Greater Adherence and Persistence with Injectable Dulaglutide Compared with Injectable Semaglutide at 1-Year Follow-up: Data from US Clinical Practice.

PURPOSE: Greater medication adherence and persistence have been associated with improved glycemic control in patients with type 2 diabetes mellitus. This study compared adherence, persistence, and treatment patterns among patients naïve to glucagon-like peptide 1 receptor agonists initiating once-weekly injectable treatment with dulaglutide versus semaglutide over 6-month (6M) and 12-month (12M) follow-up periods. METHODS: This retrospective, observational cohort study used administrative claims data from three IBM MarketScan research databases. Data from adult patients with type 2 diabetes newly initiating treatment with dulaglutide or semaglutide between January 2018 and January 2020 (index date was defined as the earliest fill date), without evidence of glucagon-like peptide 1 receptor agonist use in the 6M baseline period, and with continuous enrollment in the 6M baseline and 6M or 12M follow-up period were included. Dulaglutide initiators were propensity score-matched, in a 1:1 ratio, to semaglutide initiators in each 6M and 12M follow-up cohort (26,284 and 13,837 pairs, respectively). FINDINGS: In the matched cohorts, baseline characteristics were balanced; the mean age was 53 years, and 50% of patients were women. Compared to semaglutide initiators, dulaglutide initiators were more adherent (6M, 63.4% vs 47.8%; 12M, 54.4% vs 43.3%; both, P < 0.0001), more persistent on therapy (6M, 72% vs 62%, 12M, 55.5% vs 45.3%, both, P < 0.001), and had more mean days of persistence (6M, 145 vs 132, 12M, 254.3 vs 220.7; both, P < 0.001). IMPLICATIONS: At both 6M and 12M follow-up, dulaglutide initiators had significantly greater adherence and greater persistence compared with matched semaglutide initiators.

Real-World Evidence: A Primer.

SUMMARY: The insights that real-world data (RWD) can provide, beyond what can be learned within the traditional clinical trial setting, have gained enormous traction in recent years. RWD, which are increasingly available and accessible, can further our understanding of disease, disease progression, and safety and effectiveness of treatments with the speed and accuracy required by the health care environment and patients today. Over the decades since RWD were first recognized, innovation has evolved to take real-world research beyond finding ways to identify, store, and analyze large volumes of data. The research community has developed strong methods to address challenges of using RWD and as a result has increased the acceptance of RWD in research, practice, and policy. Historic concerns about RWD relate to data quality, privacy, and transparency; however, new tools, methods, and approaches mitigate these challenges and expand the utility of RWD to new applications. Specific guidelines for RWD use have been developed and published by numerous groups, including regulatory authorities. These and other efforts have shown that the more RWD are used and understood and the more the tools for handling it are refined, the more useful it will be.

Real-World Evidence: A Review of Real-World Data Sources Used in Orthopaedic Research.

SUMMARY: Real-world data (RWD) play an increasingly important role in orthopaedics as demonstrated by the rapidly growing number of publications using registry, administrative, and other databases. Each type of RWD source has its strengths and weaknesses, as does each specific database. Linkages between real-world data sets provide even greater utility and value for research than single data sources. The unique qualities of an RWD data source and all data linkages should be considered before use. Close attention to data quality and use of appropriate analysis methods can help alleviate concerns about validity of orthopaedic studies using RWD. This article describes the main types of RWD used in orthopaedics and provides brief descriptions and a sample listing of publications from selected, key data sources.

Randomized Clinical Trial or Real-World Evidence: How Historical Events, Public Demand, and the Resulting Laws and Regulations Shaped the Body of Medical Evidence.

