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Long-term outcome of stem cell transplantation with and without anti-tumor necrotic factor therapy in perianal fistula with Crohn’s disease

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World Journal of Stem Cells 2024年第3期16卷 257-266页

作者： Min Young Park Yong Sik Yoon Jae Ha Park Jong Lyul Lee Chang Sik Yu Division of Colon and Rectal Surgery Department of SurgeryYonsei University College of MedicineSeoul 03722South Korea Division of Colon and Rectal Surgery Department of SurgeryUniversity of Ulsan College of MedicineAsan Medical CenterSeoul 05505South Korea

BACKGROUND Stem cell transplantation is a promising therapeutic option for curing perianal fistula in Crohn’s disease(CD).Anti-tumor necrotic factor(TNF)therapy combined with drainage procedure is effective as well.However,previous studies are limited to proving whether the combination treatment of biologics and stem cell transplantation improves the effect of fistula closure.AIM This study aimed to evaluate the long-term outcomes of stem cell transplantation and compare Crohn’s perianal fistula(CPF)closure rates after stem cell transplantation with and without anti-TNF therapy,and to identify the factors affecting CPF closure and recurrence.METHODS The patients with CD who underwent stem cell transplantation for treating perianal fistula in our institution between Jun 2014 and December 2022 were enrolled.Clinical data were compared according to anti-TNF therapy and CPF closure.RESULTS A total of 65 patients were included.The median age of females was 26 years(range:21-31)and that of males was 29(44.6%).The mean follow-up duration was 65.88±32.65 months,and complete closure was observed in 50(76.9%)patients.The closure rates were similar after stem cell transplantation with and without anti-TNF therapy(66.7%vs 81.6%at 3 year,P=0.098).The patients with fistula closure had short fistulous tract and infrequent proctitis and anorectal stricture(P=0.027,0.002,and 0.008,respectively).Clinical factors such as complexity,number of fistulas,presence of concurrent abscess,and medication were not significant for closure.The cumulative 1-,2-,and 3-year closure rates were 66.2%,73.8%,and 75.4%,respectively.CONCLUSION Anti-TNF therapy does not increase CPF closure rates in patients with stem cell transplantation.However,both refractory and non-refractory CPF have similar closure rates after additional anti-TNF therapy.Fistulous tract length,proctitis,and anal stricture are risk factors for non-closure in patients with CPF after stem cell transplantation.

关键词： Crohn’s disease Anus Fistula Stem cell transplantation Tumor necrosis factor-alpha inhibitors infliximab

Is tumor necrosis factor-α monoclonal therapy with proactive therapeutic drug monitoring optimized for inflammatory bowel disease? Network meta-analysis

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World Journal of Gastrointestinal Surgery 2024年第2期16卷 571-584页

作者： Fang-Yuan Zheng Kai-Si Yang Wen-Cheng Min Xin-Zhu Li Yu Xing Shuai Wang Ying-Shi Zhang Qing-Chun Zhao Teaching Hospital of Shenyang Pharmaceutical University General Hospital of Northern Theater CommandShenyang 110016Liaoning ProvinceChina

BACKGROUND The efficacy and safety of anti-tumor necrosis factor-α(TNF-α)monoclonal antibody therapy[adalimumab(ADA)and infliximab(IFX)]with therapeutic drug monitoring(TDM),which has been proposed for inflammatory bowel disease(IBD)patients,are still controversial.AIM To determine the efficacy and safety of anti-TNF-αmonoclonal antibody therapy with proactive TDM in patients with IBD and to determine which subtype of IBD patients is most suitable for proactive TDM interventions.METHODS As of July 2023,we searched for randomized controlled trials(RCTs)and observa-tional studies in PubMed,Embase,and the Cochrane Library to compare anti-TNF-αmonoclonal antibody therapy with proactive TDM with therapy with reactive TDM or empiric therapy.Pairwise and network meta-analyses were used to determine the IBD patient subtype that achieved clinical remission and to determine the need for surgery.RESULTS This systematic review and meta-analysis yielded 13 studies after exclusion,and the baseline indicators were balanced.We found a significant increase in the number of patients who achieved clinical remission in the ADA[odds ratio(OR)=1.416,95%confidence interval(CI):1.196-1.676]and RCT(OR=1.393,95%CI:1.182-1.641)subgroups and a significant decrease in the number of patients who needed surgery in the proactive vs reactive(OR=0.237,95%CI:0.101-0.558)and IFX+ADA(OR=0.137,95%CI:0.032-0.588)subgroups,and the overall risk of adverse events was reduced(OR=0.579,95%CI:0.391-0.858)according to the pairwise meta-analysis.Moreover,the network meta-analysis results suggested that patients with IBD treated with ADA(OR=1.39,95%CI:1.19-1.63)were more likely to undergo TDM,especially in comparison with patients with reactive TDM(OR=1.38,95%CI:1.07-1.77).CONCLUSION Proactive TDM is more suitable for IBD patients treated with ADA and has obvious advantages over reactive TDM.We recommend proactive TDM in IBD patients who are treated with ADA.

