Bessette Louis, Boulos Pauline, Arendse Regan, Rahman Proton, Aseer Sam, Ruban Thanu, Rachich Meagan, Nantel Francois, Calce Adriana, Asin-Milan Odalis, Haaland Derek
Department of Medicine, Laval University, Québec, QC, Canada.
Department of Medicine, McMaster University, Hamilton, ON, Canada.
Patient Prefer Adherence. 2025 Jun 25;19:1843-1853. doi: 10.2147/PPA.S516794. eCollection 2025.
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.
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.
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.
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.
ClinicalTrials.gov identifier, NCT03729349.
评估在常规临床实践中，类风湿关节炎（RA）患者使用戈利木单抗治疗的依从性与疾病复发率之间的关联。
在加拿大27个中心进行了一项为期12个月的前瞻性观察性研究，纳入接受戈利木单抗治疗作为常规临床护理一部分的RA患者。使用风湿病依从性问卷（CQR）评估治疗依从性；不依从定义为预测依从性≤80%的加权基线评分。次要定义涉及第6个月和第12个月时的CQR评分。使用RA - 复发问卷（RA - FQ）评估疾病复发情况；复发定义为对问题7（“您正在复发吗？”）的肯定回答。通过比较高依从性组和低依从性组之间的RA - FQ评分以及报告复发的患者比例，分析依从性与疾病复发之间的关联。同样评估了依从性与糖皮质激素使用或不良事件（AE）发生率之间的关联。
在纳入的215例患者中，169例（78.6%）完成了研究。在第6个月（22.5对23.8；p = 0.56）和第12个月（20.8对19.9；p = 0.70）时，低依从性组和高依从性组之间的平均RA - FQ评分无显著差异；低依从性患者中有35.7%报告疾病复发，高依从性组为28.2%（p = 0.34）。在第12个月时，这些比率分别为30%和24.7%（p = 0.49）。尽管根据第6个月的CQR评分，低访视预测依从性组的糖皮质激素使用率较高（30.5%对16.3%；p = 0.04），但基线依从性组之间的糖皮质激素使用情况相当。AE发生率无显著差异。
在本研究中，预测对戈利木单抗依从性低和高的RA患者之间，RA - FQ评分、报告疾病复发或AE的患者比例无显著差异。低依从性患者中糖皮质激素使用增加值得进一步研究。
ClinicalTrials.gov标识符，NCT03729349。
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