SUMMARY: The signing of the 21st Centuries Cures Act in 2016 was a confirmational step in a long journey toward an understood use and need for real-world evidence (RWE), even though the Food and Drug Administration (FDA) had the legislative authority to accept RWE since 1962 to demonstrate efficacy. The 21st Century Cures Act, as well as the subsequent FDA guidance published in 2017 and other supporting guidance, documents that since are opening the doors for the clinical and research community. They specifically allow for labeling changes and indication expansion based on RWE. The legislative discussion of efficacy requirements started in the late 1950s, when evidence of effectiveness was not required in the United States before the marketing of a drug or medical device, and calls for the real-world comparative effectiveness research were being made by Senator Estes Kefauver. When the thalidomide tragedy stuck, Congress and the Kennedy Administration rushed to pass a new law to require that drugs be "effective in use." The regulations subsequently drafted by the FDA to enforce the law often required placebo-controlled, randomized clinical trials (RCTs). In the 1980s, some started to label the RCT as the gold standard for medical evidence. The use of real-world data for new indication approval was not specifically prohibited by the 1962 law, but the new 2016 law sent a clear mandate to FDA, requiring the agency to review new forms of evidence such as RWE.

Breaking Barriers: Studying Fracture Healing in the BONES Program.

SUMMARY: The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This article outlines the design and methodology within the fifth metatarsal fracture study; similar approaches are taken in the second and third BONES Program studies, which examine nonunions of the tibia and scaphoid. The BONES Program is an external comparator design and incorporates several unique, fit-for-purpose components to strengthen the approach and allow it to be submitted to the US Food and Drug Administration (FDA) to be considered for a label expansion. BONES consisted of 2 cohorts: (1) EXOGEN-treated patients recruited into a patient registry and (2) comparator patients from a large administrative health claims database. The study used International Classification of Diseases, Tenth Revision, nonunion diagnosis codes reported by the treating clinician for the primary outcome measure. Many data sources (medical and billing records, patient-reported health data, usage data from the device itself, and commercial product complaint system) were used on the registry side, alongside insurance claims data to source the external comparator cohort, to achieve broader understanding of factors predisposing patients to the development of nonunions. In step with the FDA's increasing acceptance of real-world evidence for use in regulatory decision making and coupled with the infeasibility of a randomized clinical trial in this setting, the innovative study design of the BONES Program allowed for both an evaluation of the effect of EXOGEN in mitigating nonunions in a real-world setting and an assessment of the patient experience with EXOGEN treatment.

Methodologies for Validation of Diagnoses in Real-World Data: BONES-A Case Study.

SUMMARY: The accuracy of any claim-based study is dependent on the quality of real-world coding of the condition of interest. This retrospective, administrative claims analysis presents a method for using a real-world data source to evaluate the accuracy of coding for nonunion of a fifth metatarsal fracture. Patients 21-80 years old with a diagnosis of a fifth metatarsal fracture between January 1, 2016, and October 31, 2016, and a nonunion of the fifth metatarsal fracture within the next 9 months were identified in the MarketScan Databases. Patient health care claims in the 12 months after the nonunion diagnosis were examined for health care encounters and pharmaceutical treatments considered indicative of treatment for nonunion, such as claims for bone growth stimulation or a second claim with a diagnosis of nonunion. Of the 230 patients who had at least one health care encounter attributable to a nonunion of the fifth metatarsal, 95.2% had at least one subsequent health care encounter confirming nonunion diagnosis. The mean number of supporting health care claims was 5.8, and the mean time between nonunion and first confirmatory claim was 33 days. This analysis demonstrated a method for evaluating the quality of coding for a specific condition when a traditional medical chart comparison is not feasible.

Prevalence, characteristics, and costs of diagnosed homocystinuria, elevated homocysteine, and phenylketonuria in the United States: a retrospective claims-based comparison.

