BACKGROUND:Rifaximin treatment is associated with reduced rates of overt hepatic encephalopathy (OHE) hospitalization relative to lactulose alone. This real-world study evaluated the impact of treatment on rehospitalizations following an initial OHE hospitalization among commercial, Medicare, and Medicaid patients treated with rifaximin±lactulose or lactulose only. METHODS:Claims data from January 1, 2016, to September 30, 2023, were used to identify adults with an initial OHE hospitalization under commercial, Medicare, and/or Medicaid coverage (index date was the day following discharge). Patients were stratified into either the rifaximin cohort (±lactulose) or the lactulose-only cohort based on treatments received within 30 days following discharge. The 30-day OHE rehospitalization rate and OHE rehospitalization rate per-patient-per-year were compared between cohorts using adjusted logistic regression and negative binomial regressions, respectively. Subgroup analyses were conducted based on the timing of rifaximin treatment and adherence to treatment guidelines. RESULTS:The study included 7880 patients with an OHE hospitalization with commercial insurance (rifaximin: 5997; lactulose only: 1883), 4131 patients with Medicare insurance (rifaximin: 2419; lactulose only: 1712), and 2924 patients with Medicaid insurance (rifaximin: 1854; lactulose only: 1070). After adjustment, rifaximin was associated with a lower risk of 30-day OHE rehospitalization and lower OHE rehospitalization rates per-patient-per-year than lactulose in commercial (OR=1.75, incidence rate ratio [IRR]=1.67, respectively), Medicare (OR=1.61, IRR=1.51), and Medicaid (OR=1.50, IRR=1.54; all p<0.05) populations. Patients immediately receiving rifaximin and those with AASLD guideline-adherent escalation to rifaximin had the fewest rehospitalizations. CONCLUSIONS:Timely treatment with rifaximin in adherence with clinical practice guidelines following an initial OHE hospitalization was associated with improved short-term and longer-term rehospitalization outcomes, regardless of insurance type.

Contemporary real-world data on treatment patterns and clinical outcomes in patients with programmed death ligand 1 (PD-L1)-negative locally recurrent inoperable or metastatic triple-negative breast cancer (lr/mTNBC) are sparse. We describe first-line (1L) systemic therapies and real-world survival outcomes in this population in the United States (US). Adults with PD-L1-negative lr/mTNBC initiating 1L systemic treatment in the US were identified using the Komodo Research Data (KRD+; 1/1/2016-12/31/2023). Treatment patterns, including treatment durations and sequences from 1L through three lines of therapy, real-world overall survival (rwOS) and progression-free survival (rwPFS) from 1L, were analyzed. rwOS and rwPFS were summarized using Kaplan-Meier methods in subgroups of patients with ≥ 18 months and ≥ 6 months of potential follow-up, respectively. Overall, 929 patients were included (median age 59.0 years, 60.1

Immunoglobulin-G4-related disease (IgG4-RD) is a rare recurring fibroinflammatory autoimmune condition that can affect multiple organs. Although it is gaining recognition, few studies have assessed the clinical and economic burden of this disease. This study aimed to characterize patients with IgG4-RD in the United States and describe healthcare resource utilization (HRU) and costs before and after diagnosis. This retrospective cohort study used a validated algorithm to identify commercially insured adult patients with IgG4-RD from health plan claims data obtained from the IQVIA PharMetrics Plus database (January 1, 2011, to June 30, 2022). The index date was defined as the date of the first observed IgG4-RD-related diagnosis. The baseline and study periods were defined as the 12 months before and after diagnosis, respectively. Demographic characteristics were reported on the index date. Clinical characteristics, IgG4-RD-related treatments, and all-cause HRU and healthcare costs (2022 US dollars, payer’s perspective) were reported during the baseline and study periods. A total of 295 patients with IgG4-RD were included in the study. Comorbid burden was substantial, with hypertension (31.5%), hyperlipidemia (22.4%), and type 2 diabetes (17.3%) being the most common comorbidities after diagnosis. Most patients received IgG4-RD-related treatment before (60.3%) and after (87.8%) diagnosis, with prednisone being the most common (71.5% after diagnosis). Pancreatic and biliary involvement each occurred in nearly a third of patients. Annual HRU was high before (mean of 30.4 outpatient [OP] visits; 22.7% with ≥1 inpatient [IP] admission, lasting a mean of 9.0 days) and after diagnosis (mean of 40.7 OP visits; 35.3% with ≥1 IP admission, lasting a mean of 10.6 days). Mean annual healthcare costs were 1.5 times higher after diagnosis ($69,753) than before diagnosis ($45,844), predominantly driven by increased OP and IP costs. Patients with IgG4-RD had a substantial clinical and economic burden, including high rates of glucocorticoid use, HRU, and healthcare costs both before and after diagnosis. This may suggest a need for earlier detection and improved management of this complex condition. This study provides important insights into the high clinical and economic burden observed in IgG4-RD. Future studies are warranted to gain a deeper understanding of the possible impact of management strategies on patient outcomes.

