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To develop a claims-based algorithm identifying systemic lupus erythematosus (SLE) flares using a linked claims-electronic medical record (EMR) dataset. This study was a retrospective analysis of linked administrative claims and EMR data spanning 1 January 2003 to 31 March 2019. Included were adult SLE patients with at least 12 months of continuous enrollment in claims data, 12 months of clinical activity in EMR, and an absence of malignancies excluding basal and squamous cell carcinoma. Patient follow-up was divided into 30-day windows, and a proxy SLEDAI-2K score based on the EMR data was calculated for each 30-day period. A flare was defined as an increase of at least 4 from the baseline score. A series of potential flare predictor variables identified in claims were based on a combination of established variables from a previous algorithm, with the addition of other SLE-related indicators based on clinical input. Logistic regression models were built to predict monthly SLE flares. Inclusion criteria identified 2427 patients. Results from a logistic model with forward selection capping the number of variables at 10 performed well with a c-statistic of 0.76 and a Brier score of 0.07. The top five predictors were any inpatient admission (OR = 4.76), outpatient office visit (OR = 3.04), MRI (OR = 2.26), ER visit (OR = 2.25), and number of rheumatology visits (OR = 1.75); p < .01 for all. The final algorithm shows promise in providing an alternative and more streamlined way for identifying likely flares in administrative claims data that will advance the study of SLE within the context of flares.

Introduction Reliable cost and resource use data for COVID-19 hospitalizations are crucial to better inform local healthcare resource decisions; however, available data are limited and vary significantly. Methods COVID-19 hospital admissions data from the Premier Healthcare Database were evaluated to estimate hospital costs, length of stay (LOS), and discharge status. Adult COVID-19 patients (ICD-10-CM: U07.1) hospitalized in the US from April 1 to December 31, 2020, were identified. Analyses were stratified by patient and hospital characteristics, levels of care during hospitalization, and discharge status. Factors associated with changes in costs, LOS, and discharge status were estimated using regression analyses. Monthly trends in costs, LOS, and discharge status were examined. Results Of the 247,590 hospitalized COVID-19 patients, 49% were women, 76% were aged ≥ 50, and 36% were admitted to intensive care units (ICU). Overall median hospital LOS, cost, and cost/day were 6 days, US$11,267, and $1772, respectively; overall median ICU LOS, cost, and cost/day were 5 days, $13,443, and $2902, respectively. Patients requiring mechanical ventilation had the highest hospital and ICU median costs ($47,454 and $41,510) and LOS (16 and 11 days), respectively. Overall, 14% of patients died in hospital and 52% were discharged home. Older age, Black and Caucasian race, hypertension and obesity, treatment with extracorporeal membrane oxygenation, and discharge to long-term care facilities were major drivers of costs, LOS, and risk of death. Admissions in December had significantly lower median hospital and ICU costs and LOS compared to April. Conclusion The burden from COVID-19 in terms of hospital and ICU costs and LOS has been substantial, though significant decreases in cost and LOS and increases in the share of hospital discharges to home were observed from April to December 2020. These estimates will be useful for inputs to economic models, disease burden forecasts, and local healthcare resource planning. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01887-4.

