Amgen (Europe) GmbH

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更新于：2025-05-07

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项与 Amgen (Europe) GmbH 相关的临床试验

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Description of (re-)induction therapies prior to a planned stem cell transplantation in patients with relapsed / refractory multiple myeloma in Germany

开始日期2021-08-10

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Amgen (Europe) GmbH

100 项与 Amgen (Europe) GmbH 相关的临床结果

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0 项与 Amgen (Europe) GmbH 相关的专利（医药）

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项与 Amgen (Europe) GmbH 相关的文献（医药）

2025-04-01·Rheumatology and Therapy

Real-World Osteoporosis Treatment Gap and Costs in Spain: Data from Women with a First Fragility Fracture or Diagnosis of Postmenopausal Osteoporosis

Article

作者: Gatell, Sonia ; Sorio-Vilela, Francesc ; Sicras-Mainar, Antoni ; Sacrest-Soy, Marta ; Sicras-Navarro, Aram ; Villoro-Valdés, Renata ; Hernández, Ignacio ; Rebollo-Gómez, Elena

INTRODUCTIONPostmenopausal osteoporosis (PMO) increases the risk of fragility fractures (FF), leading to disability, higher mortality, and elevated healthcare costs. Despite available treatments, osteoporosis (OP) remains undertreated, especially in women over 50 years at high risk for FF. Real-world data on OP care in Spain are limited. This study aims to assess the OP treatment gap, healthcare resource utilisation (HCRU), and costs among Spanish women following a first FF or PMO diagnosis.METHODSThis retrospective study used data from the BIG-PAC^® administrative database on women aged ≥ 50 years with a first FF (cohort 1) or newly diagnosed PMO (cohort 2) between 2014 and 2018. Patients were followed for 2 years after the index event. The primary outcome was the proportion of women not prescribed OP medication within 6 months after the index event (treatment gap). Secondary outcomes included fracture incidence, mortality, HCRU, and costs.RESULTSThe study included 22,142 women: 3190 in cohort 1 and 18,952 in cohort 2. The OP treatment gap was higher in cohort 1 vs cohort 2 (41.5% vs 23.6%). In cohort 1, 59.2% were diagnosed with PMO after the first FF, with 88% experiencing subsequent fracture(s). OP treatment persistence decreased over time in both cohorts. Fracture rates were lower in women prescribed OP treatment vs those who were not (8.35 vs 13.8 per 1000 patient-years) and in those who showed 24-month-persistence and 12-month adherence to treatment vs those who did not (8.98 and 7.66 vs 10.79 and 10.76). The 2-year mean cost per patient was higher in cohort 1 (€10,601) than in cohort 2 (€1659), with the highest costs incurred for hip (€15,833) and vertebral (€10,593) fractures.CONCLUSIONThis study highlights a significant treatment gap in Spanish women aged ≥ 50 with a first FF or newly diagnosed PMO. Costs are particularly high for those with a first FF, especially for hip or vertebral fractures. Improving treatment adherence could reduce fracture risk, healthcare costs, and resource utilisation.

2025-02-01·Journal of Clinical Oncology

Real-world biomarker testing and first-line treatment patterns among locally advanced, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma patients in the US.

作者: Gleason, Michelle Kathleen ; Majer, Istvan Matyas ; Wellen, Maria ; Tzala, Lia ; Reading, Stephanie Rummans ; Luu, Tony

