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Boons, Christel C. L. M.; Timmers, Lonneke; Janssen, Jeroen J. W. M.; Westerweel, Peter E.; Blijlevens, Nicole M. A.; Smit, Willem M.; Bartelink, Imke H.; Wilschut, Janneke A.; Swart, Eleonora L.; Hendrikse, N. Harry; Hugtenburg, Jacqueline G.

Response and Adherence to Nilotinib in Daily practice (RAND study): an in-depth observational study of chronic myeloid leukemia patients treated with nilotinib

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  • Medientyp: E-Artikel
  • Titel: Response and Adherence to Nilotinib in Daily practice (RAND study): an in-depth observational study of chronic myeloid leukemia patients treated with nilotinib
  • Beteiligte: Boons, Christel C. L. M.; Timmers, Lonneke; Janssen, Jeroen J. W. M.; Westerweel, Peter E.; Blijlevens, Nicole M. A.; Smit, Willem M.; Bartelink, Imke H.; Wilschut, Janneke A.; Swart, Eleonora L.; Hendrikse, N. Harry; Hugtenburg, Jacqueline G.
  • Erschienen: Springer Science and Business Media LLC, 2020
  • Erschienen in: European Journal of Clinical Pharmacology, 76 (2020) 9, Seite 1213-1226
  • Sprache: Englisch
  • DOI: 10.1007/s00228-020-02910-3
  • ISSN: 0031-6970; 1432-1041
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Introduction</jats:title> <jats:p>This comprehensive observational study aimed to gain insight into adherence to nilotinib and the effect of (non)adherence on exposure (<jats:italic>C</jats:italic><jats:sub>min</jats:sub>) and treatment outcomes.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>Chronic myeloid leukemia (CML) patients using nilotinib were followed for 12 months. Adherence was measured by Medication Event Monitoring System (MEMS), pill count, and Medication Adherence Report Scale (MARS-5). Nilotinib <jats:italic>C</jats:italic><jats:sub>min</jats:sub> and patient-reported outcomes (i.e., quality of life, side effects, beliefs, satisfaction) were measured at baseline, 3, 6, and 12 months.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>Sixty-eight patients (57.5 ± 15.0 years, 49% female) participated. Median adherence to nilotinib (MEMS and pill count) was ≥ 99% and adherence &lt; 90% was rare. Self-reported nonadherence (MARS-5) increased in the first year of treatment to a third of patients. In line with the strong beliefs in the necessity of taking nilotinib, forgetting to take a dose was more prevalent than intentionally adjusting/skipping doses. Nilotinib <jats:italic>C</jats:italic><jats:sub>min</jats:sub> were generally above the therapeutic target in 95% of patients. Patients reported a variety of side effects, of which fatigue was most frequent. The mean <jats:italic>C</jats:italic><jats:sub>min</jats:sub> was higher in patients who reported severe itching and fatigue. The overall 1-year MMR rate ranged from 47 to 71%.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>Substantial nonadherence (&lt; 90%) to nilotinib was rare and nilotinib <jats:italic>C</jats:italic><jats:sub>min</jats:sub> were generally above the therapeutic target. Lack of response in our group of patients was not related to nonadherence or inadequate <jats:italic>C</jats:italic><jats:sub>min</jats:sub>. Nevertheless, a considerable number of patients experienced difficulties in adhering to the twice daily fasted dosing regimen, emphasizing the importance of continuous support of medication adherence in CML.</jats:p> </jats:sec><jats:sec> <jats:title>Clinical trial registration</jats:title> <jats:p>NTR3992 (Netherlands Trial Register, <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.trialregister.nl">www.trialregister.nl</jats:ext-link>)</jats:p> </jats:sec>