BACKGROUND: Classical homocystinuria (HCU), an inborn error of homocysteine metabolism, has previously been estimated to affect approximately 1 in 100,000-200,000 people in the United States (US). HCU is poorly detected by newborn screening, resulting in underestimates of its prevalence. This study compared characteristics, healthcare use and costs, and projected prevalence between patients with diagnosed HCU, elevated total homocysteine (tHcy), and diagnosed phenylketonuria (PKU). METHODS: Patients in the MarketScan® Research Databases were identified with strictly-defined HCU (> 2 diagnoses, including 1 ICD-10), broadly-defined HCU (> 1 ICD-10), elevated tHcy (> 20 µmol/L) without an HCU diagnosis, or > 1 ICD-9/ICD-10 PKU diagnosis during 1/1/2010-12/31/2016 (first qualifying claim = index). Demographics and healthcare utilization and costs per patient per month (PPPM) were compared between all cohorts, frequencies of comorbidities and medications were compared between HCU and elevated tHcy patients, and healthcare provider types were assessed among HCU patients. The prevalence of patients meeting each cohort definition was projected to the United States (US) population. RESULTS: Patients with strictly-defined (N = 2450) and broadly-defined (N = 6613) HCU, and with elevated tHcy (N = 2017), were significantly older than PKU patients (N = 5120) (57 vs. 56 vs. 53 vs. 18 years; p < 0.05). Vitamin D deficiency, hyperlipidemia, folic acid/B vitamins, and lipid-lowering medications, among others, were more common among diagnosed HCU patients vs. those with elevated tHcy (all p < 0.05). Rates of healthcare utilization were generally higher among HCU and elevated tHcy patients, compared to PKU, though total healthcare costs were similar between groups. Most HCU patients (~ 38%) received their index diagnosis from a primary care physician; very few (~ 1%) had any claim from a geneticist during their enrollment. The age-adjusted national prevalence of HCU was projected at 31,162 (95% CI: 30,411 - 31,913; ~ 1 in 10,000 of the US population) using the broad definition. CONCLUSIONS: The actual prevalence of HCU may be > 10 times prior estimates, at 1 in 10,000 in the US, and this study suggests that HCU is not being diagnosed until later in life. Improvements to newborn screening, detection in young children, and physician education regarding HCU among patients may be necessary to alleviate the burden of this genetic disease.

Estimated prevalence of moderate to severely elevated total homocysteine levels in the United States: A missed opportunity for diagnosis of homocystinuria?

Classical homocystinuria (HCU) is a genetic disorder caused by mutations in the cystathionine beta synthase gene, which results in impaired metabolism of the sulfur-bearing amino acid homocysteine and its accumulation in blood and tissues. Classical HCU can be detected via newborn screening in the United States, but the test is widely acknowledged to miss many patients. While severely elevated homocysteine levels (>100 µmol /L) frequently lead to a classical HCU diagnosis, intermediate levels (>30 to 100 µmol /L), though linked to many of the known complications of HCU, are not always recognized as associated with HCU. We aimed to identify and describe potentially undiagnosed classical HCU patients using a nationally-representative database of administrative claims and laboratory results. We estimated the national prevalence of patients with homocysteine >30 µmol /L, and compared their demographic and clinical characteristics to those of patients with homocysteine levels ≤30 µmol/L. Among 57,580 patients with a homocysteine test result, 1.8% had a value >30 µmol /L. Patients with homocysteine >30 µmol /L were more frequently diagnosed with hypothyroidism (39.2% vs. 20.7%, p < .001) and renal disease (9.7% vs. 5.5%, p < .001), and were more likely to have a prescription for an anxiolytic/antidepressant (44.5% vs. 38.9%), opioid (58.4% vs. 53.1%), steroid (46.4% vs. 42.5%), or thyroid hormone (38.8% vs. 18.8%), compared to patients with homocysteine ≤30 µmol /L (all p < .05). Both groups were equally likely to have a diagnosis of homocystinuria or another disorder of sulfur-bearing amino acid metabolism (3.8% vs. 4.0%, p = .752). The age-adjusted national prevalence of homocysteine >30 µmol /L was estimated at 33,068 (95% CI: 1033 - 35,104). These findings suggest that thousands of people in the US may be living with intermediate to severely elevated homocysteine levels and may require further evaluation for the presence of classical HCU.

Real-world healthcare resource utilization in patients with indolent non-Hodgkin lymphoma: differences between patients treated with first-line ibrutinib or bendamustine + rituximab.

