Treatment of Critical Bleeds in Patients With Immune Thrombocytopenia: A Systematic Review.

Objectives: Evidence-based protocols for managing bleeding emergencies in patients with immune thrombocytopenia (ITP) are lacking. We conducted a systematic review of treatments for critical bleeding in patients with ITP.

Methods: We included all study designs and extracted data in aggregate or individually for patients who received one or more interventions and for whom any of the following outcomes were reported: platelet count response, bleeding, disability, or death.

Comparative Efficacy and Safety of Lorlatinib Versus Alectinib and Lorlatinib Versus Brigatinib for ALK-Positive Advanced/Metastatic NSCLC: Matching-Adjusted Indirect Comparisons.

Introduction: The comparative efficacy and safety of lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), versus second-generation ALK TKIs as a first-line treatment for ALK+ advanced/metastatic nonsmall cell lung cancer (NSCLC) remains uncertain as there are no head-to-head clinical trials.

Methods: Matching-adjusted indirect comparisons (MAICs) were conducted using phase III trial data demonstrating superior efficacy over crizotinib, a first-generation ALK TKI. MAICs were conducted to compare lorlatinib (CROWN) versus alectinib (ALEX and ALESIA) and brigatinib (ALTA-1L) with matching based on prespecified effect modifiers.

Bleeding self-assessments by patients with immune thrombocytopenia (ITP): An agreement study.

We designed anagreement study to compare the results of bleeding assessments done in tandem by ITP patients and trained research staff. We used a modified version of the ITP Bleeding Scale, which captured the patients' worst bleeding event at any of nine anatomical sites since the time of the last assessment. Interrater agreement was determined using the 2-way kappa for the assessment of severe vs.

The Impact of Biosimilar Use on Total Cost of Care and Provider Financial Performance in the Medicare Oncology Care Model: A Population-Based Simulation Study.

Introduction: Payment for oncology care is increasingly moving from fee-for-service to value-based payment (VBP). VBPs are agreements in which providers are held accountable for total cost of care (TCOC) through risk-sharing arrangements with payers that tie reimbursement levels to TCOC benchmarks. Oncology biosimilars may play an important role in managing financial risk in the VBPs like Medicare's Oncology Care Model (OCM), but there has been limited research in this area.

Biomarker Testing Trends in Patients With Metastatic Colorectal Cancer Who Live in Rural Areas and Urban Clusters in the US.

Background: There is a paucity of data on biomarker testing rates in rural populations with metastatic colorectal cancer (mCRC). To assess biomarker testing practices, oncologists in rural areas and urban clusters in the US were surveyed.

Materials And Methods: A web-based survey was administered to oncologists spending ≥40% of their time practicing in rural areas or urban clusters and who had treated ≥2 patients with stage IV mCRC in the prior month.

Antibodies against platelet factor 4 and the risk of cerebral venous sinus thrombosis in patients with vaccine-induced immune thrombotic thrombocytopenia.

Background: Vaccine-induced immune thrombotic thrombocytopenia (VITT) is a rare complication of adenoviral vector-based vaccines against SARS-CoV-2. This syndrome is caused by antibodies against platelet factor 4 (PF4; CXCL4) that lead to platelet activation and is characterized by thrombocytopenia and thrombosis in unusual locations, including cerebral venous sinus thrombosis (CVST). VITT can be classified based on anti-PF4 antibodies properties in vitro: those that require PF4 to activate platelets (PF4-dependent) and those that can activate platelets without additional PF4 (PF4-independent) in the serotonin release assay.

Prevalence and significance of large granular lymphocytes in patients with immune thrombocytopenia.

The association between T-cell large granular lymphocytes (T-LGL) and ITP is uncertain. The aims of this study were to determine the prevalence of T-LGL in patients with ITP and to describe its association with ITP disease severity. We analyzed flow cytometry results for T-LGL (using a threshold of 0.

Clinical and laboratory predictors of fetal and neonatal alloimmune thrombocytopenia.

Background: Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is the most common cause of intracranial hemorrhage (ICH) in thrombocytopenic term infants. We investigated clinical and laboratory predictors of severe FNAIT in a tertiary care referral center.

Study Design And Methods: Retrospective cohort study over a 30-year period.

Practical Strategies for Advanced Practitioners Streamlining the Integration of Oncology Biosimilar Therapies Into Practice.

In oncology practices across the United States, biosimilars-highly similar versions of licensed, innovator (reference) biological medicines-are currently emerging as more affordable therapeutic options. Only after a rigorous product development program, during which a proposed biosimilar is analyzed and compared with its reference biologic to demonstrate comparable clinical efficacy, safety, and tolerability, is biosimilarity supported and licensure granted by the US Food and Drug Administration. Coincidentally, many advanced practitioners (APs) are finding themselves at the forefront of introducing monoclonal antibody (mAb) biosimilars in their oncology practice.

The clinical and laboratory diagnosis of vaccine-induced immune thrombotic thrombocytopenia.

Vaccine-induced immune thrombotic thrombocytopenia (VITT) is a rare but serious adverse syndrome occurring 5 to 30 days after adenoviral vector COVID-19 vaccination. Therefore, a practical evaluation of clinical assessments and laboratory testing for VITT is needed to prevent significant adverse outcomes as the global use of adenoviral vector vaccines continues. We received the clinical information and blood samples of 156 patients in Canada with a suspected diagnosis of VITT between April and July 2021.

