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ustekinumab: “Real-world” outcomes and potential predictors of nonresponse in treatment-refractory Crohn’s disease

World Journal of Gastroenterology 2019年第31期25卷 4481-4492页

作者： Peter Hoffmann Johannes Krisam Cyrill Wehling Petra Kloeters-Plachky Yvonne Leopold Nina Belling Annika Gauss Department of Gastroenterology and Hepatology University Hospital HeidelbergHeidelberg 69120Germany Department of Medical Biometry University Hospital HeidelbergHeidelberg 69120Germany

BACKGROUND ustekinumab was approved in Europe for the treatment of adults with moderate to severe Crohn's disease(CD)in 2016,and there is an urgent need for data on its everyday use.AIM To obtain data on the daily use of ustekinumab.METHODS This is a retrospective monocentric study.Patients with moderate to severe CD who began ustekinumab therapy at the inflammatory bowel diseases outpatient clinic of the Heidelberg University Hospital between December 2016 and March 2018 were selected based on electronic patient files.The primary study endpoint was combined steroid-free clinical remission or steroid-free clinical response at 24±6 wk of ustekinumab therapy.Secondary study endpoints were:achievement of mucosal healing,sonographic and magnetic resonance imaging response,biochemical response,the need for intestinal surgery within 24±6 wk after treatment initiation,the occurrence of adverse events,treatment discontinuation due to nonresponse or adverse events,improvement of extraintestinal manifestations,clinical response at 48±6 wk of therapy,and association of response with nucleotid oligodimerisation domain 2 mutations.RESULTS Fifty-seven patients with CD(5.3%anti-tumour necrosis factorαnaive,63.2%having undergone at least one intestinal surgery)were included in the study.Twenty patients(35.1%)achieved steroid-free clinical remission,6(10.5%)steroid-free clinical response and 31(54.4%)were non-responders.Treatment discontinuation due to adverse events occurred in two patients(3.5%).Male sex,the presence of extraintestinal manifestations and the use of steroids at baseline were predictors of nonresponse to ustekinumab therapy.CONCLUSION In a“real-world”treatment-refractory cohort of patients with CD,ustekinumab appeared efficacious and safe.

关键词： Eeal-world ustekinumab Crohn’s disease

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ustekinumab Treatment in Patients with Moderate-to-Severe Psoriasis and Latent Tuberculosis Infection: A Study of 3 Case Reports

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Journal of Cosmetics, Dermatological Sciences and Applications 2022年第2期12卷 95-99页

作者： Waqas S. Abdulwahhab Alaa S. Mehair Al Shayma F. Iedi Department of Dermatology and Venereology Al Qassimi Hospital Sharjah United Arab Emirates College of Medicine Sharjah University Sharjah United Arab Emirates

Background: ustekinumab is a human monoclonal antibody that binds to the shared P40 subunit of interleukin (IL)-12 and IL-23 and is approved for the treatment of moderate-to-severe psoriasis. Latent tuberculosis (LTBI) was diagnosed based on a positive tuberculin skin test (TST) or QuantiFERON-TB test without evidence of active tuberculosis (TB). Aim: To evaluate the risk of active tuberculosis reinfection in patients with a history of psoriasis and LTBI after INH prophylaxis treated with ustekinumab. Case Report: We are describing 3 patients with a history of moderate-to-severe plaque psoriasis and newly identified LTBI who have been treated with INH monotherapy before starting ustekinumab therapy followed-up over 2 years for any sign of tuberculosis reinfection. Conclusion: ustekinumab is an option for treating psoriasis and LTBI with minimal risk of reactivation after INH prophylaxis.

关键词： Psoriasis ustekinumab Latent Tuberculosis QuantiFERON-TB Test

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Exit strategies in inflammatory bowel disease:Looking beyond antitumor necrosis factors

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World Journal of Clinical Cases 2023年第12期11卷 2657-2669页

作者： Federica Crispino Andrea Michielan Mauro Grova Chiara Tieppo Marta Mazza Teresa Marzia Rogger Franco Armelao Azienda Provinciale per i Servizi Sanitari Gastroenterology and Digestive Endoscopy UnitSanta Chiara HospitalTrento 38122Italy Inflammatory Bowel Disease Unit Department of MedicineAzienda Ospedaliera Ospedali RiunitiVilla Sofia-CervelloPalermo 90146Italy

