Chemotherapy-induced febrile neutropenia (FN): healthcare resource utilization (HCRU) and costs in commercially insured patients in the US.

PURPOSE: Febrile neutropenia (FN) is a known side effect of chemotherapy, often requiring hospitalization. Economic burden increases with an FN episode and estimates of cost per episode should be updated from real-world data. METHODS: A retrospective claims analysis of FN episodes in patients with non-myeloid malignancies from 2014 to 2021 was performed in IQVIA PharMetrics® Plus database. FN episodes were defined as having same-day claims for neutropenia and fever or infection, plus antibiotic in outpatient settings, following a claim for chemotherapy; index date was defined as the first claim for neutropenia/fever/infection. Patients receiving bone marrow/stem cell transplant and CAR-T therapy were excluded, as were select hematologic malignancies or COVID-19. Healthcare utilization and costs were evaluated and described overall, by episode type (w/wo hospitalization), index year, malignancy type, NCI comorbidity score, and age group. RESULTS: 7,033 FN episodes were identified from 6,825 patients. Most episodes had a hospitalization (91.2%) and 86% of patients had ≥1 risk factor for FN. Overall, FN episodes had a mean (SD) FN-related cost of $25,176 ($39,943). Episodes with hospitalization had higher average FN-related costs versus those without hospitalization ($26,868 vs $7,738), and costs increased with comorbidity score (NCI=0: $23,095; NCI >0-2: $26,084; NCI ≥2: $26,851). CONCLUSIONS: FN continues to be associated with significant economic burden, and varied by cancer type, comorbidity burden, and age. In this analysis, most FN episodes were not preceded by GCSF prophylaxis. The results of this study highlight the opportunity to utilize GCSF in appropriate oncology scenarios.

Real-World Efficacy and Tolerability of Brigatinib in Patients with Non-Small Cell Lung Cancer with Prior ALK-TKIs in the United States.

BACKGROUND: Real-world evidence for brigatinib, a next-generation anaplastic lymphoma kinase-tyrosine kinase inhibitor (ALK-TKI) used in ALK-rearranged non-small cell lung cancer, is scarce. This retrospective study evaluated real-world brigatinib utilization in the US post other ALK-TKIs. MATERIALS AND METHODS: Adults with ≥1 brigatinib claim (index date) between 1 April 2017 and 30 September 2020 in the IQVIA longitudinal pharmacy claims database were followed until dose reduction, discontinuation, or end of follow-up. Patients had ≥12 months pre- and ≥1-month post-index observations. RESULTS: A total of 413 patients treated with brigatinib were analyzed. Over 80% received ≥1 prior ALK-TKI; alectinib and crizotinib were the most common (58.8% and 51.3% patients, respectively). The median follow-up was 8.4 months. The median time to treatment discontinuation (TTD) for brigatinib was 10.3 months (95% CI, 8.2-15.0), with 45% remaining on therapy at 12 months. The TTD was shortest (~8 months) in patients receiving both crizotinib and alectinib and longest in patients who received alectinib only prior to brigatinib (11.8 months). Adherence was high, with 92.7% of patients having a medication possession ratio of >80%. The mean dose compliance score was 1.0. Most patients reached the brigatinib dose of 180 mg/day (77%); 13.2% of patients had a dose reduction, with 89.3% and 84.6% continuing 180 mg/day therapy at 3 and 6 months, respectively. CONCLUSIONS: Brigatinib appears to be effective and well-tolerated in the real-world ALK+ NSCLC population in the US, showing benefit in patients after a next-generation ALK-TKI. Notably, dose reduction rates appeared markedly less than those seen in trials when most trial-related dose reductions were for asymptomatic laboratory abnormalities.

Physician treatment preferences for relapsed/refractory multiple myeloma: a discrete choice experiment.

Aim: This study aimed to assess physician preferences for later lines (third to fifth) of therapy in patients with relapsed/refractory multiple myeloma (RRMM) in the USA. Materials & methods: Factors relevant to physicians' treatment preferences for RRMM were identified from a literature search and refined in a qualitative phase. Preferences were quantitatively assessed using a discrete choice experiment. Physicians (n = 227) made choices regarding treatment scenarios for RRMM. Results: Efficacy had the highest mean relative importance, with overall survival valued as most important when making treatment decisions for patients with RRMM. Reduced incidences of keratopathy and thrombocytopenia had similar relative importance in later-line treatment. Conclusion: Greater understanding of physicians' criteria for clinical decision-making may help inform wider adoption of new treatments.

