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Comparative efficacy of secukinumab against adalimumab and infliximab in patients with moderate-to-severe plaque psoriasis

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Chinese Medical Journal 2022年第1期135卷 11-19页

作者： Ran Pan Xiaolun Wang Min Shu Jaydeep Das Manik Kalra Zhidong Wang Beijing novartis pharma Co.Ltd. ShanghaiChina novartis Healthcare Pvt.Ltd. HyderabadIndia

Background: Psoriasis is a common, chronic, immune-mediated inflammatory skin disease with increased epidermal proliferation. The objective of this review was to systematically identify the evidence and perform a network meta-analysis (NMA) to estimate the relative efficacy of secukinumab (SEC) against adalimumab (ADA) and infliximab (INF) for the treatment of moderate-to-severe plaque ***: A systematic literature review (SLR) was conducted according to a pre-specified protocol to identify relevant studies. Initially, the databases were searched from database inception till June 2013, and the SLR was updated in April 2020. The eligibility criteria included adult patients (≥18 years old) with moderate-to-severe plaque psoriasis, and the SLR included randomized controlled trials (RCTs). The comparators of interest were SEC, ADA, INF, and placebo (PLA), while outcomes of interest were Psoriasis Area and Severity Index (PASI) (50, 75, and 90) at weeks 12, 16, and 24. A Bayesian NMA for PASI was utilized with a framework that evaluated the probability of PASI responses in different categories of PASI thresholds within a single ***: A total of 23 RCTs that assessed the efficacy of SEC, ADA, and INF in patients with moderate-to-severe plaque psoriasis were identified. At 12 weeks, SEC was associated with a significantly better response compared with PLA and ADA for PASI 75 and 90, while response results were comparable against INF. At 12 weeks, risk ratio (95% confidence interval) derived from NMA for SECvs. ADA and INF for PASI 75 was 1.35 (1.19, 1.57) and 1.01 (0.90, 1.18), respectively. At the 16-week and 24-week time interval, SEC was significantly better than PLA, ADA, and INF for PASI 75 and ***: Efficacy of SEC in the treatment of patient populations with moderate-to-severe plaque psoriasis is well demonstrated through NMA.

关键词： Moderate-to-severe plaque psoriasis Secukinumab against adalimumab and infliximab Indirect comparison PASI response

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Management of acute heart failure-Is there a paradigm shift around the corner?

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World Journal of Cardiovascular Diseases 2013年第2期3卷 1-7页

作者： C. Pater, T. Severin novartis pharma AG Basel Switzerland

It has become increasingly apparent that the looming epidemic of heart failure calls for systematic treatment approaches tailored to the needs of individual patient phenotypes. Although chronic heart failure (CHF) therapies are continuously evolving based on the increasing understanding of the involved etiology, acute heart failure (AHF) therapies are still based on hemodynamic improvements and symptom alleviation. Guidelines on AHF management have highlighted that the currently administered AHF therapies lack evidence and have raised concerns on the safety and efficacy of some of the hitherto accepted treatment modalities. Additionally, the high mortality and morbidity rates associated with the current AHF therapies also add to the imperative need to revisit AHF management. The last decade has witnessed a paradigm shift in the way we define and diagnose AHF. Apart from it being recognized as a distinct clinical entity, research has also led to new data on the pathophysiological changes associated with AHF. These developments along with the limited short- and long-term effects of currently used therapies may herald a paradigm shift in the way we plan and deliver management strategies to treat the pathological progression of heart failure.

关键词： Acute Heart Failure Hemodynamic Clinical and Residual Congestion Vasodilators Diuretics Management Strategies

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Effect of vildagliptin as add-on therapy to a low-dose metformin

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World Journal of Diabetes 2010年第1期1卷 19-26页

作者： Claudia Filozof Sherwyn Schwartz James E Foley Diabetes Principal Medical Scientific Expert Novartis Pharma AG Diabetes and Glandular Disease Clinic novartis pharmaceuticals Corporation