Objective: This study evaluated the real-world healthcare resource utilization (HCRU) and costs in patients diagnosed with an indolent non-Hodgkin lymphoma (iNHL) and treated with either first-line ibrutinib monotherapy (IbM) therapy or bendamustine plus rituximab combination therapy (BR).Methods: Treatment-naïve iNHL patients in the IBM MarketScan Research Databases were identified based on the first prescription of either IbM or BR therapy between 02/01/2014 and 08/30/2017.Results: A greater proportion of IbM patients (n = 207) had at least one inpatient admission (IP) or emergency room visit (ER), both all-cause and iNHL-related, than BR (n = 1337) patients. In addition, the mean number of IP admissions and ER visits was significantly higher in the IbM cohort. No differences in total costs were found. Outpatients costs were higher in IbM patients and medical costs were higher in BR patients.Conclusions: These real-world findings highlight the importance of considering the healthcare resource utilization and the associated costs of iNHL patients which may be associated with their first-line therapy.

Benchmarking HIV Quality Measures Across US Payer Types.

Despite advances in antiretroviral therapy (ART), human immunodeficiency virus (HIV) remains a significant issue in the United States. Early diagnosis, continuous treatment access/adherence, and long-term care engagement help patients benefit fully from ART; however, a shortfall in care engagement remains, potentially leading to poorer health outcomes. This analysis benchmarks rates of health care quality and process measures to identify areas for improvement. This retrospective, claims-based, real-world cohort study assessed the percentage of prevalent (existing) and incident (newly diagnosed) patients with HIV with commercial or public health insurance meeting 4 National Quality Forum (NQF)-endorsed, 1 Pharmacy Quality Alliance (PQA), and 3 Centers for Disease Control and Prevention (CDC) measures over a 4-year period. Most prevalent patients consistently met the NQF-endorsed prescribed ART and gaps in visits measures. Longer-term visit frequency measure rates were well below the 90% Joint United Nations Programme on HIV/AIDS target. Proportion of prevalent patients meeting each NQF-endorsed measure was maintained/increased with increasing age in 2015-2016. Substantially fewer incident patients than prevalent patients met NQF-endorsed measures across all measurement periods, particularly for visit frequency (32%-51%). PQA ART adherence was low (36%-73%). CDC receipt of care rates were high (83%-92%), whereas retention in care rates were low (67%-72%) among prevalent patients. For incident patients, linkage to care rates were consistently low (21%-44%). This study benchmarks current US HIV care engagement and highlights the need for improvement in early care engagement, ART adherence and long-term retention of care among patients with HIV.

Meningococcal-group B (MenB) vaccine series completion and adherence to dosing schedule in the United States: A retrospective analysis by vaccine and payer type.

BACKGROUND: Two MenB vaccines with different dosing schedules are approved in the US: MenB-4C (2 doses) and MenB-FHbp (2-3 doses). Both vaccines were licensed on the basis of immunogenicity demonstrated after vaccine series completion. We evaluated vaccination completion and adherence to dosing schedules. METHODS: This retrospective analysis used data from MarketScan Commercial Claims and Encounters Database (Commercial) January 1, 2015 - February 28, 2018 and Multi-State Medicaid Database (Medicaid) January 1, 2015 - December 31, 2017 to examine vaccine series completion and adherence to dosing schedule in individuals who initiated a MenB series at ages 16-23 years. Vaccine series completion and dose schedule adherence were assessed during a 15-month follow-up period after the first dose. Completion was defined as individual receipt of the recommended number of doses, with current recommendations applied retroactively to allow individuals who initiated the MenB-FHbp series to be complete with either the 2- or the 3-dose schedule. RESULTS: The study population comprised 65,205 commercially-insured individuals (36,118 initiated MenB-4C; 29,087 initiated MenB-FHbp) and 13,535 Medicaid-covered individuals (10,153 initiated MenB-4C; 3382 initiated MenB-FHbp). In Commercial, 63% of individuals who initiated MenB-4C and 52% of individuals who initiated MenB-FHbp completed vaccination within 15 months; dosing schedule adherence was 62% for MenB-4C initiators and 18% for MenB-FHbp initiators. In Medicaid, 15-month completion rates for MenB-4C and MenB-FHbp initiators were 49% and 31%, respectively, with corresponding dosing schedule adherence of 48% and 8%. Among individuals who completed the series, median time to completion was 68 days for MenB-4C versus 258 days for MenB-FHbp in Commercial and 88 days for MenB-4C versus 309 days for MenB-FHbp in Medicaid. CONCLUSION: During the study period, MenB vaccine series completion was suboptimal. However, completion was significantly higher for MenB-4C, with notably shorter time to completion. This may reflect the flexible dosing schedule of MenB-4C.

