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Efficacy and Safety of Teriflunomide in Chinese Patients with relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study

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Chinese Medical Journal 2018年第23期131卷 2776-2784页

作者： Wei Qiu De-Hui Huang Shi-Fang Hou Mei-Ni Zhang Tao Jin Hui-Qing Dong Hua Peng Chao-Dong Zhang Gang Zhao Yi-Ning Huang Dong Zhou Wei-Ping Wu Bao-Jun Wang Ji-Mei Li Xing-Hu Zhang Yan Cheng Hai-Feng Li Ling Li Chuan-Zhen Lu Xu Zhang Bi-Tao Bu Wan-Li Dong Dong-Sheng Fan Xue-Qiang Hu Xian-Hao Xu Department of Neurology The Third Affiliated Hospital of Sun Yat-Sen UniversityGuangzhouGuangdong 510000China Department of Neurology Peking University First HospitalBeijing 100034China Department of Neurology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Neurology Baotou Central HospitalBaotouInner Mongolia 014040China Department of Neurology Beijing Friendship HospitalCapital Medical UniversityBeijing 100000China Department of Neurology Beijing Tian Tan HospitalCapital Medical UniversityBeijing 100050China Department of Neurology Tianjin Medical University General HospitalTianjin 300052China Department of Neurology The Affiliated Hospital of Qingdao UniversityQingdaoShandong 266003China Department of Neurology Hebei General HospitalShijiazhuangHebei 050051China Department of Neurology Hua Shah Hospital of the Shanghai Fudan University Medical CollegeShanghai 200040China Department of Neurology The First Affiliated Hospital of Wenzhou Medical UniversityWenzhouZhejiang 325000China Department of Neurology Chinese People's Liberation Army General HospitalBeijing 100853China Department of Neurology Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430030China Department of Neurology The First Affiliated Hospital of Soochow UniversitySuzhouJiangsu 215000China Department of Neurology Beijing HospitalNational Center of GerontologyBeijing 100083China Qilu Hospital of Shandong University JinanShandong 250012China Department of Neurology Beijing HospitalBeijing 100730China Department of Neurology The First Hospital of Shanxi Medical UniversityTaiyuanShanxi 030001China Department of Neurology The First Hospital of Jilin UniversityChangchunJilin 130012China Department of Neurology Xuanwu HospitalCapital Medical UniversityBeijing 100053China Department of Neurology Shanghai Chang Zheng HospitalShanghai 200003China Department of Neurology The First Hospital of China Medical UniversityShenyang

Background:Disease-modifying therapy is the standard treatment for patients with multiple sclerosis (MS)in remission.The primary objective of the current analysis was to assess the efficacy and safety of two teriflunomide doses (7mg and 14mg)in the subgroup of Chinese patients with relapsing MS included in the TOWER study. Methods:TOWER was a multicenter,multinational,randomized, double-blind,parallel-group (three groups),placebo-controlled study.This subgroup analysis includes 148 Chinese patients randomized to receive either teriflunomide 7mg (n =51), teriflunomide 14mg (n=43),or placebo (n=54). Results:Of the 148patients in the intent-to-treat population, adjusted annualized-relapse rates were 0.63(95% confidence interval [CI]:0.44,0.92)in the placebo group,0.48(95%CI:0.33, 0.70)in the teriflunomide 7mg group,and 0.18(95%CI:0.09,0.36)in the terifltmomide 14mg group;this corresponded to a significant relative risk reduction in the teriflunomide 14mg group versus placebo (-71.2%,P =0.0012).Terifiunomide 14mg also tended to reduce 12-week confirmed disability worsening by 68.1% compared with placebo (hazard ratio:0.319,P =0.1194).There were no differences across all treatment groups in the proportion of patients with treatment-emergent adverse events (TEAEs;72.2% in the placebo group,74.5%in the teriflunomide 7mg group,and 69.8% in the teriflunomide 14mg group);corresponding proportions for serious adverse events were 11.1%,3.9%,and 11.6%,respectively.The most frequently reported TEAEs with teriflunomide versus placebo were neutropenia,increased alanine aminotransferase,and hair thinning. Conclusions:Teriflunomide was as effective and safe in the Chinese subpopulation as it was in the overall population of patients in the TOWER trial.Teriflunomide has the potential to meet unmet medical needs for MS patients in China.

