abstract
- OBJECTIVE: To assess the association between adherence to golimumab treatment and the incidence of disease flares in patients with rheumatoid arthritis (RA) in routine clinical practice. METHODS: A 12-month (M) prospective observational study conducted across 27 Canadian centers, involving patients with RA receiving golimumab as part of routine clinical care. Treatment adherence was assessed with the Compliance Questionnaire in Rheumatology (CQR); non-adherence was defined as a weighted baseline score predictive of ≤80% compliance. Secondary definitions involved the CQR score at M6 and M12. Disease flaring was assessed with the RA-Flare Questionnaire (RA-FQ); flare was defined as a positive response to question 7 ("Are you having a flare?"). The association between adherence and disease flares was analyzed by comparing RA-FQ scores and the proportion of patients reporting flares between the high and low adherence groups. The association between adherence and glucocorticoid use or adverse event (AE) incidence was similarly assessed. RESULTS: Of 215 patients enrolled, 169 (78.6%) completed the study. No significant difference in mean RA-FQ scores was observed between low and high adherence groups at M6 (22.5 vs 23.8; p=0.56) and M12 (20.8 vs 19.9; p=0.70); disease flares were reported by 35.7% of low adherence patients, compared to 28.2% in the high adherence group (p=0.34). At M12, these rates were 30% vs 24.7%, respectively (p=0.49). Glucocorticoid use was comparable between baseline adherence groups, although a higher rate was observed in the low visit-predicted adherence group based on the M6 CQR score (30.5% vs 16.3%; p=0.04). No significant differences were observed in AE incidence. CONCLUSION: In this study, no significant differences in RA-FQ scores and the proportions of patients reporting disease flares or AEs were observed between patients with RA with low and high predicted adherence to golimumab. The increased glucocorticoid use in patients with low adherence merits further investigation. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03729349.