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Publications (197)
Fabry disease (FD) is a rare lysosomal storage disorder that is associated with pain and progressive damage to the renal, cardiac, and cerebrovascular systems. Enzyme replacement therapy (ERT) is one of the treatment options for FD and the most recently approved ERT agent, pegunigalsidase alfa, has shown clinical efficacy in three phase 3 clinical...
Aim
Insufficient adherence to colorectal cancer (CRC) screening impedes individual and population health benefits, with about one-third of individuals non-adherent to available screening options. The impact of poor adherence is inadequately considered in most health economics models, limiting the evaluation of real-world population-level screening...
Immunocompromised host pneumonia (ICHP) is an important cause of morbidity and mortality, yet usual care (UC) diagnostic tests often fail to identify an infectious etiology. A US-based, multicenter study (PICKUP) among ICHP patients with hematological malignancies, including hematological cell transplant recipients, showed that plasma microbial cel...
Objectives
The goal of the research was to assess the quantitative relationship between median progression-free survival (PFS) and median overall survival (OS) specifically among patients with relapsed/refractory multiple myeloma (RRMM) based on published randomized controlled trials (RCTs).
Methods
Two bibliographic databases (PubMed and Embase,...
Background
Helicobacter pylori eradication rates achieved with clarithromycin-based triple therapies are declining due to antibiotic resistance, but data regarding temporal changes in efficacy with these eradication therapies are scarce.
Objective
To evaluate the efficacy of clarithromycin-based triple eradication regimens over time.
Design
A com...
Aim: The correlation between response and survival has not been well-studied in relapsed or refractory multiple myeloma (RRMM). Materials & methods: A systematic literature review of Medline, Embase and Cochrane databases (2010-06/2020) and relevant congresses (2018-2020) was performed to identify randomized clinical trials in RRMM reporting median...
Purpose
To estimate the cost-effectiveness of Nefecon in addition to the best supportive care (BSC) vs BSC in a hypothetical cohort of commercially insured adult patients with primary immunoglobulin A nephropathy (IgAN) from a United States (US) societal perspective.
Methods
A lifetime horizon, semi-Markov model was developed that consisted of nin...
BACKGROUND
A new class of interventions called digital therapeutics (DTx) is emerging and shows promise in the treatment of a spectrum of medical disorders and diseases. DTx are software-based interventions which could deliver unprecedented portability and scalability for patients. Their adoption and implementation were accelerated by the need for...
Background
Digital therapeutics (DTx), a class of software-based clinical interventions, are promising new technologies that can potentially prevent, manage, or treat a spectrum of medical disorders and diseases as well as deliver unprecedented portability for patients and scalability for health care providers. Their adoption and implementation wer...
Aim: This research evaluated standard Weibull mixture cure (WMC) network meta-analysis (NMA) with
Bayesian hierarchical (BH)WMCNMAto inform long-term survival of therapies. Materials & methods: Four
trials in previously treated metastatic non-small-cell lung cancer with PD-L1 >1% were used comparing
docetaxel with nivolumab, pembrolizumab and atezo...
Importance:
Platform trial design allows the introduction of new interventions after the trial is initiated and offers efficiencies to clinical research. However, limited guidance exists on the economic resources required to establish and maintain platform trials.
Objective:
To compare cost (US dollars) and time requirements of conducting a plat...
Background and aims
Effective acid suppression is a crucial component of Helicobacter pylori (H. pylori) eradication regimens. Approved treatments include dual, triple, and quadruple therapies composed of certain antibiotics in combination with proton pump inhibitors (PPIs). Vonoprazan, a potassium-competitive acid blocker, provides more potent and...
Progression-free survival (PFS) is a common primary endpoint in newly diagnosed multiple myeloma (NDMM). Patients with NDMM typically have longer PFS and are more likely to achieve minimal residual disease (MRD) or complete response (CR) compared to patients with relapsed or refractory multiple myeloma. Response-based surrogate endpoints may hold v...
Importance:
Sexual orientation and gender identity change efforts (SOGICE), also called conversion therapy, is a discredited practice attempting to convert lesbian, gay, bisexual, transgender, queer, or questioning (LGBTQ) individuals to be heterosexual and/or cisgender.
Objectives:
To identify and synthesize evidence on the humanistic and econo...
Aims: To compare clinical trial results for crizotinib and entrectinib in ROS1-positive non-small-cell lung cancer and compare clinical trial data and real-world outcomes for crizotinib. Patients & methods: We analyzed four phase I–II studies using a simulated treatment comparison (STC). A STC of clinical trial versus real-world evidence compared c...
