Golimumab for Adherence in Rheumatoid Arthritis (GO FAR): A Multicenter, Prospective, Observational Study of Patients Treated with Golimumab for Rheumatoid Arthritis

Objectives Adherence to prescribed drug therapies is crucial to prevent irreversible joint damage in rheumatoid arthritis (RA). However, reported adherence rates in RA patients have shown significant variability, ranging from 49.5% and 98.5%, depending on the definition and method used. Despite this, real word evidence on adherence to golimumab, a biologic DMARD used in RA, remains limited. This study aimed to investigate whether non-adherence to RA drugs in patients treated with biologic DMARDs is associated with a higher frequency of RA flares in real-world clinical practice.

Methods This was a prospective, non-interventional study conducted in 27 Canadian centers, which assessed real-world golimumab use in treating RA. The study collected data from medical records and patient/physician questionnaires. The study utilized the Rheumatoid Arthritis Flare Questionnaire (RA-FQ), a tool designed to assess disease activity and identify flares in patients with RA. Patients were categorized into low (≤80%) and high (>80%) predicted compliance groups using the Compliance Questionnaire in Rheumatology (CQR). Assessments occurred at baseline and 6-month intervals, covering joint counts, global assessments, adherence, and flares. Statistical analysis aimed to estimate flare rate differences between adherent (>80%) and non-adherent groups (≤80%), considering a 95% confidence interval.

Results A total of 215 patients were treated and analyzed in the study, with 78.6% (169/215) completing the study. At 6 months, the mean RA-FQ was 22.5 (SD 13.1) and 23.8 (SD 13.2) in low and high baseline predicted compliance groups, respectively (p=0.55). At 12 months, the mean RA-FQ scores were 20.8 (SD 12.9) and 19.9 (SD 13.5) for the low and high baseline predicted compliance groups, respectively (p=0.70). Disease flares were observed in 35.7% (25/70) and 28.2% (20/71) of patients at 6 months in the low and high baseline predicted compliance groups, respectively (p=0.34). At 12 months, disease flares were observed in 30% (21/7) and 24.7% (18/71) of patients in the low and high baseline predicted compliance groups, respectively (p=0.49). No significant differences were observed in the incidence of adverse events between the low and high adherence compliance groups.

Conclusion This study did not identify major differences in the RA-FQ total score or the proportion of participants reporting a flare in RA patients in the real-world clinical setting. Sensitivity analyses will be conducted to further explore RA-FQ and disease flare frequency by varying the CQR compliance classification.