Numa Keijiro, Kakimoto Kazuki, Tanaka Yasuyoshi, Mizuta Noboru, Kinoshita Naohiko, Nakazawa Kei, Koshiba Ryoji, Hirata Yuki, Ota Kazuhiro, Miyazaki Takako, Nakamura Shiro, Higuchi Kazuhide, Nishikawa Hiroki
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, 2-7 Daigakumachi, Takatsuki City 569-8686, Japan.
J Clin Med. 2023 Oct 23;12(20):6699. doi: 10.3390/jcm12206699.
Tacrolimus (TAC) effectively induces remission in refractory ulcerative colitis (UC). However, TAC therapy usually lasts for 3 months. Although azathioprine (AZA) is often used in maintenance therapy, the relapse rate remains high. Herein, we evaluated the efficacy of adalimumab (ADA) for remission maintenance in patients with UC after induction therapy with TAC.
We prospectively enrolled patients with moderate-to-severe UC who achieved clinical remission after 3 months of TAC therapy with endoscopic non-mucosal healing (Cohort A). After TAC discontinuation, the remission maintenance rate up to 1 year after starting ADA therapy was examined. We retrospectively enrolled patients with UC treated with TAC (Cohort B). Among patients in clinical remission after TAC treatment for 3 months, those who received AZA as remission maintenance therapy after TAC discontinuation constituted the AZA group. Patients in Cohort A who received ADA and AZA as remission maintenance therapy after TAC discontinuation constituted the ADA + AZA group. We compared the remission maintenance rates in the AZA and ADA + AZA groups for up to 5 years after TAC discontinuation.
In Cohort A, of the 46 patients with UC treated with TAC, 17 were eligible for analysis after receiving ADA as remission maintenance therapy. A notable 88.2% (15/17) were still in remission 1 year after starting ADA. The ADA + AZA group ( = 16) exhibited a significantly higher relapse-free rate than the AZA group ( = 26) ( < 0.05; log-rank test).
switching to ADA for remission maintenance in patients with refractory UC who achieved clinical remission with TAC is clinically useful.
他克莫司（TAC）可有效诱导难治性溃疡性结肠炎（UC）缓解。然而，TAC治疗通常持续3个月。尽管硫唑嘌呤（AZA）常用于维持治疗，但复发率仍然很高。在此，我们评估了阿达木单抗（ADA）在TAC诱导治疗后对UC患者缓解维持的疗效。
我们前瞻性纳入了中度至重度UC患者，这些患者在接受3个月TAC治疗后达到临床缓解但内镜下黏膜未愈合（队列A）。停用TAC后，检查开始ADA治疗后长达1年的缓解维持率。我们回顾性纳入了接受TAC治疗的UC患者（队列B）。在接受3个月TAC治疗后达到临床缓解的患者中，那些在停用TAC后接受AZA作为缓解维持治疗的患者组成AZA组。队列A中在停用TAC后接受ADA和AZA作为缓解维持治疗的患者组成ADA + AZA组。我们比较了停用TAC后长达5年的AZA组和ADA + AZA组的缓解维持率。
在队列A中，46例接受TAC治疗的UC患者中，17例在接受ADA作为缓解维持治疗后符合分析条件。开始ADA治疗1年后，显著有88.2%（15/17）的患者仍处于缓解状态。ADA + AZA组（n = 16）的无复发率显著高于AZA组（n = 26）（P < 0.05；对数秩检验）。
对于使用TAC达到临床缓解的难治性UC患者，换用ADA进行缓解维持在临床上是有用的。
