Burden of Infection in Patients With and Without Secondary Immunodeficiency Disease Following Diagnosis of a Mature B Cell Malignancy.

BACKGROUND: This retrospective cohort study compared patient characteristics and burden of infection in patients with mature B cell malignancies with and without secondary immunodeficiency disease (SID). PATIENTS AND METHODS: Data were extracted from the Humedica database (H-DB) and Guardian Research Network (GRN) database from October 1, 2015 to March 10, 2020, including a 6-month pre-index period (PIP) and 12-month follow-up. Patients aged ≥18 years diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma, multiple myeloma, or non-Hodgkin's lymphoma in the PIP were stratified into 2 cohorts: SID (hypogammaglobulinemia [using ICD-10-CM codes] or serum IgG levels <5.0 g/L, both with signs and symptoms of SID or at least 1 infection) and no-SID. Patients with SID or primary immunodeficiency diseases in the PIP were excluded. RESULTS: Overall, 2221 patients with SID (H-DB/GRN: n = 1959/262), and 19,141 patients without SID (n = 17,598/1543) were included. Baseline characteristics were similar across cohorts. At 12-month follow-up, significantly more patients with SID had experienced ≥1 infection and ≥1 severe bacterial infection than those without SID (both P < .001). H-DB/GRN mean (standard deviation) number of severe bacterial infections was 7.6 (9.9)/2.9 (2.7) for the SID cohort versus 5.2 (6.8)/2.4 (2.2) for the no-SID cohort. CONCLUSION: This study confirms that patients with mature B cell malignancies and SID face a significantly higher burden of infections than those without SID.

Awareness, attitudes, and practices on meningococcal serogroup B vaccination in the United States among parents of older adolescents and among young adults.

OBJECTIVE: Meningococcal serogroup B (MenB) vaccination is recommended by the Advisory Committee on Immunization Practices (ACIP) for adolescents and young adults 16-23-years-old under shared clinical decision-making (SCDM). However, MenB vaccination coverage in this population remains low in the United States (US). We investigated the awareness, attitudes, and practices regarding MenB disease and vaccination among parents of 16-18-year-old older adolescents and among 19-23-year-old young adults. METHODS: An online survey was conducted in September-October 2022 among parents of older adolescents and among young adults recruited from a US-based patient panel. RESULTS: There were 606 total participants, including parents of MenB-vaccinated (n = 151) and non-vaccinated (n = 154) adolescents, and also MenB-vaccinated (n = 150) and non-vaccinated (n = 151) young adults. Non-vaccinated cohorts reported low awareness of MenB disease (58.3-67.5%) and vaccination (49.7-61.0%), though awareness was higher among non-vaccinated parents. However, all cohorts reported high interest in learning more about MenB disease and vaccination. Vaccinated cohorts relied on primary care providers (PCPs) to initiate MenB vaccination conversation and had a low awareness of SCDM at 35.1-45.3%, though those aware of SCDM were more likely to participate in decision-making. Barriers to MenB vaccination included lack of PCP recommendation, vaccine side effects, and uncertainty about vaccination need. CONCLUSIONS: There are gaps in awareness of MenB disease, vaccination, and SCDM among parents and patients in the US, resulting in missed opportunities for discussing and administering MenB vaccination. Targeted education on MenB and vaccination recommendations may increase these opportunities and improve MenB vaccination awareness and initiation.

MenB disease, a type of meningitis, is a serious and life-threatening illness. The US Centers for Disease Control and Prevention (CDC) recommends that 16­23-year-olds get a MenB vaccine after talking with their healthcare provider and deciding it is the right choice. As of 2021, only about 3 in 10 17-year-olds had received a MenB vaccine. In this study, we used an online survey to learn about parents of older teens' (16­18-years-old) and young adults' (19­23-years-old) awareness, thoughts, and practices related to meningitis and the MenB vaccine. Parents of non-vaccinated teens, and non-vaccinated young adults, had a lower awareness of the causes, risks, and symptoms of meningitis, and the MenB vaccine. In addition, most parents thought the impact of meningitis would be severe, compared with young adults who thought it would be less severe. Most participants were also not aware of their role in deciding if they or their child should be vaccinated against MenB. However, most showed a high interest in learning more about meningitis and the MenB vaccine. We also found that most teens and young adults who did receive the MenB vaccine received it right after talking about it with their healthcare provider. These findings show a clear opportunity to address gaps in awareness and thoughts about meningitis and MenB vaccination. Providing education and resources to parents, young adults, and healthcare providers could create more opportunities to discuss MenB vaccination and lead to more teens and young adults accessing vaccination and being protected against meningitis.

