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Safety of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: A
Kuan Peng1,2, Vincent K C Yan2, Shirley C W Chan1
1Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong Kong SAR, China.
Drug Safety
|June 26, 2026
Summary
Biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) show similar safety profiles for rheumatoid arthritis patients over 5 years. This comparative study helps guide safer prescribing by assessing risks of major adverse events.
Area of Science:
- Rheumatology
- Clinical Pharmacology
- Epidemiology
Background:
- Biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) are effective for rheumatoid arthritis (RA).
- These medications carry varying risks of adverse events, necessitating comparative safety assessments.
- Understanding these risks is crucial for optimizing RA management and patient safety.
Purpose of the Study:
- To compare the risk of key clinical events across various biologic and targeted synthetic DMARDs for rheumatoid arthritis.
- To provide evidence-based guidance for safer prescribing practices in RA treatment.
- To evaluate the comparative safety profiles of different DMARDs in a real-world setting.
Main Methods:
- A population-based cohort study in Hong Kong analyzed RA patients initiated on 12 different DMARDs from 2009-2022.
- Adverse events, including major adverse cardiovascular events, infections, malignancies, and mortality, were assessed over a 5-year period.
- Marginal structural models with inverse probability weighting were used to address confounding and selection bias, with death as a competing risk.
Main Results:
- The 5-year cumulative probabilities of adverse events were broadly comparable across most biologic and targeted synthetic DMARDs.
- Tocilizumab was associated with a higher hospitalization risk compared to etanercept (Risk Difference: 0.205).
- Tofacitinib showed a higher risk of gastritis compared to etanercept (Risk Difference: 0.055).
Conclusions:
- Biologic and targeted synthetic DMARDs exhibit largely similar safety profiles after rigorous statistical adjustment.
- The study alleviates concerns regarding severe adverse events associated with these RA treatments.
- Findings support clinicians in making informed treatment decisions for rheumatoid arthritis patients based on comparative safety data.
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