Eberl Anja, Hallinen Taru, Af Björkesten Clas-Göran, Heikkinen Markku, Hirsi Eija, Kellokumpu Mikko, Koskinen Inka, Moilanen Veikko, Nielsen Christian, Nuutinen Heikki, Suhonen Ulla-Maija, Utriainen Karri, Vihriälä Ilkka, Soini Erkki, Wennerström Christina, Nissinen Riikka, Borsi Andras, Koivunen Minni, Tillonen Jyrki, Sipponen Taina
Gastroenterology, University of Helsinki and Helsinki University Hospital , Helsinki , Finland.
ESiOR Oy , Kuopio , Finland.
Scand J Gastroenterol. 2019 Jun;54(6):718-725. doi: 10.1080/00365521.2019.1624817. Epub 2019 Jun 11.
Ustekinumab (UST), a human anti-IL12/23p40 monoclonal antibody, has been approved for treatment of Crohn's Disease (CD) since the end of 2016. This nationwide noninterventional, retrospective chart review explored real-life data in patients receiving UST to provide guidance in UST treatment in the era of increasing prevalence of CD. The study assessed UST treatment patterns such as dosing frequency, concomitant medication and persistence in 48 CD patients commencing UST therapy in 12 Finnish hospitals during 2017. Clinical remission and response rates were explored using a modified Harvey-Bradshaw index (mHBI) and endoscopic response via the simple endoscopic score for Crohn's disease (SES-CD) as proportions of patients at week 16 and at the end of follow-up. Forty patients (83%) continued UST-treatment at the end of follow-up. At week 16, clinical response and endoscopic healing was observed, where data were available; mHBI decreased from 9 to 3 ( = .0001) and SES-CD from 12 to 3 ( = .009). Clinical benefit was achieved by 83% (19/23) at week 16 and by 76% (16/21) at the end of follow-up. The proportion of patients using corticosteroids decreased from 48% to 25% at week 16 and to 13% at the end of the follow-up. UST showed to be effective and persistent, inducing short-term clinical benefit and endoscopic response in this real-life nationwide study of CD patients. Significant corticosteroid tapering in patients with highly treatment refractory and long-standing CD was observed.
优特克单抗（UST）是一种人源抗IL12/23p40单克隆抗体，自2016年底起已被批准用于治疗克罗恩病（CD）。这项全国性的非干预性回顾性病历审查探讨了接受UST治疗的患者的真实数据，以便在CD患病率不断上升的时代为UST治疗提供指导。该研究评估了2017年期间在芬兰12家医院开始接受UST治疗的48例CD患者的UST治疗模式，如给药频率、联合用药和持续用药情况。使用改良的哈维-布拉德肖指数（mHBI）探索临床缓解率和缓解率，并通过克罗恩病简单内镜评分（SES-CD）评估内镜反应，分别以第16周和随访结束时的患者比例表示。40例患者（83%）在随访结束时继续接受UST治疗。在第16周，观察到有可用数据的患者的临床反应和内镜愈合情况；mHBI从9降至3（P = 0.0001），SES-CD从12降至3（P = 0.009）。在第16周时，83%（19/23）的患者获得了临床益处，在随访结束时这一比例为76%（16/21）。使用皮质类固醇的患者比例在第16周时从48%降至25%，在随访结束时降至13%。在这项针对CD患者的全国性真实研究中，UST显示出有效且具有持续性，可诱导短期临床益处和内镜反应。在治疗难治性高且病程长的CD患者中观察到显著的皮质类固醇减量。