Real-World Systemic Treatment Patterns after Atezolizumab and Bevacizumab in Patients with Hepatocellular Carcinoma in the United States.

Real-world (RW) evidence is needed to evaluate atezolizumab plus bevacizumab (atezo + bev) utilization for hepatocellular carcinoma (HCC) in clinical practice. This retrospective cohort study used administrative claims databases to evaluate treatment patterns in individuals with HCC ≥18 years of age who were initiated on atezo + bev between June 2020 and June 2022. The endpoints of this study were the proportion of individuals who discontinued atezo + bev and received subsequent systemic therapies, time to discontinuation (TTD), and time to next treatment. Overall, 825 individuals were eligible (median age 67 years; 80% male). Over a median follow-up of 15.3 months, most (72%) discontinued atezo + bev, with a median TTD of 3.5 months. A minority (19%) received subsequent therapies, with the most common second-line agents being lenvatinib (6%), cabozantinib (4%), and nivolumab (4%). The median time from index to next treatment post-atezo + bev was 5.4 months. Further research is needed to identify the patients who are most likely to benefit from atezo + bev as well as later-line HCC therapies to optimize overall survival.

Real-world treatment patterns and clinical outcomes after introduction of immune checkpoint inhibitors: Results from a retrospective chart review of patients with advanced/metastatic non-small cell lung cancer in the EU5.

BACKGROUND: Real-world evidence is increasingly used to guide treatment and regulatory decisions for non-small cell lung cancer (NSCLC). Real-world treatment patterns and clinical outcomes among patients with advanced/metastatic NSCLC in France, Germany, Italy, Spain, and the UK (EU5) were assessed. METHODS: This retrospective physician-completed patient chart review assessed treatment patterns (regimen, duration of treatment [DOT], time to discontinuation), and clinical outcomes (duration of response [DOR], progression-free survival [PFS], and overall survival [OS]) of patients with stage IIIB/C or IV NSCLC who received pembrolizumab-based first-line induction chemotherapy. RESULTS: Overall, 322 patients were included; at first-line maintenance (1LM), 92% had stage IV NSCLC, 68% had nonsquamous histology, and 89% had no central nervous system (CNS)/brain metastasis. The two most common 1LM regimens were pembrolizumab monotherapy (76% overall) and pembrolizumab + pemetrexed (21% overall). Docetaxel monotherapy was the most common second-line regimen in all countries except Germany (54% overall). For 1LM therapy, the overall median DOT and DOR were 5 and 10 months, respectively; PFS was 7 months and OS was 8 months. Germany had a longer duration of each outcome except for DOR which was longer in Spain. Clinical outcomes were generally poorer for patients with squamous histology and CNS/brain metastases. CONCLUSIONS: This study demonstrated differences in treatment patterns and clinical outcomes in NSCLC across the EU5 and patient subgroups. Improved survival was generally associated with response to first-line therapy, nonsquamous histology, and CNS/brain metastases absence. These real-world data provide valuable insights which may aid treatment decision-making and clinical trial design.

Previously unrecognized risk factors for severe hypoglycaemia requiring emergency medical care in insulin-treated type 2 diabetes: Results from a real-world nested case-control study.