AIM:To evaluate the efficacy and safety of the addition of vildagliptin to low-dose metformin and compare it to an uptitration of metformin in type 2 diabetes mellitus(T2DM) patients who have inadequate control with metformin ***:Eligible patients were randomized to receive vildagliptin 100 mg qd or metformin(500 mg qd for 2 wk and then 500 mg bid) added to open label me tformin 500 mg bid for the 24 *** primary endpoi nt was baseline to endpoint hemoglobin A1c(HbA1c) ***:The adjusted mean change from baseline in HbA1c at the 24th wk was-0.51% in the vildagliptin/metformin group(mean baseline HbA1c:7.4%) and-0.37% in the metformin monothera py group(mean baseline HbA1c:7.3%).The mean diffe rence was-0.14% with 95% Confidence Interval(-0.24%,-0.05%).As non-inf e riority(margin of 0.4%) was achieved,a test for superiority was *** test showed statistically significant superiority of the combination over monotherapy group(P = 0.002).Gastrointestinal(GI) adverse events were signif icantly more frequent in the metformin group than the combin ation group(21.0% vs 15.4%,P = 0.032).CONCLUSION:In patients with T2DM inadequately controlled with metformin up to 1000 mg daily,the addition of vildagliptin 100 mg daily achieved larger HbA1c reduction with fewer GI events than with increa sing the metformin dose.

关键词： Vildagliptin Metformin Dipeptidyl peptid ase-4 Hemoglobin A1c Glucagon-like peptide-1 Gastrointestinal side effects

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Impact of human sequences in variable domains of therapeutic antibodies on the location of CD4 T-cell epitopes

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Cellular & Molecular Immunology 2020年第6期17卷 656-658页

作者： Sylvain Meunier Moustafa Hamze Anette Karle Marie de Bourayne Abdelaziz Gdoura Sebastian Spindeldreher Bernard Maillère CEA-Saclay Institut Frederic JoliotSIMOPROUniversitéParis-Saclay91191 Gif sur YvetteFrance novartis pharma AG BaselSwitzerland Present address:Integrated Biologix GmbH BaselSwitzerland

The clinical efficacy of therapeutic antibodies is recognized in many indications,explaining their rapid rise in the worldwide drug ***,therapeutic antibodies can be immunogenic by inducing a specific immune response characterized by the production of anti-drug antibodies(ADAs).ADAs can potentially increase the clearance of therapeutic antibodies,decrease their therapeutic effects1 and induce hypersensitivity *** humans are thought to be tolerant to their own proteins,sequences of the therapeutic antibodies have been humanized or human antibodies have been directly generated by technologies using human ***,human(ized)antibodies exhibit highly variable levels of immunogenicity,1,2 illustrating the poor understanding of the role of sequence humanization in mitigating the immunogenicity of therapeutic *** lines of evidence highlight the role of CD4 T lymphocytes during the initiation of an ADA response,3 but few T-cell epitopes of marketed therapeutic antibodies have been described to date.

关键词： therapeutic antibodies clinical

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Applying Item Response Theory Methods to Improve the Measurement of Fatigue in a Clinical Trial of Rheumatoid Arthritis Patients Treated with Secukinumab

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Open Journal of Rheumatology and Autoimmune Diseases 2013年第4期3卷 192-201页

作者： Mark Kosinski Jakob B. Bjorner Ari Gnanasakthy Usha Mallya Shephard Mpofu novartis pharma AG Basel Switzerland. novartis pharmaceuticals Corporation East Hanover USA Quality Metric Incorporated Lincoln Rhode Island

Background: Many clinical trials include multiple patient-reported outcomes (PROs) to measure fatigue as secondary or exploratory endpoints of treatment effectiveness. Often, these instruments have overlapping content. The objective of this study was to compare the combined measurement properties of two fatigue scales, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and SF-36 vitality (VT) scale using item response theory (IRT). Methods: The FACIT-Fatigue and SF-36v2 were administered at baseline and weeks 2, 4, 7, 12, and 16 to rheumatoid arthritis (RA) patients (n = 237) enrolled in a 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy and safety of subcutaneous secukinumab administered to pa- tients with active RA. Confirmatory factor analysis (CFA) was used to investigate unidimensionality among FACIT- Fatigue and VT items. A generalized partial credit IRT model was used to cross-calibrate the FACIT-Fatigue and VT items and weighted maximum-likelihood estimation was used to score a composite fatigue index. Analysis of variance was used to compare the composite fatigue index with the original scales in responding to ACR improvement and treatment effects. Results: CFA found less than adequate fit to a unidimensional model. However, specifications of alternative multidimensional models were insufficient in explaining the common variance among items. An IRT model was successfully fitted and the composite fatigue index score was found to be more responsive than the original scales to ACR improvement and treatment effects. Effect sizes and significance tests for changes in scores on the composite index were generally larger than those observed with the original scales. Conclusion: IRT methods offer a promising approach to combining items from different scales measuring the same concept that could improve the detection of treatment effects in clinical studies of RA.

