Department of Gastroenterology and Hepatology, University Medical Center Utrecht, PO box L00.418, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Department of Hospital Pharmaceutics, Meander Medical Center Amersfoort, Maatweg 3, 3812 TZ, Amersfoort, The Netherlands.
Dig Dis Sci. 2021 May;66(5):1477-1487. doi: 10.1007/s10620-020-06395-z. Epub 2020 Jun 16.
Adherence to adalimumab in inflammatory bowel disease (IBD) patients is reported to be below par. Non-adherence may result in loss-of-response and increased hospitalization. We analyzed the effect of an electronic needle container (ENC) on adherence to adalimumab.
In this multicenter, 12-months observational study, we included adalimumab treated IBD patients. All patients were invited to receive an ENC. Patients who declined or did not complete the registration for an ENC served as controls. Primary endpoint was whether an ENC increased adherence, calculated from pharmacy refills as proportion of days covered (PDC). Secondary endpoints were clinical outcomes, including loss-of-response, identification of predictors of adherence and correlation between different modalities for measuring adherence. Loss-of-response was defined as a disease flare, dose-escalation or IBD-related hospitalization or surgery.
The pharmacies' records identified 198 eligible patients, of whom 32 were excluded. The ENC was supplied to 69 patients, the remaining 97 patient formed the control group. Median baseline PDC (98.4% vs. 96.1%, p = 0.047) and the proportion of adherent (PDC ≥ 86%) patients (87.0% vs. 74.2%, p = 0.045) was higher for the ENC group. The ENC did not improve the adherence of patients during follow-up (odds ratio 1.26, 95% CI 0.55-2.86). During follow-up, five (7.2%) patients in the ENC group and 13 (13.4%) in the control group discontinued adalimumab (log-rank p = 0.22). Loss-of-response occurred in 12 (17.4%) and 14 (14.4%) patients, respectively (log-rank p = 0.66).
Our results show no beneficial effect of a reminder-based intervention on adherence or treatment outcomes.
炎症性肠病（IBD）患者对阿达木单抗的依从性较差。不依从可能导致治疗反应丧失和住院率增加。我们分析了电子针筒容器（ENC）对阿达木单抗依从性的影响。
在这项多中心、12 个月的观察性研究中，我们纳入了接受阿达木单抗治疗的 IBD 患者。所有患者均被邀请使用 ENC。拒绝或未完成 ENC 注册的患者作为对照组。主要终点是通过药房补充计算的依从性（用覆盖天数比例[PDC]表示）是否增加。次要终点是临床结局，包括治疗反应丧失、确定依从性的预测因素以及不同测量依从性方法之间的相关性。治疗反应丧失定义为疾病发作、剂量升级或与 IBD 相关的住院或手术。
药房记录确定了 198 名符合条件的患者，其中 32 名被排除。ENC 供应给 69 名患者，其余 97 名患者为对照组。ENC 组的中位基线 PDC（98.4% vs. 96.1%，p=0.047）和依从性（PDC≥86%）患者的比例（87.0% vs. 74.2%，p=0.045）更高。在随访期间，ENC 并未改善患者的依从性（优势比 1.26，95%CI 0.55-2.86）。在随访期间，ENC 组有 5 名（7.2%）患者和对照组有 13 名（13.4%）患者停用阿达木单抗（对数秩检验 p=0.22）。治疗反应丧失分别发生在 12 名（17.4%）和 14 名（14.4%）患者（对数秩检验 p=0.66）。
我们的结果表明，基于提醒的干预措施对依从性或治疗结局没有有益影响。