OBJECTIVE Crohn’s Disease (CD) is a chronic disease characterized by transmural inflammation and may involve any portion of the gastrointestinal tract. Children with CD are more likely to present with extensive disease and have more rapid clinical progression than adults.1 This study aimed to compare the treatment patterns between pediatric and adult patients with CD. METHODS This is a retrospective claims-based study using the Merative L.P Marketscan® Research database (January 1, 2014 through December 31, 2021). Pediatric (≤ 17 years) and adult (≥ 18 years) patients with a CD diagnosis code and ≥12 months continuous enrollment with medical and pharmacy benefits before and after the first diagnosis of CD (index date) were included. Descriptive statistics described treatment patterns for pediatric and adult CD cohorts. RESULTS There were 2810 pediatric and 25,934 adult patients with CD included in the analysis. The mean (SD) ages in years for pediatric and adult patients were 13.5 (3.1) and 46.0 (15.9), respectively (Table 1). While females (53.6%) were slightly predominant in the adult cohort, there was a numerically higher proportion of males (59.5%) in the pediatric cohort. The most common monotherapy in children was corticosteroids (22.9%) or biologics (34.9%), while adult monotherapy was primarily corticosteroids (29.6%) or aminosalicylates (32.9%). The time from diagnosis to initiation of corticosteroids and immunomodulators was numerically shorter in children than adults (median days between index and corticosteroids or immunomodulators initiations: 14 vs. 54 and 26 vs 34, respectively). Combination therapies, including biologics and/or immunomodulators with corticosteroids, were numerically more often used in children than in adults (32.4% vs 15.0%). Among all biologic users, adalimumab (18.1%) was numerically more commonly prescribed for adults while infliximab (38.2%) was numerically more common in children. Pediatric patients showed numerically higher 6-month persistence from initiation of a biologic when compared with adult patients (persistence rate: 94.6% vs 87.2%; Table 2). Notably, a small proportion of pediatric patients were on either ustekinumab or vedolizumab (0.1% and 0.2%, respectively) as add-on therapy despite those medications not being currently approved in this population. CONCLUSION The study suggests that children with newly diagnosed CD receive combination therapies more frequently than adults. This may be related to greater disease severity in children. Children treated with biologics had numerically greater persistence, suggesting similar efficacy compared to adults. REFERENCE 1. Freeman H.J., Natural history and long-term clinical course of Crohn’s disease. World J Gastroenterol. 2014 Jan 7;20(1):31-6.

OBJECTIVE Ulcerative Colitis (UC) is a chronic disease characterized by continuous inflammation of the colonic and rectal mucosa. Children with UC are more likely to present with extensive disease and have more rapid clinical progression than adults.1 This study compared treatment patterns between pediatric and adult patients with UC. METHODS This retrospective, claims-based, cohort study used data from the Merative L.P Marketscan® Research Database to identify newly diagnosed patients with a confirmed UC diagnosis from January 1, 2014 through December 31, 2021. Pediatric (≤ 17 years) and adult (≥ 18 years) patients with continuous enrollment for 12 months before and 12 months following the first UC diagnosis (index date) who also received at least 1 medication related to inflammatory bowel disease (aminosalicylates, corticosteroids, immunomodulators, or biologics) after the first diagnosis date, were included. Descriptive statistics described treatment patterns for both cohorts. RESULTS This analysis included 1343 pediatric and 37,617 adult patients with UC. The mean (SD) ages (years) for pediatric and adult patients were 13.7 (3.3) and 48.8 (15.3) years, respectively (Table 1). The time from diagnosis to initiation of corticosteroids was numerically shorter in children in contrast to adults (median days between index date and corticosteroids initiation: 15 vs 56). Among all UC patients, aminosalicylates (74.0% adults vs 72.5% children) were the most prescribed monotherapy, followed by corticosteroids (16.6% adults vs 15.3% children) and immunomodulators (5.1% adults vs. 7.4% children). Additionally, children were started on combination therapies numerically more often than adults (32.3% vs 16.7%). The most used combination therapies for both cohorts were aminosalicylates plus corticosteroids (63.0% adults vs 62.4% children), followed by aminosalicylates and immunomodulators (15.3% adults vs 8.3% children). Children had numerically higher utilization of biologics than adults (22.6% vs 10.8%). The persistence rates of all drug therapies within 6 months following initiation in both cohorts were similar (Table 2). Notably, a small proportion of pediatric patients were on ustekinumab, vedolizumab, or tofacitinib as add-on therapy (0.2%, 2.0%, and 0.2%, respectively), despite those medications not being currently approved in this population. CONCLUSION More children with newly diagnosed UC receive combination therapies and have higher utilization of biologics compared to adults. This may reflect greater disease progression and complications in children. REFERENCE 1. Ruemmele, F., Turner, D. Differences in the management of pediatric and adult-onset ulcerative colitis – lessons from the joint ECCO and ESPGHAN consensus guidelines for the management of pediatric ulcerative colitis. Journal of Crohn’s and Colitis, 8(1), January 2014, pages 1-4.

