Zagórowicz Edyta, Cichoż-Lach Halina, Kopertowska-Majchrzak Maria, Eder Piotr, Stawczyk-Eder Kamila, Talar-Wojnarowska Renata, Zatorski Hubert, Solarska-Półchłopek Anna, Filip Rafał, Janiak Maria, Skrobot Krzysztof, Kłopocka Maria, Liebert Ariel, Kaczka Aleksandra, Wojciechowski Krzysztof, Drygała Szymon, Michalak Agata
Department of Oncological Gastroenterology, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland.
Adv Clin Exp Med. 2024 Jan;33(1):69-77. doi: 10.17219/acem/162969.
Vedolizumab is recommended as a first-line biological treatment, along with other biological drugs, in ulcerative colitis (UC) patients in whom conventional therapy failed and as a second-line biological treatment following a failure of a tumor necrosis factor alpha (TNF-α) antagonist.
We aimed to assess the real-world effectiveness and safety of vedolizumab induction therapy in UC patients treated in the scope of the National Drug Program (NDP) in Poland.
The endpoints were the proportions of patients who reached clinical response, clinical remission and mucosal healing at week 14. Partial Mayo scores, Mayo subscores and C-reactive protein (CRP) levels were also evaluated.
Our study population consisted of 100 patients (55 biologic-naïve and 45 biologic-exposed). The median total Mayo score at baseline was 10 (interquartile range (IQR): 9-11), and 52 patients (52%) had extensive colitis. The clinical response at week 14 was achieved in 83 (83%) and clinical remission in 24 (24%) cases. Mucosal healing was observed in 56 (62%) patients at week 14. In patients with prior failure of biologic treatment (n = 25), 17 (68%) responded to vedolizumab treatment. A decrease in the median CRP level (from 3.7 mg/L to 2.6 mg/L) and the median total Mayo score (from 10 to 4) was observed. No new safety concerns were recorded and no patients discontinued the treatment due to adverse events (AEs).
Vedolizumab was effective and safe as induction therapy for UC in a Polish real-world population including patients with severely active UC and a low number of patients with prior biological treatment failures.
维多珠单抗与其他生物药物一样，被推荐作为传统治疗失败的溃疡性结肠炎（UC）患者的一线生物治疗药物，以及在肿瘤坏死因子α（TNF-α）拮抗剂治疗失败后的二线生物治疗药物。
我们旨在评估维多珠单抗诱导治疗在波兰国家药物计划（NDP）范围内治疗的UC患者中的真实疗效和安全性。
终点指标为第14周时达到临床缓解、临床缓解和黏膜愈合的患者比例。还评估了部分梅奥评分、梅奥子评分和C反应蛋白（CRP）水平。
我们的研究人群包括100例患者（55例未使用过生物制剂，45例曾使用过生物制剂）。基线时梅奥总分中位数为10（四分位间距（IQR）：9 - 11），52例患者（52%）患有广泛性结肠炎。第14周时83例（83%）患者达到临床缓解，24例（24%）患者达到临床缓解。第14周时56例（62%）患者观察到黏膜愈合。在既往生物治疗失败的患者（n = 25）中，17例（68%）对维多珠单抗治疗有反应。观察到CRP中位数水平下降（从3.7 mg/L降至2.6 mg/L），梅奥总分中位数下降（从10降至4）。未记录到新的安全问题，也没有患者因不良事件（AE）而停药。
在波兰的真实世界人群中，包括重度活动性UC患者和既往生物治疗失败患者数量较少的情况下，维多珠单抗作为UC的诱导治疗药物有效且安全。