关键词： Inflammatory bowel disease Therapeutic drug monitoring Adalimumab infliximab Network meta-analysis

Nursing Care of infliximab for Injection in Crohn’s Disease

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Yangtze Medicine 2024年第2期8卷 41-47页

作者： Liu Yang Xiaomei Cai Zhimin Tian The First Affiliated Hospital of Yangtze University Jingzhou China

Objective: To summarize the nursing experience of infliximab injection in the treatment of Crohns disease. Methods: 25 patients with Crohns disease admitted to our hospital from November 2017 to February 2024 were treated with infliximab. The therapeutic effect and adverse drug reactions were observed, nursing intervention was given, and follow-up was performed at 2 weeks, 6 weeks after the first treatment and every 2 months after the treatment cycle. According to Crohns disease activity index (CDAI) score, 23 cases with 4 were classified as remission stage and 2 cases with 6 were classified as mild activity stage. infliximab-treated Crohns patients had a good prognosis and minor adverse reactions. A correct grasp of the basic knowledge of the drug, standardized operation, attention to the psychological state of the patient, close observation of the change of the patients condition, and predictability of the treatment of adverse drug reactions are the guarantee of smooth treatment.

关键词： Crohn’s Disease infliximab Adverse Reactions Nursing

Navigating treatment resistance:Janus kinase inhibitors for ulcerative colitis

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World Journal of Clinical Cases 2024年第24期12卷 5468-5472页

作者： Jonathan Soldera Acute Medicine and Gastroenterology University of South WalesCardiff CF371DLUnited Kingdom

The management of refractory ulcerative colitis(UC)and acute severe UC(ASUC)is challenging due to the lack of standardized approaches in cases resistant to multiple treatments.In this editorial,I investigate the efficacy and safety of Janus kinase inhibitors,particularly upadacitinib and tofacitinib,in controlling severe and refractory disease.I highlight a notable case report by Xu et al,which explores the case of a patient with primary nonresponse to two classes of biologics and two fecal microbiota transplants who exhibited a remarkable response to upadacitinib.Furthermore,I discuss the use of tofacitinib in refractory UC and ASUC,either as monotherapy or in combination with biologics,which has shown promising response rates.Additionally,emerging evidence of upadacitinib efficacy in ASUC is presented.Overall,these cases emphasize the complex nature of managing refractory ASUC and the potential of small-molecule therapies to achieve remission.Further research is needed to refine treatment strategies for patients with treatment-resistant UC.

关键词： Inflammatory bowel disease Ulcerative colitis Janus kinase inhibitor Upadacitinib Tofacitinib infliximab

infliximab vs adalimumab:Points to consider when selecting antitumor necrosis factor agents in pediatric patients with Crohn’s disease

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World Journal of Gastroenterology 2023年第18期29卷 2784-2797页

作者： Eun Sil Kim Ben Kang Department of Pediatrics Kangbuk Samsung HospitalSungkyunkwan University School of MedicineSeoul 03181South Korea Department of Pediatrics School of MedicineKyungpook National UniversityDaegu 41944South Korea

Biologic agents with various mechanisms against Crohn’s disease(CD)have been released and are widely used in clinical practice.However,two anti-tumor necrosis factor(TNF)agents,infliximab(IFX)and adalimumab(ADL),are the only biologic agents approved by the Food and Drug Administration for pediatric CD currently.Therefore,in pediatric CD,the choice of biologic agents should be made more carefully to achieve the therapeutic goal.There are currently no headto-head trials of biologic agents in pediatric or adult CD.There is a lack of accumulated data for pediatric CD,which requires the extrapolation of adult data for the positioning of biologics in pediatric CD.From a pharmacokinetic point of view,IFX is more advantageous than ADL when the inflammatory burden is high,and ADL is expected to be advantageous over IFX in sustaining remission in the maintenance phase.Additionally,we reviewed the safety profile,immunogenicity,preference,and compliance between IFX and ADL and provide practical insights into the choice of anti-TNF therapy in pediatric CD.Careful evaluation of clinical indications and disease behavior is essential when prescribing anti-TNF agents.In addition,factors such as the efficacy of induction and maintenance of remission,safety profile,immunogenicity,patient preference,and compliance play an important role in evaluating and selecting treatment options.