Introduction This study describes the frequency of prescription claims for drugs that may interact with Janus kinase (JAK) inhibitors among adult patients with rheumatoid arthritis (RA) in a large US claims database. Methods This observational, retrospective, cross-sectional study of the IBM® MarketScan® Research Commercial and the Medicare Supplemental Database included adults (≥ 18 years) with ≥ 2 outpatient claims 30 or more days apart or ≥ 1 inpatient visit claim with an RA diagnosis between January 1, 2013 and March 31, 2017 (the index period). During the study period, from January 1, 2013 to March 31, 2018, strong organic anion transporter (OAT3) inhibitors, strong cytochrome P450 (CYP) 3A4 inhibitors, and moderate or strong CYP3A4 inhibitors in combination with strong CYP2C19 inhibitors, were identified as drugs with potential for drug–drug interactions (DDIs) with JAK inhibitors approved for RA treatment in the US. Descriptive statistics were conducted. Results A total of 152,853 patients met eligibility criteria. Approximately 76% were women and the median age was 57 years. Of these patients

Cluster headache (CH) is a rare trigeminal cephalalgia that is associated with extremely painful unilateral headache attacks and autonomic symptoms. Attacks may be episodic or chronic and associated with substantial suffering due to excruciating pain and limited treatment options. Frequent cluster headaches cause substantial burden for patients, resulting in reduced productivity caused by disability, as well as direct costs in some European countries. Less is known, however, about direct costs of recurring health care resource utilization (HCRU) in the United States.To characterize HCRU and direct costs associated with CH in the United States from a third-party payer perspective.This retrospective observational study analyzed claims data from the Truven Health Analytics MarketScan Research Databases from 2009-2014. Two cohorts were compared: CH (2 diagnostic CH claims) and controls (nonheadache patients). All patients were enrolled continuously for ± 12 months from date of first CH claim. HCRU and direct costs were examined during 12 months post-index as all-cause and CH-specific. Cost and HCRU differences were compared using propensity score-adjusted bin bootstrapping.CH and control cohorts comprised 6,562 and 143,761 patients (aged ≥ 18 years), respectively. Post-index, 36.9% of CH patients versus 16.2% of controls were admitted to the emergency department (ED), and 14.8% versus 6.1% were hospitalized for any reason, respectively (each P0.001). CH patients had a 2- to 3-fold significantly greater number of all-cause mean claims for outpatient visits (26.5 vs. 12.4 visits), hospital visits (0.2 vs. 0.1 visits), and ED visits (1.0 vs. 0.3 visits) versus controls (all P0.001). The mean number of all-cause visits with reported radiology and laboratory claims was 1.5- to 2.0-fold greater in CH patients versus controls (each P0.001). Mean total direct costs for all-cause claims were more than 2-fold greater in post-index ($16,530) for CH patients versus controls ($7,197, P0.0001). Similarly, mean direct all-cause costs attributable to outpatient, inpatient, and pharmacy claims were significantly (2-fold) greater; radiology and ED claims were 3- to 4-fold greater among CH patients versus controls (all P0.001). However, CH was cited infrequently as a reason for HCRU, indicating that comorbid conditions may substantially increase HCRU in CH patients. The most common reasons for ED admission in CH patients were gastric ulcer with hemorrhage, sub-arachnoid hemorrhage, and headache symptoms. The most common hospital discharge diagnoses for CH patients not observed in top 10 reasons in controls included cerebral artery occlusion/unspecified with cerebral infarction, headache symptoms, syncope/collapse, and diverticulitis.These findings suggest that, from a payer perspective, CH patients incur significantly higher health care costs versus controls. However, these high costs were not exclusively headache-related. Extrapolating our cost findings to estimated U.S. prevalence rates, approximate total direct cost for CH is greater than $2.8 billion/year.Eli Lilly and Company was the sole sponsor and funder for this study and was responsible for the study design, data collection, data analysis, interpretation of data, and decision to publish the findings. All authors are employees and minor stockholders of Eli Lilly and Company.

