Effectiveness of Additional Risk Minimization Measures When Using Baricitinib (RISK-BARI): Preliminary Analysis

OBJECTIVES: Baricitinib, a JAK1 and JAK2 inhibitor, treats moderate to severe rheumatoid arthritis, atopic dermatitis, and severe alopecia areata in adults. Additional risk minimization measures (aRMMs) include educational materials to mitigate the risks of malignancies, major adverse cardiovascular events, serious infections, venous thromboembolism, and mortality. These materials include a Healthcare Professionals (HCP) Guide, a Patient Alert Card (PAC), and Direct Healthcare Professional Communications (DHPC). This study assesses awareness and knowledge among professionals most involved in prescribing this product in Portugal about its associated risks and the accessibility of educational materials.

METHODS: This national, cross-sectional, non-interventional study invited dermatologists, rheumatologists, and immunoallergologists to complete an online questionnaire to assess their awareness, knowledge, and adherence to aRMMs. Recruitment included professional and social networks and collaboration with professional associations. Data collection occurred over 105 days between 09/2023 and 12/2023.

RESULTS: 66 valid responses were analyzed, 53 of which were complete (50.0% from immunoallergologists, 25.8% from dermatologists, and 24.2% from rheumatologists). Respondents were aware of most risks addressed by aRMMs, except for malignant neoplasms (24.8% answered incorrectly, 18.0% were unaware). Only 27.9% were aware of aRMMs; 63.5% recognized the Pharmaceutical Industry as the primary information source, followed by symposia/conferences(39.9%) and scientific journals(37.9%). Most physicians(65.0%) found materials accessible, but 52.6% were unaware of their availability through the national medicines database(INFOMED).

Adherence to educational materials:

• • HCP Guide: 25.0% consulted it, 46.4% unaware or never used it.
  • PAC: 17.1% consulted it, 60.0% unaware or never used it.
  • DHPC: 35.1% consulted it, 43.1% unaware or never used it.

Barriers to implementing aRMMs were lack of time(39.2%), insufficient dissemination(32.1%), and difficulty communicating with patients(12.3%).

CONCLUSIONS: This study's findings could be used to optimize communication and educational strategies, making aRMMs more accessible, understandable, and implementable. This ensures healthcare professionals are fully informed and equipped to manage baricitinib risks, improving patient safety and healthcare quality.