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Biological therapy safety in chronic inflammatory arthropathy patients
Noemi Martínez-López-de-Castro1,2, Miriam Álvarez-Payero1,2, Marisol Samartín-Ucha1,2
1Department of Pharmacy, University Hospital Complex of Vigo, Pontevedra, Spain.
Objective:
The marketing of biological therapies transformed the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. But there is still concern about patient safety and management in daily clinical practice. The aim of this study was to estimate risk factors of the adverse effects in a cohort of Spanish patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.
Methods:
A single institution, descriptive, retrospective, cohort study was developed from January 2009 to December 2016. Patients diagnosed with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis on biological therapies were included. Undesirable events affecting patients during biological therapy, their clinical implications and the use of health resources related to adverse effects were collected.
Results:
Three hundred and sixty-two patients corresponding to 478 biological therapy lines were analysed. It implied 1192 years of monitoring. There were 57 adverse effects per 100 biological patient- years and 4.8 serious adverse effects per 100 biological patient-years. The only significant factor for a likely serious adverse effect was having a Charlson Index ≥10, OR of 6.2 (CI 95%: 3.4-11.1, p<0.001). Around 15 % of patients with adverse effects were admitted to hospital and 25% received attention at the Emergency Department.
Conclusion:
Over half of the patients with arthropathies on biological therapy can suffer adverse effect during treatment but only 8.5% of these effects are serious. Special vigilance must be paid to patients with a higher number of comorbidities because they are more likely to experience serious adverse effects.
Insights
Biological therapies significantly improved arthritis treatment, but patient safety remains a concern. Patients with more comorbidities are at higher risk for serious adverse effects from these treatments.
Area of Science:
- Rheumatology
- Clinical Pharmacology
- Patient Safety
Background:
- Biological therapies have revolutionized rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis treatment.
- Concerns persist regarding patient safety and management of adverse effects in clinical practice.
Purpose of the Study:
- To identify risk factors for adverse effects in Spanish patients undergoing biological therapy for inflammatory arthropathies.
- To analyze the clinical implications and healthcare resource utilization associated with these adverse events.
Main Methods:
- A retrospective cohort study was conducted from January 2009 to December 2016.
- Data on undesirable events, clinical outcomes, and healthcare resource use were collected for patients on biological therapies.
Main Results:
- 57 adverse effects and 4.8 serious adverse effects per 100 patient-years were observed.
- A Charlson Index ≥10 was the sole significant predictor of serious adverse effects (OR 6.2).
- 15% of patients with adverse effects required hospitalization, and 25% visited the Emergency Department.
Conclusions:
- Over half of patients on biological therapy experience adverse effects, though serious events are less common (8.5%).
- Patients with a higher comorbidity burden require heightened vigilance due to increased risk of serious adverse effects.
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