When deciding which treatment patients with relapsed or refractory multiple myeloma should receive, physicians have to weigh the benefits of each treatment against the risk of side effects. This study required physicians to complete a survey on aspects involved in their treatment decisions and identified those of highest importance. Physicians chose patient survival as the most important factor and minimization of side effects as less important considerations. Reducing patients' risk of developing corneal conditions or low platelet (a type of blood cell) count were of equal importance to doctors. Understanding physicians' treatment preferences and the reasons behind them will help identify gaps in education about new therapies as they become available.

Factors influencing series completion rates of recombinant herpes zoster vaccine in the United States: A retrospective pharmacy and medical claims analysis.

BACKGROUND/OBJECTIVES: Vaccination against herpes zoster (HZ) is an effective strategy in protecting the population against consequences of varicella zoster virus reactivation. Optimal immunogenicity with recombinant zoster vaccine (RZV) relies on completion of the 2-dose series within 2-6 months from the first dose. The objectives of this study were to estimate RZV completion rates and adherence with the recommended administration schedule in the general United States population aged at least 50 years and to evaluate factors influencing completion rates. METHODS: Longitudinal, open-source pharmacy and medical claims databases were analyzed for adults aged at least 50 years with a first RZV prescription filled between October 2017 and September 2019. The data were linked to Experian Marketing Services Consumer View data to obtain information regarding race. Completion rates and adherence were calculated overall and stratified according to claim source, age class, sex, and payer type. Logistic regression models were built for each subpopulation of interest to identify factors correlating with completion rates. RESULTS: Overall, cumulative completion rates were 70.41% and 81.80% at 6 and 12 months, respectively. Median time to second dose was approximately 4 months (4.08-5.13 months) and adherence 67.62%. Completion rates were lower in the medical claims database compared with the pharmacy claims database (48.98% vs. 73.23% at 6 months). Regression models confirmed that pharmacy claim was an independent factor for higher completion rates, while African American race and Medicaid status were associated with lower completion rates. Most comorbidities, including chronic obstructive pulmonary disease and type 2 diabetes mellitus, were associated with lower completion rates. CONCLUSION: Pharmacists contribute substantially to the overall high RZV completion rates in the United States. However, completion rates can be improved, especially in people receiving their first RZV dose at a physician's office. Future strategies should aim at lowering barriers to completing vaccination series in African Americans, Medicaid beneficiaries, and people with comorbidities.

Evaluation of Resource Utilization and Treatment Patterns in Patients with Actinic Keratosis in the United States.

OBJECTIVE: To compare health care resource utilization and treatment patterns between patients with actinic keratosis (AK) treated with ingenol mebutate gel (IngMeb) and those treated with other field-directed AK therapies. METHODS: A retrospective, propensity-score-matched, cohort study compared refill/repeat and adding-on/switching patterns and outpatient visits and prescriptions (health care resource utilization) over 6 months in patients receiving IngMeb versus those receiving imiquimod, 5-fluorouracil, diclofenac sodium, and methyl aminolevulinate or aminolevulinic acid photodynamic therapy (MAL/ALA-PDT). RESULTS: The final sample analyzed included four matched treatment cohort pairs (IngMeb and comparator; n = 790-971 per treatment arm). Refill rates were similar except for imiquimod (15% vs. 9% for imiquimod and IngMeb, respectively; P < 0.05). MAL/ALA-PDT treatment repetition rates were higher than IngMeb refill rates (20% vs. 10%; P < 0.05). Topical agent add-on/switch rates were comparable. PDT had higher switch rates than did IngMeb (5% vs. 2%; P < 0.05). The IngMeb cohort had a significantly lower proportion of patients with at least one AK-related outpatient visit during the 6-month follow-up than did any other cohort: versus imiquimod (50% vs. 66%; P < 0.0001), versus 5-fluorouracil (50% vs. 69%; P < 0.0001), versus diclofenac sodium (51% vs. 56%; P = 0.034), and versus MAL/ALA-PDT (50% vs. 100%; P < 0.0001). There were significantly fewer AK-related prescriptions among patients receiving IngMeb than among patients in other cohorts. CONCLUSIONS: Results based on the first 6 months after treatment initiation suggested that most field-directed AK therapies had clinically comparable treatment patterns except imiquimod, which was associated with higher refill rates, and PDT, which was associated with significantly more frequent treatment sessions and higher switching rates. IngMeb was also associated with significantly fewer outpatient visits than were other field-directed therapies.

