Publications by authors named "Boris Gorsh"
Red blood cell transfusions for anemia impose high financial and healthcare resource utilization burdens on patients with myelofibrosis (MF). This study estimates projected differences in medical costs and transfusion-related cost and time burdens with momelotinib vs. ruxolitinib or best available therapy (BAT) in Janus kinase (JAK) inhibitor-naive and -experienced patients.
View Article and Find Full Text PDFPurpose: The Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) comprises 7 common MF symptom items (fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, bone pain) and is the first patient-reported outcome (PRO) instrument designed to assess MF symptom burden.
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- Myelofibrosis (MF) is an aggressive blood cancer mainly affecting older adults, often causing anemia and leading to transfusion dependency, which negatively impacts survival and quality of life.
- The study aimed to analyze the characteristics, healthcare usage, and costs associated with patients diagnosed with MF in the US Medicare population, considering their transfusion status and anemia severity.
- Findings showed higher healthcare utilization and costs among patients dependent on transfusions or with moderate to severe anemia compared to those who were independent or had mild/no anemia.
Article Synopsis
- The study compares the projected costs and time burdens for US patients with myelofibrosis and anemia treated with momelotinib versus danazol, based on data from the MOMENTUM trial and earlier research.
- It indicates that momelotinib leads to significant reductions in transfusion frequency, resulting in lower annual medical costs ($53,143 vs. $46,455) and outpatient transfusion costs ($42,021 vs. $8,370) for transfusion-dependent and independent patients.
- Additionally, patients treated with momelotinib are expected to save an average of 173 hours for transfusion-dependent and 35 hours for transfusion-independent patients, highlighting benefits in both
Article Synopsis
- JAK inhibitors are the main treatment for myelofibrosis, but they often overlook anemia and may even make it worse.
- The authors discuss their findings from phase III trials of momelotinib, the first FDA-approved treatment for myelofibrosis patients with anemia, to demonstrate how varying criteria can affect reported benefits related to anemia.
- They suggest forming an expert consensus panel to standardize the definition of anemia-related responses in myelofibrosis treatment to improve consistency and clarity in clinical trial reporting.
Introduction: Patients with relapsed or refractory multiple myeloma (RRMM) are likely to be living with persistent symptoms, especially bone pain and fatigue, and experiencing restrictions in their physical and social functioning, which reduce health-related quality of life.
Methods: This qualitative interview study evaluated patients' perspectives about living with RRMM and their treatment with belantamab mafodotin, using interviews embedded in the Phase II DREAMM-2 trial (NCT03525678) with belantamab mafodotin. Patients consented to participate in up to 2 recorded telephone interviews (at treatment cycle 4 [C4] and at end of treatment [EOT]) comprising open-ended questions.
Introduction: Newer treatment options for relapsed/refractory multiple myeloma (RRMM) with efficacy and safety profiles that differ from traditional therapies have facilitated personalized management strategies to optimize patient outcomes. In the context of such personalized management, understanding how treatment characteristics influence patients' preferences is essential. This study assessed patients' preferences for RRMM treatment attributes and determined trade-offs between potential benefits, administration procedures, and adverse effects.
View Article and Find Full Text PDFArticle Synopsis
- Myelofibrosis (MF) is a chronic condition causing severe symptoms, particularly fatigue and anemia, which greatly affect patients' quality of life.
- The JAK1/JAK2/activin A receptor type 1 inhibitor momelotinib has shown promising results in clinical trials, significantly improving both anemia and overall MF-related symptoms compared to danazol.
- The phase 3 MOMENTUM trial confirmed these benefits, with patients on momelotinib experiencing faster and lasting symptom relief, particularly in fatigue and physical functioning, as demonstrated by various patient-reported outcome measures.
Article Synopsis
- - In the DREAMM-2 study, belantamab mafodotin showed significant effectiveness and a manageable safety profile for patients with relapsed/refractory multiple myeloma (RRMM), particularly those who had failed multiple previous treatments.
- - Patient-reported outcomes (PROs) indicated that while some patients experienced ocular symptoms (like difficulties with vision, driving, and reading), these symptoms improved over time with recovery times ranging from 23.5 to 44 days.
- - Overall health-related quality of life (HRQOL) and core symptoms of multiple myeloma, including fatigue and pain, were maintained during treatment, supporting the use of belantamab mafodotin in RRMM patients and suggesting potential for
Article Synopsis
- Belantamab mafodotin (belamaf) is a new treatment for patients with relapsed/refractory multiple myeloma (RRMM), targeting myeloma cells and enhancing immune response.
- The DREAMM-2 trial tested belamaf in heavily pretreated patients, revealing an overall response rate (ORR) of 32% to 35%, with median progression-free survival (PFS) of 2.8 to 3.9 months and overall survival (OS) of 14 to 15.3 months.
- The treatment demonstrated a manageable safety profile, with common side effects including keratopathy and thrombocytopenia, while also maintaining or
To explore treatment selection for relapsed/refractory multiple myeloma (RRMM), which remains complex due to heterogeneity of available treatments and lack of defined standard of care. The Adelphi Real World MM Disease Specific Programme surveyed physicians in the USA and their patients with MM to collect real-world data on patterns and perceptions of MM treatment across lines of therapy (LOT). Triplets were the most common regimens across each LOT.