The long-term management of patients with inflammatory bowel disease(IBD)is still a matter of debate,and no clear guidelines have been issued.In clinical practice,gastroenterologists often have to deal with patients in prolonged remission after immunomodulatory or immunosuppressive therapies.When planning an exit strategy for drug withdrawal,the risk of disease relapse must be balanced against the risk of drug-related adverse events and healthcare costs.Furthermore,there is still a dearth of data on the withdrawal of novel biologics,such as the anti-α4β7 integrin antibody(vedolizumab)and anti-IL12/23 antibody(ustekinumab),as well as the small molecule tofacitinib.Models for estimating the risk of disease relapse and the efficacy of retreatment should be evaluated according to the patient's age and IBD phenotype.These models should guide clinicians in programming a temporary drug withdrawal after discussing realistic outcomes with the patient.This would shift the paradigm from an exit strategy to a holiday strategy.

关键词： Exit strategy Biologic withdrawal Drug holiday Vedolizumab ustekinumab Tofacitinib

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Interleukin 12/interleukin 23 pathway: Biological basis and therapeutic effect in patients with Crohn's disease

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World Journal of Gastroenterology 2018年第36期24卷 4093-4103页

作者： Ioanna Aggeletopoulou Stelios F Assimakopoulos Christos Konstantakis Christos Triantos Division of Gastroenterology Department of Internal MedicineMedical SchoolUniversity of Patras Department of Internal Medicine University Hospital of Patras

Considering that both innate and adaptive immune responses are involved in the pathogenesis of Crohn's disease(CD), novel therapeutic options have significantly been developed. Biological agents represent an important addition to the conventional treatments for immuno-inflammatory conditions, acting as antagonists of adhesion molecules or various inflammatory cytokines. The interleukin 12(IL-12)/IL-23 common pathway has been found to play a determinant role in the induction of inflammation in adaptive immune responses. In particular, IL-23 promotes the differentiation of na?ve T helper cells into Th17 phenotype with the concomitant secretion of several inflammatory cytokines such as IL-17 and IL-22, whereas IL-12 induces the Th1 polarization and production of critical cytokines such as interferon-γ and tumor necrosis factor. Nowadays, there is increased interest regarding the role of IL-23 as a therapeutic target of CD through the blockage of IL-23 mediated pathways. In this editorial, we focus on the role of IL-12/IL-23 pathway in the regulation of mucosal immunity and in the induction and maintenance of chronic inflammation. In parallel, we critically discuss the available data regarding the therapeutic effect of the IL-12/IL-23 inhibitors and especially of ustekinumab, a human monoclonal antibody which has been recently approved by the United States Food and Drug Administration for the management of moderateto-severe CD and its potential to be used as first-line therapy in everyday clinical practice.

关键词： Crohn’s disease Interleukin 12 Interleukin 23 Monoclonal antibodies ustekinumab Biological agents Interleukin 12/interleukin 23 blockade

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Recalcitrant paradoxical pustular psoriasis induced by infliximab:Two case reports

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World Journal of Clinical Cases 2021年第15期9卷 3655-3661页

作者： Ping Xia Yan-Hong Li Zhong Liu Xu Zhang Qian Jiang Xiao-Yong Zhou Wei Su Department of Dermatology The First Hospital of WuhanWuhan 430022Hubei ProvinceChina Department of Dermatology Midwest Center for Dermatology and Cosmetic SurgeryClinton TownshipMI 48038United States

BACKGROUND Paradoxical psoriasis induced by tumor necrosis factor alpha antagonists is a rare side effect of those drugs and has similarities with and differences from classical psoriasis in clinical and pathological characteristics.Treating severe paradoxical psoriasis is challenging because the reported cases are rare,with treatment experience being only anecdotal.CASE SUMMARY We report 2 cases of paradoxical psoriasis caused by infliximab.Both cases manifested with a significant number of pustular lesions and had protracted and complicated clinical courses.In case 1,secukinumab alone could not control the eruptions,but colchicine supplementation markedly decreased disease activity.In case 2 miscellaneous medications were administered,including the systemic drug acitretin,the immunosuppressive drug cyclosporine,and the biologic agent ustekinumab.However,multiple applications of those medications failed to prevent new lesions from occurring.Both cases showed moderate-to-high antinuclear antibody titers.CONCLUSION Based on these cases,moderate-to-high anti-nuclear antibody titer seems to be a risk factor for paradoxical psoriasis.In addition,extensive pustular presentation may be a negative prognostic indicator and may portend a protracted clinical course refractory to therapy.

