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biological therapy for ulcerative colitis:An update

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World Journal of Gastroenterology 2014年第37期20卷 13234-13238页

作者： Geom Seog Seo Soo-Cheon Chae Department of Gastroenterology Wonkwang University School of MedicineDigestive Disease Research Institute Department of Pathology Wonkwang University School of MedicineDigestive Disease Research Insti-tute

Of the diverse biological agents used for patients with ulcerative colitis, the anti-tumor necrosis factor-α agents infliximab and adalimumab have been used in large-scale clinical trials and are currently widely used in the treatment of inflammatory bowel disease patients. Recent studies have indicated that golimumab, oral tofacitinib and vedolizumab reportedly achieved good clinical response and remission rates in ulcerative colitis patients. Thus, we believe that the detailed investigation of various studies on clinical trials may provide important information for the selection of appropriate biological agents, and therefore, we have extensively reviewed such trials in the present study.

关键词： Ulcerative colitis Immune dysfunction biological therapy Remission Clinical trial Inflammatory bowel disease

Optimizing the use of biological therapy in patients with inflammatory bowel disease

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Gastroenterology Report 2015年第1期3卷 63-68页

作者： Alan C.Moss Division of Gastroenterology Beth Israel Deaconess Medical Center&Harvard Medical SchoolBostonMAUSA

biological therapy revolutionized the treatment of inflammatory bowel disease(IBD)during the last *** monoclonal antibodies,which target tumor necrosis factor(TNF),integrins or IL12/23,have been approved—or are in development for—both Crohn’s disease(CD)and ulcerative colitis(UC).Early use of these agents taught clinicians that induction and maintenance therapy,coupled with immunomodulator agents,reduced the immunogenicity of these agents,and led to sustained remission in many *** recent data has demonstrated that,through dose adjustments,optimizing serum drug levels may also provide more durable maintenance of remission,and improved mucosal *** review examines clinical practices that may enhance clinical outcomes from biological therapy in IBD.

关键词： inflammatory bowel disease biological therapy

Drug Survival of biological therapy in Patients with Rheumatoid Arthritis

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Open Journal of Rheumatology and Autoimmune Diseases 2024年第4期14卷 165-178页

作者： Bruna Moura Valquiria Dinis Poliane Buffon Eliana Zandonade Isac Moulaz Valeria Valim Cassiano Antonio Moraes University Hospital Federal University of Esprito Santo Esprito Santo Brazil

Background: biological therapy prevents structural damage, improves functional capacity, and has provided an important advance in the treatment of rheumatoid arthritis (RA). In a real-life scenario, drug survival is an indirect measure of the efficacy, safety, and tolerability of a drug. The objective of the study was to analyze the drug survival rate of biological therapy in a national health system (SUS). Methods: A retrospective cohort study of the medication process of RA was carried out in public pharmacies of a Brazilian state from January 2010 to April 2017. The Kaplan-Meier survival analysis was applied. The survival rate was defined as the incidence of drug discontinuation. The retention rate was defined as the mean of months using the drug. Results: Of the total of 902 individuals, 83.6% were female with a mean age of 56 years. Anti-TNF, mostly adalimumab (ADA), was the main biological agent prescribed. Mean drug retention of the first biological was 59.6 months (95% CI: 56.7 - 62.5), followed by 53.7 (95% CI: 48 - 59.4) and 28.2 (95% CI: 23.1 - 23.3) months for the second and third biologicals, respectively. Among the anti-TNF group, ADA, ETN, IFX had the better retention rate. There was no statistical difference in the general survival analyses (p = 0.18) among the groups. However, along the first 2 years, ADA, ETN, and RTX had the three better drug survival. The drug retention seems to increase with age (p = 0.036), with the subgroups > 70 years of age having the highest means (70 - 80 years: 67.29;>80: 67.53). Among all, 27.1% of patients switched to a second biologic. Conclusion: The anti-TNF group, mostly adalimumab (ADA), is the most prescribed medication as first and second-line therapy, reflecting its accessibility in the SUS and efficiency of the follow-up protocols. Among the anti-TNF group, ADA, ETN, and IFX had the better retention rate. Additionally, ADA and ETN had the better drug survival for the first treatment in the first 2 years. RTX wa

