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Assessing the effectiveness of the TURALIO (pexidartinib) risk evaluation and mitigation strategy program: patient
Charles Dharmani1, Oluwatosin Fofah1, Margaret Wooddell2
1Epidemiology, Clinical Safety and Pharmacovigilance, Daiichi Sankyo Inc, Basking Ridge, NJ, USA.
Background:
Treatment of tenosynovial giant cell tumor with TURALIO (pexidartinib) is associated with serious hepatotoxicity risk. To ensure its safe use, a Risk Evaluation and Mitigation Strategy (REMS) program was implemented, incorporating structured education, mandatory enrollment, and liver function monitoring. The assessment of patient and caregiver knowledge, attitudes, and behaviors (KAB) is a central component of evaluating REMS effectiveness.
Methods:
Four waves of TURALIO Patient KAB Survey were conducted between 2020 and 2024 among REMS-enrollees. Surveys assessed understanding of two Key Risk Messages (KRMs): (KRM 1) hepatotoxicity risk and symptom recognition, and (KRM 2) liver monitoring requirements before and during treatment. Response rates and demonstrated understanding of KRMs were summarized descriptively.
Results:
Across four waves of this voluntary survey, 239 participants completed KAB surveys. Survey response rates ranged from approximately one-third to one-half of invited participants across waves. Correct response rates for individual knowledge items were consistently high. Demonstrated understanding of hepatotoxicity risk remained at ≥80% (the predefined threshold) across waves (87.5% in Wave 1; 80.0% in Wave 4). Understanding liver monitoring requirements improved over time, reaching 100% in Wave 3. Combined demonstrated understanding of KRM1 and KRM2 was <80% in three survey waves, particularly in Wave 2 (73.4%). Demonstrated understanding of KRMs remained generally stable despite evolving patient demographics and treatment duration over time.
Conclusion:
Across KAB Survey waves, patients receiving TURALIO demonstrated sustained knowledge of hepatotoxicity risk and monitoring requirements supporting the effectiveness of the tREMS program in ensuring the safe real-world use of pexidartinib.