AIM: Several risk factors for severe hypoglycaemia (SH) are associated with insulin-treated diabetes. This study explored potential risk factors in adults with insulin-treated type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: In this case-control study, adults with T2DM initiating insulin were identified in the IQVIA PharMetrics® Plus database. The index date was the date of the first SH event (cases). Using incidence-density sampling, controls were selected from those who had been exposed 'at risk' of SH for the same amount of time as each case. After exact-matching on the well-established factors, previously unreported risk factors were evaluated through conditional logistic regression. RESULTS: In 3153 case-control pairs, pregnancy [odds ratios (OR) = 3.20, p = .0003], alcohol abuse (OR = 2.43, p < .0001), short-/rapid-acting insulin (OR = 2.22/1.47, p < .0001), cancer (OR = 1.87, p < .0001), dementia/Alzheimer's disease (OR = 1.73, p = .0175), peripheral vascular disease (OR = 1.59, p < .0001), antipsychotics (OR = 1.59; p = .0059), anxiolytics (OR = 1.51, p = .0012), paralysis/hemiplegia/paraplegia (OR = 1.51, p = .0416), hepatitis (OR = 1.50, p = .0303), congestive heart failure (OR = 1.47, p = .0002), adrenergic-corticosteroid combinations (OR = 1.45, p = .0165), ß-adrenoceptor agonists (OR = 1.40, p = .0225), opioids (OR = 1.38, p < .0001), corticosteroids (OR = 1.35, p = .0159), cardiac arrhythmia (OR = 1.29. p = .0065), smoking (OR = 1.28, p = .005), Charlson Comorbidity Index score 2 (OR = 1.28, p = .0026), 3 (OR = 1.41, p = .0016) or ≥4 (OR = 1.57, p = .0002), liver/gallbladder/pancreatic disease (OR = 1.26, p = .0182) and hypertension (OR = 1.19, p = .0164) were independently associated with SH. CONCLUSIONS: Although all people with insulin-treated diabetes are at risk of SH, these results have identified some previously unrecognized risk factors and sub-groups of insulin-treated adults with T2DM at greater risk. Scrutiny of current therapies and comorbidities are advised as well as additional glucose monitoring and education, when identifying and managing SH in vulnerable populations.

Clinical and economic burden of neovascular age-related macular degeneration by disease status: a US claims-based analysis.

BACKGROUND: New treatment alternatives have revolutionized the management of nAMD. However, there is limited evidence on the clinical and economic burden of nAMD in commercially insured US patients. OBJECTIVES: To examine the clinical and economic burden in patients with nAMD by disease status in the commercially insured US patient population and to identify drivers of nAMD-related costs. METHODS: Patients with at least 1 International Classification of Diseases, 10th Revision Clinical Modification (ICD-10-CM) diagnosis for nAMD were identified from the IQVIA PharMetrics Plus database between April 2016 and August 2017 (index period). Patients had continuous enrollment for at least 6 months before and at least 12 months after the index date. Eye-level disease status was reported, along with intravitreal anti-VEGF treatment patterns. Health care resource utilization (HRU) (all-cause and nAMD-related) and direct health care costs were estimated over the 12 month follow-up period. Outcomes associated with falls and fractures were also assessed. Multivariate analysis identified drivers of annual nAMD-related outpatient costs among patients with anti-VEGF therapy. Incident patients (defined as those without an nAMD diagnosis 6 months prior to the index date) with at least 18 months of continuous enrollment after the index date were identified for a subset analysis to evaluate documented changes in disease status. RESULTS: A total of 6,076 patients with nAMD were identified for the prevalent cohort; 60.1%, 17.2%, and 5.9% had active CNV, inactive CNV, and inactive scar disease stage at index, respectively. The nAMD-related outpatient visit costs were roughly 4 and roughly 7 times higher, respectively, for the active CNV group ($8,658 [SD = $11,612]) compared with the inactive CNV ($2,406 [SD = $5,510]) and inactive scar ($1,198 [SD = $3,035]) groups (P < 0.0001). About 10% of prevalent patients had a fall/fracture claim over 12 months of follow-up. A total of 3,623 prevalent patients (59.6%) were eligible for the anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 7.7 [4.5] months; mean [SD] number of injections = 6.0 [3.7]). Qualified incident cases comprised 17.8% (n = 1,081) of the prevalent cohort. Approximately 20% of incident eyes with active CNV at baseline transitioned to inactive CNV. A total of 427 incident patients (39.5%) qualified for anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 6.2 [4.7] months, mean [SD] number of injections = 5.2 [3.5]). Significant drivers of total nAMD-related costs were the initial anti-VEGF agent and anti-VEGF injection frequency (P < 0.0001) in both prevalent and incident cohorts. CONCLUSIONS: The clinical and economic burden of nAMD treatment is substantial to the US healthcare system, where economic burden is higher among those with active CNV. Appropriate treatment may increase the duration of inactive disease periods and preserve visual acuity while lowering costs. DISCLOSURES: This study was funded by Allergan, an AbbVie Company. Allergan employees were involved in the study design, interpretation of data, writing of the manuscript, and the decision to submit for publication. Keyloun and Campbell are employees of Allergan. Multani, McGuiness, and Chen are employees of IQVIA, which received funding from Allergan for conducting the analysis. Almony and Shah-Manek have nothing to disclose.