关键词： Rheumatoid Arthritis biological therapy Survival Rate Anti-TNF-α

Perioperative use of immunosuppressive medications in patients with Crohn’s disease in the new"biological era"

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Gastroenterology Report 2017年第3期5卷 165-177,I0001页

作者： Amy L.Lightner Bo Shen Division of Colon and Rectal Surgery Mayo ClinicRochesterMinnesotaMNUSA Center for Inflammatory Bowel Diseases Digestive Disease and Surgery Institutethe Cleveland Clinic FoundationClevelandOHUSA

Crohn’s disease(CD)is characterized by transmural inflammation of the gastrointestinal tract leading to inflammatory,stricturing and/or and fistulizing *** a patient develops medically refractory disease,mechanical obstruction,fistulizing disease or perforation,surgery is ***,surgery is not curative in most cases,underscoring the importance of bowel preservation and adequate perioperative medical *** many of the medications used to treat CD are immunosuppressive,the concern for postoperative infectious complications and anastomotic healing are particularly concerning;these concerns have to be balanced with preventing and treating residual or recurrent *** herein review the available literature and make recommendations regarding the preoperative,perioperative and postoperative administration of immunosuppressive medications in the current era of biological therapy for *** algorithms for perioperative medical management would greatly assist future research for optimizing surgical outcomes and preventing disease recurrence in the future.

关键词： Crohn’s disease biological therapy perioperative period medical management

Risk of infections of biological and targeted drugs in patients with spondyloarthritis: meta-analysis of randomized clinical trials

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Chinese Medical Journal 2022年第8期135卷 911-919页

作者： Lidong Hu Siliang Man Xiaojian Ji Yiwen Wang Xingkang Liu Jiaxin Zhang Chuan Song Jian Zhu Feng Huang Department of Rheumatology and Immunology The Rrst Medical CenterChinese PLA General HospitalBeijing 100853China Department of Rheumatology Beijing Jishuitan HospitalBeijing 100035Chini

Background: Concerns exist regarding the risk of infections in patients with spondyloarthritis (SpA) treated with biologics. We assessed the risk of infections of biological and targeted drugs in patients with SpA by performing a meta-analysis based on randomized controlled trials (RCTs).Methods: A systematic literature search was conducted in PubMed, Embase, Web of Science, the Cochrane Library, and China Biology Medicine Disc for RCTs evaluating the risk of infections of biological therapy in patients with SpA from inception through August 9, 2021. We calculated a pooled Peto odds ratio (OR) for infections in biologics-treated patientsvs. placebo patients. The risk of bias on the included RCTs was assessed by using the Cochrane Risk of Bias ***: In total, 62 studies were included in this meta-analysis. Overall, the risk of infection (Peto OR: 1.16, 95% confidence interval [CI]: 1.07-1.26,P < 0.001), serious infection (Peto OR: 1.65, 95% CI: 1.26-2.17,P < 0.001), upper respiratory tract infection (URTI) (Peto OR: 1.17, 95% CI: 1.04-1.32,P = 0.008), nasopharyngitis (Peto OR: 1.25, 95% CI: 1.10-1.42,P < 0.001), andCandida infection (Peto OR: 2.64, 95% CI: 1.48-4.71,P = 0.001) were increased in SpA patients treated with biologics compared with placebo. Sensitivity analysis based on biologics classes was conducted, and results demonstrated that compared with placebo, there was a higher risk of infection for tumor necrosis factor (TNF)-α inhibitors (Peto OR: 1.38, 95% CI: 1.13-1.68,P = 0.001) and interleukin (IL)-17 inhibitors (Peto OR: 1.55, 95% CI: 1.08-2.22,P = 0.018) in axial SpA, and for Janus kinase inhibitors in peripheral SpA (Peto OR: 1.39, 95% CI: 1.14-1.69,P = 0.001);higher risk of serious infection for IL-17 inhibitors in peripheral SpA (Peto OR: 3.46, 95% CI: 1.26-9.55,P = 0.016) and axial SpA (Peto OR: 2.01, 95% CI: 1.38-2.91,P < 0.001);higher risk of URTI for TNF-α inhibitors in axial SpA (Peto OR: 1.37, 95% CI: 1.05-1.78,P= 0.019), and for aprem