关键词： Patient-Reported Outcomes Fatigue Rheumatoid Arthritis Item Response Theory Clinical Trial

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Efficacy and safety of secukinumab over 52 weeks in Chinese psoriasis patients with concomitant psoriatic arthritis

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Chinese Medical Journal 2021年第21期134卷 2629-2631页

作者： Lin Cai Jian-Zhong Zhang Min Zheng Shi-Fa Zhang Manmath Patekar Department of Dermatology Peking University People’s HospitalBeijing 100044China Department of Dermatology Second Affiliated Hospital School of MedicineZhejiang UniversityHangzhouZhejiang 310009China Department of Dermatology General Hospital of Shenyang Military RegionShenyangLiaoning 110016China novartis pharma AG BaselSwitzerland

Psoriasis is a chronic,systemic inflammatory disease characterized by demarcated,scaly,erythematous skin *** arthritis(PsA)is the most common comorbidity.

关键词： patients plaques morbidity

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Short-Term Efficacy of Treating Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Based on Cold Pattern Differentiation with Hot Herbs: A Randomized Controlled Trial

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Chinese Journal of Integrative Medicine 2016年第8期22卷 573-580页

作者：郭玉明李丰衣宫嫚张琳王伽伯肖小河李筠赵艳玲王立福张晓锋 China Military Institute of Chinese Materia Medica 302 Military HospitalBeijing 100039China Treatment and Research Center for Infectious Diseases 302 Military HospitalBeijing 100039China Integrative Medical Center for Liver Diseases 302 Military HospitalBeijing 100039China Medical Affairs Novartis Pharma ChinaBeijing 100004China

Objective： To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction（茵陈术附汤, YCZFD） in the treatment of acute-on-chronic liver failure caused by hepatitis B virus（HBV-ACLF） with cold pattern in Chinese medicine（CM）. Methods： This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine（WM） for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM（integrative treatment） or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease（MELD） score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported. Results： The mortality was decreased 14.28% in the integrative treatment group compared with WM group（χ^2=6.156, P=0.013）. The integrative treatment was found to significantly improve the MELD score（t=2.353, P=0.020）. There were statistically significant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups（P〈0.05 or P〈0.01）. The complications of ascites（χ^2=9.033, P=0.003） and spontaneous bacteria peritonitis（χ^2=4.194, P=0.041） were improved significantly in the integrative treatment group. No serious adverse event was reported. Conclusions： The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle ＂treating cold pattern with hot herbs＂ remains valuable to the clinical therapy.（Trial registration No. Chi CTR-TRC-10000766）

关键词： hepatitis B virus-related acute-on-chronic liver failure mortality Chinese medicine cold pattern Yinchen Zhufu Decoction

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Prevalence of Wild-Type Butyrylcholinesterase Genotype in Patients with Alzheimer’s Dementia

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World Journal of Neuroscience 2015年第3期5卷 175-179页

作者： Beate Mueller Georg Adler novartis pharma GmbH Nürnberg Germany Institut für Studien zur Psychischen Gesundheit Mannheim Germany

Approximately, two-thirds patients with Alzheimer’s disease (AD) are reported to have homozygous wild-type butyrylcholinesterase (BuChE) gene expression. It is associated with a higher rate of hydrolysis of acetylcholine, which ultimately leads to increase in the levels of BuChE in advanced stages of the disease. Rivastigmine, a dual inhibitor of acetylcholinesterase (AChE) and BuChE, might be of additional benefit in patients with AD with wild-type BuChE allele.