Erenumab patient characteristics, medication adherence, and treatment patterns in the United States.

OBJECTIVE: To describe patient characteristics, adherence, and treatment patterns, among adult migraine patients in the United States prescribed erenumab. BACKGROUND: Migraine is a highly prevalent and debilitating disease characterized by recurrent attacks of moderate to severe headache accompanied by non-headache symptoms. Erenumab is a first-in-class calcitonin gene-related peptide receptor (CGRP-R) antagonist indicated for migraine prophylaxis in adults. METHODS: This retrospective longitudinal cohort study used IQVIA's open-source longitudinal pharmacy (LRx) and medical (Dx) claims databases to identify adult migraine patients with an initial claim (index date) for erenumab between May 1, 2018 and April 30, 2019. Patients were required to have ≥180 days of follow-up. Erenumab dosing patterns, persistence, and adherence (using medication possession ratio [MPR] and proportion of days covered [PDC]), and discontinuation of other commonly prescribed acute and prophylactic anti-migraine therapies were assessed. Dose changes in acute therapies after initiation of erenumab were assessed in a subset of patients with an adequate trial of erenumab (≥2 additional erenumab claims within the 80 days following the index claim). RESULTS: A total of 64,174 patients met the study criteria. Mean (SD) age was 48 (13) years and 85.2% (n = 54,656) were female. The initial erenumab dose was 70 mg for the majority of patients (65.1%; n = 41,790); most (81.4%; n = 34,019) maintained their index dose during follow-up. Overall, 30.8% (n = 19,797) of patients had a PDC ≥ 0.80 and 41.7% (n = 26,769) had a MPR ≥ 0.80. Discontinuation rates of acute and other prophylactic migraine therapies after initiation of erenumab (among users of the respective therapies) were 48.7% (22,965/47,190) and 36.1% (16,602/46,006), respectively. Dose decreases among triptan, ergot compound, opioid, and barbiturate users were observed after initiation of erenumab. CONCLUSIONS: Almost all patients had prior use of acute or preventive therapy. Adherence to erenumab was higher than traditional oral prophylactic migraine therapies; however, overall adherence was still suboptimal. The decrease in use of acute and preventive prescription medications following initiation of erenumab suggests effectiveness in the real-world setting.

Clinical and Economic Burden of Glaucoma by Disease Severity: A United States Claims-Based Analysis.

