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External Validation of a Risk Score for Major Toxicity Among Nonsteroidal Anti-Inflammatory Drug Users: Real-World
Daniel H Solomon1, Nina P Paynter1, Hongshu Guan1
1Brigham and Women's Hospital, Boston, Massachusetts.
ACR Open Rheumatology
|April 22, 2020
Summary
A validated risk score for major nonsteroidal anti-inflammatory drug (NSAID) toxicity performed well in real-world data. This tool can help predict NSAID risks in typical clinical practice.
Area of Science:
- Rheumatology
- Clinical Pharmacology
- Public Health
Background:
- A prior randomized controlled trial established a risk score for major nonsteroidal anti-inflammatory drug (NSAID) toxicity.
- Validation in real-world data is crucial for clinical applicability.
Purpose of the Study:
- To evaluate the performance of a previously derived NSAID toxicity risk score in an external, real-world patient population.
- To assess the score's discrimination and calibration in predicting major NSAID toxicity events.
Main Methods:
- Patients initiating NSAID use in the Corrona Rheumatoid Arthritis (RA) Registry were analyzed.
- Key risk factors (age, sex, comorbidities, lab values) and toxicity outcomes were defined.
- Cox regression was used to assess discrimination and calibration of the original risk score.
Main Results:
- The study included 5231 patients with new NSAID exposure.
- The risk score demonstrated good discrimination (C-index 0.70) in this cohort.
- A significant proportion of patients fell into intermediate (68.3%) and high (5.7%) risk categories.
Conclusions:
- The NSAID major toxicity risk score showed good model fit in a real-world setting.
- The findings support the score's validity for use in routine clinical practice.
- This risk score can aid in managing NSAID-related toxicity.
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