Real-world usage of bevacizumab-bvzr biosimilar in US oncology practice.

Objectives: Bevacizumab is commonly used to treat solid tumors. However, little is known about the manner and the extent to which bevacizumab biosimilars are utilized in real-world oncology practice in the United States. The objective of this study was to describe patient and provider characteristics and treatment patterns associated with the recently introduced bevacizumab-bvzr biosimilar.

Real-world cost-effectiveness of primary prophylaxis with G-CSF biosimilars in patients at intermediate/high risk of febrile neutropenia.

Real-world data suggests superiority of pegfilgrastim (PEG) over filgrastim (FIL) in reducing the incidence of chemotherapy-induced febrile neutropenia (FN), probably attributable to underdosed FIL in practice. We used real-world data to assess the cost-effectiveness of primary prophylaxis with PEG versus FIL in cancer patients at intermediate-to-high risk of FN from a US payer perspective. A Markov model with lifetime horizon.

Lessons from vaccine-induced immune thrombotic thrombocytopenia.

Adenoviral vector vaccines are effective against SARS-CoV-2 but have been associated with a rare side effect termed vaccine-induced immune thrombotic thrombocytopenia (VITT). Here, we discuss our understanding of how vaccine-induced antibodies to platelet factor 4 (PF4) form immune complexes that activate platelets and trigger the thrombotic events seen in VITT.

Platelet variability index: a measure of platelet count fluctuations in patients with immune thrombocytopenia.

Fluctuations in platelet count levels over time may help distinguish immune thrombocytopenia (ITP) from other causes of thrombocytopenia. We derived the platelet variability index (PVI) to capture both the fluctuations in platelet count measurements and the severity of the thrombocytopenia over time. Raw PVI values, ranging from negative (less severe thrombocytopenia and/or low fluctuations) to positive (more severe thrombocytopenia and/or high fluctuations) were converted to an ordinal PVI score, from 0 to 6.

Definition of a critical bleed in patients with immune thrombocytopenia: Communication from the ISTH SSC Subcommittee on Platelet Immunology.

Background: Immune thrombocytopenia (ITP) is an autoimmune disease characterized by low platelet counts and increased risk of bleeding. In preparation for an upcoming guideline, the ITP Emergency Management Guideline Panel, including clinical experts in hematology, emergency medicine, research methodology, and patient representatives, identified the need for a standardized definition of a critical ITP bleed. The goal of the definition was to distinguish critical bleeds from bleeds that may not require urgent treatment, typically in the context of severe thrombocytopenia.

Real-world use and acceptance of biosimilar monoclonal antibodies of rituximab in oncology practice in the USA.

To describe treatment patterns and patient and provider characteristics associated with the recently introduced biosimilar rituximab-pvvr. This retrospective analysis included adult patients with one or more claims for rituximab-pvvr, with an index date of 23 January 2020 and a study period covering 1 January 2019-31 July 2020. Of 249 patients included, the most common rituximab-pvvr indications were non-Hodgkin's lymphoma (77.

Antibody epitopes in vaccine-induced immune thrombotic thrombocytopaenia.

Vaccine-induced immune thrombotic thrombocytopaenia (VITT) is a rare adverse effect of COVID-19 adenoviral vector vaccines. VITT resembles heparin-induced thrombocytopaenia (HIT) in that it is associated with platelet-activating antibodies against platelet factor 4 (PF4); however, patients with VITT develop thrombocytopaenia and thrombosis without exposure to heparin. Here we sought to determine the binding site on PF4 of antibodies from patients with VITT.

Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar.

Background: Infusion-related reactions (IRRs) are the most common adverse event (AE) associated with infusion of rituximab, an anti-CD20 monoclonal antibody.

Objective: Our objective was to evaluate the impact of dosing/infusion patterns and certain baseline characteristics on IRR occurrence during the first rituximab infusion administered as the biosimilar PF-05280586 (RTX-PF) or reference rituximab sourced from the EU (RTX-EU, MabThera) in patients with CD20+ low-tumor-burden follicular lymphoma.

Patients And Methods: Rituximab (RTX-PF, n=196; RTX-EU, n=198) was administered (375 mg/m) on days 1, 8, 15, and 22 (one cycle), with a follow-up period through 52 weeks.

Performance characteristics of platelet autoantibody testing for the diagnosis of immune thrombocytopenia using strict clinical criteria.

Misclassification of immune thrombocytopenia (ITP) is common, which might undermine the value of platelet autoantibody testing. We determined the sensitivity and specificity of platelet autoantibody testing using the direct antigen capture assay for anti-glycoprotein (GP) IIb/IIIa or anti-GPIbIX in patients with 'definite ITP', defined as those with a documented treatment response. Sensitivity of platelet autoantiboody testing increased from 48·3% [95% confidence interval (CI) 43·5-53·2] for all ITP patients to 64·7% (95% CI 54·6-73·9) for definite ITP patients.

Adjunct Immune Globulin for Vaccine-Induced Immune Thrombotic Thrombocytopenia.

The use of high-dose intravenous immune globulin (IVIG) plus anticoagulation is recommended for the treatment of vaccine-induced immune thrombotic thrombocytopenia (VITT), a rare side effect of adenoviral vector vaccines against coronavirus disease 2019 (Covid-19). We describe the response to IVIG therapy in three of the first patients in whom VITT was identified in Canada after the receipt of the ChAdOx1 nCoV-19 vaccine. The patients were between the ages of 63 and 72 years; one was female.