关键词： Pustular psoriasis Paradoxical Infliximab Secukinumab ustekinumab Antinuclear antibody Case report

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First United Arab Emirates consensus on diagnosis and management of inflammatory bowel diseases:A 2020 Delphi consensus

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World Journal of Gastroenterology 2020年第43期26卷 6710-6769页

作者： Maryam Alkhatry Ahmad Al-Rifai Vito Annese Filippos Georgopoulos Ahmad N Jazzar Ahmed M Khassouan Zaher Koutoubi Rahul Nathwani Mazen S Taha Jimmy K Limdi Gastroenterology and Endoscopy Department Ibrahim Bin Hamad Obaid Allah HospitalMinistry of Health and PreventionRas Al KhaimanUnited Arab Emirates Department of Gastroenterology Sheikh Shakbout Medical CityAbu DhabiUnited Arab Emirates Department of Gastroenterology Valiant ClinicDubaiUnited Arab Emirates Department of Gastroenterology and Endoscopy American HospitalDubaiUnited Arab Emirates Gastroenterology and Endoscopy Unit Al Zahra HospitalDubaiUnited Arab Emirates Gastroenterology Division Sheikh Khalifa Medical CityAbu DhabiUnited Arab Emirates Digestive Disease Unit Rashid HospitalDubaiUnited Arab Emirates Digestive Disease Institute Cleveland ClinicAbu DhabiUnited Arab Emirates Department of Gastroenterology Mediclinic City HospitalDubaiUnited Arab Emirates Gastroenterology and Hepatology Tawam HospitalAl AinUnited Arab Emirates Department of Gastroenterology The Pennine Acute Hospitals NHS TrustManchester Academic Health SciencesUniversity of ManchesterManchester M85RBUnited Kingdom

Ulcerative colitis and Crohn’s disease are the main entities of inflammatory bowel disease characterized by chronic remittent inflammation of the gastrointestinal tract.The incidence and prevalence are on the rise worldwide,and the heterogeneity between patients and within individuals over time is striking.The progressive advance in our understanding of the etiopathogenesis coupled with an unprecedented increase in therapeutic options have changed the management towards evidence-based interventions by clinicians with patients.This guideline was stimulated and supported by the Emirates Gastroenterology and Hepatology Society following a systematic review and a Delphi consensus process that provided evidence-and expert opinion-based recommendations.Comprehensive up-to-date guidance is provided regarding diagnosis,evaluation of disease severity,appropriate and timely use of different investigations,choice of appropriate therapy for induction and remission phase according to disease severity,and management of main complications.

关键词： Ulcerative colitis Crohn’s disease Infliximab Adalimumab Vedolizumab ustekinumab Tofacitinib

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Approach to medical therapy in perianal Crohn’s disease

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World Journal of Gastroenterology 2021年第25期27卷 3693-3704页

作者： Abhinav Vasudevan David H Bruining Edward V Loftus Jr William Faubion Eric C Ehman Laura Raffals Division of Gastroenterology and Hepatology Mayo ClinicRochesterMN 55905United States Department of Radiology Mayo ClinicRochesterMN 55905United States

Perianal Crohn’s disease remains a challenging condition to treat and can have a substantial negative impact on quality of life.It often requires combined surgical and medical interventions.Anti-tumor necrosis factor(anti-TNF)therapy,including infliximab and adalimumab,remain preferred medical therapies for perianal Crohn’s disease.Infliximab has been shown to be efficacious in improving fistula closure rates in randomized controlled trials.Clinicians can be faced with a number of questions relating to the optimal use of anti-TNF therapy in perianal Crohn’s disease.Specific issues include evaluation for the presence of perianal sepsis,the treatment target of therapy,the ideal time to commence treatment,whether additional medical therapy should be used in conjunction with anti-TNF therapy,and the duration of treatment.This article will discuss key studies which can assist clinicians in addressing these matters when they are considering or have already commenced anti-TNF therapy for the treatment of perianal Crohn’s disease.It will also discuss current evidence regarding the use of vedolizumab and ustekinumab in patients who are failing to achieve a response to anti-TNF therapy for perianal Crohn’s disease.Lastly,new therapies such as local injection of mesenchymal stem cell therapy will be discussed.

