Department of Pharmacy, Eastern Health, Melbourne, VIC, Australia.
Department of Gastroenterology, Eastern Health, Melbourne, VIC, Australia; Eastern Health Clinical School, Monash University, Melbourne, VIC, Australia.
Res Social Adm Pharm. 2021 Aug;17(8):1420-1425. doi: 10.1016/j.sapharm.2020.10.011. Epub 2020 Oct 22.
The intravenous biologics infliximab and vedolizumab are effective long-term therapies for inflammatory bowel disease (IBD). Though highly effective, suboptimal adherence may result in loss of response and adverse sequelae. The extent and outcomes of suboptimal adherence with intravenous biologics, including in IBD, requires further evaluation.
To ascertain adherence to infliximab and vedolizumab infusions, and determine factors associated with poorer adherence within an IBD cohort.
A retrospective single-centre cohort study of IBD patients, assessing adherence to infliximab and vedolizumab over 2 years (July 1, 2017 to June 30, 2019) was conducted. Medical and pharmacy dispensing records were used to determine date of infusion. Adherence was assessed using the continuous, multiple interval measure of medication gaps (CMG). Objectively measured disease remission was achieved if one or more of endoscopic remission, faecal calprotectin <100 μg/mL and/or CRP <5 mg/mL occurred within 3 months of end of follow-up. Bivariate analysis and multiple linear regression elucidated factors associated with poorer adherence.
Of 193 IBD patients, 132 (68.4%) had Crohn's disease. One hundred and thirty six (70.5%) patients received infliximab and 57 (29.5%) received vedolizumab with a median 13 [IQR 11-14] doses administered per patient over 2 years. Adherence according to CMG was similar between infliximab and vedolizumab groups (median 1.5% vs 1.2%, p = 0.31). In multiple linear regression analysis male sex, shorter IBD duration and clinic non-attendances were each associated with poorer adherence (Beta 4.69, 3.90, 3.56 respectively, p < 0.05) and objective disease remission was inversely associated with poorer adherence (Beta -3.27, p < 0.05).
There was a wide range of adherence to biologic infusions in this IBD cohort with poorer adherence associated with patient related factors. Conversely, objectively measured remission was strongly associated with adherence. This emphasises the need for targeted interventions to improve adherence and monitoring, and mitigate treatment delays.
英夫利昔单抗和维得利珠单抗这两种静脉生物制剂是治疗炎症性肠病（IBD）的有效长期疗法。尽管它们非常有效，但不依从治疗方案可能导致治疗效果丧失和产生不良后果。需要进一步评估静脉生物制剂的不依从治疗的程度和结果，包括在 IBD 中的情况。
确定 IBD 患者接受英夫利昔单抗和维得利珠单抗输注的依从性，并确定与该人群中较差依从性相关的因素。
对 IBD 患者进行了一项回顾性单中心队列研究，评估了 2017 年 7 月 1 日至 2019 年 6 月 30 日期间英夫利昔单抗和维得利珠单抗的输注依从性。使用医疗和药房配药记录来确定输注日期。采用连续、多次间隔药物间隙测量法（CMG）评估依从性。如果在结束随访后 3 个月内发生内镜缓解、粪便钙卫蛋白<100μg/mL 和/或 CRP<5mg/mL 中的一种或多种情况，则达到客观测量的疾病缓解。采用双变量分析和多元线性回归来阐明与较差依从性相关的因素。
193 名 IBD 患者中，132 名（68.4%）患有克罗恩病。136 名（70.5%）患者接受了英夫利昔单抗治疗，57 名（29.5%）患者接受了维得利珠单抗治疗，每位患者在 2 年内平均接受了 13[IQR 11-14]次治疗。CMG 显示英夫利昔单抗和维得利珠单抗组的依从性相似（中位数 1.5%比 1.2%，p=0.31）。多元线性回归分析显示，男性、较短的 IBD 病程和未就诊与较差的依从性相关（Beta 值分别为 4.69、3.90 和 3.56，p<0.05），客观疾病缓解与较差的依从性呈负相关（Beta 值为-3.27，p<0.05）。
在这个 IBD 队列中，生物制剂输注的依从性范围很广，较差的依从性与患者相关因素有关。相反，客观测量的缓解与依从性密切相关。这强调了需要有针对性的干预措施来改善依从性和监测，并减轻治疗延误。