Proteinuria is a key predictor of kidney failure in Immunoglobulin A nephropathy (IgAN) patients, but few real-world studies establishing this association have been conducted in the United States (US). This study evaluated the association between time-averaged proteinuria (TA-P) and risk of kidney failure in patients with IgAN in the US, including TA-P levels of < 0.5 g/day and below. This retrospective cohort study used integrated administrative claims from the Komodo Research Data and electronic medical record data from Norstella (January 2016–2026). Adults (≥ 18 years) with IgAN diagnosis, ≥ 3 proteinuria measurements, and no kidney failure before the index date (the day after the third proteinuria measurement) were included. TA-P was calculated as the area under the curve of serial proteinuria measurements divided by the duration of observation. Primary TA-P categories were < 0.5, 0.5-1.0, 1.0-1.5, and ≥ 1.5 g/day; additional analyses used a more granular stratification of TA-P < 0.5 g/day (< 0.3 g/day and 0.3–0.5 g/day). The composite study outcome was kidney failure (chronic kidney disease stage 5, sustained eGFR < 15 mL/min/1.73 m2, dialysis, or kidney transplantation). Associations between TA-P and kidney failure were assessed using Cox proportional hazards models adjusted for baseline characteristics such as demographics, race/ethnicity, hypertension, diabetes, hematuria, and eGFR. A total of 1820 patients with IgAN were included in the study (median age 46.8 years; 51.4

BACKGROUND:Individuals with narcolepsy or idiopathic hypersomnia (IH) present with a high comorbidity burden that may confer elevated risk for negative clinical outcomes associated with excess sodium intake. This study characterized the prevalence and profiles of sodium-relevant comorbidity risk factors among individuals with either condition. METHODS:Individuals with narcolepsy or IH (index: first diagnosis) and corresponding non-narcolepsy or non-IH cohorts (index: random date) were identified from Komodo Research Data (01/01/2016-01/31/2024) and entropy balanced on age, sex, race/ethnicity, region of residence, health plan type, and year of index. Sodium-relevant risk factors were identified through literature review and included cardiovascular, cardiometabolic, and renal comorbidities, liver cirrhosis, and sleep apnea. Risk factor prevalence was assessed in the 12-month pre-index period defined by diagnosis, treatment, or procedure code(s). RESULTS:The narcolepsy and non-narcolepsy cohorts included 29,317 and 146,585 individuals, respectively, and the IH and non-IH cohorts included 11,951 and 59,755 individuals, respectively. Individuals with vs without narcolepsy had a higher prevalence of at least 1 sodium-relevant risk factor (69.2% vs 43.6%), including cardiovascular (40.8% vs 27.8%), cardiometabolic (49.9% vs 35.8%), and renal (5.3% vs 3.0%) conditions. Similarly, individuals with vs without IH had a higher prevalence of at least 1 sodium-relevant risk factor (74.4% vs 43.0%), including cardiovascular (40.2% vs 26.5%), cardiometabolic (51.8% vs 35.3%), and renal (4.2% vs 2.6%) conditions. CONCLUSION:This study demonstrates the high prevalence of sodium-relevant comorbidity risk factors among individuals with narcolepsy or IH. Careful management, including limiting sodium exposure, may mitigate the clinical burden in these populations.