Objective To characterize demographics, clinical characteristics, and treatment patterns of patients with cluster headache (CH). Background CH is an uncommon trigeminal autonomic cephalalgia with limited evidence‐based treatment options. Patients suffer from extremely painful unilateral headache attacks and autonomic symptoms with episodic and chronic cycles. Design/Methods This retrospective analysis used insurance claims from Truven Health Analytics MarketScan® research databases from 2009 to 2014. Two cohorts were compared: CH patients (with ≥2 CH claims) were propensity score matched with 4 non‐headache controls, all with continuous enrollment for 12 months before and after the date of first CH claim or matched period among controls. Results CH patients (N = 7589) were mainly male (57.4%) and 35‐64 years old (73.2%), with significantly more claims for comorbid conditions vs controls (N = 30,341), including depressive disorders (19.8% vs 10.0%), sleep disturbances (19.7% vs 9.1%), anxiety disorders (19.2% vs 8.7%), and tobacco use disorders (12.8% vs 5.3%), with 2.5 times greater odds of suicidal ideation (all P 12 unique prescription drug claims. Most commonly prescribed drug classes for CH patients included: opiate agonists (41%), corticosteroids (34%), 5HT‐1 agonists (32%), antidepressants (31%), NSAIDs (29%), anticonvulsants (28%), calcium antagonists (27%), and benzodiazepines (22%). Only 30.4% of CH patients received recognized CH treatments without opioids during the 12‐month post‐index period. These patients were less likely to visit emergency departments or need hospitalizations (26.8%) as compared to CH patients with no pharmacy claims for recognized CH treatments or opioids (33.6%; P

Background & Aims: There are currently no validated claims-based indicators for identifying a worsening of disease in patients with inflammatory bowel disease (IBD). Therefore, we aimed to develop and validate indicators that identify flare-ups of IBD using data from Danish nationwide registries. Methods: Using Danish nationwide administrative data, we identified all patients with Crohn’s disease (CD) or ulcerative colitis (UC) who had at least one measurement of faecal calprotectin between 1 January 2015 and 31 June 2017. We tested several different claims-based indicators of disease flare-ups against levels of faecal (F-)calprotectin (no flare-up: Results: A total of 890 children and 4719 adults with CD, and 592 children and 5467 adults with UC were included in the study. During the observation period, 48–61% and 48–55% of the CD and UC patients, respectively, had no flare-up, 26–29% (CD) and 24–26% (UC) experienced a mild flare-up, and 12–23% (CD) and 21–27% (UC) experienced a severe flare-up. Combinations of indicators that could predict a flare-up in CD and UC adults included hospitalisation, surgery, initiation or switch of biological therapy, treatment with systemic steroids, locally acting steroids or topical 5-aminosalicylates, colonoscopy/sigmoidoscopy, and magnetic resonance imaging/computed tomography. In children, only the number of gastroenterology visits was significant as an indicator among UC patients, and none were seen in children with CD. Overall, the indicator combinations resulted in a predictive ability of 0.62–0.67. Conclusion: Administrative claims data can be useful for identifying patients exhibiting (F-calprotectin defined) flare-ups of their IBD. Clinically relevant events captured in the Danish national patient registry are associated with increased levels of calprotectin and hence increased disease activity, and can be used as valid outcomes in future studies.