Real-world persistence and adherence of ofatumumab versus oral and injectable disease-modifying therapies in patients with multiple sclerosis.

BACKGROUND: Ofatumumab (OMB) was approved as a self-injectable disease-modifying therapy (DMT) for relapsing multiple sclerosis (MS) in August 2020. This study aimed to examine treatment persistence and adherence of OMB to oral and platform self-injectable DMTs in a real-world setting. METHODS: This was a retrospective cohort study using IQVIA Pharmetrics Plus® in adults diagnosed with MS and treated with OMB, oral DMTs, or platform self-injectable DMTs (index treatment) between August 2020 and November 2021. Patients had at least 12 months of continuous enrollment before the index date and 6 months of follow-up after the index date; the index date was defined as the date of the first pharmacy claim for an index treatment. Inverse probability of treatment weighting (IPTW) analysis was used to account for differences in baseline characteristics among patients initiating OMB versus oral DMTs and, separately, OMB versus platform self-injectable DMTs. Persistence was defined as the number of days from the index date until the earliest time of discontinuation (>60-day gap) or switch to a new DMT. Adherence was calculated based on proportion of days covered (PDC) with adherence defined as PDC ≥0.8. Persistence and adherence were compared between OMB versus oral DMTs and OMB versus platform self-injectable DMTs. Persistence was assessed via Kaplan-Meier analyses of the weighted sample, and log-rank tests were used to compare time to treatment discontinuation and treatment switch. The proportion of patients adherent at 6 and 12 months post index were compared using chi-square tests. RESULTS: A total of 11,167 patients were identified with an incident claim of OMB, an oral DMT, or a platform self-injectable DMT. After applying all inclusion and exclusion criteria and IPTW, two sets of study cohorts were created. For the oral DMT analysis, 577 patients treated with OMB and 2,468 patients treated with oral DMTs were identified. For the self-injectable DMT analysis, 574 patients treated with OMB and 578 patients treated with a platform self-injectable DMT were identified. At 6- and 12-month follow-up, the proportion of patients who were persistent on DMT was higher in the OMB cohort compared with the oral DMT cohort (6 months: 79.9% vs. 75.4 %, 12 months: 71.4% vs. 62.9 %; p < 0.05), as well as in the OMB cohort compared with the self-injectable DMT cohort (6 months: 79.3% vs. 60.4 %, 12 months: 71.5% vs. 48.7 %; p < 0.0001). A similar proportion of patients were adherent to OMB versus oral DMTs at 6- and 12-months post index, whereas a higher proportion of patients treated with OMB versus platform self-injectable DMTs were adherent at 6- and 12-months post index. CONCLUSIONS: OMB showed better persistence and adherence compared with platform self-injectable DMTs, as well as better persistence compared with oral DMTs. This real-world analysis provides additional insights into OMB utilization among patients with MS in clinical practice and demonstrates that OMB is a valuable treatment option for these patients.

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 characteristics of patients with sickle cell disease who initiated crizanlizumab therapy.