ABSTRACT Introduction Patients with relapsed/refractory (R/R) testicular germ cell tumor (GCT) progressing after salvage chemotherapy only have palliative therapeutic options. Real‐world data on this population are needed. Methods Adult men with testicular GCT receiving palliative chemotherapy in the United States were identified in the Komodo Research Database (01/2016–03/2023; index date = date of palliative chemotherapy initiation). Treatment patterns were analyzed for patients with continuous health plan enrollment from diagnosis to index date. Clinical outcomes (time to real‐world progression [TTrwP] and real‐world overall survival [rwOS]) were assessed among patients with prior salvage chemotherapy using the Kaplan–Meier method. Results In the treatment pattern analysis (N = 51; median age 32 years), median (interquartile range) time from diagnosis to first‐line treatment was 0.9 (0.5–2.1) months, and to palliative chemotherapy was 12.5 (9.0–16.8) months. Index palliative chemotherapy regimens included gemcitabine‐oxaliplatin (37.3%), oral etoposide (15.7%), and gemcitabine‐oxaliplatin‐paclitaxel (15.7%). Prior to palliative chemotherapy, 33 patients (64.7%) received salvage chemotherapy. In the clinical outcome analysis (N = 80; median age: 33 years), 49 (61.3%) patients were exposed to high‐dose chemotherapy (HDCT; ±conventional‐dose chemotherapy [CDCT]) and 31 (38.8%) only to CDCT. Overall median (95% confidence interval [CI]) TTrwP was 3.8 (2.6–4.7) months, 3.5 (2.3–4.7) months after HDCT±CDCT, and 4.0 (1.7–6.6) months after only CDCT, and median (95% CI) rwOS was 7.7 (6.3–9.6) months, 6.4 (5.6–9.6) months, and 9.3 (7.5–22.0) months, respectively. Conclusions Real‐world data captured heterogeneous treatment patterns and poor outcomes for patients with R/R testicular GCT receiving palliative chemotherapy, highlighting the need for novel therapies.

Generalized myasthenia gravis (gMG) is a chronic autoimmune condition characterized by muscle weakness. If frontline treatments inadequately manage symptoms, patients may require use of glucocorticoids (GC); however, long-term use of GCs is associated with toxicities. Few studies have examined the incidence of GC-related toxicities and economic burden among patients with gMG. This study aims to describe GC toxicities, healthcare resource utilization, and costs among US adults with gMG, stratified by level of GC use. Adults with gMG were identified using IQVIA PharMetrics® Plus data and classified into 2 mutually exclusive cohorts based on GC use during the most recent 12 months of health plan enrollment (study period): "no GC use" (no GC fills) or "any GC use" (≥1 GC fill). The "any GC use" cohort was stratified into "≥5 mg/d" (mean prednisone equivalent daily dose ≥5 mg) and "≥10 mg/d" (mean prednisone equivalent daily dose ≥10 mg) subgroups. GC use, incident GC toxicities, and all-cause healthcare resource utilization and costs were described during the study period for each cohort and subgroup. Among 8833 patients with gMG, 5076 (57.5%) had no GC use and 3757 (42.5%) had any GC use (≥5 mg/d: 1537 [40.9%]; ≥10 mg/d: 860 [22.9%]). Use of nonsteroidal immunosuppressants was higher among patients with GC use than those without (37.6% any GC use vs 19.6% no GC use). Incident GC toxicities were higher in patients with any GC use than those without (61.9% vs 52.3%). Common acute toxicities included nausea and vomiting, pneumonia, fungal infections, sepsis, and urinary tract infection; chronic toxicities were dyslipidemia, sleep disturbances, obesity, cardiac arrhythmias, and hypertension. Annual all-cause costs were >2x higher among patients with any GC use than those with no GC use ($76,381 vs $35,309). GC acute and chronic toxicities and costs tended to increase with increasing GC use. Since claims data do not contain reasons for diagnoses, toxicities could not be confirmed to be related to GC use. Additionally, results may be confounded by disease severity or concomitant medications. Effective GC-sparing treatments are needed to mitigate the clinical and economic burden of GC use in adults with gMG.