关键词： Anti-tumor necrosis factor infliximab Adalimumab Crohn’s disease Pediatric

Efficacy and safety of adalimumab in comparison to infliximab for Crohn's disease:A systematic review and meta-analysis

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World Journal of Clinical Cases 2022年第18期10卷 6091-6104页

作者： Hua-Hua Yang Yi Huang Xu-Chun Zhou Ruo-Nan Wang Department of Gastroenterology The First Affiliated Hospital of Chongqing Medical UniversityChongqing 400016China Department of Endocrinology Liyuan HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430077Hubei ProvinceChina

BACKGROUND Adalimumab(ADA)and infliximab(IFX)are the cornerstones of the treatment of Crohn’s disease(CD).It remains controversial whether there is a difference in the effectiveness and safety between IFX and ADA for CD.AIM To perform a meta-analysis to compare the effectiveness and safety of ADA and IFX in CD.METHODS Pub Med,Embase,Cochrane Library,and Web of Science databases were searched.Cohort studies were considered for inclusion.The primary outcomes were induction of response and remission,maintenance of response and remission,and secondary loss of response.Adverse events were secondary outcomes.RESULTS Fourteen cohort studies were included.There was no apparent difference between the two agents in the induction response[odds ratio(OR):1.27,95%confidence interval(CI):0.93-1.74,P=0.14]and remission(OR:1.11,95%CI:0.78–1.57,P=0.57),maintenance response(OR:1.08,95%CI:0.76–1.53,P=0.67)and remission(OR:1.26,95%CI:0.87–1.82,P=0.22),and secondary loss of response(OR:1.01,95%CI:0.65–1.55,P=0.97).Subgroup analysis revealed ADA and IFX had similar rates of response,remission,and loss of response either in anti-tumor necrosis factor-αna?ve or non-na?ve patients.Further,there was a similar result regardless of whether CD patients were treated with optimized therapy,including dose intensification,shortening interval,and combination immunomodulators.However,ADA had a fewer overall adverse events than IFX(OR:0.62,95%CI:0.42–0.91,P=0.02).CONCLUSION ADA and IFX have similar clinical benefits for anti-tumor necrosis factor-αna?ve or non-na?ve CD patients.Overall adverse events rate is higher in patients in the IFX group.

关键词： Crohn disease Adalimumab infliximab Clinical efficacy Adverse effects Meta-analysis

infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis： a randomized, double-blind, placebo-controlled multicenter trial

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Chinese Medical Journal 2012年第11期125卷 1845-1851页

作者： YANG Hai-zhen WANG Ke JIN Hong-zhong GAO Tian-wen XIAO Sheng-xiang XU Jin-hua WANG Bao-xi ZHANG Fu-ren LI Chun-yang LIU Xiao-ming TU Cai-xia JI Su-zhen SHEN Yang ZHU Xue-jun Department of Dermatology Peking University First Hospital Beijing 100034 China Department of Dermatology Peking Union Medical College Hospital Chinese Academy of Medical Sciences ＆ Peking Union Medical College Beijing 100730 China Department of Dermatology Xijing Hospital Fourth Military Medical University Xi＇an Shaanxi 710032 China Department of Dermatology Northwest Hospital Xi＇an Jiaotong University Xi＇an Shaanxi 710004 China Department of Dermatology Huashan Hospital Fudan University Shanghai 200040 China Institute of Dermatology Chinese Academy of Medical Sciences ＆ Peking Union Medical College Nanjing Jiangsu 210042 China Shandong Provincial Hospital of Dermatology Shandong Provincial Institute of Dermatology and Venereology Jinan Shandong 250022 China Department of Dermatology Qilu Hospital of Shandong University Jinan Shandong 250012 China Department of Dermatology First Affiliated Hospital of Dalian Medical University Dalian Liaoning 116011 China Department of Dermatology Second Affiliated Hospital of Dalian Medical University Dalian Liaoning 116027 China China Rescarch and Development Xian Janssen Pharmaceutical Ltd Beijing 100025 China