OBJECTIVE: To provide real-word evidence of patients with SCD initiating crizanlizumab, their use of other SCD treatments, and crizanlizumab treatment patterns. METHODS: Using IQVIA's US-based, Longitudinal Patient-Centric Pharmacy and Medical Claims Databases patients with a diagnosis of SCD between November 1, 2018, and April 30, 2021, and ≥1 claim for crizanlizumab (date of first claim = index date) between November 1, 2019, and January 31, 2021 who were ≥16 years of age, and had ≥12 months of pre-index data were selected for analysis. Two cohorts were identified based on available follow-up time (3- and 6-month cohorts). Patient characteristics were reported along with pre- and post-index SCD treatments and crizanlizumab treatment patterns (e.g. total doses received, gap-days between doses, days on therapy, discontinuation, and restarts). RESULTS: 540 patients met the base inclusion criteria (345 in the 3-month cohort and 262 in the 6-month cohort. Most patients (64%) were female with a mean (SD) age of 35 (12) years overall. Concomitant hydroxyurea use was observed in 19-39% of patients, while concomitant L-glutamine use was observed for 4-8% of patients. 85% of 3-month cohort patients received at least two doses of crizanlizumab, while 66% of the 6-month cohort received at least 4 doses of crizanlizumab. The median number of gap days between doses was 1 or 2. CONCLUSIONS: 66% of patients who receive crizanlizumab receive at least 4 doses within 6-months. The low median number of gap days suggests high adherence.

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.

Incidence of corneal adverse events in patients with multiple myeloma and their clinical and economic impact: A real-world retrospective cohort study.

AIMS: Ocular toxicities are common adverse events (AEs) associated with anticancer agents. There is a paucity of data documenting their impact on patient care. This study assessed the clinical and economic burden of corneal AEs and related symptoms (collectively termed corneal AEs) in patients receiving multiple myeloma (MM) treatment. MATERIALS AND METHODS: Adults with a newly diagnosed MM (MM cohort) were identified from PharMetrics Plus, a US insurance claims database. Incidence, outpatient (OP) care, emergency department (ED) visits, hospitalizations, and costs were assessed for corneal AEs of interest: keratopathy/keratitis, blurred vision/decreased acuity, dry eye, eye pain, and photophobia. Incidence of new corneal AEs, healthcare resource utilization (HCRU), corneal AE-related HCRU, and costs were assessed and benchmarked against a hematology cohort of patients. RESULTS: The MM cohort included 2,120 patients with a median follow-up of 734.5 days. Overall, 11.7% of patients in the MM cohort and 7.4% in the hematology cohort had ≥1 corneal AE of interest. In the MM cohort, dry eye (6.1%), blurred vision/decreased acuity (3.4%), and keratopathy/keratitis (2.5%) were the most frequent. The overall median corneal AE-related per-patient-per-month (PPPM) cost was $27, predominantly contributed by OP care (median $19 PPPM). During follow-up, 4.8% of patients visited the ED, 3.6% were hospitalized, and 42.5% of patients visited an ophthalmologist/optometrist (∼1.69 visits/year). Costs of these visits were negligible (median PPPM $19) compared to total all-cause costs (median PPPM $17,286). LIMITATIONS: The results can only be generalized to commercially insured and Medicare Advantage patients. Claims-based diagnosis of corneal AEs may underestimate true incidences. CONCLUSIONS: Corneal AEs were observed in ∼12% of patients in the MM cohort, the most common were keratopathy/keratitis, dry eye, and blurred vision. Most of them required only OP care. The clinical and economic burden for treating corneal AEs was low when compared with total all-cause or MM-related PPPM costs.

Burden of chemotherapy in patients with relapsed/refractory acute myeloid leukemia in the United States: a retrospective claims database study.

BACKGROUND: Real-world estimates of relapsed or refractory (R/R) acute myeloid leukemia (AML) chemotherapy episode costs are scarce. We quantified chemotherapy episode-related costs and healthcare resource use (HRU) in R/R AML. RESEARCH DESIGN AND METHODS: This real-world, retrospective analysis of United States claims from IQVIA's PharMetrics® Plus database (October 2008-September 2019) identified adults with R/R AML and ≥1 chemotherapy episode. Chemotherapy episode (ie, low- [LIC] or high-intensity [HIC] chemotherapy) costs and HRU were determined using inpatient, outpatient, and pharmacy claims. RESULTS: Mean (SD) and median total all-cause healthcare costs per R/R AML chemotherapy episode were $230,799 ($300,770) and $129,117. Mean (SD) and median adjusted direct R/R AML chemotherapy episode costs were $116,384 ($151,425) and $63,298, with increases noted from the first to the second and subsequent episodes and with HIC. Hospitalizations were the major cost driver; 64.1% of patients had ≥1 hospitalization and 36% required an intensive care unit stay. CONCLUSIONS: R/R AML chemotherapy episode costs were high, with higher costs reported with HIC and increasing lines of chemotherapy. Hospitalizations were a main cost driver. Novel therapies with comparable or improved effectiveness and decreased need for hospitalizations versus chemotherapy may help alleviate the clinical and economic burden of R/R AML.