Introduction Chemoimmunotherapy with atezolizumab or durvalumab has been the standard-of-care first-line (1L) treatment for extensive-stage small cell lung cancer (ES-SCLC) in the United States (US) since 2019. However, real-world evidence on treatment patterns, progression-free survival (rwPFS), and overall survival (rwOS) in this era is lacking. Methods This retrospective study identified patients with ES-SCLC treated with 1L chemoimmunotherapy from a claims database in the US (Komodo Research Data; 03/2018-09/2023); treatment patterns were described from diagnosis by line of therapy. rwPFS and rwOS were assessed from 1L chemoimmunotherapy initiation using the Kaplan-Meier estimator. Mortality risk factors were assessed using a multivariable Cox proportional hazards model. Results A total of 2,788 patients with ES-SCLC receiving 1L chemoimmunotherapy were identified (median age 65 years, 49.5% female); 89.5% received atezolizumab-based and 10.5% received durvalumab-based 1L chemoimmunotherapy. One-third (33.2%) of patients received a second-line regimen, and 10.3% received a third-line regimen. Among patients with sufficient follow-up, median rwPFS and rwOS from 1L chemoimmunotherapy was 4.2 (95% CI: 4.0-4.4) months and 10.8 (95% CI: 10.3-11.3) months, respectively. Risk factors significantly associated with increased mortality included older age (≥75 years), male sex, comorbidities (cardiovascular, renal, and chronic obstructive pulmonary diseases), and distant metastases (liver, brain, bone, adrenal gland). Conclusions In real-world clinical practice, patients with ES-SCLC treated with 1L chemoimmunotherapy experience rapid disease progression and death and infrequently receive subsequent treatment. Prognosis is particularly poor among older patients and those with comorbidities or distant metastases. These findings underscore a need for effective treatment options in 1L and beyond.

Adalimumab (ADA)-adaz (Hyrimoz®; Sandoz, Inc.) became available in the United States (US) in July 2023. This study assessed real-world ADA-adaz adoption experience by describing characteristics and treatment history of patients initiating ADA-adaz in the months following its US availability and preliminarily assessing persistence and adherence to ADA-adaz. A retrospective cohort study using open and closed claims from Komodo Research Data (01/2016-05/2024) was conducted. The index date was the first ADA-adaz prescription after July 2023. For the demographics and clinical assessment subgroup, ≥12 months of continuous data availability pre-index (baseline period) was required. For the persistence and adherence assessment subgroup, ≥3 months of continuous health plan enrollment post-index (study period) was required. Persistence was measured as time from index to the earlier of switch or discontinuation (45-day gap). Adherence was measured as the proportion of days covered (PDC) while on ADA-adaz. A total of 23,737 patients with an ADA-adaz prescription after July 2023 were included. For patients in the demographics and clinical assessment subgroup, the median age was 49.0 years, 59.4% were female, and 91.0% had commercial insurance. Patients received ADA-adaz mostly for rheumatoid arthritis (33.0%) and Crohn disease (23.2%). Common baseline comorbidities included hyperlipidemia (29.2%), hypertension (29.0%), anxiety (22.8%), and osteoarthritis (21.4%). During baseline, 93.2% of patients received a biologic; 98.2% received the reference ADA, and 83.0% were treated with biologics for at least 6 to 12 months. Other baseline treatments included systemic corticosteroids (52.3%), non-steroidal anti-inflammatory drugs (35.4%), and disease-modifying antirheumatic drugs (34.6%). Of the 1108 (4.7%) patients in the persistence and adherence assessment subgroup, persistence at 3 months was 65.7%, and average PDC was 93.9% while on ADA-adaz. These findings should be interpreted with caution due to limited follow-up availability. In summary, patients who initiated ADA-adaz in the months following its US availability were predominantly commercially insured. The high rate of prior ADA use highlighted a transition to biosimilars in biologic-experienced patients. The end of ADA-adaz persistence was largely driven by switching to other ADA treatments. Among patients with available short-term follow-up, adherence while on ADA-adaz was high. Further studies with longer follow-up can assess ADA-adaz utilization patterns and long-term outcomes.

