未经证实:我们之前已经证明,霉酚酸酯(MMF)可以代替硫唑嘌呤(AZA)用于自身免疫性肝炎(AIH)患者的一线治疗。在这里,我们提供了我们对MMF一线治疗后AIH患者的反应和结果的长期前瞻性数据,类似的数据缺失。
未经批准:在21年的研究中,包括292名AIH患者(女性:213;平均年龄:59[17-85]岁)。患者单独接受泼尼松龙0.5-1mg/kg/天(n=19)或与AZA1-2mg/kg/天(n=64)或MMF(n=183)联合使用。泼尼松龙的逐渐减少方案在组间是相同的。我们评估了6个月时的完全生化反应(CBR)率,12个月,和随访结束;无应答(治疗4周);泼尼松龙的CBR;不良反应;CBR治疗;组织学缓解;AZA和MMF组之间的总体和肝脏相关死亡率。
未经评估:MMF组在12个月时的无反应率较低(p=0.02),CBR率较高(86vs.71.8%;p<0.05)和随访结束(96vs.87.2%;p=0.03)比AZA组。AZA组的治疗变化更为频繁(43.7vs.11%;p<0.001),主要是因为不宽容,而MMF被证明是安全的(严重并发症3.8vs.18.8%;p=0.0003)。根据指南,MMF治疗的患者更经常有资格停止免疫抑制(p<0.05)。诊断时的肝硬化,诊断年龄>60岁,和更长的病程是肝脏相关死亡率的独立预测因素.
未经评估:MMF似乎是AIH的有效替代一线治疗选择,与AZA相比,4周时的无应答率较低,12个月时和随访结束时的CBR率较高。此外,MMF被证明是安全的,根据指南,更频繁地导致有资格停止免疫抑制。
未经授权:40多年来,硫唑嘌呤(AZA)被认为是诱导和维持自身免疫性肝炎(AIH)反应的标准治疗方法。然而,治疗通常需要终生维持,因为AZA停止后复发很常见。因此,需要替代治疗方案。在这里,我们发现,与AZA相比,使用霉酚酸酯(MMF)作为替代一线免疫抑制剂的长期疗效要高得多,4周时无缓解率较低,12个月时和随访结束时的缓解率较高.此外,AZA治疗的患者更容易因为不耐受而改变治疗,而接受MMF治疗的患者更有资格退出治疗.
UNASSIGNED: We have shown previously that mycophenolate mofetil (MMF) might be used as first-line treatment instead of azathioprine (AZA) in individuals with autoimmune hepatitis (AIH). Herein, we present our long-term prospective data on response and outcome after first-line therapy with MMF in treatment-naïve individuals with AIH, as similar data are missing.
UNASSIGNED: During the 21 years of the study, 292 individuals with AIH were included (females: 213; median age: 59 [17-85] years). Patients received either prednisolone 0.5-1 mg/kg/day alone (n = 19) or in combination with AZA 1-2 mg/kg/day (n = 64) or MMF (n = 183). The tapering schedule of prednisolone was identical between groups. We assessed the rates of complete biochemical response (CBR) at 6 months, 12 months, and the end of follow-up; non-response (4 weeks of treatment); CBR off prednisolone; adverse effects; CBR off treatment; histological remission; and overall and liver-related mortality between the AZA and MMF groups.
UNASSIGNED: The MMF group had lower non-response (p = 0.02) and higher CBR rates at 12 months (86 vs. 71.8%; p <0.05) and the end of follow-up (96 vs. 87.2%; p = 0.03) than the AZA group. Treatment change was more frequent in the AZA group (43.7 vs. 11%; p <0.001), mostly because of intolerance, whereas MMF was proven safe (serious complications 3.8 vs. 18.8%; p = 0.0003). MMF-treated patients were more frequently eligible to stop immunosuppression according to the guidelines (p <0.05). Cirrhosis at diagnosis, age at diagnosis >60 years, and longer disease duration were independent predictors of liver-related mortality.
UNASSIGNED: MMF seems an efficient alternative first-line treatment option for AIH, bearing lower non-response at 4 weeks and higher CBR rates at 12 months and the end of follow-up than AZA. In addition, MMF was proven to be safe, leading more frequently to the eligibility for stopping immunosuppression according to the guidelines.
UNASSIGNED: For more than 40 years, azathioprine (AZA) has been considered the standard treatment for induction and maintenance of response in autoimmune hepatitis (AIH). However, treatment usually needs to be maintained for life, as relapses are common after AZA cessation. Therefore, alternative treatment options are needed. Herein, we showed that the use of mycophenolate mofetil (MMF) as an alternative first-line immunosuppressant was much more efficient in the long-term than AZA as attested by the lower non-response rates at 4 weeks and higher response rates at 12 months and the end of follow-up. Moreover, AZA-treated patients were more prone to change treatment because of intolerance, whereas MMF-treated patients were more often eligible to achieve treatment withdrawal.