关键词： Fistula Biologics Inflammatory bowel disease Surgery Stem cells Infliximab ustekinumab

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ustekinumab治疗斑块状银屑病疗效和安全性的分析

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循证医学 2012年第3期12卷 157-162页

作者：杨惠芳王群南方医科大学广州510515 广东省人民医院皮肤科、广东省医学科学院广州510080

目的评价ustekinumab治疗斑块状银屑病的疗效和安全性。方法计算机检索中英文数据库,按照制定的标准纳入随机对照试验,手工查找检索到文献的参考文献。由2名研究者独立对各临床试验进行数据提取和质量评估。采用RevMan4.2.2软件进行Met... 详细信息

目的评价ustekinumab治疗斑块状银屑病的疗效和安全性。方法计算机检索中英文数据库,按照制定的标准纳入随机对照试验,手工查找检索到文献的参考文献。由2名研究者独立对各临床试验进行数据提取和质量评估。采用RevMan4.2.2软件进行Meta分析。结果纳入4项随机对照研究,共计2437例患者。Meta分析结果显示,ustekinumab治疗斑块状银屑病12周获得的疗效(三项指标)优于安慰剂,但ustekinumab90mg组和ustekinumab45mg组的疗效无显著差异,相对危险度为0.94(95%可信区间0.82～1.07),P=0.34;治疗28周,在皮损消退方面的疗效ustekinumab90mg组优于ustekinumab 45 mg组,相对危险度为0.89(95%可信区间0.84～0.95),P=0.0006,在生活质量改善方面两组无显著差异,相对危险度为0.93(95%可信区间0.85～1.01),P=0.08。最常见的不良反应是上呼吸道感染、鼻咽炎、头痛,ustekinumab与安慰剂、ustekinumab两个剂量之间的发生率无显著差异。结论皮下注射ustekinumab治疗中重度斑块状银屑病安全有效。

关键词：斑块状银屑病 ustekinumab 随机对照试验 Meta分析

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ustekinumab治疗斑块状银屑病疗效和安全性的Meta分析

Ustekinumab治疗斑块状银屑病疗效和安全性的Meta分析

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作者：杨惠芳南方医科大学

学位级别：硕士

研究背景：银屑病是一种常见、易复发、慢性炎症性的皮肤病,在我国总患病率约为0.123%,在国外,欧洲患病率可达1%-2%,日本为0.2%-1%之间,发病年龄以青壮年为多,国内有人报道(1992年)1246例患者的平均发病年龄为26.5岁。银屑病病情顽固,... 详细信息