关键词： Chinese Patients Efficacy Phase 3 relapsing Multiple Sclerosis Safety Teriflunomide TOWER

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Usefulness of mizoribine administration in children with frequently relapsing nephrotic syndrome, and the relationship between pharmacokinetic parameters and efficacy: a multicenter prospective cohort study in China

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World Journal of Pediatrics 2019年第3期15卷 262-269页

作者： Zheng-Kun Xia Yuan-Fu Gao Li-Ping Rong Xi-Qiang Dang Qian Shen Xiao-Yun Jiang Zhu-Wen Yi Hong Xu Department of Pediatrics Jinling HospitalNanjing University School of MedicineNanjing 210002China Department of Pediatrics The First Affiliated Hospital of Sun Yat—Sen UniversityGuangzhou 510080China Department of Pediatric Nephrology Children’s Medical CenterSecond Xiangya HospitalCentral South University Changsha 410011China Department of Nephrology and Rheumatology Children’s Hospital of Fudan UniversityShanghai 201102China

Background Mizoribine (MZR) is an immunosuppressant used to treat adult nephropathy.There is little experience with the drug in treating Chinese children with frequently relapsing nephrotic syndrome (FRNS).We investigated the efficacy and safety for treating MZR with FRNS.Furthermore,the relationship between efficacy and serum concentration was investigated.Methods A prospective multicenter observational 12-month study was performed for evaluating the usefulness of MZR with FRNS.Serum MZR concentration was measured,and the relationships between pharmacokinetic parameters (Cmax,AUC),number of relapses,and urinary protein were evaluated.Results Eighty-two pediatric patients from four hospitals were treated with MZR and prednisone.MZR treatment significantly reduced the number of relapses and steroid doses.A correlation between pharmacokinetic parameters and relapses was observed,which fits well with the sigmoidal Emax model.Even in the relationship between pharmacokinetic parameters and urinary proteins,it was recognized that there was a threshold in the pharmacokinetic parameters for the therapeutic effect similar to the results obtained with the sigmoidal Emax model.Eleven patients (13.4%) experienced mild adverse events.Conclusions MZR therapy was effective in reducing the number of relapses and steroid doses.No severe adverse reactions were observed.Therapeutically effective serum concentrations were estimated to be Cmax > about 2 μg/mL or AUC > about 10 lag h/mL.MZR and steroid treatment were effective and safe for pediatric FRNS.

关键词： Frequently relapsing nephrotic syndrome Mizoribine Pharmacokinetic parameters

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Immunomodulatory activity of berberine in alleviating experimental chronic relapsing colitis via inhibition of the JAK/STAT signalling

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中国药理学通报 2015年第B11期31卷 50-51页

作者： LIYan-hong BIANZhao-xiang HongKongBaptistUniversityShenzhenResarchInsituteandContinuingEducaton ShenzhenLabofBrainandGutResearchhongKongChineseMedicineResachCentreSchoolofChineseMedicineHongKongBupistUniversityHongKong