PURPOSE: To provide updated estimates of the clinical and economic burden in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG) by disease severity in the United States and to estimate incremental costs associated with disease progression. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients with 1 or more International Classification of Diseases, 10th Revision, Clinical Modification, diagnoses for OAG or OHT who are 40 years of age or older. METHODS: Patients were identified from IQVIA's PharMetrics Plus database during the index period (October 1, 2015, to August 31, 2017). Patients had continuous health plan enrollment for 12 months or more before and after the index date (first OAG or OHT diagnosis during index period) and were stratified by baseline disease severity based on diagnosis code. Annual eye-related outpatient healthcare use and costs were estimated on a per-user basis. A generalized linear model was used to estimate adjusted mean costs by severity and to evaluate the impact of observed disease worsening on costs. A multivariate logistic regression analysis evaluated the relationship between severity and odds of falls or fractures. MAIN OUTCOME MEASURES: Total eye-related outpatient costs and odds of falls or fractures. RESULTS: One hundred seventy-seven thousand three hundred fifty-two OHT and OAG patients were identified (67.8% with OAG). Open-angle glaucoma patients showed higher eye-related outpatient costs than OHT patients (median, $516 [interquartile range (IQR), $323-$898] vs. $344 [IQR, $197-$617], respectively). Patients with severe OAG showed higher eye-related outpatient costs than moderate and mild OAG patients (median, $639 [IQR, $381-$1264] vs. $546 [IQR, $345-$950] vs. $476 [IQR, $304-$765], respectively; P < 0.0001), as well as higher glaucoma-related pharmacy costs (median, $493 [IQR, $122-$1457] vs. $244 [IQR, $84-$1113] vs. $139 [IQR, $66-$818], respectively; P < 0.0001). In adjusted analyses, disease worsening was associated with at least 2-fold higher annual eye-related outpatient costs (P < 0.0001). Severe OAG patients had significantly higher odds of fall or fracture compared with OHT patients (odds ratio, 1.34; 95% confidence interval, 1.13-1.59). CONCLUSIONS: Updated estimates showed highest eye-related costs for those with severe disease and disease progression among patients with OAG and OHT. Severe OAG was associated with increased risk of falls or fractures compared with patients with OHT. Therapies that delay disease progression may provide clinical and economic benefits.

Economic and Clinical Burden Associated With Intensification of Glaucoma Topical Therapy: A US Claims-based Analysis.

PRECIS: Incremental addition of intraocular pressure-lowering topical drops is associated with shorter-lasting benefit and higher health-related costs with each additional agent, suggesting a need for new treatment options to improve disease control and reduce treatment burden. PURPOSE: The purpose of this study was to evaluate treatment intensification as a driver of clinical and economic burden in patients receiving topical glaucoma medications for open-angle glaucoma/ocular hypertension. METHODS: This retrospective analysis of administrative claims data (January 2011 to July 2017) from the IQVIA PharMetrics Plus database included diagnosed patients who initiated or intensified treatment with 1 to 4 topical glaucoma medications of a different drug class between January 2012 and July 2015 (index date being the first such event during this period). Patients with prior open-angle glaucoma surgery or an equal or greater number of topical glaucoma medication classes during the preindex period were excluded. Treatment intensification rates and eye-related outpatient costs were assessed over 24 months postindex. RESULTS: Of 48,402 patients (mean age: 61.4 y), 22,874 (47.3%), 16,214 (33.5%), 7137 (14.7%), and 2177 (4.5%) received a first, second, third, or fourth medication class, respectively, as their first observed initial or intensified regimen. Among cohorts receiving 1, 2, 3, or 4 medication classes, 7.8%, 12.2%, 17.2%, and 22.6% of patients and 12.6%, 18.5%, 25.9%, and 33.7% of patients had subsequent treatment augmentation (class addition or glaucoma procedure, laser or surgical) within 12 and 24 months postindex, respectively. Eye-related outpatient costs over 24 months increased with each additional topical glaucoma medication class at index [mean (SD): $1610 ($3460), $2418 ($4863), $2872 ($5110), and $3751 ($6608) in the 1, 2, 3, or 4 class cohorts, respectively]. CONCLUSION: Multiple-drop therapies yielded shorter-lasting benefits with each additional agent and were associated with the increased clinical and economic burden.

Health Care Costs and Savings Associated with Increased Dairy Consumption among Adults in the United States.