Background Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis. Methods In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy （weeks 0, 2 and 6） with infliximab 5 mg/kg （n=84） or placebo （n=45）, followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index （PASI 75 response rate） from baseline at week 10. Results At week 10, 81.0% of patients treated with infliximab （5 mg/kg） achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo （P 〈0.001）. A significant improvement in PASI, Physician＇s Global Assessment （PGA） and Dermatology Life Quality Index （DLQI）, was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal. Conclusions infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.

关键词： infliximab psoriasis, biologics

infliximab in pediatric inflammatory bowel disease rapidly decreases fecal calprotectin levels

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World Journal of Gastroenterology 2011年第47期17卷 5166-5171页

作者： Anssi Hmlinen Taina Sipponen Kaija-Leena Kolho Hospital for Children and Adolescents Helsinki University Central Hospital University of Helsinki Division of Gastroenterology Helsinki University Central Hospital

AIM: To study the response to infliximab in pediatric inflammatory bowel disease (IBD), as reflected in fecal calprotectin levels. METHODS: Thirty-six pediatric patients with IBD [23 Crohn's disease (CD), 13 ulcerative colitis (UC); median age 14 years] were treated with infliximab. Fecal calprotectin was measured at baseline, and 2 and 6 wk after therapy, and compared to blood inflammatory markers. Maintenance medication was unaltered until the third infusion but glucocorticoids were tapered off if the patient was doing well. RESULTS: At introduction of infliximab, median fecal calprotectin level was 1150 μg/g (range 54-6032 μg/g). By week 2, the fecal calprotectin level had declined to amedian 261 μg/g (P infliximab, fecal calprotectin levels reflecting intestinal inflammation normalized rapidly in one third of pediatric patients suggesting complete mucosal healing.

关键词： Crohns 疾病 Ulcerative 大肠炎代理人标记儿科 Monoclonal 抗体 infliximab

infliximab therapy and outcomes in patients with polyarticular juvenile idiopathic arthritis:a single-center study in China

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World Journal of Pediatrics 2020年第1期16卷 68-73页

作者： Da-Wei Liu Jiao-Jiao Chen Xue-Mei Tang Yu ZhangJuan Zhou Ministry of Education Key Laboratory of Child Development and Disorders Children's Hospital of Chongqing Medical UniversityChongqingChina Chongqing Key Laboratory of Child Infection and Immunity Children's Hospital of Chongqing Medical UniversityChongqingChina Division of Immunology and Rheumatology Children's Hospital of Chongqing Medical UniversityChongqingChina

Background Juvenile idiopathic arthritis(JIA)is a chronic inflammatory disease that includes seven heterogeneous subgroups with different prognoses.In particular,polyarticular JIA(pJIA)has a longer period of active disease and a poorer prognosis.Tumor necrosis factor(TNF)-alpha inhibitors are effective in patients with pJIA,but the therapeutic regimen remains controversial.Here,we performed a single-center study to determine the potential correlation between TNF-alpha inhibitor(infliximab)therapy and outcomes in these patients.Methods Clinical data of 40 pJIA patients were collected at our center from January 1,2010 to January 1,2018,and patients were grouped according to the timing of infliximab therapy.The erythrocyte sedimentation rate(ESR),the number of joints with active disease,and the 27-point juvenile arthritis disease activity score(JADAS-27)were analyzed.Results The ESR,the active joint count,and the JADAS-27 decreased significantly in all groups after 3 months(P=0.041/0.415/0.008,0.022/0.030/infliximab treatment,although the rates of change of these parameters were similar.However,after 12 months,only patients treated with infliximab within 3 months of disease onset had a stable ESR,active joint count,and JADAS-27,while these parameters increased sharply when infliximab was administered 3 months and especially 1 year after disease onset.Conclusions TNF-alpha is a pleiotropic pro-inflammatory cytokine of crucial importance in the pathogenesis of JIA.infliximab can improve the outcomes of patients with pJIA significantly,and should be introduced early during the clinical course.

关键词： infliximab Outcomes Polyarticular juvenile idiopathic arthritis Treatment opportunity