Aim Ulcerative colitis （UC） is an increasingly common condition particularly in developed countries. The lack of satisfactory treatment fuels the search for alternative therapeutic strategies. In the present study, we as- sessed the preclinical activity of berberine for the treatment of dextran sodium sulphate （DSS）-induced chronic re- lapsing colitis in C57BL/6 mice. Methods Colitis of mice was induced by three cycles of 2.0% DSS. From day13 onward, colitis mice were orally administered with 20 mg/kg berberine for 30 days. The disease severity was de- termined by daily monitoring the body weight, stool consistency, and stool bleeding of mice. At the end of treat- ment, colons were collected and subjected to histological, RT-qPCR, Western blot, and LC-MS analyses. Lympho- eytes were isolated from spleens and cultured for assessment of eytokine secretion. Results Berberine significantly ameliorated disease severity, colon shortening, histological injuries of colitis mice. Further, berberine treatment consistently and notably regulated DSS-assoeiated increase in mRNAs levels of Thl7-related eytokines （inhibition of IL-17 and ROR-γt） in the colon out of all tested eytokines. Moreover, the increases of TNF-α, IL-6 and IL-23 mRNA, and the phosphorylated STAT3 in colons of DSS - treated mice were significantly reversed by berberine. In addition, berberine directly inhibited TNF-α and IL-17 secretion from cultured lymphoeytes upon PMA/ionomyein -1 re-stimulation. In the meanwhile, a six-time amount of berberine in colon tissue （4.26 ± 2.62 ng · g^-1 colon） was measured when compared that in serum （0.76 ± 0.23 ng · m1^-1） and no detected histological changes was found in major organs of colitis mice. Conclusion We demonstrate for the first time that berberine exerts immuno- modulatory effect in alleviating DSS-indueed chronic relapsing colitis via inhibition of the JAK/STAT signalling acti- vation in the inflamed colon. The demonstration of activity in this model supports the possibility of clinical efficacy of berberin

关键词： berberine DSS chronic relapsing colitis JAIL/STAT signaling

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Pediatric acute viral hepatitis with atypical variants:Clinical dilemmas and natural history

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World Journal of Hepatology 2022年第5期14卷 944-955页

作者： Moinak Sen Sarma Aathira Ravindranath Department of Pediatric Gastroenterology Sanjay Gandhi Postgraduate Institute of Medical SciencesLucknow 226014Uttar PradeshIndia Division of Pediatric Gastroenterology Apollo BGS HospitalsMysuru 570023KarnatakaIndia

Classical acute viral hepatitis(AVH)has an uncomplicated outcome.Acute liver failure has a grave prognosis.Atypical manifestations of AVH are a group of disorders that causes significant morbidity and dilemmas in children.These include prolonged cholestasis,relapsing hepatitis,ascitic form of AVH,late-onset hepatic failure(LOHF),intravascular hemolysis,and provoking an autoimmune trigger leading to autoimmune hepatitis.These entities cause significant liver dysfunction or worsening and are often difficult to differentiate from chronic liver disease(CLD).Ascitic form of AVH,LOHF,decompensated CLD and acute-onchronic liver failure have significant overlapping features that need to be carefully dissected out.In many cases,only on long-term follow-up,these clinical entities can be separately identified.Intravascular hemolysis is usually caused by associated glucose-6-phosphate dehydrogenase deficiency.Rarely CLD such as Wilson disease and autoimmune hepatitis can also present with hemolysis in the initial presentation,which can mimic AVH with hemolysis.Identifying deviations from typical manifestations aid in avoiding unnecessary investigations,allowing focused therapy and alleviating anxiety.

关键词： Viral Hepatitis Atypical Cholestasis relapsing Hemolysis Ascites

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relapsing polychondritis with p-ANCA associated vasculitis: Which triggers the other?

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World Journal of Clinical Cases 2014年第12期2卷 912-917页

