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GMDS 2012: 57. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

16. - 20.09.2012, Braunschweig

Database study of lenalidomide (Revlimid®) in Germany: monitoring off-label use

Meeting Abstract

  • Michael Dörks - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland
  • Ingo Langner - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland
  • Denise Heuer - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland
  • Sigrid Behr - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland
  • Antje Timmer - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland
  • Edeltraut Garbe - BIPS – Institut für Epidemiologie und Präventionsforschung, Bremen, Deutschland

GMDS 2012. 57. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). Braunschweig, 16.-20.09.2012. Düsseldorf: German Medical Science GMS Publishing House; 2012. Doc12gmds187

DOI: 10.3205/12gmds187, URN: urn:nbn:de:0183-12gmds1870

Veröffentlicht: 13. September 2012

© 2012 Dörks et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Background: The term 'off-label use’ refers to the use of a drug outside the terms of its marketing authorisation, including prescribing for an unlicensed indication. In Germany, lenalidomide, a derivate of thalidomide, is indicated in combination with dexamethasone in the treatment of multiple myeloma, a bone marrow cancer involving plasma cells, in patients who received at least one prior therapy. In the USA, lenalidomide is also licensed for the treatment of transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes (MDS) with a deletion 5q abnormality. The drug was first marketed in Germany on June 14th, 2007. Monitoring of off-label use is part of the risk management plan for lenalidomide.

Objectives: The objectives of this study were to determine the frequency and proportion of off-label use of lenalidomide by indication in 2007.

Methods: Data were obtained from the German Pharmacoepidemiological Research Database, including prescription data as well as inpatient and outpatient diagnoses of more than 14 million insurance members from all over Germany for the period from market authorisation until the end of 2007. Incidence of lenalidomide use was assessed in 2007 by considering all cases with a first dispensation of lenalidomide. Incident users were characterised by age and sex. Off-label use by indication was identified by an algorithm searching for a diagnosis of multiple myeloma in the same quarter of a year as well as in the four quarters preceding the first lenalidomide dispensation. For potential off-label users, other diagnoses of cancer or benign neoplasms were ascertained. Further, the initial dosing of lenalidomide was assessed.

Results: In 2007, 235 lenalidomide users were identified, resulting in an incidence rate of lenalidomide use of 4.0 per 100,000 person years (95% CI: 3.5–4.5). In 40 (17.0%) users of lenalidomide, no diagnosis of multiple myeloma was found. Of the 40 off-label users, 29 (72.5%) have been diagnosed with myelodysplastic syndrome (MDS) of whom seven (17.5%) were diagnosed with both MDS and acute myeloid leukaemia (AML). Four of the off-label users (10.0%) were diagnosed with AML. The initial dose of 25 mg was more frequently observed in on-label users (65.6%) than in off-label users (5.0%). The most frequently dispensed initial dose in off-label users was 10 mg which was dispensed to 60.0% of all off-label users.

Conclusions: Off-label use of lenalidomide in Germany was low and was mainly associated with a diagnosis of MDS. Since about 30% of patients with MDS develop AML, lenalidomide use in these latter patients may have also been related to MDS. The most frequently observed initial dose in off-label users corresponds to the recommended dose for the treatment of MDS in the USA (10 mg). The most frequently observed initial dose in on-label users (25 mg) conforms to the Summary of Product Characteristics in treatment of multiple myeloma.