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A multinational, drug utilization study of lipegfilgrastim use in real-world setting in Europe

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Abstract

Purpose

Lipegfilgrastim (Lonquex, Teva Pharma B.V.) is approved for reduction in neutropenia duration and febrile neutropenia incidence. In the framework of lipegfilgrastim regulatory approval in the EU, the Health Authorities requested a drug utilization study. This study was conducted to characterize prescribing patterns of lipegfilgrastim and quantify the extent of on- and off-label use of lipegfilgrastim in real-world setting in Europe.

Methods

Information on lipegfilgrastim use between January 2014 and March 2020 was abstracted from medical records in hospital and outpatient clinical settings. Indication for lipegfilgrastim was classified either as on-label or off-label use according to pre-determined criteria. The primary endpoint was the extent of lipegfilgrastim off-label use based on the most recent lipegfilgrastim cycle.

Results

Records of 481 patients were obtained from five European countries. Lipegfilgrastim was most commonly prescribed for prevention of neutropenia by oncologists and hematologists. Patients who were administered lipegfilgrastim were primarily ≥ 55 years old (65.1%) and female (65.7%). The most frequent underlying diagnosis was breast cancer (38.3%).

For the most recent lipegfilgrastim cycle, on-label use was recorded in 452/459 patients with no missing data (98.5%), while off-label use was recorded in 7/459 patients (1.5%). The majority of off-label use was attributed to use with non-cytotoxic chemotherapy (57.1%). Off-label use of lipegfilgrastim across all treatment cycles with no missing data was 11/1547 cycles (0.7%).

Conclusion

Using real-world data, these findings confirm the low rate of lipegfilgrastim off-label use as reported in a preceding feasibility study, indicating very high adherence to the approved indication.

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Data availability

The original contributions presented in the study are included in the article/supplementary material.

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Acknowledgements

The authors would like to acknowledge George Haralabopoulos, PhD, from PRA for executing the study.

Funding

This study was funded by Teva Pharmaceutical Industries Ltd.

Author information

Authors and Affiliations

  1. Teva Pharmaceutical Industries Ltd, 12 Hatrufa St, 4250483, Netanya, Israel

    Sigal Kaplan

  2. Teva Pharmaceutical Industries Ltd, 400 Interpace Pkwy, Parsippany, NJ, 07054, USA

    Dana Ilic Bogojevic

  3. Teva Pharmaceutical Industries Ltd, 41 Moores Road, Malvern, PA, 19355, USA

    Carolyn Rainville

  4. Teva Pharmaceutical Industries Ltd, 145 Brandywine Pkwy, West Chester, PA, 19380, USA

    Nicholas Gross

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Contributions

SK: study concept and design, interpretation of the data, manuscript writing. DIB: interpretation of the data. CR: project administration, acquisition of data, and interpretation of the data. NG: Statistical analysis and interpretation of the data. All the authors reviewed and approved the final manuscript.

Corresponding author

Correspondence to Sigal Kaplan.

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Ethics approval and a waiver for patient informed consent were obtained for all participating centers. The study was performed in accordance with local ethics committees and regulatory requirements in participating countries.

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Conflict of interest

All authors are employees of Teva Pharmaceutical Industries Ltd (and/or its affiliates). The sponsor had a role in study design, analysis and interpretation of data, and manuscript writing.

Role of the sponsor

The sponsor had a role in the design and conduct of the study; study supervision, management, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.

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Kaplan, S., Bogojevic, D.I., Rainville, C. et al. A multinational, drug utilization study of lipegfilgrastim use in real-world setting in Europe. Support Care Cancer 30, 9191–9201 (2022). https://doi.org/10.1007/s00520-022-07341-7

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