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Soft Tissue Tumors

(P 381) KNOWLEDGE, ATTITUDES, AND BEHAVIOR OF HEALTHCARE PROVIDERS ENROLLED IN THE PEXIDARTINIB RISK MITIGATION AND EVALUATION PROGRAM

    Author(s)

  • Charles Dharmani, DrPH, PharmD, MPH, MS

    Senior Director, Epidemiology, Clinical Safety & Pharmacovigilance
    Daiichi Sankyo, Inc., Basking Ridge, NJ, USA
    Basking Ridge, New Jersey, United States

    • Co-Author(s)

  • OF

    Oluwatosin Fofah, MD

    Epidemiology, Clinical Safety and Pharmacovigilance, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA
    Basking Ridge, New Jersey, United States

  • Abdul Waheed Rajper, MD

    Director Clinical Safety
    Clinical Safety & Pharmacovigilance, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA
    Basking Ridge, New Jersey, United States

  • MW

    Margaret J. Wooddell, PhD, MBA

    Global Oncology Medical Affairs, Daiichi Sankyo, Inc., Basking Ridge, NJ, USA
    Basking Ridge, New Jersey, United States

Objective: Upon approval of TURALIO® (pexidartinib) in the United States, a Risk Evaluation and Mitigation Strategy (REMS) Program was required to ensure that benefits of its treatment outweigh its potential risk of serious and fatal liver injury. A core component of the TURALIO REMS (tREMS) assessment plan is the conduct of a knowledge, attitudes, and behavior (KAB) survey of healthcare providers (HCPs). This survey was conducted annually during 2019-2022 (waves 1-3), and every 2 years since then (wave 4). This survey assesses: (i) HCP knowledge of the risks associated with its use and of the requirements of the tREMS; (ii) the attitudes and behavior of HCPs regarding the key risk messages (KRMs). The goal of KRMs is to ensure awareness that: TURALIO can cause serious and potentially fatal liver injury; monitoring of liver tests is required prior to and during treatment with TURALIO and HCPs must modify the dose based upon liver tests; HCPs must counsel patients on the risk of serious and potentially fatal liver injury, liver test monitoring prior to and during treatment with TURALIO, and to report any signs and/or symptoms of liver injury during therapy. The objective of this study is to retrospectively assess the results of the TURALIO HCP KAB surveys conducted during 2019-2024.

Methods: The survey was administered via internet, telephone, or paper. HCPs who had received tREMS training and were certified in the tREMS Program were targeted.

Results: 83.1-100% of the HCPs understood that TURALIO can cause serious and potentially fatal liver injury; 87.5-96.7% were aware that monitoring of liver tests is required prior to and during treatment and HCPs must modify the TURALIO dose based upon liver tests. All (100%) HCPs were aware that they must counsel patients on the risk of serious and potentially fatal liver injury, liver test monitoring prior to and during treatment with TURALIO, and to report any signs and/or symptoms of liver injury during therapy.

Conclusion: The tREMS Program is considered to be meeting its goal if the point estimates of all KRMs achieve a demonstrated understanding of ≥80%. The results from retrospective assessment of all survey waves indicate that this threshold was consistently exceeded since TURALIO approval. The HCPs demonstrated a solid understanding of all 3 KRMs. The tREMS is consistently meeting its goal to mitigate the potential risk of serious and fatal liver injury associated with TURALIO use.