Maternal Immunization in the U.S.: A Nationwide Retrospective Cohort Study.

INTRODUCTION: At present, pregnant women in the U.S. are recommended to receive tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) and influenza vaccines. This study assessed maternal coverage of these 2 vaccinations. METHODS: Data for this retrospective cohort study were extracted from 2 large administrative claims databases, the MarketScan Commercial and Multi-State Medicaid Databases, for 2009-2017 and analyzed in 2018. Women aged 15-44 years on the date of pregnancy end were included. Pregnancies with gestational age of less than 23 weeks were excluded from the Tdap vaccination endpoint owing to the optimal recommended gestational age for Tdap vaccination. Multivariable logistic regression models identified predictors of vaccination. RESULTS: The Tdap vaccination subpopulation included 1,421,452 Commercial and 523,635 Medicaid pregnancies; the influenza vaccination subpopulation included 1,862,705 Commercial and 628,079 Medicaid pregnancies. There were marked increases in vaccination coverage from 2010 to 2017: from 1.0% to 56.3% (Commercial) and from 0.5% to 31.4% (Medicaid) for Tdap, and from 14.7% to 31.3% (Commercial) and from 9.7% to 17.5% (Medicaid) for influenza. The likelihood of Tdap/influenza vaccination increased significantly with receipt of the other vaccine and more pregnancy-related healthcare visits. CONCLUSIONS: Although maternal Tdap and influenza vaccination coverage increased substantially from 2010 to 2017 among large, geographically diverse U.S. cohorts, coverage remained suboptimal, potentially putting newborns at risk of pertussis and influenza. Strategies to increase maternal vaccination coverage could target women identified to have a reduced likelihood of vaccination: those who are younger, black, residing in rural areas, with multiple gestation, and a prepregnancy inpatient admission.

Health Care Resource Utilization and Costs for Patients with Tardive Dyskinesia.

BACKGROUND: Tardive dyskinesia (TD) is an often-irreversible movement disorder affecting any part of the body. Patients experience debilitating symptoms that lower quality of life and increase mortality. Prolonged exposure to dopamine antagonists, which are frequently prescribed for psychiatric disorders as neuroleptic (antipsychotic) drugs, is a common cause of TD. The estimated prevalence of TD is 20%-50% among patients on antipsychotics, and the reported incidence of TD ranges from < 1% to 42%, depending on the antipsychotics studied. However, there are few real-world studies examining health care utilization and the economic burden of TD. OBJECTIVE: To assess health care utilization and costs in a sample of patients with TD from the commercially insured and Medicare supplemental U.S. METHODS: A retrospective analysis was conducted using Truven MarketScan Commercial and Medicare administrative claims data. Patients were included in the TD group if they had the first TD diagnosis (index date) between January 1, 2008, and September 30, 2014, with ≥ 1 inpatient or ≥ 2 outpatient nondiagnostic claims for TD (ICD-9-CM code 333.85). Patients without TD were randomly assigned an index date. Further inclusion criteria for all patients were ≥ 12 months of pre- and post-index medical and pharmacy continuous enrollment and no evidence of TD claims during the pre-index period. Patients with TD were directly matched to patients without TD within subgroups for schizophrenia, major depressive disorder, bipolar disorder, and other psychiatric disorders and propensity matched on other demographic and clinical factors. Descriptive statistics on the incidence of resource utilization and costs of health care were reported. RESULTS: Of 3,397 patients with TD, 834 met the selection criteria and were matched to 834 non-TD controls. Patients with TD generally had significantly greater utilization during the 12 months after TD diagnosis than in the 12 months before TD diagnosis. Their rates for health care utilization and costs were also substantially higher than for those without TD. During the post-TD-diagnosis time, inpatient admissions (55.5% vs. 26.1%; P < 0.001) and emergency room visits (61.5% vs. 50.6%; P < 0.001) occurred more for patients with TD than for patients without TD. Total health care costs were significantly greater for patients with TD than for those without TD ($54,656 vs. $28,777; P < 0.001). CONCLUSIONS: Patients diagnosed with TD demonstrate significantly higher health care utilization and costs compared with non-TD patients. DISCLOSURES: This study was funded by Teva Pharmaceuticals (Petach Tikva, Israel). Truven Health Analytics, an IBM Watson Health Company, received payment from Teva Pharmaceuticals for the analysis in this study. Carroll is employed by Teva Pharmaceuticals and Irwin is employed by Truven Health Analytics, an IBM Watson Health Company.

