Llano Ernesto M, Shrestha Shreeju, Burstein Ezra, Boktor Moheb, Fudman David I
Division of Digestive Liver Diseases, UT Southwestern Medical Center, Dallas, TX, USA.
Crohns Colitis 360. 2021 Jun 9;3(3):otab030. doi: 10.1093/crocol/otab030. eCollection 2021 Jul.
Combining advanced therapies may improve outcomes in inflammatory bowel disease (IBD), but there are little data on the effectiveness and safety of this approach.
We examined outcomes of patients who received vedolizumab in combination with another biologic or tofacitinib between 2016 and 2020.
Fourteen patients (10 ulcerative colitis [UC], 3 Crohn disease, 1 indeterminate colitis) received a combination of advanced therapies. Vedolizumab was combined with tofacitinib in 9 patients, ustekinumab in 3, and adalimumab in 2. Median follow-up on combination therapy was 31 weeks. Normalization of C-reactive protein (CRP) or fecal calprotectin (<5 mg/L and <150 µg/g, respectively) was achieved in 56% (5/9) and 50% (4/8) of patients. Paired median CRP decreased from 14 mg/L to <5 mg/L with combination therapy (n = 9, = 0.02), and paired median calprotectin from 594 µg/g to 113 µg/g (n = 8, = 0.12). Among patients with UC, paired median Lichtiger score decreased from 9 to 3 (n = 7, = 0.02). Prednisone discontinuation was achieved in 67% (4/6) of prednisone-dependent patients. There were 4 infections: 2 required hospitalization (rotavirus, ), and 2 did not (pneumonia, sinusitis). During follow-up, 5/14 patients discontinued combination therapy (2 nonresponse; 1 improvement and de-escalation; 1 noninfectious adverse effect; 1 loss of coverage).
In this retrospective case series of a cohort with refractory IBD, combining vedolizumab with other biologics or tofacitinib improved inflammatory markers, reduced clinical disease activity and steroid use, and was well tolerated.
联合使用先进疗法可能改善炎症性肠病(IBD)的治疗效果,但关于这种方法的有效性和安全性的数据很少。
我们研究了2016年至2020年间接受维多珠单抗联合另一种生物制剂或托法替布治疗的患者的治疗效果。
14例患者(10例溃疡性结肠炎[UC]、3例克罗恩病、1例未定型结肠炎)接受了先进疗法联合治疗。9例患者将维多珠单抗与托法替布联合使用,3例与优特克单抗联合使用,2例与阿达木单抗联合使用。联合治疗的中位随访时间为31周。56%(5/9)和50%(4/8)的患者实现了C反应蛋白(CRP)或粪便钙卫蛋白(分别<5 mg/L和<150 µg/g)正常化。联合治疗时,配对的中位CRP从14 mg/L降至<5 mg/L(n = 9,P = 0.02),配对的中位钙卫蛋白从594 µg/g降至113 µg/g(n = 8,P = 0.12)。在UC患者中,配对的中位利希特格评分从9降至3(n = 7,P = 0.02)。67%(4/6)依赖泼尼松的患者停用了泼尼松。发生了4次感染:2次需要住院治疗(轮状病毒, ),2次不需要(肺炎、鼻窦炎)。在随访期间,14例患者中有5例停用了联合治疗(2例无反应;1例病情改善并降级;1例非感染性不良反应;1例失去医保覆盖)。
在这个难治性IBD队列的回顾性病例系列中,将维多珠单抗与其他生物制剂或托法替布联合使用可改善炎症指标,降低临床疾病活动度和类固醇使用量,且耐受性良好。