Abstract：
OBJECTIVE: Granulocyte-monocyte apheresis (GMA) has shown to be safe and effective in ulcerative colitis (UC), also in combination with biologics, mainly with anti-TNF. The aim of this study was to evaluate the efficacy and safety of combining GMA after primary non-response (PNR) or loss of response (LOR) to ustekinumab (UST) in patients with UC.
METHODS: A retrospective study was performed in 12 IBD Units, including all patients with refractory UC or unclassified IBD (IBD-U) who received combined GMA plus UST. The number and frequency of GMA sessions, filtered blood volume and time of each session were registered. Efficacy was assessed 1 and 6 months after finishing GMA by partial Mayo score, C-reactive protein (CRP) and fecal calprotectin (FC). Descriptive statistics and non-parametric tests were used in the statistical analysis.
RESULTS: Seventeen patients were included (15 UC, 2 IBD-U; median age 47 years [IQR, 35-61]; 59% male; 53% E3). Most patients (89%) had prior exposure to anti-TNF agents and 53% to vedolizumab; 65% were also receiving steroids at baseline. Median partial Mayo score at baseline was 6 (IQR, 5-7) and it significantly decreased after 1 and 6 months (p=0.042 and 0.007, respectively). Baseline FC significantly decreased after 6 months (p=0.028) while no differences were found in CRP. During follow-up, 18% patients started a new biologic therapy and 12% required surgery; 64% of patients under steroids were able to discontinue them. Adverse events were reported in one patient.
CONCLUSIONS: GMA can recapture the response to UST in selected cases of UC after PNR or LOR to this drug.
METHODS: A retrospective study was performed in 12 IBD Units, including all patients with refractory UC or unclassified IBD (IBD-U) who received combined GMA plus UST. The number and frequency of GMA sessions, filtered blood volume and time of each session were registered. Efficacy was assessed 1 and 6 months after finishing GMA by partial Mayo score, C-reactive protein (CRP) and fecal calprotectin (FC). Descriptive statistics and non-parametric tests were used in the statistical analysis.
RESULTS: Seventeen patients were included (15 UC, 2 IBD-U; median age 47 years [IQR, 35-61]; 59% male; 53% E3). Most patients (89%) had prior exposure to anti-TNF agents and 53% to vedolizumab; 65% were also receiving steroids at baseline. Median partial Mayo score at baseline was 6 (IQR, 5-7) and it significantly decreased after 1 and 6 months (p=0.042 and 0.007, respectively). Baseline FC significantly decreased after 6 months (p=0.028) while no differences were found in CRP. During follow-up, 18% patients started a new biologic therapy and 12% required surgery; 64% of patients under steroids were able to discontinue them. Adverse events were reported in one patient.
CONCLUSIONS: GMA can recapture the response to UST in selected cases of UC after PNR or LOR to this drug.
摘要：
目的：粒细胞-单核细胞单采术（GMA）已证明对溃疡性结肠炎（UC）安全有效，还与生物制剂相结合，主要用抗TNF。这项研究的目的是评估UC患者对ustekinumab（UST）的原发性无应答（PNR）或应答消失（LOR）后联合GMA的疗效和安全性。
方法：对12个IBD单位进行了回顾性研究，包括接受GMA+UST联合治疗的所有难治性UC或未分类IBD(IBD-U)患者。GMA会议的数量和频率，记录每个疗程的过滤血容量和时间.通过部分Mayo评分在完成GMA后1个月和6个月评估疗效，C反应蛋白（CRP）和粪便钙卫蛋白（FC）。统计分析采用描述性统计和非参数检验。
结果：纳入17例患者（15例UC，2IBD-U；平均年龄47岁[IQR，35-61]；59％男性；53％E3）。大多数患者（89％）先前曾暴露于抗TNF药物，53％接受维多珠单抗；65％也在基线接受类固醇治疗。基线时部分Mayo评分中位数为6(IQR，5-7），并且在1个月和6个月后显着降低（分别为p=0.042和0.007）。6个月后，基线FC显着降低（p=0.028），而CRP无差异。随访期间,18％的患者开始了新的生物治疗，12％的患者需要手术;64％的患者使用类固醇能够停止他们。在一名患者中报告了不良事件。
结论：在PNR或LOR后，GMA可以在某些UC病例中重新获得对UST的反应。
方法：对12个IBD单位进行了回顾性研究，包括接受GMA+UST联合治疗的所有难治性UC或未分类IBD(IBD-U)患者。GMA会议的数量和频率，记录每个疗程的过滤血容量和时间.通过部分Mayo评分在完成GMA后1个月和6个月评估疗效，C反应蛋白（CRP）和粪便钙卫蛋白（FC）。统计分析采用描述性统计和非参数检验。
结果：纳入17例患者（15例UC，2IBD-U；平均年龄47岁[IQR，35-61]；59％男性；53％E3）。大多数患者（89％）先前曾暴露于抗TNF药物，53％接受维多珠单抗；65％也在基线接受类固醇治疗。基线时部分Mayo评分中位数为6(IQR，5-7），并且在1个月和6个月后显着降低（分别为p=0.042和0.007）。6个月后，基线FC显着降低（p=0.028），而CRP无差异。随访期间,18％的患者开始了新的生物治疗，12％的患者需要手术;64％的患者使用类固醇能够停止他们。在一名患者中报告了不良事件。
结论：在PNR或LOR后，GMA可以在某些UC病例中重新获得对UST的反应。
