Abstract：
OBJECTIVE: Granulocyte-monocyte apheresis (GMA) has shown to be safe and effective in treating ulcerative colitis (UC), also in combination with biologics. The objective of this study is to evaluate the efficacy and safety of combining GMA after primary non-response (PNR) or loss of response (LOR) to tofacitinib (TOFA) in patients with UC.
METHODS: Retrospective study including all patients with refractory UC who received GMA plus TOFA. 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: Twelve patients were included (median 46 years [IQR, 37-58]; 67% female; 67% E3). Patients were mostly receiving TOFA 10mg bid (75%), and 33% also concomitant steroids at baseline. Median partial Mayo score at baseline was 7 (IQR, 5-7), and it decreased to a median of 2 (IQR, 0-3) and 0 (IQR, 0-3) after 1 and 6 months (p=0.027 and 0.020, respectively), while no differences were found in CRP and FC. Clinical remission was achieved by 6 patients both at 1 (50%) and 6 months (67%). CF values<250mg/kg were achieved by 2 and 4 patients at 1 and 6 months (data available in 5 and 7 patients, respectively). No patient required dose-escalation of TOFA, and one patient was able to de-escalate the drug. No patient required colectomy and all patients under steroids were able to stop them.
CONCLUSIONS: The combination of GMA and TOFA can be effective in selected cases of UC after PNR or LOR to this drug.
METHODS: Retrospective study including all patients with refractory UC who received GMA plus TOFA. 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: Twelve patients were included (median 46 years [IQR, 37-58]; 67% female; 67% E3). Patients were mostly receiving TOFA 10mg bid (75%), and 33% also concomitant steroids at baseline. Median partial Mayo score at baseline was 7 (IQR, 5-7), and it decreased to a median of 2 (IQR, 0-3) and 0 (IQR, 0-3) after 1 and 6 months (p=0.027 and 0.020, respectively), while no differences were found in CRP and FC. Clinical remission was achieved by 6 patients both at 1 (50%) and 6 months (67%). CF values<250mg/kg were achieved by 2 and 4 patients at 1 and 6 months (data available in 5 and 7 patients, respectively). No patient required dose-escalation of TOFA, and one patient was able to de-escalate the drug. No patient required colectomy and all patients under steroids were able to stop them.
CONCLUSIONS: The combination of GMA and TOFA can be effective in selected cases of UC after PNR or LOR to this drug.
摘要：
目的：粒细胞-单核细胞分离术（GMA）已被证明是治疗溃疡性结肠炎（UC）安全有效的，还与生物制剂结合。这项研究的目的是评估原发性无应答（PNR）或失效（LOR）后联合GMA对托法替尼（TOFA）的疗效和安全性。
方法：回顾性研究包括所有接受GMA加TOFA的难治性UC患者。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12例患者（中位数46年[IQR，37-58]；67%女性；67%E3）。患者大多接受TOFA10mgbid（75％），和33%也伴随类固醇在基线。基线时部分Mayo评分中位数为7(IQR，5-7),下降到中位数2(IQR，0-3)和0(IQR，0-3）在1个月和6个月后（分别为p=0.027和0.020），而CRP和FC没有发现差异。6例患者在1个月（50％）和6个月（67％）均实现了临床缓解。在1个月和6个月时，2名和4名患者的CF值<250mg/kg（5名和7名患者的数据可用，分别)。没有患者需要TOFA的剂量递增，一名患者能够降低药物的浓度。没有患者需要结肠切除术，所有接受类固醇治疗的患者都能够停止结肠切除术。
结论：GMA和TOFA的组合在选择的UC病例中PNR或LOR后对该药物有效。
方法：回顾性研究包括所有接受GMA加TOFA的难治性UC患者。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12例患者（中位数46年[IQR，37-58]；67%女性；67%E3）。患者大多接受TOFA10mgbid（75％），和33%也伴随类固醇在基线。基线时部分Mayo评分中位数为7(IQR，5-7),下降到中位数2(IQR，0-3)和0(IQR，0-3）在1个月和6个月后（分别为p=0.027和0.020），而CRP和FC没有发现差异。6例患者在1个月（50％）和6个月（67％）均实现了临床缓解。在1个月和6个月时，2名和4名患者的CF值<250mg/kg（5名和7名患者的数据可用，分别)。没有患者需要TOFA的剂量递增，一名患者能够降低药物的浓度。没有患者需要结肠切除术，所有接受类固醇治疗的患者都能够停止结肠切除术。
结论：GMA和TOFA的组合在选择的UC病例中PNR或LOR后对该药物有效。
