Clinical use of vedolizumab subcutaneous formulation in inflammatory bowel diseases: a review of real-world evidence.

Introduction: Vedolizumab is an advanced therapy indicated for the treatment of moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC). After induction with vedolizumab intravenous (IV), maintenance is with vedolizumab 300 mg IV every 8 weeks, or patients can transition to vedolizumab 108 mg subcutaneous (SC) every 2 weeks.

Methods: This was a literature review of the PubMed and Embase databases up to March 2024 to identify publications describing clinical practice experiences on the transition from vedolizumab IV to SC.

Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naïve Patients With Early or Late Crohn's Disease: Results From the EVOLVE Expansion Study.

Background: We evaluated the real-world effectiveness and safety of vedolizumab and ustekinumab as first-line biologics in patients with Crohn's disease (CD), by disease duration.

Methods: EVOLVE Expansion (ClinicalTrials.gov, NCT05056441) was a retrospective medical chart review study in Australia, Belgium, and Switzerland.

Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Biologic-Naive Patients With Crohn's Disease By Disease Location: Results from the EVOLVE Expansion Study.

Goals: This analysis compared the real-world effectiveness and safety of vedolizumab versus ustekinumab in biologic-naive patients by CD location.

Background: Crohn's disease (CD) location may affect disease course and treatment decisions.

Study: Medical charts of biologic-naive patients with CD aged 18 years or older initiating vedolizumab or ustekinumab were analyzed in the multicenter, observational, retrospective EVOLVE Expansion study.

Effect of KiwiBiotic on functional constipation and related symptoms: A prospective, single-center, randomized, comparative, crossover study.

Background: Functional constipation (FC) is a common gastrointestinal disorder characterized by abdominal pain and bloating, which can greatly affect the quality of life of patients. Conventional treatments often yield suboptimal results, leading to the exploration of alternative therapeutic approaches.

Aim: To evaluate the efficacy of KiwiBiotic in the management of FC and related symptoms.

A randomized phase 2 study of the 5-HT receptor agonist felcisetrag for postoperative gastrointestinal dysfunction after bowel surgery.

Background: Felcisetrag (5-hydroxytryptamine-4 receptor [5-HT] agonist) is under investigation as prophylaxis or active treatment for accelerating resolution of gastrointestinal function post-surgery.

Methods: Phase 2, randomized, placebo-controlled, parallel five-arm, double-blind, multicenter study (NCT03827655) in 209 adults undergoing open or laparoscopic-assisted bowel surgery. Patients received intravenous placebo, felcisetrag 0.

Effectiveness and safety of vedolizumab and infliximab in biologic-naive patients with Crohn's disease: results from the EVOLVE study.

Objectives: This study compared the real-world effectiveness and safety of α 4 β 7 -integrin inhibitor vedolizumab and anti-tumor necrosis factor alpha (anti-TNFα) inhibitor infliximab in biologic-naive patients with Crohn's disease (CD).

Methods: EVOLVE was a retrospective, multicenter, medical chart review of biologic-naive adults with inflammatory bowel disease receiving vedolizumab or anti-TNFα treatment as first-line biologics in Canada, Greece, and the USA. Twelve-month outcomes were analyzed in vedolizumab- or infliximab-treated patients with moderate-to-severe CD (and subgroups with complicated and noncomplicated CD) including cumulative rates of clinical response, clinical remission, and mucosal healing, and incidence rates of serious adverse events (SAEs) and serious infections (SIs).

Real-World Effectiveness of Vedolizumab Dose Escalation in Patients With Inflammatory Bowel Disease: A Systematic Literature Review.

Background: Vedolizumab is a gut-selective anti-lymphocyte trafficking agent approved for the treatment of moderate to severely active inflammatory bowel disease (IBD: ulcerative colitis [UC] and Crohn's disease [CD]).

Methods: A systematic literature review (SLR) of real-world studies was conducted to assess the effectiveness of dose escalation of vedolizumab every 8 weeks (Q8W) during maintenance treatment to achieve a response in patients who were either vedolizumab responders experiencing secondary loss of response (SLOR) or non-responders. MEDLINE and EMBASE databases were searched from January 2014 to August 2021.

