Validating Clinical Risk Score of NSAID Toxicity in Osteoarthritis, RA

Data from the PRECISION trial were used to develop and validate a clinical risk score for NSAID toxicity in OA and RA.

The following article is part of conference coverage from the 2018 American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, Illinois. Rheumatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in rheumatology. Check back for the latest news from ACR/ARHP 2018 .

CHICAGO — A risk score to predict major nonsteroidal anti-inflammatory drug (NSAID) toxicity at 1 year in patients with osteoarthritis (OA) or rheumatoid arthritis (RA) has been internally validated using data from the PRECISION trial. Results of the study were presented at the 2018 ACR/ARHP Annual Meeting, held October 20-24in Chicago, Illinois.

Patients who were recruited during the first 4 years of enrollment in the PRECISION (NCT00346216) trial (n=15,196) were used to derive a risk score; patients who were enrolled in the last 5 years of the trial (n=8757) were used for validation. Participants were censored at 1 year, at termination of the study NSAID, or at the time of experiencing their first major toxicity. Major NSAID toxicity outcomes included a cardiovascular event, a clinically significant gastrointestinal event, significant renal events, or death. Overall, 3 risk categories were established: very low (<1%), moderate (1% to 4%), and high (>4%).

Statistically significant variables in the derivation cohort included age (hazard ratio [HR], 1.03 per year), male gender (HR, 1.51), history of cardiovascular disease (HR, 1.94), history of diabetes (HR, 1.42), history of hypertension (HR, 1.29), aspirin use (HR, 1.37), statin use (HR, 1.43), tobacco use (HR, 1.55), elevated serum creatinine level (HR, 2.83), hematocrit ≥43% (HR, 1.05), and presence of RA (vs OA; HR, 1.79).

Among the total study population (N=23,953), 5.8% of participants had a predicted 1-year risk of <1%; 66.7% of participants had a predicted 1-year risk of 1% to 4% and 26.6% of participants had a predicted 1-year risk of >4%.

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The investigators concluded that elements of this risk score to predict NSAID toxicity among patients with OA or RA are easy to obtain and, if deemed to be externally valid, could help patients and clinicians determine the risks and benefits associated with chronic NSAID use.

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Solomon D, Shao M, Wolski KE, Nissen SE, Husni ME, Paynter N. Major NSAID toxicity: derivation and internal validation of a simple clinical risk score. Presented at: American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) 2018 Annual Meeting; October 20-24, 2018; Chicago, IL. Abstract 2952.

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