BACKGROUND: The purpose of this study is to estimate the impact on health care costs if United States (US) adults increased their dairy consumption to meet Dietary Guidelines for Americans (DGA) recommendations. METHODS: Risk estimates from recent meta-analyses quantifying the association between dairy consumption and health outcomes were combined with the increase in dairy consumption under two scenarios where population mean dairy intakes from the 2015-2016 What We Eat in America were increased to meet the DGA recommendations: (1) according to proportions by type as specified in US Department of Agriculture Food Intake Patterns and (2) assuming the consumption of a single dairy type. The resulting change in risk was combined with published data on annual health care costs to estimate impact on costs. Health care costs were adjusted to account for potential double counting due to overlapping comorbidities of the health outcomes included. RESULTS: Total dairy consumption among adults in the US was 1.49 cup-equivalents per day (c-eq/day), requiring an increase of 1.51 c-eq/day to meet the DGA recommendation. Annual cost savings of $12.5 billion (B) (range of $2.0B to $25.6B) were estimated based on total dairy consumption resulting from a reduction in stroke, hypertension, type 2 diabetes, and colorectal cancer and an increased risk of Parkinson's disease and prostate cancer. Similar annual cost savings were estimated for an increase in low-fat dairy consumption ($14.1B; range of $0.8B to $27.9B). Among dairy sub-types, an increase of approximately 0.5 c-eq/day of yogurt consumption alone to help meet the DGA recommendations resulted in the highest annual cost savings of $32.5B (range of $16.5B to $52.8B), mostly driven by a reduction in type 2 diabetes. CONCLUSIONS: Adoption of a dietary pattern with increased dairy consumption among adults in the US to meet DGA recommendations has the potential to provide billions of dollars in savings.

Health Economic Evaluation Modeling Shows Potential Health Care Cost Savings with Increased Conformance with Healthy Dietary Patterns among Adults in the United States.

BACKGROUND: Many American adults have one or more chronic diseases related to a poor diet, resulting in significant direct and indirect economic impacts. The 2015-2020 Dietary Guidelines for Americans (DGA) recognized that dietary patterns may be more relevant for predicting health outcomes compared with individual diet elements and recommended three healthy patterns based on evidence of favorable associations with many chronic disease risk factors and outcomes. Health economic assessments provide a model to estimate the potential influence on costs associated with changes in chronic disease risk resulting from improved diet quality in the US adult population. OBJECTIVE: To estimate the impact on health care costs associated with increased conformance with the three healthy patterns recommended in the 2015-2020 DGA, including the Healthy US-Style, the Healthy Mediterranean-Style, and the Healthy Vegetarian eating patterns. METHODS: Recent moderate- to high-quality meta-analyses of health outcomes associated with increased conformance with the Healthy US-Style eating pattern as measured by the Healthy Eating Index (HEI) or the Healthy Mediterranean-Style eating pattern measured by a Mediterranean diet score (MED) were identified. Given the lack of quantification of the association between an increased conformance with a vegetarian pattern and health outcomes, the analysis was limited to studies that evaluated Healthy US-style and Healthy Mediterranean-style eating patterns. The 2013-2014 What We Eat in America data provided estimates of conformance with these two eating patterns using the HEI-2015 and the 9-point MED among the US adult population. Risk estimates quantifying the association between eating patterns and health outcomes were combined with the eating pattern score increase under two conformance scenarios: increasing the average HEI-2015 and MED by 20% and increasing the average HEI-2015 and MED to achieve 80% of complete conformance. The resulting change in risk was combined with published data on annual health care and indirect costs, inflated to 2017 US dollars to estimate cost. To address double counting, costs were adjusted to minimize potential overlap of comorbidities. RESULTS: Overall modeled cost savings were $16.7 billion (range=$6.7 billion to $25.4 billion) to $31.5 billion (range=$23.9 billion to $38.9 billion) based on a 20% increase in the MED and HEI-2015, respectively, resulting from reductions in cardiovascular disease, cancer, and type 2 diabetes for both patterns and including Alzheimer's disease and hip fractures for the MED. In the case that diet quality of US adults were to improve to achieve 80% of the maximum MED and HEI-2015, cost savings were estimated at $88.2 billion (range=$35.7 billion to $133 billion) and $55.1 billion (range=$41.8 billion to $68.2 billion), respectively. CONCLUSIONS: This is the first study quantifying savings from all health outcomes identified to be associated with the HEI and the MED to assess conformance with two eating patterns recommended as part of the 2015-2020 DGA. Findings from this study suggest that increasing conformance with healthy eating patterns among US adults could reduce costs, with billions of dollars in potential savings.