关键词： Spondyloarthritis biological therapy Infection Herpes zoster Meta-analysis

Risk of tuberculosis in patients with rheumatoid arthritis treated with biological and targeted drugs:meta-analysis of randomized clinical trials

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Chinese Medical Journal 2022年第4期135卷 409-415页

作者： Xiaojian Ji Lidong Hu Yiwen Wang Siliang Man Xingkang Liu Chuan Song Jiaxin Zhang Jian Zhu Jianglin Zhang Feng Huang Department of Rheumatology and Immunology The First Medical CenterChinese PLA General HospitalBeijing 100853China Xiamen Key Laboratory of Translational Medicine for Nucleic Acid Metabolism and Regulation Xiang’an Hospital of Xiamen UniversityXiamenFujian 361102China

Background:Concerns exist regarding the potential development of tuberculosis in patients with rheumatoid arthritis(RA)treated with biological and targeted *** assessed systematically whether biological therapy increased the risk of tuberculosis in patients with RA by meta-analysis of randomized controlled trials(RCTs).Methods:A systematic literature search was conducted in PubMed,Embase,the Cochrane Library,and China Biology Medicine disc for RCTs evaluating biological therapy in patients with RA from inception through August *** meta-analysis and network meta-analysis were performed to compare the risk of tuberculosis for each biologics class in patients with *** odds ratio(Peto OR)and its 95%confidence interval(CI)were calculated as the primary effect ***:In total,39 studies with 20,354 patients were included in this meta-analysis,and 82 patients developed *** risk of tuberculosis was increased in patients treated with biologics compared with non-biologics(Peto OR:3.86,95%CI:2.36-6.32,P<0.001).Also,tumor necrosis factor-α(TNF-α)inhibitors had a higher probability of developing tuberculosis than placebo(Peto OR:3.98,95%CI:2.30-6.88,P<0.001).However,network meta-analysis demonstrated that there was no significant difference in the risk of tuberculosis for each biologics class in patients with ***,tuberculosis was significantly more common in patients treated with a high dose compared with patients receiving a low dose of tofacitinib(Peto OR:7.39,95%CI:2.00-27.31,P=0.003).Conclusion:This meta-analysis demonstrates the evidence of an elevated risk of tuberculosis in patients with RA treated with TNF-αinhibitors,and a dose-dependent elevated risk of tuberculosis in patients treated with tofacitinib.

关键词： Rheumatoid arthritis biological therapy Tuberculosis Systematic review Meta-analysis Network meta-analysis

Correlations between skin lesions induced by anti-tumor necrosis factor-α and selected cytokines in Crohn's disease patients

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World Journal of Gastroenterology 2014年第22期20卷 7019-7026页

作者： Marcin Wodarczyk Aleksandra Sobolewska Bartosz Wójcik Karolina Loga Jakub Fichna Maria Wisniewska-Jarosińska Department of Gastroenterology Medical University of Lodz90-647 LodzPoland Jakub Fichna Department of Biochemistry Medical University of Lodz 92-215 Lodz Poland

AIM:To investigate the correlation between the appearance of skin lesions and concentration of interleukin(IL)-17A,IL-23 and interferon-γ(IFN-γ)in Crohn’s disease(CD)patients during anti-tumor necrosis factor-α(TNF-α)therapy METHODS:A prospective study included 30 adult patients with CD of Caucasian origin(19 men and 11women;mean age±SD 32.0±8.6 years)during biological therapy with anti-TNF-αantibodies from January2012 to March *** patients were treated with infliximab,seven with adalimumab and five *** criteria were exacerbation of the underlying disease,Crohn’s Disease Activity Index over 300 and the ineffectiveness of previously used non-biological *** with a history of psoriasis,atopic dermatitis and other autoimmune skin lesions were excluded from the *** control group consisted of 12 healthy subjects.A diagnostic survey was carried out,blood tests and careful skin examination were performed,and the serum levels of IL-17,IL-23 and IFN-γwere measured using an enzyme-linked immunosorbent assays *** that have developed in the course of biological therapy in patients who had no pre-existing skin lesions of similar character were qualified as skin lesions induced by antiTNF-α***:Skin manifestations occurred in 18 of CD patients during the anti-TNF-αtherapy(60%),in the average time of 10.16±3.42 mo following the beginning of the 52-wk treatment *** lesions observed in CD patients during biological therapy included psoriasiform lesions(44.4%),and eczema forms lesions(22.2%).In CD patients with drug induced skin lesions significantly higher levels of hemoglobin(13.3±1.5 g/dL vs 10.8±1.9 g/dL,P=0.018)and hematocrit(39.9%±4.5%vs 34.3%±5.4%,P=0.01),as well as a significantly lower level of platelets(268±62×103/μL vs 408±239×103/μL,P=0.046)was observed compared with CD patients without skin *** concentrations of IL-17A and IL-23in CD patients with skin lesions developed