The Influence of Socioeconomic Status on Esophageal Cancer in Taiwan: A Population-Based Study.

BACKGROUND: Esophageal cancer has extreme worldwide demographic and histologic variations in occurrence; thus, understanding the pathogenesis of esophageal cancer must be region- or country-based. We examined the incidence and tumor stage at diagnosis of esophageal cancer in relation to patients' socioeconomic status (SES) in Taiwan. METHOD: This retrospective cohort study used data from Taiwan's National Health Insurance Research Database and Taiwan Cancer Registry collected between January 2008 and December 2014. The records of 40- to 79-year-old patients diagnosed with esophageal cancer were retrieved. The distribution of the crude incidence rates of esophageal cancer by occupation and income variables was studied retrospectively. Cox proportional hazard model was used to adjust for potential confounders and compare the esophageal cancer incidence among four independent variables: age, gender, occupation, and income. Logistic regression analysis was applied to find the power of the independent variables on the odds ratio of late-stage presentation. RESULTS: The analysis included 7763 subjects. Esophageal squamous cell carcinoma (ESCC) was the predominant histological type (96.6%) and 94.4% of patients were male. The peak affected age for ESCC was 50 to 59 years, whereas the risk of esophageal adenocarcinoma increased progressively with age. The risk of ESCC was significantly unfavorable for the most disadvantaged group, either in occupation or income, while in EAC, risk was unrelated to either factor. The stage of cancer at diagnosis was lower in the highest income groups than in the other two groups. CONCLUSION: Significant SES disparities in esophageal cancer incidence, based on occupation and income, are present in Taiwan. Low SES populations have a higher percentage of late-stage diagnosis. Resolution of the increasing socioeconomic disparities and narrowing the gaps in health inequities in Taiwan are needed.

Real-World Effectiveness of Dupilumab in Atopic Dermatitis Patients: Analysis of an Electronic Medical Records Dataset.

INTRODUCTION: While the efficacy of dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been demonstrated in several clinical trials, patients in such trials may not necessarily reflect the real-world clinical practice setting. This study evaluated the real-world effectiveness of dupilumab in adults with moderate-to-severe AD based on physician global assessment, percent body surface area affected, and patient-reported itch. METHODS: From Modernizing Medicine's Electronic Medical Assistant dermatology-specific electronic medical records, adults (≥ 18 years) were identified with a diagnosis of AD and ≥ 1 dupilumab prescription (index event) between 1 April 2017 and 31 January 2019. Three cohorts were identified based on 3-month pre-index (1) Investigator Global Assessment (IGA) score ≥ 3, (2) an itch severity numerical rating scale (NRS) score ≥ 3, and (3) body surface area (BSA) affected ≥ 10%. Changes from pre-index on the outcome within each cohort were evaluated at 4 months post-index. Patients were also stratified for evaluation of outcomes by baseline demographic (sex, age) and prior AD treatments (topical therapy only or no treatment, any systemic therapy). RESULTS: More than 70% of the 435 AD patients with baseline IGA score ≥ 3 improved to an IGA score of ≤ 2 at month 4 post-dupilumab initiation, including 42.8% who achieved IGA 0/1 (clear/minimal). Among 112 patients with a pre-index itch severity NRS ≥ 3, scores were reduced from mean (SD) 7.0 (2.4) pre-index to 2.8 (2.8) at month 4 (p < 0.0001); 70.5% of patients had a reduction ≥ 3 points. In the BSA cohort (n = 387), affected BSA was significantly reduced from a pre-index mean (SD) of 39.3% (26.1%) to 16.3% (21.2%) at month 4 (p < 0.0001). Significant improvements in IGA, itch NRS, and BSA were observed regardless of demographic (age and sex) or clinical characteristics such as treatment history (all p < 0.0001 compared with pre-index). CONCLUSIONS: Consistent with outcomes observed in clinical trials, patients treated with dupilumab in real-world clinical settings achieved clinically meaningful improvements in severity and extent of AD and severity of itch comparable to those reported in clinical trials at a similar time point.

