Nakafero Georgina, Grainge Matthew J, Card Tim, Mallen Christian D, Riley Richard, van der Windt Danielle, Fox Christopher P, Taal Maarten W, Aithal Guruprasad P, Williams Hywel C, Abhishek Abhishek
Academic Rheumatology.
Lifespan and Population Health.
Rheumatol Adv Pract. 2022 Jun 2;6(2):rkac046. doi: 10.1093/rap/rkac046. eCollection 2022.
The aim was to examine the incidence and pattern of MMF discontinuation associated with abnormal monitoring blood-test results.
Data from people prescribed MMF for common inflammatory conditions in the Clinical Practice Research Datalink were used. Participants were followed from the first MMF prescription. The primary outcome was drug discontinuation with an associated abnormal blood-test result within 60 days. Secondary outcomes were drug discontinuation for any reason and discontinuation associated with severely abnormal blood-test results within 60 days. Multivariable Cox regression was used to examine factors associated with the primary outcome.
The cohort included 992 participants (68.9% female, mean age 51.95 years, 47.1% with SLE) contributing 1885 person-years of follow-up. The incidence of MMF discontinuation associated with any (severely) abnormal blood-test results was 153.46 (21.07) per 1000 person-years in the first year of prescription and 32.39 (7.91) per 1000 person-years in later years. Of those patients prescribed MMF, 11.5% (1.7%) discontinued treatment with any (severely) abnormal blood-test results in the first year of prescription. After this period, a mean of 2.6% (0.7%) of patients discontinued treatment with any (severely) abnormal blood-test results per year. Increased serum creatinine and cytopenia were more commonly associated with MMF discontinuation than elevated liver enzymes. Chronic kidney disease stage3 or higher was significantly associated with MMF discontinuation with any blood-test abnormalities [adjusted hazard ratio (95% CI) 2.22 (1.47, 3.37)].
MMF is uncommonly discontinued for blood-test abnormalities and even less often discontinued for severe blood-test abnormalities after the first year of prescription. Consideration can be given to less frequent monitoring after 1 year of treatment, especially in those without chronic kidney disease stage3 or higher.
本研究旨在探讨与血液检测结果异常相关的霉酚酸酯（MMF）停药发生率及模式。
使用临床实践研究数据链中因常见炎症性疾病而开具MMF处方的患者数据。从首次开具MMF处方开始对参与者进行随访。主要结局是在60天内出现与血液检测结果异常相关的药物停药。次要结局是因任何原因导致的药物停药以及在60天内出现与严重血液检测结果异常相关的停药。采用多变量Cox回归分析与主要结局相关的因素。
该队列包括992名参与者（68.9%为女性，平均年龄51.95岁，47.1%患有系统性红斑狼疮），共随访1885人年。在处方的第一年，与任何（严重）血液检测结果异常相关的MMF停药发生率为每1000人年153.46（21.07）例，在随后几年为每1000人年32.39（7.91）例。在开具MMF处方的患者中，11.5%（1.7%）在处方的第一年因任何（严重）血液检测结果异常而停药。在此之后，平均每年有2.6%（0.7%）的患者因任何（严重）血液检测结果异常而停药。血清肌酐升高和血细胞减少比肝酶升高更常与MMF停药相关。慢性肾脏病3期或更高分期与任何血液检测异常导致的MMF停药显著相关[调整后风险比（95%置信区间）2.22（1.47，3.37）]。
MMF因血液检测异常而停药的情况并不常见，在处方第一年之后因严重血液检测异常而停药更是少见。治疗1年后可考虑减少监测频率，尤其是对于那些没有慢性肾脏病3期或更高分期的患者。