Introduction: Myelofibrosis (MF) is a Philadelphia chromosome-negative myeloproliferative neoplasm with an estimated prevalence of 4-6/100,000 persons in the USA. Patients with MF experience aberrant hematopoiesis, bone marrow fibrosis, splenomegaly, and cytopenias, including thrombocytopenia, as well as diminished survival ranging from months to y...
Background
Selinexor is an oral, selective nuclear export inhibitor. STORM was a phase 2b, single-arm, open-label, multicenter trial of selinexor with low dose dexamethasone in patients with penta-exposed relapsed/refractory multiple myeloma (RRMM) that met its primary endpoint, with overall response of 26% (95% confidence interval [CI], 19 to 35%)...
Background: Despite the availability of new treatments, multiple myeloma (MM) is an incurable cancer with nearly all patients relapsing and undergoing multiple lines of treatment. Performing head-to-head comparisons of all treatment options is not feasible. Thus, network meta-analyses play an important role in allowing health-care decision makers t...
Background and Objective
Nearly all patients with multiple myeloma undergo multiple rounds of therapy. The phase III BOSTON trial of once-weekly selinexor and once-weekly bortezomib with dexamethasone (XVd) vs twice-weekly bortezomib and dexamethasone (Vd) is the basis for this cost-effectiveness analysis in previously treated multiple myeloma from...
Background: Despite the availability of new treatments, multiple myeloma (MM) is an incurable cancer with nearly all patients relapsing and undergoing multiple lines of treatment. Performing head-to-head comparisons of all treatment options is not feasible. Thus, network meta-analyses play an important role in allowing health-care decision makers t...
Objective:
The analysis estimates projected population outcomes resulting from the introduction of a plant-derived influenza vaccine formulated as quadrivalent virus-like particles (QVLP) in Canada.
Methods:
Using Monte Carlo simulations, the number of influenza cases, general practitioner visits, inpatient admissions, intensive care unit (ICU)...
Purpose
To estimate the budget impact of selinexor, bortezomib, and dexamethasone (XVd) in patients with previously treated multiple myeloma (MM) from the perspective of a private third-party payer and Medicare in the US.
Methods
The introduction of XVd as an option for patients with previously treated MM compared to no introduction of XVd was con...
**Background:** Despite the availability of new treatments, multiple myeloma (MM) is an incurable cancer with nearly all patients relapsing and undergoing multiple lines of treatment. Performing head-to-head comparisons of all treatment options is not feasible. Thus, network meta-analyses play an important role in allowing health-care decision make...
e18839
Background: Despite advances in the treatment of MM, prognosis remains poor for most patients due to its refractory nature. In a phase 3 study, a once-per-week regimen of XVd showed a novel, effective, and convenient option for patients with previously treated MM. This study was conducted to estimate the projected budget impact (BI) of XVd i...
Background: Two combination therapies recently approved and recommended for use in combination with low-dose cytarabine (LDAC) in acute myeloid leukemia patients unfit for intensive chemotherapy are glasdegib+LDAC and venetoclax+LDAC. Materials & methods: An indirect treatment comparison used median overall survival, overall survival hazard ratios,...
Background: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) can be a lifesaving treatment for hematologic malignancies, but acute graft-versus-host-disease (aGVHD) is a potentially deadly adverse effect experienced by up to half of allo-HSCT recipients. Inadequate response to steroid therapy for aGVHD is associated with poor prognosi...
Aim: Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Patients & methods: Functional Assessment of Cancer Therapy (FACT) – Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase I...
Background: Older patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy have a poor prognosis, further encumbered by the lack of well-tolerated standard therapies. Combinations of glasdegib with low-dose cytarabine (GLAS+LDAC) and venetoclax with LDAC (VEN+LDAC) are non-intensive chemotherapy (NIC) options recommended...
Objective: Novel anaemia treatments have greatly improved patient outcomes in the last decade and have also undergone economic evaluations in various settings using heterogenous model structures, costs, and inputs. The objectives were to review published economic evaluation studies in major red blood cell disorders, identify limitations in the appl...
Background
Midostaurin (MIDO) combined with standard chemotherapy was approved by the European Medicines Agency in 2017 for the treatment of adults with newly diagnosed FLT3-mutated acute myeloid leukemia (AML) based on results from the RATIFY trial.MethodsA cost-effectiveness model was developed to compare MIDO and standard-of-care (SOC) to SOC al...
e20522
Background: Selinexor, a novel oral selective inhibitor of nuclear export, was recently approved for use in relapsed/refractory multiple myeloma (MM). The efficacy and safety of selinexor and dexamethasone was evaluated in a phase 2b, single-arm, open-label, multicenter trial in patients with penta-exposed, triple-class refractory MM. Patien...