Induction Therapy With a Combination of Weekly Adalimumab Plus Intensive Granulocyte and Monocyte Adsorptive Apheresis in Patients With Ulcerative Colitis and Failure of Conventional Agents, Biologics and Janus Kinase Inhibitor.

Satoshi Tanida, Keiji Ozeki, Takahito Katano, Mamoru Tanaka, Takaya Shimura, Eiji Kubota, Hiromi Kataoka, Takuya Takahama, Shun Sasoh, Yoshimasa Kubota, Tesshin Ban, Tomoaki Ando, Makoto Nakamura, Takashi Joh
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Abstract

Every-week (ew) adalimumab (ADA) maintenance following induction therapy with a standard induction regimen has recently been approved for use in Japan. The efficacy and safety of combination therapy with ew-ADA maintenance following standard induction regimen plus intensive granulocyte and monocyte adsorptive apheresis (GMA) (two sessions/week) for the treatment of refractory ulcerative colitis (UC) displaying failure of conventional, biologics and Janus kinase inhibitor have not been evaluated previously. The present retrospective study evaluated the 10-week efficacy of this combination therapy among refractory UC patients. Six patients were given initial ADA combination therapy (ADA at 160 mg in week 0, ADA 80 mg in week 2, and 40 mg in week 4, followed by ew-ADA at 40 mg/week) plus intensive GMA. One patient (16.6%) achieved clinical remission and two patients (33.3%) achieved endoscopic improvement by week 10. After excluding two patients who discontinued treatment, mean full Mayo score (P = 0.14), endoscopic subscore (P = 0.18) and C-reactive protein level (P = 0.27) at 10 weeks were numerically decreased compared with baseline in the remaining four cases, although the differences were not significant. Use of ew-ADA maintenance following standard induction regimen plus intensive GMA appears unlikely to achieve satisfactory induction of clinical remission in UC patients for whom conventional agents, biologics and Janus kinase inhibitors have failed.

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阿达木单抗联合强化粒细胞和单核细胞吸附采珠术治疗溃疡性结肠炎和常规药物、生物制剂和Janus激酶抑制剂治疗失败
诱导治疗后每周(新)阿达木单抗(ADA)维持标准诱导方案最近已被批准在日本使用。对于难治性溃疡性结肠炎(UC),在常规、生物制剂和Janus激酶抑制剂治疗失败的情况下,在标准诱导方案下联合使用新ada维持加上强化粒细胞和单核细胞吸附采珠术(GMA)(2次/周)的疗效和安全性尚未得到评估。目前的回顾性研究评估了这种联合治疗在难治性UC患者中的10周疗效。6例患者接受初始ADA联合治疗(第0周ADA 160 mg,第2周ADA 80 mg,第4周40 mg,随后是新ADA 40 mg/周)加强化GMA。到第10周,1例患者(16.6%)达到临床缓解,2例患者(33.3%)达到内镜改善。在排除2例停止治疗的患者后,其余4例患者在10周时的平均完全Mayo评分(P = 0.14)、内镜亚评分(P = 0.18)和c反应蛋白水平(P = 0.27)与基线相比在数值上有所下降,但差异不显著。在常规药物、生物制剂和Janus激酶抑制剂治疗失败的UC患者中,使用标准诱导方案后的ew-ADA维持加上强化GMA似乎不太可能达到令人满意的临床缓解诱导。
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