Meningococcal Vaccination Among Adolescents in the United States: A Tale of Two Age Platforms.

PURPOSE: Despite recommended routine vaccination with meningococcal conjugate vaccine (MenACWY) at ages 11-12 years with a booster at age 16 years, national estimates indicate MenACWY uptake is lower in older adolescents than younger adolescents. This study aimed to identify factors associated with MenACWY uptake among adolescents. METHODS: Commercial Claims and Encounters (CCAE) and Medicaid MarketScan Databases from 2011 to 2016 were retrospectively analyzed (2017) to determine receipt of ≥1 dose of MenACWY during early (10.5 through 13 years) and late (15.5 through 18 years) adolescence. Multivariable logistic regression and nonlinear decomposition analyses were used to identify factors associated with MenACWY vaccination, potential missed opportunities, and differences between age groups. RESULTS: A larger proportion of younger adolescents than older adolescents received MenACWY: CCAE, 71.7% versus 48.9% (p < .001); Medicaid, 59.3% versus 31.8% (p < .001), respectively. In multivariable models (CCAE), older adolescents were less likely than younger ones to receive MenACWY (adjusted odds ratios [95% confidence intervals]: .68 [.67, .69]) and more likely to have a potential missed opportunity (1.27 [1.25, 1.28]). Decomposition results showed lower MenACWY uptake in older adolescents is largely attributed to fewer non-MenACWY vaccines received, fewer preventive care visits, and interaction with nonpediatric healthcare providers. DISCUSSION: Missed opportunities and infrequent preventive care encounters contribute to lack of vaccination in younger and older adolescents. However, the disparity in uptake between the two age groups was largely attributable to differences in healthcare utilization, suggesting a need for unique strategies to increase uptake among older adolescents, such as solidifying a vaccination platform for ages 16-18 years through encouragement of annual preventive care visits.

Analysis of Vascular Event Risk After Herpes Zoster From 2007 to 2014 US Insurance Claims Data.

