SOC alone. The median age was 51 years for SOC and 58 years for IVIG. APACHE II scores and Charlson comorbidity indices were similar for IVIG and SOC (median 7.5 vs 7 and 2 for both, respectively). Seven SOC versus 2 IVIG subjects required mechanical ventilation (p=0.12, Fisher exact test). Among subjects with A-a gradient of >200 mm Hg at enrollment, the IVIG group showed i) a lower rate of progression to requiring mechanical ventilation (2/14 vs 7/12, p=0.038 Fisher exact test), ii) shorter median hospital length of stay (11 vs 19 days, p=0.01 Mann Whitney U), iii) shorter median ICU stay (2.5 vs 12.5 days, p=0.006 Mann Whitey U), and iv) greater improvement in PaO2/FiO2 at 7 days (median [range] change from time of enrollment +131 [+35 to +330] vs +44.5 [-115 to +157], p=0.01, Mann Whitney-U test) than SOC. Conclusion. This pilot prospective randomized study comprising largely of Latino patients showed that IVIG significantly improved hypoxia and reduced hospital length of stay and progression to mechanical ventilation in COVID-19 patients with A-a gradient >200 mm Hg.

scholarly journals 182. Missed Opportunities to Discontinue Unnecessary Vancomycin During Pharmacist Therapeutic Monitoring

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S98-S98
Author(s):  
Corey J Medler ◽  
Mary Whitney ◽  
Juan Galvan-Cruz ◽  
Ron Kendall ◽  
Rachel Kenney ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Adverse Drug Events ◽  
Academic Medical Center ◽  
Total Duration ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Therapeutic Monitoring ◽  
Resistant Bacteria ◽  
Therapeutic Drug ◽  
Missed Opportunities

Abstract Background Unnecessary and prolonged IV vancomycin exposure increases risk of adverse drug events, notably nephrotoxicity, which may result in prolonged hospital length of stay. The purpose of this study is to identify areas of improvement in antimicrobial stewardship for vancomycin appropriateness by clinical pharmacists at the time of therapeutic drug monitoring (TDM). Methods Retrospective, observational cohort study at an academic medical center and a community hospital. Inclusion: patient over 18 years, received at least three days of IV vancomycin where the clinical pharmacy TDM service assessed for appropriate continuation for hospital admission between June 19, 2019 and June 30, 2019. Exclusion: vancomycin prophylaxis or administered by routes other than IV. Primary outcome was to determine the frequency and clinical components of inappropriate vancomycin continuation at the time of TDM. Inappropriate vancomycin continuation was defined as cultures positive for methicillin-susceptible Staphylococcus aureus (MRSA), vancomycin-resistant bacteria, and non-purulent skin and soft tissue infection (SSTI) in the absence of vasopressors. Data was reported using descriptive statistics and measures of central tendency. Results 167 patients met inclusion criteria with 38.3% from the ICU. SSTIs were most common indication 39 (23.4%) cases, followed by pneumonia and blood with 34 (20.4%) cases each. At time of vancomycin TDM assessment, vancomycin continuation was appropriate 59.3% of the time. Mean of 4.22 ± 2.69 days of appropriate vancomycin use, 2.18 ± 2.47 days of inappropriate use, and total duration 5.42 ± 2.94. 16.4% patients developed an AKI. Majority of missed opportunities were attributed to non-purulent SSTI (28.2%) and missed MRSA nares swabs in 21% pneumonia cases (table 1). Conclusion Vancomycin is used extensively for empiric treatment of presumed infections. Appropriate de-escalation of vancomycin therapy is important to decrease the incidence of adverse effects, decreasing hospital length of stay, and reduce development of resistance. According to the mean duration of inappropriate therapy, there are opportunities for pharmacy and antibiotic stewardship involvement at the time of TDM to optimize patient care (table 1). Missed opportunities for vancomycin de-escalation Disclosures All Authors: No reported disclosures

scholarly journals Association of Emergency Department Waiting Times With Patient Experience in Admitted and Discharged Patients

2021 ◽  
Vol 8 ◽  
pp. 237437352110114
Author(s):  
Andrew Nyce ◽  
Snehal Gandhi ◽  
Brian Freeze ◽  
Joshua Bosire ◽  
Terry Ricca ◽  
...  
Keyword(s):  
Emergency Department ◽  
Length Of Stay ◽  
Patient Experience ◽  
Waiting Times ◽  
Hospital Length ◽  
Short Length ◽  
Hospital Length Of Stay ◽  
Patient’S Experience ◽  
Discharged Patients ◽  
The Impact

Prolonged waiting times are associated with worse patient experience in patients discharged from the emergency department (ED). However, it is unclear which component of the waiting times is most impactful to the patient experience and the impact on hospitalized patients. We performed a retrospective analysis of ED patients between July 2018 and March 30, 2020. In all, 3278 patients were included: 1477 patients were discharged from the ED, and 1680 were admitted. Discharged patients had a longer door-to-first provider and door-to-doctor time, but a shorter doctor-to-disposition, disposition-to-departure, and total ED time when compared to admitted patients. Some, but not all, components of waiting times were significantly higher in patients with suboptimal experience (<100th percentile). Prolonged door-to-doctor time was significantly associated with worse patient experience in discharged patients and in patients with hospital length of stay ≤4 days. Prolonged ED waiting times were significantly associated with worse patient experience in patients who were discharged from the ED and in inpatients with short length of stay. Door-to-doctor time seems to have the highest impact on the patient’s experience of these 2 groups.

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