Biological therapy safety in chronic inflammatory arthropathy patients

Area of Science:

• Rheumatology
• Clinical Pharmacology
• Patient Safety

Background:

• Biological therapies have revolutionized the treatment of inflammatory arthropathies like rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
• Despite efficacy, concerns persist regarding patient safety and management of adverse effects in routine clinical practice.

Purpose of the Study:

• To identify risk factors associated with adverse effects in Spanish patients undergoing biological therapy for rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.
• To evaluate the incidence and characteristics of adverse events and serious adverse events in this patient cohort.

Main Methods:

• A retrospective cohort study was conducted from January 2009 to December 2016.
• Data were collected on patients diagnosed with rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis receiving biological therapies.
• Adverse events, their clinical implications, and associated healthcare resource utilization were documented.

Main Results:

• Analysis included 362 patients and 478 biological therapy lines, totaling 1192 patient-years of monitoring.
• An incidence of 57 adverse effects and 4.8 serious adverse effects per 100 biological patient-years was observed.
• A Charlson Index ≥10 was the sole significant predictor of serious adverse effects (OR 6.2, p<0.001).
• Approximately 15% of patients with adverse effects required hospitalization, and 25% sought emergency department care.

Conclusions:

• Over half of patients with arthropathies on biological therapy experience adverse effects, though only 8.5% are serious.
• Patients with a higher burden of comorbidities are significantly more prone to serious adverse effects.
• Vigilant monitoring is crucial, particularly for patients with multiple comorbidities, to ensure safe and effective biological therapy.