Background/Purpose: Rheumatoid arthritis (RA), a chronic autoimmune disease affecting approximately 1.5 million people in the U.S., is characterized by inflammation of the synovial tissues with the potential for destruction of articular cartilage and the juxtaarticular bone. Initiating disease-modifying anti-rheumatic drugs (DMARDs) within three months of diagnosis is currently recommended to prevent the potential effects of untreated synovitis (i.e., joint destruction, loss of joint function, and pain). Patients taking DMARDs commonly experience medication adverse events. The purpose of this study is to report factors predictive of medication adverse events in patients with RA over time.

Methods: We conducted a secondary analysis of a prospective study (baseline, 1 week, 8 weeks, 16 weeks and 24 weeks) in a sample of 143 RA patients at one University health system. Trust in provider was measured with the Trust in Physician Scale, an 11-item scale using a 5-point Likert scale (1 = strongly disagree – 5 strongly agree; Cronbach’s α = .87). Disease activity was measured with the Routine Assessment of Patient Index Data 3 (RAPID3) on three domains: physical function, pain, and patient global assessment on a scale of 0 to 10 (range 0 – 30). The RAPID3 has been significantly correlated with other measures of disease activity. Adverse events and demographic factors were self-reported. We used repeated measures models using last observation carried forward for participants with missing follow-up data.

Results: In the sample of 143 participants, the average age was 52 years (SD=10.8). The majority of participants were female (81%) and White (91%). Disease activity scores were low (mean 2.6; SD=0.6) and trust in the provider scores were high (mean 87.4; SD=9.9; Table 1). Approximately half of the sample experienced an adverse event. For the adverse events model, the only significant predictor in the model was gender. Females compared to males (Odds ratio [OR] = 0.13, 95% confidence interval [CI] for OR: 0.03 – 0.47; p = .002; see Table 2) were more likely to report adverse events. Time was significantly associated with decreased experiences of adverse events (OR = 0.12-0.16, 95% CI for OR: 0.04 – 0.41; p < .001). Trust in the provider and disease activity were not significant predictors.

Conclusion: Females were more likely to report adverse events suggesting either an increased likelihood of experiencing an adverse event or this group is more likely to report the adverse event if it occurs. Identifying this high risk group could facilitate targeted interventions to decrease medication adverse events, and in turn, improving treatment effectiveness.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-prospective-analysis-of-factors-impacting-medication-adverse-events-in-patients-with-rheumatoid-arthritis/