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Risk management plan adherence and clinical outcomes in patients receiving targeted therapies
Li-Fong Wang1,2, Hsiu-Lan Li3, Yi-Hsien Huang4
1Department of Internal Medicine, Division of Allergy, Immunology and Rheumatology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
Clinical Rheumatology
|June 16, 2026
Summary
Risk management plans (RMPs) for biologic and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs/tsDMARDs) show suboptimal adherence but significantly reduce risks of Pneumocystis jirovecii pneumonia, cardiovascular events, and mortality in autoimmune diseases.
Area of Science:
- Rheumatology
- Immunology
- Pharmacovigilance
Background:
- Biologic and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs/tsDMARDs) improve autoimmune disease outcomes but pose safety risks.
- Risk management plans (RMPs) aim to mitigate these risks, yet real-world adherence and impact are not fully understood.
Purpose of the Study:
- To evaluate real-world adherence to RMPs before initiating bDMARDs/tsDMARDs in autoimmune disease patients.
- To assess the association between RMP implementation and key clinical outcomes, including infections, cardiovascular events, and mortality.
Main Methods:
- Retrospective cohort study of 1,078 adult autoimmune disease patients treated with bDMARDs, tsDMARDs, or biosimilars.
- Patients categorized into RMP (pre-treatment safety assessments completed) and non-RMP groups.
- Clinical outcomes analyzed: Pneumocystis jirovecii pneumonia (PJP), major adverse cardiovascular events (MACE), respiratory events, and all-cause mortality.
Main Results:
- Only 32.3% of patients met RMP criteria prior to treatment.
- Non-RMP group showed significantly higher incidences of PJP (11.9% vs. 2.3%), MACE (8.5% vs. 2.6%), and mortality (7.3% vs. 1.7%).
- RMP implementation independently associated with lower risks of PJP (aOR 0.18), MACE (aOR 0.30), and mortality (aOR 0.21).
Conclusions:
- Suboptimal RMP adherence in real-world practice is linked to adverse infectious, cardiovascular, and survival outcomes.
- RMP implementation demonstrates benefits beyond infection prevention, highlighting the need for standardized risk management.
- Anti-CD20 therapy poses higher early risks, emphasizing careful stratification and monitoring.
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