作者： Ibolya File Csilla Trinn Zsolt Mátyus László Ujhelyi József Balla János Mátyus Institute of Internal Medicine University of Debrecen Clinical Centre H-4032 Debrecen Hungary Borsod-Abaúj-Zemplén County and University Teaching Hospital 2nd Department of Internal Medicine H-3526 Miskolc Hungary

relapsing polychondritis(RP) is a rare autoimmune disease with chronic inflammatory/destructive lesions of the cartilaginous tissues. In one third of the cases it is associated with other autoimmune disorders, mostly with anti-neutrophil cytoplasmic antibody(ANCA) associated vasculitis(AAV). We report three cases of RP with p-ANCA positive AAV. In the first patient RP developed 1.5 years after the onset of AAV. In the others the signs of RP were present before the onset of severe crescent glomerulonephritis. Patients responded well on steroid and cyclophosphamide. In dialysis dependent cases plasmapheresis was also used successfully. During the 2 and 1.5 years of follow up, they were symptom-free, and had stable glomerular filtration rate. The first patient died after four years of follow-up due to the complications of sudden unset pancytopenia,which raises the possibility of associated hemophagocytic syndrome. In the setting of RP or AAV physicians should always be aware of the possibility of sudden or insidious appearance of the other disease.

关键词： relapsing polychondritis Anti-neutrophil cytoplasmic antibody Anti-neutrophil cytoplasmic antibody-associated vasculitis Rapidly progressive glomerulonephritis Immunosuppressive treatment

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relapsing Polychondritis Associated with Myelodysplastic Syndrome

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Open Journal of Clinical Diagnostics 2015年第1期5卷 10-13页

作者： Mahfoudhi Madiha Mamlouk Habiba Lahiani Rym Turki Sami Kheder Adel Department of Internal Medicine A Charles Nicolle Hospital Tunis Tunisia

A 62-year-old man had arthritis and an infiltrated purpuric eruption of the legs. He presented then a cyanosis and aches of the left ear’s pinna with a voice disturbance and an inflammatory aspect of the nose. He had an anemia and a thrombopenia. The infectious and auto-immune research was negative. The laryngo-tracheal scan revealed calcifications of the larynx, the trachea and the initial portion of bronchi. Moreover, the biopsy from ear’s pinna cartilage confirmed the diagnosis of chondritis and peri-chondritis. He was thus considered to have the association with relapsing polychondritis and a myelodysplastic syndrome. The patient was treated with corticosteroids and iterative transfusions. The articular and skinny patient’s symptoms completely resolved. The anemia and the thrombopenia were partially improved. The relapsing polychondritis can be considered as paraneoplastic complication in the context of a myelodysplastic syndrome or as a fortuitous association. The mechanism of such an association remains unknown.

关键词： relapsing Polychodritis Biopsy Myelodysplastic Syndrome Prognosis

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Impact of an Exercise Training Program in a Patient with relapsing Polychondritis: A Case Report

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Open Journal of Rheumatology and Autoimmune Diseases 2018年第3期8卷 93-98页

作者： Alexandre Moura dos Santos Diego Sales de Oliveira Rafael Giovani Misse Letícia Alves Perin Jean Marcos de Souza Fernanda Rodrigues Lima Rosa Maria Rodrigues Pereira Samuel Katsuyuki Shinjo Division of Rheumatology Hospital das Clinicas HCFMUSP Faculdade de Medicina Universidade de Sao Paulo Sao Paulo Brazil

Background: Exercise training has demonstrating to be safe and promote benefits for several rheumatologic autoimmune diseases. However, no study has evaluated the safety and benefits of exercise in relapsing polychondritis. Aim: To evaluate the effectiveness of an exercise training program in a patient with relapsing polychondritis. Case presentation: A 67-year-old female patient with relapsing polychondritis in remission was submitted to a 12-week, twice weekly, aerobic and resistance training program. Aerobic capacity, muscle strength and function capacity, as well as body composition, were evaluated at baseline and after 12-weeks. Conclusions: Exercise training program demonstrated to be effective for increasing aerobic capacity, muscle strength and function, and for improving body composition in the patient. Further studies are necessary to confirm these findings.