Real-world Effectiveness of Liraglutide vs. Sitagliptin Among Older Patients with Type 2 Diabetes Enrolled in a Medicare Advantage Prescription Drug Plan: A Retrospective Observational Study.

Introduction: Liraglutide and sitagliptin were compared on glycemic control and all-cause healthcare costs over a 1-year period among older adults with type 2 diabetes (65-89 years) enrolled in a national Medicare Advantage Prescription Drug health plan.

Methods: This was a retrospective study in which the index date was the first prescription fill for liraglutide or sitagliptin between 25 January 2010 and 31 December 2014. Post-index treatment persistence and glycosylated hemoglobin (HbA1) at baseline and 1 year (± 90 days) post-index date were required.

Healthcare utilization and costs with fixed-source versus variable-source tacrolimus in patients receiving a kidney transplant.

Aims: Switching drug manufacturers in transplant patients may require an increased intensity of therapeutic monitoring, leading to additional healthcare visits, associated laboratory tests, and perhaps hospitalizations. As real-world studies examining the interchangeability of tacrolimus from different manufacturers are limited, the purpose of this study was to examine the healthcare resource utilization (HRU) and economic impact of tacrolimus-switching in kidney transplantation.

Materials And Methods: This cross-sectional, retrospective study examined HRU and healthcare costs (HCCs) among patients with a kidney transplant who were prescribed tacrolimus from fixed-source (FS) vs variable-source (VS) manufacturers using claims data from the large US health plan Humana from October 1, 2012, to December 31, 2013.

The Effect of an Educational Intervention on Adherence to Intraocular Pressure-Lowering Medications in a Large Cohort of Older Adults with Glaucoma.

Background: Glaucoma is a progressive, irreversible disease that can lead to vision loss and lower quality of life if treatment is not optimized. Effective glaucoma therapies are available to lower intraocular pressure (IOP) and minimize or delay disease progression. Nonetheless, adherence to treatment remains suboptimal for many patients.

Association of obesity with healthcare resource utilization and costs in a commercial population.

Objective: To examine the association of obesity with healthcare resource utilization (HRU) and costs among commercially insured individuals.

Methods: This retrospective observational cohort study used administrative claims from 1 January 2007 to 1 December 2013. The ICD-9-CM status codes (V85 hierarchy) from 2008 to 2012 classified body mass index (BMI) into the World Health Organizations' BMI categories.

Understanding Prediabetes in a Medicare Advantage Population Using Data Adaptive Techniques.

The objective was to identify individuals with undiagnosed prediabetes from administrative data using adaptive techniques. The data source was a national Medicare Advantage Prescription Drug (MAPD) plan administrative data set. A retrospective, cross-sectional study developed and evaluated data adaptive logistic regression, decision tree, neural network, and ensemble predictive models for metabolic syndrome and prediabetes using 3 mutually exclusive cohorts (N = 279,903).

Positive predictive value between medical-chart body-mass-index category and obesity versus codes in a claims-data warehouse.

Objective: To evaluate the positive predictive value of claims-based V85 codes for identifying individuals with varying degrees of BMI relative to their measured BMI obtained from medical record abstraction.

Methods: This was a retrospective validation study utilizing administrative claims and medical chart data from 1 January 2009 to 31 August 2015. Randomly selected samples of patients enrolled in a Medicare Advantage Prescription Drug (MAPD) or commercial health plan and with a V85 claim were identified.

Association of obesity with healthcare utilization and costs in a Medicare population.

Objectives: To examine the association of obesity with healthcare resource utilization and costs in a Medicare population.

Methods: This study was a retrospective cohort study using Humana Medicare Advantage (MA) claims data. Body mass index (BMI) was assessed using ICD-9-CM status codes (V85 hierarchy) that have been validated in the data source to classify patients into BMI categories: normal (N), overweight (Ow), obese class I (ObI), obese class II (ObII), and obese class III (ObIII).

A comparison of entropy balance and probability weighting methods to generalize observational cohorts to a population: a simulation and empirical example.