The Short- and Long-Term Burden of Acute Pancreatitis in the United States: A Retrospective Cohort Study.

OBJECTIVES: This retrospective cohort study assessed short- and long-term economic, clinical burden, and productivity impacts of acute pancreatitis (AP) in the United States. METHODS: United States claims data from patients hospitalized for AP (January 1, 2011-September-30, 2016) were sourced from MarketScan databases. Patients were categorized by index AP severity: severe intensive care unit (ICU), severe non-ICU, and other hospitalized patients. RESULTS: During index, 41,946 patients were hospitalized or visited an emergency department for AP. For inpatients, median (interquartile range) AP-related total cost was $13,187 ($12,822) and increased with AP severity (P < 0.0001). During the postindex year, median AP-related costs were higher (P < 0.0001) for severe ICU versus severe non-ICU and other hospitalized patients. Hours lost and costs due to absence and short-term disability were similar between categories. Long-term disability costs were higher (P = 0.005) for severe ICU versus other hospitalized patients. Factors associated with higher total all-cause costs in the year after discharge included AP severity, length of hospitalization, readmission, AP reoccurrence, progression to chronic pancreatitis, or new-onset diabetes (P < 0.0001). CONCLUSIONS: An AP event exerts substantial burden during hospitalization and involves long-term clinical and economic consequences, including loss of productivity, which increase with index AP event severity.

Early examination of real-world uptake and second-dose completion of recombinant zoster vaccine in the United States from October 2017 to September 2019.

Shingrix (Recombinant zoster vaccine, RZV) was approved in October 2017 in the United States (US) for the prevention of herpes zoster in adults aged 50 years and older. The vaccine is administered in two doses, with the second dose administration recommended between two and six months after the first dose. Examination of uptake and series completion is important to ensure appropriate use, especially at the time of vaccine introduction. This report provides demographic characteristics of patients receiving RZV between October 2017 and September 2019, first- and second-dose uptake, and a cumulative estimation of second-dose completion by month for US adults aged 50 years and older. Monthly uptake increased rapidly since October 2017; overall, 7,097,441 first doses of RZV were administered along with 4,277,636 second doses during the observed timeframe. Among people with an observed first-dose administration, 70% and 80% completed the two-dose series within six and 12 months post initial dose, respectively. This evidence suggests that RZV has rapidly been adopted by a large population in the US and most are following manufacturer or policy recommendations regarding series completion. Further analyses are needed to explore potential patient, provider, and policy-relevant characteristics associated with second-dose completion that could serve as targets for further improvement.

Real-World Satisfaction with Secukinumab in Clearing the Skin of Patients with Plaque Psoriasis through 24 Months of Follow-Up: Results from US Dermatology Electronic Medical Records.

INTRODUCTION: Information on the long-term treatment satisfaction with secukinumab for patients with plaque psoriasis in real-world settings is limited. The objective of this study was to describe real-world treatment satisfaction in patients with plaque psoriasis who initiated secukinumab using data from an electronic medical records-based dermatology database. METHODS: Patients aged ≥ 18 years with plaque psoriasis in Modernizing Medicine Data Services' affiliate's database who received secukinumab 3/1/2018-1/21/2020 were included. Satisfaction with the treatment's effectiveness in clearing the skin of psoriasis was evaluated using a 5-point Likert scale during the 12-month baseline period and at 6-, 12-, 18-, and 24-month postindex visits for the overall population and at 6-, 12-, and 18-month postindex visits for subgroups stratified by prior biologic and systemic therapy use. Additionally, satisfaction levels were assessed among patients who were unsatisfied with treatment at baseline. RESULTS: Overall, 82.3% agreed that secukinumab was effective in clearing their skin at 6 months, which was maintained through 12 (81.7%), 18 (83.3%), and 24 months (81.4%). Similar results were observed in biologic-experienced/naive and systemic-experienced/naive patients. Overall mean (SD) treatment satisfaction improved from 2.49 (1.36) at baseline to 1.77 (1.06) at 6 months, with similar improvements in satisfaction scores reported at each follow-up period up through 24 months. Of the patients who were not satisfied at baseline, 77.9% reported being satisfied with their treatment at 6 months, which continued through 12 (74.4%), 18 (82.8%), and 24 months (71.4%). Patients receiving secukinumab experienced meaningful changes in percent affected body surface area and Physician Global Assessment scores that were sustained through 24 months, regardless of prior treatment experience. CONCLUSIONS: These real-world findings highlight the high level of sustained satisfaction with secukinumab treatment for improving and maintaining skin clearance in patients with moderate-to-severe disease, regardless of prior treatment experience.