关键词： Exercise Training relapsing Polychondritis Aerobic Training Resistance Training

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Stenosis of the Subglottic Trachea Revealing relapsing Polychondritis of a Young Adult

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International Journal of Clinical Medicine 2015年第9期6卷 646-651页

作者： Mounira El Euch Madiha Mahfoudhi Imen Gorsane Souha Hadded Wifek Bani Moez Karoui Sami Turki Taieb Ben Abdallah Department of Internal Medicine A Charles Nicolle Hospital Tunis Tunisia

relapsing polychondritis is a rare inflammatory disease involving essentially cartilaginous structures. Other systemic manifestations can be encountered as the eye and ear disturbance. Aortic aneurysms affect few cases. If affection of airway cartilages occurs, prognosis may be worsened by eventual stenotic lesions. We report a 22-year-old woman with relapsing polychondritis. When she was referred to our hospital 4 weeks after the onset of respiratory symptoms, she was having severe breathing difficulty. Immediate tracheostomy followed by steroid therapy improved her respiratory condition, although the treatment was complicated because of her diabetes. While airway involvement of relapsing polychondritis can be life threatening, it is curable with steroid therapy. Clinicians should keep in mind that airway obstruction could be caused by this disease.

关键词： relapsing Polychondritis Airway Narrowing Prognosis

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Larngeal Manifestations of relapsing Polychondritis

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Open Journal of Rheumatology and Autoimmune Diseases 2013年第2期3卷 108-112页

作者： Abdul Latif Hamdan Doja Sarieddine Department of Otolaryngology Head and Neck Surgery American University of Beirut Medical Center Beirut Lebanon

The incidence of relapsing Polychondritis is estimated to be 3.5 cases per million with only 600 cases being reported in the world. It can affect any age ranging from 5 to 84 years with predominance in the fourth and fifth decade. Male to female ratio varies from 1:1 to 1:3. It is believed to be an immunologic reaction to collagen Type II which is predominantly presented in the cartilaginous structures of the body and in the eye. The diagnosis is based on the presence of three or more clinical signs, one clinical sign in addition to histological confirmation, or involvement of two or more sites with a favorable response to treatment based on Mc Adam diagnostic criteria. The otolaryngologic manifestations of RP span the ears, nose, larynx and tracheobronchial tree. The symptoms include change in voice quality, respiratory discomfort, stridor, dyspnea, cough, chocking, anterior neck tenderness mainly over the thyroid cartilage and cricoid cartilages, aspiration and difficulty in swallowing. The laryngeal manifestations should be evaluated using high resolution computerized tomography, Magnetic resonance imaging, pulmonary function testing, plain radiography and pulmonary function testing.

关键词： relapsing Polychondritis Larynx Stridor

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A Case of relapsing Polychondritis Successfully Treated with Combination of a Glucocorticoid and Cyclosporine

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International Journal of Clinical Medicine 2015年第7期6卷 439-443页

作者： Koichiro Takahashi Hiroshi Inoue Hironori Sadamatsu Hitomi Umeguchi Naoko Sueoka-Aragane Shinya Kimura Division of Hematology Respiratory Medicine and Oncology Department of Internal Medicine Faculty of Medicine Saga University Saga Japan

relapsing polychondritis is a rare cartilaginous inflammatory disease affecting the external ear, nose, peripheral joints and tracheobronchial tree. It is characterized by recurrent inflammation and degeneration of cartilage and connective tissue. A 72-year-old man complained of dyspnea, cough and wheezing for 2 months. Diffuse wall thickening and narrowing from the trachea to segmental bronchus were seen on chest CT. Tracheostomy was performed in order to avoid as-phyxia, and he was diagnosed as relapsing polychondritis on the basis of pathology evaluation of a tracheal biopsy specimen. He was treated with high doses of a glucocorticoid, with which his symptoms improved. However, the cough and wheezing recurred after tapering of the glucocorticoid. His symptoms thereafter were improved by combination of the glucocorticoid with cyclosporine. The immunosuppressive agent provided effective treatment for glucocorticoid-resistant relapsing polychondritis.

关键词： relapsing Polychondritis Trachea Cyclosporine

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