研究背景：银屑病是一种常见、易复发、慢性炎症性的皮肤病,在我国总患病率约为0.123%,在国外,欧洲患病率可达1%-2%,日本为0.2%-1%之间,发病年龄以青壮年为多,国内有人报道(1992年)1246例患者的平均发病年龄为26.5岁。银屑病病情顽固,难以治愈,对患者的身心健康影响较大。近年来随着对银屑病发病机制研究的不断深入,认为银屑病是多基因遗传背景下的自身免疫紊乱性疾病,其发病主要与T细胞介导的免疫有关,致病过程包括初始T细胞活化为记忆-效应T细胞,记忆-效应T细胞进入循环移行至皮肤,分泌细胞因子发挥多种生物功能。银屑病目前尚无根治方法,治疗方法有光疗、服用甲氨蝶呤、维甲酸类药物、环孢素A,局部或系统应用糖皮质激素等,但因药物缺乏组织特异性,疗效不容乐观,且长期应用可能产生严重的副作用或不方便(光疗)而受到限制。因此开发和应用具有靶位特异性的生物制剂治疗银屑病非常必要,基于对银屑病发病机制新的认识,人们在银屑病生物治疗方面已取得重大进展。银屑病生物制剂包括单克隆抗体、融合蛋白、重组人源细胞因子或生长因子,根据其作用机制可分为以下几类：抑制T细胞活化,如阿法赛特、依法利珠、达克珠单抗、Siplizumab;TNF-α阻断剂,如英利昔单抗、阿达木单抗、依那西普;调节细胞因子平衡,如IL-4、IL-10、IL-11;抗IL-12/IL-23,如ustekinumab。美国食品与药物管理局(Food and Drug Administration,FDA)是国际上最严格、最权威的医疗药品监督机构之一,经美国FDA批准用于中重度斑块状银屑病的生物制剂有阿法赛特、依那西普、依法利珠、ustekinumab,用于银屑病关节炎的生物制剂有英利昔单抗、阿达木单抗、依那西普。ustekinumab是人源化抗IL-12/IL-23的单克隆抗体。IL-12与T细胞上的IL-12受体结合,诱导以IFN-y产生为代表的经典的Thl免疫反应,IL-23可诱导和维持Th17免疫反应。ustekinumab可与IL-12和IL-23的p40亚单位结合,抑制IL-12/IL-23的生物活性。ustekinumab是最新被美国FDA批准用于治疗中重度斑块状银屑病的生物制剂。有些药物虽然批准用于临床治疗,但长期使用的有效性和安全性需不断的观察与总结,例如依法利珠由于严重的不良反应,2009年初FDA就停止了依法利珠的生产及应用。因此对ustekinumab的疗效及安全性需更多的研究去分析。与传统的描述性综述不同,系统评价是针对一个具体的临床问题,根据临床流行病学减少偏倚和随机误差的原则及方法,收集全世界所有已发表和／或未发表的临床研究结果,筛选符合质量标准的文献,再进行定性或定量分析,从而获得较为可靠的结论。系统评价采用定量合成的方法对资料进行统计学处理即为Meta分析。使用Meta分析的方法评价试验的疗效和安全性,可改进和提高统计效能,可对结果不一致的情况作出较客观的判断,可解释在单独研究中尚未解释或不能解释的问题,因而应用广泛。随着更多相关试验的开展及完成,本研究收集到最新的临床试验数据,纳入患者包括欧美人和亚洲人,对因药物用法不同等引起的异质性做敏感性分析,使Meta分析的结果适用人群更广,结果更可靠。目的对ustekinumab治疗斑块状银屑病的疗效和安全性进行Meta分析,为临床合理用药提供更多可靠信息。方法 1按Meta分析的要求制定相应的详细的纳入和排除标准,包括研究类型、研究对象、干预措施、观察指标等。 2根据标准制定系统、全面的检索策略。计算机检索Cochrane图书馆、Pubmed、CNKI、万方数据库、CBM、维普期刊等数据库。手工查找检索到文献的参考文献。 3按照随机对照试验的质量评价标准评价纳入研究的方法学质量,包括随机方法、隐蔽分组、盲法实施和失访的描述,各个纳入研究的真实性可根据Cochrane系统评价员手册(Cochrane handbook for systematic reviews of interventions4.2.6)推荐的简单评估法进行质量分级,包括A、B、C三个等级。且按照Jadad量表进行评价,记分1～5分,1或2分为低质量研究,3-5分为高质量研究。并了解在有失访或退出时是否采用意向性治疗分析(intention to treat,ITT)。 4对收集的相关研究进行资料数据提取,主要是观察指标的数据提取。然后采用RevMan4.2.2统计软件进行Meta分析。计数资料采用相对危险度(relativerisk,RR)表示,并给出95%可信区间(confidence interval,CI)。并进行异质性检验,统计学异质性分析采用卡方(chi-square)χ2检验,检验水准α=0.1,如试验结果不存在异质性时采用固定效应模型(Fixed effect model)分析,如存在异质性则采

关键词： ustekinumab 斑块状银屑病随机对照试验 Meta分析

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新型靶向生物制剂ustekinumab用于自身免疫性疾病治疗

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世界临床药物 2010年第8期31卷 454-459页

作者：杨清锐白艳李璐张源潮山东大学附属省立医院风湿免疫科济南250021

细胞因子IL-12和IL-23参与多种自身免疫性疾病的发病,两者均为含有p40亚基的异源二聚体。人源化单克隆抗体ustekinumab可与IL-12和IL-23的p40亚基结合,抑制其药理作用。本文回顾分析ustekinumab在银屑病、银屑病关节炎、克罗恩病等免疫... 详细信息

细胞因子IL-12和IL-23参与多种自身免疫性疾病的发病,两者均为含有p40亚基的异源二聚体。人源化单克隆抗体ustekinumab可与IL-12和IL-23的p40亚基结合,抑制其药理作用。本文回顾分析ustekinumab在银屑病、银屑病关节炎、克罗恩病等免疫性疾病治疗中的临床评价。

关键词： ustekinumab IL-12 IL-23 银屑病银屑病关节炎克罗恩病

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