Rituximab biosimilars for lymphoma in Europe

Jurczak, Wojciech; Długosz-Danecka, Monika; Buske, Christian

doi:10.1080/14712598.2019.1665017

Cited by 17 publications

(8 citation statements)

References 89 publications

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“…These findings are important to health plan policymakers, since the launch of lower-cost rituximab biosimilars could lead to further increased use of the biosimilars for label and off-label indications. 13,14 While rituximab can be a highly effective therapy, especially for diseases that have limited treatment options, it can come at great expense to the patient and health care system when not used as intended.…”

Section: ■■ Discussionmentioning

confidence: 99%

Indications for Rituximab Use in an Integrated Health Care Delivery System

Delate

Hansen

Gutierrez

et al. 2020

JMCP

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BACKGROUND: Rituximab is a top-selling biologic that was first approved by the FDA in 1997 for a non-Hodgkin lymphoma orphan indication. It has since been approved for additional orphan indications, with rheumatoid arthritis as the only FDA-approved, nonorphan indication. Evidence suggests that rituximab is frequently used off-label, but information on its use over time and indications for use in the United States is limited. OBJECTIVE: To assess incident rituximab use over time in an integrated health care delivery system. METHODS: This was a cross-sectional, retrospective study. Data were collected from administrative databases and manual chart reviews. Patients who received their first rituximab infusion between October 1, 2009, and December 31, 2017, and who were not a part of a clinical trial were included. Indication for use (FDA-approved orphan/nonorphan, off-label) was determined. Proportions of use were assessed over time. Multivariable logistic regression modeling was performed to assess factors associated with receiving rituximab for an FDA-approved indication.RESULTS: A total of 1,674 patients were included. The majority (66.4%) of patients had an FDA-approved indication, with lymphoma being the most common approved indication (66.4%). The most common indication for off-label use was neurologic conditions (72.7%), predominantly demyelinating diseases. Off-label indication use increased from 1.2% in 2009 to 55.6% in 2017. Factors associated with rituximab use for an FDA-approved indication included increased age (adjusted odds ratio [AOR] = 1.05, 95% CI = 1.04-1.07) and increased burden of chronic disease (chronic disease score: AOR = 1.07, 95% CI = 1.02-1.12; Charlson Comorbidity Index score: AOR = 3.52, 95% CI = 3.03-4.10).CONCLUSIONS: Off-label use of rituximab grew dramatically over the course of the study. With the recent FDA approval of the rituximab biosimilar and its expected lower price, off-label use will likely continue to rise. Opportunities for cost savings and to ensure appropriate use of these medications should be evaluated.

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Section: ■■ Discussionmentioning

confidence: 99%

Indications for Rituximab Use in an Integrated Health Care Delivery System

Delate

Hansen

Gutierrez

et al. 2020

JMCP

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“…In comparison with the patients diagnosed in 1975–1986, DSS and OS for patients diagnosed in 1987–1997, 1998–2008, and 2009–2019 were all greatly improved. Of note, the addition of anti‐CD20 monoclonal antibodies (such as rituximab) has improved complete remission of CD20‐positive B LYM since the 2000s 36,37 . Meanwhile, neoadjuvant intracarotid chemotherapy has achieved encouraging therapeutic effect since it was proposed for ACC 38,39 .…”

Section: Discussionmentioning

confidence: 99%

Incidence, clinical features, and survival outcomes of primary malignant lacrimal gland tumors: A population‐based analysis

He,

Zhang,

Zhu

et al. 2024

Cancer Medicine

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BackgroundStudies on the epidemiological information and prognosis of primary malignant lacrimal gland tumors (MLGTs) are rare for its low occurrence. The goal of our research was to investigate the epidemiological characteristics and survival outcomes of patients with MLGTs.MethodsIncidence and demographic information of patients with MLGTs were collected from the Surveillance, Epidemiology, and End Results (SEER) database. To identify independent prognostic factors for disease‐specific survival (DSS) and overall survival (OS), univariate and multivariate Cox regression analysis were performed.ResultsThe overall incidence of primary MLGTs from 1975 to 2020 was 0.413/1,000,000 (according to the 2000 American standard population), with a steadily increasing incidence over years. A total of 964 patients with primary MLGTs were diagnosed, with an average age of 59.3 years. Of these, 53.2% were aged ≥60 years, 57.4% were female, and 77.1% were whites. Multivariate Cox regression analysis demonstrated that year of diagnosis, age, sex, histological type, SEER stage, surgery, and chemotherapy were independent prognostic factors of DSS or OS.ConclusionsAlthough primary MLGT is rare, its incidence has steadily increased in the past 46 years, and surgery was related to a better prognosis.

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“…Chemotherapy regimens that include anthracycline significantly improve OS and progression-free survival [ 3 ]. The addition of rituximab has markedly improved the survival of B-cell NHL [ [30] , [31] , [32] ]. The recommended treatment strategies based on previous studies included limited surgery, local radiation, and anthracycline-based chemotherapy, in which the CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) is the most common chemotherapeutic approach [ 33 , 34 ].…”

Section: Discussionmentioning

confidence: 99%

Epidemiological features of primary breast lymphoma patients and development of a nomogram to predict survival

Peng

et al. 2021

The Breast

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Background Studies on the epidemiology and prognosis of primary breast lymphoma (PBL) are lack for low incidence. Therefore, we aimed to investigate the epidemiological characteristics of PBL and develop nomograms to predict patient survival. Methods Data of patients who were diagnosed with PBL from 1975 to 2011 and incidence rate of PBL from 1975 to 2017 were extracted from the Surveillance, Epidemiology, and End Results (SEER) database. Time-varying multivariable Cox regression analysis was performed to identify independent prognostic factors for overall survival (OS) and disease-specific survival (DSS). Nomograms were constructed based on the independent prognostic factors identified in multivariate Cox regression analysis. Results A total of 1427 patients diagnosed with PBL were identified with the average age of 67.1 years. The overall incidence of PBL is 1.35/1,000,000 (adjusted to the United States standard population in 2000) from 1975 to 2017, with a significant upward trend by an annual percentage change (APC) of 2.91 (95%CI 2.29–3.94, P < 0.05). Age, sex, race, year of diagnosis, marital status, histological subtype, Ann Arbor Stage, and treatment modality were assessed as independent prognostic factors for OS and DSS by multivariable Cox regression ( P < 0.05). Nomograms were constructed to predict the 1-, 3-, 5-, and 10- year OS and DSS. The concordance index (C-index) and calibration plots showed robustness and accuracy of the nomogram. Conclusion The overall incidence of PBL was steadily increasing over the past four decades. Nomograms constructed can predicting 1-, 3-, 5-, and 10-year OS and identify patients with high-risk PBL.

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Rituximab biosimilars for lymphoma in Europe

Cited by 17 publications

References 89 publications

Indications for Rituximab Use in an Integrated Health Care Delivery System

Indications for Rituximab Use in an Integrated Health Care Delivery System

Incidence, clinical features, and survival outcomes of primary malignant lacrimal gland tumors: A population‐based analysis

Epidemiological features of primary breast lymphoma patients and development of a nomogram to predict survival

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