View Article and Find Full Text PDFPurpose: We aimed to explore patient-reported outcomes (PROs) and patient and physician concordance of side effects perception across lines of therapy (LOT) in multiple myeloma (MM) within the United States of America (USA).
Methods: Data were drawn from the Adelphi Real World MM III Disease Specific Programme™, a point-in-time survey of hemato-oncologists/hematologists and their patients with MM conducted in the USA between August 2020 and July 2021. Physicians reported patient characteristics and side effects.
Objective: Evaluate the overall survival (OS) of patients with multiple myeloma (MM) at different treatment stages in France.
Methods: This retrospective observational cohort study used data from the French National Health Insurance database to study patients with MM (diagnosis 2013-2019). Patient outcomes included OS (all-cause mortality), time-to-next treatment (TTNT), and duration of therapy (DoT) from initial diagnosis, the start of different lines of therapy (LOTs), triple-class exposure (TCE), and subsequent treatment following TCE.
Background: The patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is used to assess symptomatic adverse events in oncology trials. Currently, no standard for PRO-CTCAE analysis exists.
Methods: Key methods of descriptive analysis and longitudinal modeling using PRO-CTCAE data from an oncology clinical trial, DRiving Excellence in Approaches to Multiple Myeloma-2 (DREAMM-2), a phase II trial of belantamab mafodotin in multiple myeloma (NCT03525678), were explored.
Patients with relapsed/refractory multiple myeloma (RRMM) resistant to multiple drug classes remain a high unmet need population. This longitudinal retrospective cohort study assessed real-world treatment patterns and outcomes in adults with RRMM. Patients who had three or more prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (double-exposed) were further categorized as refractory to a PI and an immunomodulatory agent (double-class refractory, = 381) or additionally to an anti-CD38 monoclonal antibody (triple-class refractory, = 173).
View Article and Find Full Text PDFBackground: Real-world data on health care resource utilisation (HCRU) and costs for French patients with multiple myeloma (MM) are limited due to the quickly evolving MM treatment landscape. This retrospective, national-level study quantified the MM economic burden in France.
Methods: The study included patients with newly diagnosed MM from the Système National des Données de Santé coverage claims database between 2013 and 2018 who received active treatment within 30 days of diagnosis.
Introduction: Single-agent belantamab mafodotin (belamaf; BLENREP) demonstrated deep and durable responses in patients with relapsed/refractory multiple myeloma and ≥ 3 prior lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody (DREAMM-2; NCT03525678).
Methods: At the time of this study, STORM Part 2, NCT02336815 (selinexor plus low-dose dexamethasone; sel + dex) was systematically identified as the only feasible comparator to the DREAMM-2 cohort. Matching-adjusted indirect comparisons (MAIC) evaluated efficacy and safety of belamaf (2.
Purpose: Estimate the budget impact of belantamab mafodotin (belamaf) for patients with relapsed/refractory multiple myeloma (RRMM) who have received ≥4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Methods: A budget impact analysis (BIA) was developed to estimate the cost difference between current (no belamaf) and projected (with belamaf) market scenarios over 3 years. Comparators were identified from a systematic literature review and included selinexor + dexamethasone or best supportive care.
Background: Patients with relapsed/refractory multiple myeloma (RRMM) require several lines of therapy, with typically shorter remission duration with each additional line.
Research Design And Methods: The cost-effectiveness of belantamab mafodotin (belamaf; DREAMM-2; NCT03525678) was compared with selinexor plus dexamethasone (SEL+DEX; STORM Part 2; NCT02336815) among patients with RRMM who have received at least four prior therapies. The base case used a US commercial payer's perspective over a 10-year time horizon.
Introduction: Alopecia areata (AA) is a chronic, autoimmune disease of hair loss, which can significantly affect the emotional and psychological well-being of patients. A systematic literature review was conducted to better understand the burden of AA from the patient perspective.
Methods: Embase, MEDLINE and Cochrane databases were searched for published studies (2008-2018) reporting on assessments of health-related quality of life (HRQoL) for patients with AA.
The article Development of a conceptual model and patient-reported outcome measures for assessing symptoms and functioning in patients with heart failure.
View Article and Find Full Text PDFPurpose: Heart failure (HF) is a common condition that places considerable burden on patients. We aimed to develop a patient-reported outcome (PRO) measure to assess the symptoms and impacts of HF.
Methods: Phase 1: a targeted literature review, expert interviews, and concept elicitation (CE) interviews with patients with HF (n = 26) were used to develop a conceptual model of the core symptoms and impacts of HF.
Congestion is associated with adverse outcomes in heart failure (HF) patients. We characterized congestion in patients hospitalized for HF and examined the association between congestion severity at admission and postdischarge outcomes. Using the OPTIMIZE-HF registry linked to Medicare claims, we analyzed patients ≥65 years old hospitalized for HF from 2003 to 2004.
View Article and Find Full Text PDFBackground: A phase III trial evaluated the efficacy and safety of Daklinza (daclatasvir or DCV) in combination with sofosbuvir (SOF) for treatment of genotype (GT) 3 hepatitis C virus (HCV) patients.
Aim: This study evaluated the cost-effectiveness of DCV + SOF vs SOF in combination with ribavirin (RBV) over a 20-year time horizon from the perspective of a United States (US) payer.
Methods: A published Markov model was adapted to reflect US demographic characteristics, treatment patterns, costs of drug acquisition, monitoring, disease and adverse event management, and mortality risks.