Purpose: We compared methods to control bias and confounding in observational studies including inverse probability weighting (IPW) and stabilized IPW (sIPW). These methods often require iteration and post-calibration to achieve covariate balance. In comparison, entropy balance (EB) optimizes covariate balance a priori by calibrating weights using the target's moments as constraints.

"Act on Threes" Paradigm for Treatment Intensification of Type 2 Diabetes in Managed Care: Results of a Randomized Controlled Study with an Educational Intervention Targeting Improved Glycemic Control.

Background: Clinical inertia, which has been defined as the recognition of a problem with a patient's management but failing to act, is a concern in type 2 diabetes (T2D) because it places the patient at risk of diabetes-related complications. Despite managed care organizations making significant investment in this area, little is known about the impact of educational programs aimed at aligning patients and their physicians with diabetes guidelines and thus overcoming clinical inertia.

Objective: To assess the impact of an educational intervention specifically designed to align patients and their physicians with 2012 American Diabetes Association (ADA) guidelines on glycated hemoglobin (A1c) testing frequency and insulin initiation.

Cardiovascular Safety of Concomitant Use of Atypical Antipsychotics and Long-Acting Stimulants in Children and Adolescents With ADHD.

Objective: This study examined cardiovascular safety of concomitant use of long-acting stimulants (LAS) and atypical antipsychotics (AAP) in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD).

Method: The study used 2004-2007 IMS LifeLink™ claims data involving 6- to 16-year-old children with ADHD and at least one LAS prescription from July 2004 to December 2006. Time-dependent Cox regression analysis was performed to evaluate the risk of cardiovascular disease (CVD) events due to concomitant use of LAS and AAP.

Predictors of concomitant use of antipsychotics and stimulants and its impact on stimulant persistence in pediatric attention deficit hyperactivity disorder.

Background: Concomitant use of stimulants and atypical antipsychotics is common in pediatric attention deficit hyperactivity disorder (ADHD). However, little is known about the determinants of concomitant use and its utility in the management of pediatric ADHD.

Objectives: To (a) examine predictors of concomitant stimulant and atypical antipsychotic use and (b) evaluate the impact of concomitant atypical antipsychotic use on the persistence of stimulants in children and adolescents diagnosed with ADHD.

Concurrent use of stimulants and second-generation antipsychotics among children with ADHD enrolled in Medicaid.

Objective: This study examined the prevalence of and factors associated with concurrent use of long-acting stimulants (LAS) and second-generation antipsychotic agents among children and adolescents with attention-deficit hyperactivity disorder (ADHD).

Methods: The study involved retrospective longitudinal analysis of 2003-2007 Medicaid data from four states for children and adolescents between the ages of six and 17 years who were diagnosed as having ADHD and initiated LAS treatment. Concurrent use of LAS and second-generation antipsychotic medications was defined as simultaneous receipt of both medications for at least 14 days.

Persistence of stimulants in children and adolescents with attention-deficit/hyperactivity disorder.

Objective: To examine the persistence of three newly initiated stimulant preparations among Medicaid children and adolescents with attention-deficit/hyperactivity disorder (ADHD) diagnosis.

Methods: A retrospective longitudinal claims analysis was conducted by using Medicaid analytical eXtract data of four states. The study focused on patients between 6 and 19 years of age with ADHD diagnosis and a stimulant prescription from January 2003 to December 2005.

Prevalence and predictors of antidepressant prescribing in nursing home residents in the United States.

Background: Late-life depression is a common psychiatric disorder associated with increased morbidity and mortality. Depression is often under-detected and undertreated in elderly nursing home residents.

Objectives: The aim of this study was to examine the prevalence of antidepressant drug use and to identify the factors associated with its use among elderly nursing home residents.

Off-label use of second-generation antipsychotic agents among elderly nursing home residents.

Objective: This study examined off-label and evidence-based use of second-generation antipsychotic agents among elderly nursing home residents and factors associated with off-label use.

Methods: This study involved a retrospective, cross-sectional analysis of data from the 2004 National Nursing Home Survey (NNHS). The sample included nursing home residents 65 years and older who received second-generation antipsychotic agents.