Cost-per-responder analysis of patients with lenalidomide-refractory multiple myeloma receiving ciltacabtagene autoleucel in CARTITUDE-4.

Introduction: Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T-cell therapy approved for patients with relapsed/refractory multiple myeloma (RRMM). In the phase 3 trial, CARTITUDE-4 (NCT04181827), cilta-cel demonstrated improved efficacy vs. standard of care (SOC; daratumumab plus pomalidomide and dexamethasone [DPd] or pomalidomide plus bortezomib and dexamethasone [PVd]) with a ≥ complete response (≥CR) rate of 73.

Clinician and administrator perspectives on outpatient administration of ciltacabtagene autoleucel in relapsed or refractory multiple myeloma.

Introduction: Chimeric antigen receptor (CAR) T-cell therapy (CAR T therapy) is a treatment option for patients with relapsed or refractory multiple myeloma that has led to unprecedented treatment outcomes. Among CAR T therapies available, ciltacabtagene autoleucel (cilta-cel) is a good candidate for outpatient administration due to its generally predictable safety profile. There are multiple advantages of outpatient administration of cilta-cel, including reduced healthcare burden, expanded access, and patient autonomy.

Real-World Treatment Patterns and Outcomes by Line of Therapy and Race in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated in the United States: Results From the Final Analysis of the Prospective, Observational, informCLL Registry.

Background: informCLL is the largest US-based prospective, observational registry of patients with chronic lymphocytic leukemia (CLL) initiating FDA-approved treatment in the era of targeted therapy.

Patients And Methods: Patients were enrolled between October 2015 and June 2019. Data were collected for baseline characteristics, treatment patterns, outcomes, and safety.

Real-World Comparison of First-Line Treatment Adherence Between Single-Agent Ibrutinib and Acalabrutinib in Patients with Chronic Lymphocytic Leukemia.

Purpose: Increased dosing frequency adversely affects treatment adherence and outcomes in chronic diseases; however, such data related to treatment adherence is lacking in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This study compared adherence between patients treated with ibrutinib (once-daily) versus acalabrutinib (twice-daily) as first-line (1L) therapy for CLL/SLL.

Patients And Methods: Specialty pharmacy electronic medical records were used to identify adults with CLL/SLL initiating 1L ibrutinib or acalabrutinib between 01/01/2018 and 11/30/2020.

Real-world time to discontinuation of first-line venetoclax + obinutuzumab in chronic lymphocytic leukemia/small lymphocytic lymphoma.

Objective: To evaluate the time to discontinuation (TTD) and baseline characteristics among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) treated with first-line (1L) venetoclax + obinutuzumab (VO) in the United States.

Methods: A nationwide electronic health record-derived database was used to select adults with CLL/SLL initiating a 1L venetoclax-based regimen between April 11, 2016-July 31, 2020. Study measures included TTD (defined as >120-day treatment gap or switching therapy) and baseline characteristics by discontinuation status.

Hypnotic prescription trends and patterns for the treatment of insomnia in Japan: analysis of a nationwide Japanese claims database.

Background: There is limited consensus regarding the optimal treatment of insomnia. The recent introduction of orexin receptor antagonists (ORA) has increased the available treatment options. However, the prescribing patterns of hypnotics in Japan have not been comprehensively assessed.

Factors Associated with Prescriptions for an Orexin Receptor Antagonist Among Japanese Patients with Insomnia: Analysis of a Nationwide Japanese Claims Database.

Background: Few studies have examined the prescribing patterns of orexin receptor antagonists (ORAs) in the real-world clinical setting in Japan.

Objective: We sought to analyze the factors associated with ORA prescriptions for patients with insomnia in Japan.

Methods: Outpatients (aged ≥ 20 to < 75 years old) prescribed one or more hypnotic for insomnia between April 1, 2018 and March 31, 2020 with continuous enrollment for ≥ 12 months were extracted from the JMDC Claims Database.

Atypical Treatment Switches in Schizophrenia Patients: Drivers and Associated Outcomes.

Objective: To describe and compare demographics and outcomes among patients with schizophrenia who have switched atypical treatments versus non-switchers.

Methods: Data were extracted from the Adelphi Schizophrenia Disease Specific Programme™ conducted from January to May 2014 in the United States. Participating physicians provided information on their next 10 consulting schizophrenia patients aged ≥ 18 years; the same patients were invited to voluntarily complete a patient self-completion form (PSC).

A Feasibility Study: Testing Whether a Sleep Application Providing Objective Sleep Data to Physicians Improves Patient-Physician Communication Regarding Sleep Experiences, Habits, and Behaviors.

Introduction: Sleep tracker data have not been utilized routinely in sleep-related disorders and their management. Sleep-related disorders are common in primary care practice and incorporating sleep tracker data may help in improving patient care. We conducted a pilot study to assess the feasibility of a sleep program using the Fitbit Charge 2™ device and SleepLife application.

Burden of Insomnia and Sleep Disturbances and the Impact of Sleep Treatments in Patients with Probable or Possible Alzheimer's Disease: A Structured Literature Review.

