Virginia Noxon

Chemotherapy is the main treatment for diffuse large B-cell lymphoma (DLBCL); yet 30-40% of patients are considered relapsed or refractory (R/R) to initial therapy and have second-line therapy (2 L). There is a need to study real-world outcomes to address the changing treatment landscape for R/R DLBCL patients. This study examined treatment patterns, healthcare utilization and costs, and survival among Medicare R/R DLBCL patients from 2016 to 2022. Study patients (n = 3,191) were an average of 75.7 years old and only 30.6% of patients initiated 3 L. Patients with 3 L incurred higher costs ($15,133 per-patient per-month [PPPM]) than all patients ($9,487 PPPM). Half of patients died within 6.7 months from start of 2 L. Patients with older age and elevated comorbidity burden had significantly shorter survival times within 3 years after 2 L initiation. Our analyses indicate a high disease burden among R/R DLBCL patients, highlighting the need for new treatments.

Patients with active cancer and venous thromboembolism (VTE) have elevated risk of recurrent VTE (rVTE) and major bleeding (MB). The risk is even higher within those with a prior bleeding event or renal disease. There is a need to understand the risk of rVTE and MB of commonly used anticoagulants among these high-risk patients. VTE patients with active cancer and treated with apixaban, warfarin or low molecular weight heparin (LMWH) within 30 days of VTE were identified from 5 claims databases in the United States. Inverse probability of treatment weighting (IPTW) was used to balance patient characteristics. Post-IPTW population was stratified by prior bleed or renal disease status. Cox proportional hazards models were used to evaluate interactions between treatment and prior bleed or renal disease on risk of rVTE and MB, with p-value 0.1). Incidence of MB was higher among those with prior bleed or renal disease. Effects of apixaban, warfarin, or LMWH were generally consistent regardless of prior bleed or renal disease status.

Aim: Treatment effects among anticoagulant-treated patients with venous thromboembolism (VTE) and cancer across tumor types were evaluated. Methods: Patients initiating an anticoagulant within 30 d... Tweetable abstract This real-world study evaluated the effectiveness and safety of apixaban, LMWH, and warfarin among patients with VTE and with common or high risk tumor type. Further research is ...

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 li...

This study assessed the real-world United States (US) treatment patterns and the associated economic burden in patients diagnosed with advanced hepatocellular carcinoma (HCC). The MarketScan databa...

487 Background: Hepatocellular carcinoma (HCC) is often diagnosed in advanced stages. While sorafenib has been the standard of care for advanced HCC, treatment guidelines are not clearly defined. We studied real world systemic lines of therapy (LOT) and economic burden in HCC patients. Methods: The MarketScan database was used to identify patients newly diagnosed with HCC (ICD-9 155.0, ICD-10 C22.0, C22.8) from 2011-2018 and continuously enrolled for ≥6 months prior and ≥1 month post HCC diagnosis. Patients with prior liver transplantation or metastasis, or other primary cancers, pregnancy, or clinical trial participation at any time were excluded. Systemic LOT were identified and ended due to discontinuation, switch, or end of follow up. Transarterial procedures (chemoembolization [TACE], radioembolization [TARE]) were also reported. Results: A total of 1,558 patients (mean age, 62; 78% male; median follow up, 8.8 months) were studied. The first LOT was mostly sorafenib (78%). The median time from HCC diagnosis to start of sorafenib was 43 days. The median duration of therapy on sorafenib was 60 days, with patients ending sorafenib use due to discontinuation (40%) or switching (6%). Only 16% of patients received second LOT, of which 10% were PD-1 inhibitors. Use of TACE and TARE over the follow up period was 15% and 12%, respectively. TACE was more prevalent prior to first LOT (11%) compared to during first LOT (4%) and between first and second LOT (6%). This trend was also observed for TARE (7%, 3%, and 4%, respectively). Patients incurred a mean all-cause total cost of $181,036 and $17,235 per-patient per-month (PPPM), of which $9494 were HCC-specific (Table). Conclusions: Most patients received sorafenib as first line in advanced HCC, but only for 2 months. Only 16% of patients receive second line therapy. HCC patients have a high economic burden and there is a need for more effective and safe treatments.