关键词： Butyrylcholinesterase Alzheimer’s Disease Genotype

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Real-world clinical experience of secukinumab in Chinese patients with psoriasis in real-world practice:a 36-week single-center study of 24 patients

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Chinese Medical Journal 2020年第24期133卷 3020-3022页

作者： Jing Zhang Chao Ji Bo Cheng Shi-Fan Ruan Tao Liu Jin-Wen Huang Department of Dermatology Institute of Dermatology and VenereologyThe First Affiliated Hospital of Fujian Medical UniversityFuzhouFujian 350005China Key Laboratory of Skin Cancer of Fujian Higher Education Institutions the First Affiliated HospitalFujian Medical UniversityFuzhouFujian 350005China Department of Medical Affairs Beijing Novartis Pharma Company LimitedShanghai 201203China

To the Editor:Psoriasis is a chronic autoimmune inflammatory disease that has a significant negative impact on quality of ***(IL)-17A,a key molecule in the T helper 17 pathway,is important in the pathogenesis of ***,a fully human immunoglobulin G1 kappa monoclonal antibody that targets IL-17A,was the first anti-IL-17A antibody approved by the US Food and Drug Administration in *** China,it was approved in March 2019 for the treatment of moderate to severe psoriasis vulgaris(PsV),whereas in Japan,it is not only used for PsV but also psoriatic arthritis and generalized pustular psoriasis(GPP).The safety and efficacy of secukinumab have been assessed in four randomized controlled trials(RCTs)(ERASURE,FEATURE,JUNCTURE,and FIXTURE),which showed the superiority of secukinumab compared with placebo,etanercept,and ustekinumab,with long-term persistence of the clearance ***,the real-world setting of clinical practice is different from the strictly regulated setting of RCTs,which are conducted in only selected patients that fulfill strict inclusion and exclusion criteria to maximize internal *** date,there have been no official English reports of real-world studies published in China.

关键词： patients psoriasis clinical

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Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis:results from the 52-week,PhaseⅢChina-centric study,MEASURE 5

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Chinese Medical Journal 2020年第21期133卷 2521-2531页

作者： Feng Huang Fei Sun Wei-Guo Wan Li-Jun Wu Ling-Li Dong Xiao Zhang Tae-Hwan Kim Raj Sengupta Ladislav Senolt Yi Wang Hao-Min Qiu Brian Porter Sibylle Haemmerle Department of Rheumatology Chinese People’s Liberation Army General HospitalBeijing 100853China Department of Rheumatology Huashan HospitalFudan UniversityShanghai 200040China Department of Rheumatology&Immunology People's Hospital of Xinjiang Uygur Autonomous RegionUrumqiXinjiang 830001China Department of Rheumatology&Immunology Tongji HospitalTongji Medical College of Huazhong University of Science&TechnologyWuhanHubei 430030China Department of Rheumatology&Immunology Guangdong General HospitalGuangzhouGuangdong 510000China Hanyang University Hospital for Rheumatic Diseases SeoulRepublic of Korea Royal National Hospital for Rheumatic Disease Upper Borough WallsBath BA11RLUK Institute of Rheumatology PragueCzech Republic novartis pharmaceuticals Corporation East HanoverNJUSA China novartis Institutes for Biomedical Research Shanghai 201203China novartis pharma AG BaselSwitzerland

Background:Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis(AS)through 5 years in pivotal Phase III ***,we present efficacy and safety results(52-week)of secukinumab in patients with AS from the MEASURE 5 ***:MEASURE 5 was a 52-week,Phase III,China-centric *** patients were randomly assigned(2:1)to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks(q4w).All placebo patients switched to secukinumab 150 mg q4w starting at Week *** endpoint was Assessments of SpondyloArthritis international Society(ASAS)20 at Week *** was stratified by region(China ***-China).Results:Of 458 patients(secukinumab 150 mg,N=305;placebo,N=153)randomized,327(71.4%)were from China and 131(28.6%)were not from *** these,97.7%and 97.4%patients completed Week 16 and 91.1%and 95.3%(placebo-secukinumab)patients completed Week 52 of *** primary endpoint was met;secukinumab significantly improved ASAS20 response at Week 16 ***(58.4%vs.36.6%;P<0.0001);corresponding rate in the Chinese population was 56.0%vs.38.5%(P<0.01).All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16;responses were maintained with a trend toward increased efficacy from Week 16 to *** new or unexpected safety signals were reported up to Week ***:Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of *** was well tolerated and the safety profile was consistent with previous *** and safety results were comparable between the overall and Chinese populations.

关键词： Ankylosing spondylitis Biologics Cytokines Interleukin 17A Tumor necrosis factor

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