OBJECTIVE: To estimate the risk of transient ischemic attack (TIA), stroke, and myocardial infarction in periods covering 4 weeks before to 52 weeks after herpes zoster (HZ) diagnosis in US adults. PATIENTS AND METHODS: This retrospective study (GSK study identifier: HO-15-15771) with matched cohorts used the Truven Health MarketScan Commercial and Medicare claims data set linked with obesity and smoking status information. Patients 18 years and older at the date of HZ diagnosis and 1-year pre- and post-HZ diagnosis continuous insurance enrollment (from January 1, 2007, through December 31, 2014) were propensity score matched to controls in terms of demographic characteristics, risk factors for vascular events, other comorbid disorders, general health, obesity, and smoking status. A post hoc sensitivity analysis was performed not matching for obesity and smoking status information. Adjusted incidence rate ratios (IRRs) were estimated using multivariate Poisson models during an aggregate period (1-month before and after the index date). RESULTS: A total of 23,339 patients with HZ were matched to 46,378 controls (mean age, 56 years; 45,173 [65%] women). During the aggregate period, patients with HZ were statistically significantly more likely to suffer a TIA: IRRs for all patients and patients aged 18 to 49 years were 1.56 (95% confidence interval [CI], 1.13-2.15) and 5.12 (95% CI, 1.37-19.10), respectively (P<.05); the respective IRRs for stroke were 1.40 (95% CI, 0.93-2.11) and 8.12 (95% CI, 0.93-71.27). In the sensitivity analysis, IRRs for TIA and stroke were statistically significantly increased regardless of age. CONCLUSION: Herpes zoster was associated with an increased risk of composite events, TIA, and stroke in adults in the period around diagnosis. More research on the HZ and vascular risk association is needed. GSK STUDY IDENTIFIER: HO-15-15771.

Real-world characteristics and disease burden of patients with asthma prior to treatment initiation with mepolizumab or omalizumab: a retrospective cohort database study.

PURPOSE: Patients with severe asthma are eligible for asthma-specific biologics as add-on therapies, such as mepolizumab and omalizumab, when optimized controller therapies are unable to control their symptoms. However, few real-world data are available to describe the characteristics and associated economic burden of patients considered to be candidates for mepolizumab or omalizumab therapy. METHODS: This retrospective cohort study investigated patients with asthma (≥12 years of age) identified at the time of first mepolizumab or omalizumab administration (index date) in the MarketScan™ Commercial Database. Data were collected during the 12-month period before the index date (baseline period) for two mutually exclusive patient groups (patients prescribed mepolizumab and omalizumab, respectively). Baseline demographics, history of exacerbations, healthcare resource utilization (HCRU), and medical costs were investigated. RESULTS: In total, 413 and 1,834 patients who had been prescribed mepolizumab or omalizumab, respectively, were identified. During the baseline period, patients prescribed mepolizumab experienced more exacerbations (81.4% vs 57.5%, P<0.001), had higher asthma-related HCRU for outpatient services (all P<0.01), and had higher total asthma-related healthcare costs (US$11,000 vs US$7,400, P<0.001) compared with patients prescribed omalizumab. Allergic rhinitis, atopic dermatitis, and chronic idiopathic urticaria were more common among patients prescribed omalizumab vs mepolizumab. In contrast, sinusitis, nasal polyps, and comorbid COPD were more common among patients prescribed mepolizumab vs omalizumab. Prescriptions of fixed-dose inhaled corticosteroids (ICSs) with long-acting ß2-agonists (LABAs) and ICS/LABA/long-acting muscarinic antagonist triple therapy during the baseline period were higher among patients prescribed mepolizumab vs omalizumab (80.4% vs 56.8% and 27.1% vs 14.4%, respectively, both P<0.001). CONCLUSION: In the 12 months prior to initiation of asthma-specific biologics, patients prescribed mepolizumab had a different prevalence of certain comorbidities, higher disease burden, higher HCRU, and higher healthcare costs compared with patients prescribed omalizumab.

Gastrointestinal complications in patients treated with ipilimumab and nivolumab combination therapy or monotherapy.

Aim & methods: A retrospective study using the IBM Explorys Universe Database assessed the risk of gastrointestinal events (enterocolitis or diarrhea) among melanoma and lung cancer patients treated with ipilimumab and nivolumab combination or monotherapy. Results & conclusion: There were 904 melanoma patients (607 ipilimumab, 140 nivolumab and 157 combo) and 1641 lung cancer patients (68 ipilimumab, 1542 nivolumab and 31 combo). Approximately, 37% of lung patients and 46% of melanoma patients experienced at least one adverse event. After adjusting for covariates, patients receiving combination therapy were more likely to have a gastrointestinal event compared with ipilimumab monotherapy patients (melanoma hazard ratio: 1.54; 95% CI: 1.06-2.25; lung hazard ratio: 2.93; 95% CI: 1.09-7.89).