A 43‐year‐old female with multiple sclerosis developed urethral melanoma. The only potential risk factor was treatment with natalizumab, a humanized monoclonal antibody against α4 integrins. To investigate the risk‐exposure relationship, we reviewed this case, all other published cases, and cases of natalizumab‐associated melanoma reported to regulatory agencies. Data sources included the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) (2004–2014), a FDA Advisory Committee Meeting Report, and peer‐reviewed publications. In the United States, the manufacturer maintains an FDA‐mandated Tysabri Safety Surveillance Program (part of the Tysabri Outcomes Unified Commitment to Health (TOUCH)) of natalizumab‐treated patients. We statistically compared reporting completeness for natalizumab‐associated melanoma cases in FAERs for which information was obtained entirely from the TOUCH program versus cases where FAERS information was supplemented by TOUCH program information. FAERS included 137 natalizumab‐associated melanoma reports in patients with multiple sclerosis. Median age at melanoma diagnosis was 45 years (range: 21–74 years). Changes in preexisting nevi occurred in 16%, history of cutaneous nevi occurred in 22%, diagnosis within 2 years of beginning natalizumab occurred in 34%, and 74% had primary surgical treatment. Among seven natalizumab‐treated MS patients who developed biopsy‐confirmed melanoma on treatment and reported in the literature, median age at diagnosis was 41 years (range: 38–48 years); and the melanoma diagnosis occurred following a median of 12 natalizumab doses (range: 1–77 doses). A history of mole or nevi was noted in four patients and a history of prior melanoma was noted in one patient. Completeness scores for reports were significantly lower for FAERS cases reported from the TOUCH program versus FAERS cases supplemented by TOUCH information (median score of 2 vs. 4 items out of 8‐possible items, P < 0.0007). Clinicians should monitor existing nevi and maintain suspicion for melanoma developing in natalizumab‐treated patients. The TOUCH Safety Surveillance Program, currently focused on progressive multifocal leukoencephalopathy, should be expanded to include information on other serious complications including malignancies, particularly if they are immunologic in nature.

Purpose: The US Food and Drug Administration (FDA) has approved epoetin and darbepoetin for chemotherapy-induced anemia (CIA). Approved epoetin and darbepoetin dosing schedules were three times per week and weekly, respectively, although off-label, less frequent scheduling was common. In 2004, 2007, and 2008, a US Food and Drug Administration Advisory Committees warned of risks associated with erythropoiesis-stimulating agents. During this period, lawsuits alleging illegal darbepoetin marketing practices have concluded, resulting in $1.1 billion in fines and settlements and one criminal conviction. No prior study, to our knowledge, has reported on the use of darbepoetin versus epoetin for CIA. Methods: We evaluated the dosing, utilization, and costs of erythropoiesis-stimulating agents among 3,761 South Carolina Medicaid patients with CIA. Results: Epoetin and darbepoetin utilization rates were 22% and 28% in 2003, 10% and 33% in 2007, and 3% and 7% in 2010, respectively. Mean per-patient per-administration epoetin and darbepoetin doses were 40,983 IU and 191 µg, respectively, in 2003 and 47,753 IU and 369 µg, respectively, in 2010. Mean monthly patient costs for epoetin and darbepoetin were $1,030 and $981, respectively, in 2003 and $932 and $1,352, respectively, in 2010. Epoetin use decreased steadily between 2002 and 2010; darbepoetin use increased steadily between 2003 and 2007 and then decreased steadily thereafter. Per-patient dosing of darbepoetin, but not epoetin, increased steadily between 2003 and 2010, and monthly per-patient epoetin costs decreased 3% while the per-patients costs of darbepoetin increased 30% between 2003 and 2010. Conclusion: To our knowledge, our findings are the first data reporting on epoetin versus darbepoetin use for CIA and support recently concluded lawsuits involving allegations of illegal marketing practices of the manufacturer of darbepoetin.