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.

Low-density lipoprotein cholesterol lowering in real-world patients treated with evolocumab.

BACKGROUND: Low-density lipoprotein cholesterol (LDL-C) is a risk factor for atherosclerotic cardiovascular disease (ASCVD). There are limited real-world data on LDL-C lowering with evolocumab in United States clinical practice. HYPOTHESIS: We assessed LDL-C lowering during 1 year of evolocumab therapy. METHODS: This retrospective cohort study used linked laboratory (Prognos) and medical claims (IQVIA Dx/LRx and PharMetrics Plus® ) data. Patients with a first fill for evolocumab between 7/1/2015 and 10/31/2019 (index event) and LDL-C ≥ 70 mg/dL were included (overall cohort; N = 5897). Additionally, a patient subgroup with a recent myocardial infarction (MI) within 12 months (median 130 days) before the first evolocumab fill was identified (N = 152). Reduction from baseline LDL-C was calculated based on the lowest LDL-C value recorded during a 12-month follow-up period. RESULTS: The mean (SD) age was 65 (10) years; 61.9% of patients had ASCVD diagnoses and 70.7% of patients were in receipt of lipid-lowering therapy. Following evolocumab treatment, changes in LDL-C from baseline were -60% in the overall cohort (median [interquartile range (IQR)] 146 [115-180] mg/dL to 58 [36-84] mg/dL) and -65% in the recent MI subgroup (median [IQR] 137 [109-165] mg/dL to 48 [30-78] mg/dL). In the overall cohort and recent MI subgroup, 62.1% and 69.7% of patients achieved LDL-C < 70 mg/dL, respectively. CONCLUSIONS: In this real-world analysis, evolocumab was associated with significant reductions in LDL-C comparable to that seen in the FOURIER clinical trial, which were durable over 1 year of treatment.

Impact of Lurasidone and Other Antipsychotics on Body Weight: Real-World, Retrospective, Comparative Study of 15,323 Adults with Schizophrenia.

PURPOSE: The primary objectives were to describe weight changes following initiation of lurasidone versus other antipsychotics and estimate the risk of clinically relevant (≥7%) weight changes. PATIENTS AND METHODS: This retrospective, longitudinal comparative cohort study was based on electronic medical records (EMRs) of United States (US) adult patients with schizophrenia who were prescribed lurasidone or other antipsychotics as monotherapy between 1 April 2013 and 30 June 2019. RESULTS: Overall, the study included 15,323 patients with a diagnosis of schizophrenia; 6.1% of patients received lurasidone, 60.4% received antipsychotics associated with a medium-high risk of weight gain (clozapine, olanzapine, quetiapine, risperidone, paliperidone) and 33.5% received antipsychotics with a low risk of weight gain (aripiprazole, first-generation antipsychotics, ziprasidone). Lurasidone was associated with the smallest proportion of patients experiencing clinically relevant weight gain and the greatest proportion of patients with clinically relevant weight loss. The risk of clinically relevant weight gain was numerically higher with all antipsychotics versus lurasidone and was statistically significant for olanzapine (hazard ratio [HR]=1.541; 95% confidence interval [CI]=1.121; 2.119; p=0.0078) versus lurasidone. The likelihood of ≥7% weight loss was significantly greater with lurasidone versus all antipsychotics (p<0.05), except ziprasidone. CONCLUSION: This real-world study suggests that lurasidone has a lower risk of clinically relevant weight gain and a higher likelihood of clinically relevant weight loss than other commonly used antipsychotics.