628 Background: Pts with R/R testicular GCT are considered to be incurable, having experienced progressive disease (PD) after salvage conventional-dose CT (CDCT) and/or high-dose CT (HDCT). Therapeutic options are limited to palliative CT, with an estimated real-world (rw) overall survival of 8 months from initiation of their first palliative CT regimen. Understanding TTrwP may help further inform clinical care. Methods: The Komodo Research Database (KRD; 01/2016-03/2023) was used to identify adult males in the US with testicular GCT who received palliative CT after salvage CT. TTrwP was estimated using Kaplan-Meier analysis and defined as time from index date (initiation of first palliative CT regimen) to first rw proxy of PD, which included 1) radiation after the first cycle of palliative CT, 2) treatment addition/switch, 3) treatment discontinuation prior to death, 4) hospice admission, or 5) death. Treatments received pre-/post index were described. Results: Among 248 pts receiving palliative CT, 97 (39.1%) had sufficient data to confirm prior salvage CT and, of those, 80 (82.5%) had ≥12 months of potential follow-up for outcome assessment. Median age was 33.0 years and most pts had commercial (51.3%) or Medicaid (42.5%) coverage. Before index, 49 (61.3%) pts were exposed to HDCT with or without CDCT (+/- CDCT) and 31 (38.8%) pts to CDCT only. Index regimens included gemcitabine-oxaliplatin (47.5%), oral etoposide (13.8%), gemcitabine-paclitaxel (13.8%), and gemcitabine-oxaliplatin-paclitaxel (7.5%). Median (95% confidence interval) TTrwP was 3.8 (2.6-4.7) months overall, 3.5 (2.3-4.7) months after prior HDCT +/- CDCT, and 4.0 (1.7-6.6) months after CDCT only. First PD events included radiation (32.5%), treatment discontinuation (31.3%), and treatment addition/switch (22.5%), occurring at a median of 2.8, 2.1, and 4.7 months from index, respectively. Death was observed for 91.3% of pts and occurred at a median of 2.4 months from PD event, including 3 (3.8%) pts with death as their PD event (Table). Conclusions: This study is the first to use rw proxies for PD in claims data to estimate TTrwP in pts with R/R testicular GCT. With no curable treatment options remaining, the short TTrwP highlights the poor outcomes in this patient population and need for novel therapies to improve clinical outcomes. RW PD events observed in pts with R/R GCT (N=80). First PD event N (%) Time to event (months), median [IQR] Death, N (%) Time from PD event to death (months), median [IQR] Radiation 26 (32.5%) 2.8 [1.4 - 4.6] 26 (100.0%) 3.0 [1.9 - 6.3] Treatment discontinuation 25 (31.3%) 2.1 [1.0 - 3.9] 25 (100.0%) 1.8 [1.3 - 3.1] Treatment addition/switch 18 (22.5%) 4.7 [3.0 - 6.1] 16 (88.9%) 3.8 [3.2 - 6.1] Hospice 3 (3.8%) 9.9 [0.5 - 17.1] 3 (100.0%) 0.3 [0.3 - 3.0] Death 3 (3.8%) 30.4 [3.8 - 32.0] 3 (100.0%) 0.0 [0.0 - 0.0] No PD 5 (6.3%) – 0 (0.0%) –