Background: Sleep disturbances are frequent in Alzheimer's disease (AD).

Objective: To summarize the impact of sleep disturbances on AD patients and their caregivers and the effects of currently available sleep therapies.

Methods: Published studies (January 1985-March 2020) assessing the burden associated with insomnia/sleep disturbances in the AD population and insomnia treatment effects were identified by searching PubMed, Embase, and Cochrane Library and screened against inclusion criteria.

Changes in Healthcare Resource Use and Costs in Commercially Insured Insomnia Patients Initiating Suvorexant.

Introduction: Insomnia diagnosis has been associated with a significant clinical and economic burden on patients and healthcare systems. This study examined changes in healthcare resource use (HCRU) and costs in insomnia patients before and after initiation of suvorexant treatment.

Methods: This retrospective cohort study analyzed Optum Clinformatics Data Mart claims data (Jan 2010-Dec 2018).

Incremental Healthcare Utilization and Cost Burden of Comorbid Insomnia in Alzheimer's Disease Patients.

Background: Insomnia is associated with worsened clinical outcomes among Alzheimer's disease dementia (AD) patients, increased caregiver burden, and healthcare utilization.

Objective: This study aimed to characterize the incremental healthcare burden of insomnia in AD using real-world data.

Methods: A retrospective observational study was conducted on AD patients selected from the IBM® MarketScan Commercial and Medicare Supplemental Databases.

A Real-World Assessment of Outcomes in Schizophrenia Patients According to Treatment Response.

Objective: To describe and compare demographics, outcomes, and comorbidities among schizophrenia patients according to treatment response.

Methods: A cross-sectional survey was conducted in the United States through the Adelphi Schizophrenia Disease Specific Program from January to May 2014. Participating physicians provided information on the first 10 schizophrenia patients aged ≥ 18 years they saw in daily clinical practice; these patients were invited to voluntarily complete a patient self-completion form.

Do radiation oncologists and urologists endorse decision aids for active surveillance of low-risk prostate cancer: Results from a national survey.

Objective: The degree decision aids (DAs) can promote active surveillance (AS) for prostate cancer (PCa) remains poorly understood. Herein, we surveyed radiation oncologists (RO) and urologists (URO) about their attitudes towards DAs in counselling patients about AS for low-risk PCa.

Methods: We conducted a national survey of RO (n = 915) and URO (n = 940) to assess their attitudes about DAs for AS for patients with low-risk PCa.

Assessment of Real-Life Outcomes in Schizophrenia Patients according to Compliance.

Objective: To describe and compare demographics, outcomes and comorbidities in schizophrenia patients by treatment compliance.

Methods: This was a cross-sectional survey of hospital- or office-based psychiatrists who saw ≥6 schizophrenia patients per week and were responsible for treatment decisions. Recruited physicians completed a patient record form (PRF) for their first 10 consulted schizophrenia patients aged ≥18.

Dose-Dependent Hyperkalemia Among Hospitalized, HIV-Infected Patients Receiving Sulfamethoxazole/Trimethoprim.

Sulfamethoxazole-trimethoprim (SXT) therapy is commonly used in HIV-infected patients and is associated with hyperkalemia and elevated serum creatinine (SCr). The purpose of this study was to examine the frequency of hyperkalemia and elevated SCr in hospitalized, HIV-infected patients receiving SXT. This was a retrospective, single-center cohort study.

Freestanding Dialysis Facility Quality Incentive Program Scores and Mortality Among Incident Dialysis Patients in the United States.

Rationale & Objective: The Centers for Medicare & Medicaid Services introduced the Quality Incentive Program (QIP) along with the bundled payment reform to improve the quality of dialysis care in the United States. The QIP has been criticized for using easily obtained laboratory indicators without patient-centered measures and for a lack of evidence for an association between QIP indicators and patient outcomes. This study examined the association between dialysis facility QIP performance scores and survival among patients after initiation of dialysis.

Association between Freestanding Dialysis Facility Size and Medicare Quality Incentive Program Performance Scores.

Background: Medicare uses a quality incentive program (QIP) criteria to evaluate care in dialysis facilities and apply monetary penalties on underperforming facilities. Smaller dialysis facilities are likely to be rural and operate on lower profit margin; therefore, such facilities are likely to underperform and face Medicare penalties. The variation in QIP scores by facility size is not yet known.

Investigating Serious Adverse Drug Reactions in Patients Receiving Erythropoiesis-Stimulating Agents: A Root Cause Analysis Using the "ANTICIPATE" Framework.

Background: Unexpected serious adverse drug reactions (sADRs) affecting patients with chronic kidney disease (CKD) who received erythropoiesis-stimulating agents were identified by study co-authors. These included pure red cell aplasia (PRCA) after administration of the Eprex formulation of epoetin or the epoetin biosimilar HX575 and fatal anaphylaxis associated with peginesatide, an erythropoietin receptor agonist. We developed and applied a structured framework to describe these sADRs, including root cause analyses and eradication efforts.