关键词： biological therapy Crohn's disease Inter-leukin 17A Interleukin 23 Interferon γ Tumor necrosis factor-α

Risk of hepatitis B virus reactivation in patients with autoimmune diseases undergoing non-tumor necrosis factor-targeted biologics

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World Journal of Gastroenterology 2021年第19期27卷 2312-2324页

作者： Shintaro Akiyama Thomas G Cotter Atsushi Sakuraba Section of Gastroenterology Hepatology and NutritionDepartment of MedicineUniversity of ChicagoChicagoIL 60637United States

Hepatitis B virus reactivation(HBVr)can occur in patients treated with immunosuppressive *** stratification for HBVr based on hepatitis B virus(HBV)serology and viral load is an important strategy to determine appropriate HBV monitoring and antiviral prophylaxis *** advances in the understanding of pathophysiology of autoimmune diseases have led the development of cytokine-targeted *** necrosis factor(TNF)-αinhibitors have been widely used for patients with inflammatory bowel disease,psoriasis,and rheumatic ***,the clinical benefits of interleukin(IL)-12/23,IL-17,or Janus kinases inhibitors have been demonstrated in these *** is well known that TNF-αinhibitor use can lead to HBVr,however,the risk of HBVr in patients undergoing non-TNF-targeted biologics have not been fully *** this review,we discuss the risk of HBVr in patients treated with non-TNF-targeted biologics,and immunological mechanisms of these medications causing HBVr.

关键词： Hepatitis B virus Autoimmune diseases biological therapy Interleukin-23 Interleukin-17 Janus kinases

Malignant solitary fibrous tumor in the central nervous system treated with surgery,radiotherapy and anlotinib:A case report

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World Journal of Clinical Cases 2022年第2期10卷 631-642页

作者： Dong-Yong Zhang Lan Su Yi-Wei Wang Department of Neurosurgery the First Affiliated Hospital of China Medical UniversityShenyang 110001Liaoning ProvinceChina Department of Genetron Health Genetron HealthBeijing 110024China Department of Anatomy Shenyang Medical CollegeShenyang 110034Liaoning ProvinceChina

BACKGROUND Solitary fibrous tumor(SFT)of the central nervous system is *** is predominantly benign and rarely *** is no established standardized treatment regimen for malignant intracranial *** SUMMARY We present a rare case of SFT in a 9-year-old girl with a space-occupying effect in the frontal-parietal *** underwent craniotomy,and the mass was *** examination of the specimen showed that Ki-67 proliferation index staining was highly positive in 80%of tumor *** exome sequencing of the surgical tissue showed 38 somatic gene mutations and 1 gene amplification such as fibroblast growth factor receptor 4 or *** 1.5 mo after surgery,head magnetic resonance imaging revealed that the tumor had *** patient received 60 Gy and 30 fractions of intensity modulated *** patient then received anlotinib 8 mg po qd for 1-14 d of a 21 d *** this regimen,the patient achieved stable disease for>17 *** resonance imaging at 1.5 year after surgery showed that the tumor had not *** This is the first reported case of SFT of the central nervous system treated with surgery,radiotherapy and *** regimen may be an effective treatment option for malignant intracranial SFT patients.

关键词： Anlotinib biological therapy Mutation Recurrence Sequence analysis Case report