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Introduction: This comprehensive observational study aimed to gain insight into adherence to nilotinib and the effect of (non)adherence on exposure (C) and treatment outcomes.
Methods: 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 C and patient-reported outcomes (i.e., quality of life, side effects, beliefs, satisfaction) were measured at baseline, 3, 6, and 12 months.
Results: Sixty-eight patients (57.5 ± 15.0 years, 49% female) participated. Median adherence to nilotinib (MEMS and pill count) was ≥ 99% and adherence < 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 C 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 C was higher in patients who reported severe itching and fatigue. The overall 1-year MMR rate ranged from 47 to 71%.
Conclusion: Substantial nonadherence (< 90%) to nilotinib was rare and nilotinib C were generally above the therapeutic target. Lack of response in our group of patients was not related to nonadherence or inadequate C. 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.
Clinical Trial Registration: NTR3992 (Netherlands Trial Register, www.trialregister.nl ).
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7419465 | PMC |
| http://dx.doi.org/10.1007/s00228-020-02910-3 | DOI Listing |
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