348Background: Advanced-stage gastric cancer and gastroesophageal junction adenocarcinoma (advG/GEJC) are leading causes of cancer-related morbidity and mortality. Chemotherapy is the traditional first-line (1L) therapy for patients in the advanced setting, with targeted and immunotherapy considered based on biomarker expression. This study aimed to describe real-world HER2 and PD-L1 testing practices and 1L treatment patterns among advG/GEJC patients. Methods: A retrospective cohort study was conducted among adult patients diagnosed with advG/GEJC between 01 Jan 2017 and 30 Jun 2023 usingthe US-based Flatiron Health electronic health record-derived de-identified database. HER2 and PD-L1 testing practices were evaluated prior to and up to 1-month post-1L treatment initiation or 6 months post-advG/GEJC diagnosis date in untreated patients. 1L treatment regimens were described overall and stratified by HER2 and PD-L1 expression. Results: Among 4,256 advG/GEJC patients, the average age was 67 years with the majority male (68%), non-Hispanic white (44%), and with metastatic disease (64%). Nearly three quarters (72%) of patients included received a HER2 test and 55% had a HER2 test with a valid result within the timeframe mentioned above. More than a quarter of patients (27%) received a PD-L1 test and 25% had a PD-L1 test with a valid result. PD-L1 testing before the approval of nivolumab in 1L (i.e. before 2021) showed testing at 19% (490/2,629; 17% with a valid result) and from 2021 onward at 40% (643/1,627; 37% with a valid result). Across the full cohort, half of the patients received chemotherapy alone (52%) and one quarter received no treatment (25%). Similar treatment patterns were observed in the subset of 1,117 patients who did not receive a HER2 or PD-L1 test; 54% received chemotherapy alone and 36% no treatment. Of the 340 patients who were tested for HER2 and were HER2 positive, half (52%) received trastuzumab combination therapy, 23% received chemotherapy alone, and 18% had no treatment. Of the 301 patients who received a PD-L1 test with a combined positive score (CPS) ≥5 from 2021 onward, 41% received immunotherapy, 34% received chemotherapy alone and 18% had no treatment. Prior to 2021, most patients with a PD-L1 test and CPS >5 used chemotherapy alone (57%; 132/233), 13% (31/233) received PD-L1 targeted therapies and 19% (43/233) received no treatment. Conclusions: This study describes a potential subset of US advG/GEJC patients who do not receive a HER2 or PD-L1 test and/or do not receive eligible targeted or immunotherapy as part of routine clinical practice. As precision medicine options continue to evolve, these data suggest an opportunity to further understand the drivers for biomarker testing as well as the factors impacting the use of biomarker-informed treatment options.

2024-12-31·Biotechnology & Biotechnological Equipment

Routine use of denosumab for prevention of skeletal-related events in patients with bone metastases from prostate carcinoma in Bulgaria: a prospective observational study

作者: Olszewski, Adrian ; Bjorklof, Katja ; Petrova, Miglena ; Ianakieva, Valentina ; Tomova, Antoaneta

Bulgarian real-world data on denosumab use for the prevention of skeletal-related events (SREs) associated with bone metastases (BM) from prostate cancer (PC) are lacking.This observational study enrolled 100 adult PC patients with ≥1 BM receiving denosumab (EUPAS26983).Patients routine treatment was observed retrospectively for ≤6 mo and prospectively for 12 mo.Denosumab use and safety, SRE incidence, denosumab persistence (allowing ≤2 missed doses), and pain severity were evaluated using descriptive statistics.Denosumab was initiated at a median (Q1, Q3) of 1.8 (0.6, 9.6) months following BM diagnosis with earlier initiation in hormone-sensitive (HSPC; 1.5 [0.6; 4.2]; n = 74) than castration-resistant PC (CRPC; 7.9 [0.8; 16.4]; p = .082; n = 26) and in younger (<65 years; 1.2 [0.3; 2.8]; n = 19) than older patients (≥65 years; 2.0 [0.7; 9.6]; p = .161; n = 81).Ten SREs were recorded during the retrospective and 10 during the prospective period; none were symptomatic.Denosumab was used for a median of 472 (387, 599) days overall and for 443-464 days without missing more than two doses (persistence).The proportion of patients reporting acceptable pain (score ≤4 of 10) increased from 6% at baseline to 22% at month 12.Twenty-four denosumab-related adverse events were reported, 2 were serious (osteomyelitis, osteitis) and 5 were related to osteonecrosis of the jaw.In Bulgarian clin. practice, denosumab use was associated with the prevention of symptomatic SREs and pain improvement.Denosumab was mostly used persistently.No symptomatic SREs were reported.Safety findings were consistent with previous reports of denosumab use in PC.

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100 项与 Amgen (Europe) GmbH 相关的转化医学

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