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P442 Incidence of pneumonia and other respiratory tract infections with vedolizumab treatment for inflammatory bowel disease: clinical trial experience

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S301-S302页

作者： Feagan, B. Bhayat, F. Khalid, J.M. Palo, W. Blake, A. Shetzline, M. Travis, S. Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada Takeda Development Centre Europe Ltd Global Pharmacovigilance London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Takeda Development Center Americas Inc. Global Statistics and Statistical Programming Deerfield United States Takeda Development Center Europe Ltd Global Pharmacovigilance London United Kingdom Takeda Pharmaceuticals International Co. Clinical Science GI Cambridge United States University of Oxford Translational Gastroenterology Unit Nuffield Department of Medicine Oxford United Kingdom

Background:Vedolizumab (VDZ) is a humanised monoclonal antibody that binds to α4β7integrin and selectively blocks gut-specific lymphocyte trafficking. Although upper respiratory tract infections (URTIs) have been reported with VDZ [1] its gut selectivity may reduce the risk of respiratory tract infections (RTIs), including pneumonia, compared with therapies producing systemic immunosuppression (e.g. anti-tumour necrosis factor-alpha [TNFα] agents). We aimed to determine the incidence of RTIs associated with VDZ treatment in the clinical trial ***:Safety data from VDZ phase 3 randomised controlled trials (RCTs) in ulcerative colitis (UC; GEMINI 1) and Crohn's disease (CD; GEMINI 2) and a phase 3 open-label extension (OLE; C13008 ongoing study in both UC and CD) were used to calculate the incidence of lower RTIs (LRTIs), including pneumonia, and URTIs using the MedDRA High Level Terms “lower respiratory tract and lung infections” and “upper respiratory tract infections”. A Cox proportional hazards model was used to identify potential predictors of these AEs for the pooled GEMINI 1 and 2 ***:Of 1731 patients in the pooled RCT population and 2243 patients in the OLE, mean (SD) ages were 37.9 (12.7) years and 39.1 (13.2) years, respectively; 43% and 50%, respectively, had disease duration ≥7 years; and 57% and 59%, respectively, had prior anti-TNFα therapy. In the RCTs, the rate of LRTIs, including pneumonia, was similar in the VDZ and placebo groups (Table 1). Rates of LRTIs were higher for VDZ-treated patients with CD than with UC. Most LRTI and URTI AEs were not serious and did not result in treatment discontinuation. Predictors of increased incidence of LRTIs were identified as being a current or former smoker, female sex and prior anti-TNFα therapy (Table 2). Predictors of URTIs were: being a current smoker, concomitant narcotic use and prior anti-TNFα ***:In this post hoc analysis, VDZ treatment of IBD was not associated with

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193TiP: CheckMate 171: A multicenter phase 2 trial of nivolumab (nivo) in patients (pts) with stage IIIB/IV squamous cell (SQ) NSCLC who have received ≥1 prior systemic treatment

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Journal of Thoracic Oncology 2016年第4期11卷 S141页

作者： Felip, E. Van Meerbeeck, J. Wolf, J. Ardizzoni, A. Li, A. Srinivasan, S. Popat, S. Oncologia Médica Vall d'Hebron University Hospital Institut d'Oncologia Barcelona Spain Thoraxoncologie Universitair Ziekenhuis Antwerpen Antwerp Belgium Center for Integrated Oncology Köln-Bonn University Hospital of Köln Cologne Germany Medical Oncology UOC Oncologia Medica Parma Italy Global Biometric Sciences/Statistical Programming and Technologies Bristol-Myers Squibb Princeton NJ United States Medical Affairs Bristol-Myers Squibb Princeton NJ United States Department of Medicine Royal Marsden Hospital NHS Foundation Trust London United Kingdom

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DOP019 Effect of vedolizumab treatment on extraintestinal manifestations in patients with Crohn’s disease: a GEMINI 2 post hoc analysis

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S36-S38页

作者： Feagan, B.G. Sandborn, W.J. Colombel, J.-F. O’Byrne, S. Khalid, J.M. Brayshaw, N. Geransar, P. Rubin, D.T. Robarts Research Institute University of Western Ontario Robarts Clinical Trials Inc London Canada University of California San Diego Division of Gastroenterology La Jolla United States Icahn School of Medicine at Mount Sinai Gastroenterology New York United States Takeda Pharmaceuticals International AG Global Medical Affairs Zurich United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Pharmaceuticals International AG Global Medical Affairs Zürich Switzerland University of Chicago Medicine Inflammatory Bowel Disease Center Section of Gastroenterology Hepatology and Nutrition Chicago United States

Background:Extraintestinal manifestations (EIMs) pose an additional burden to patients with IBD (reported frequency: 6–47%) [1]. Vedolizumab (VDZ) is approved for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis. This post hoc exploratory analysis investigated the effect of VDZ treatment on existing and new EIMs in patients with CD enrolled in GEMINI 2 (NCT00783692).Methods:Data were collected on 5 categories of EIM and assessed using the following definitions: sustained resolution (absence of an EIM symptom, sustained to study end), worsening of existing EIM and occurrence of new EIM. For the category of arthritis/arthralgia (ar/ar), Kaplan–Meier (KM) estimates were used to describe “time to sustained resolution”. A multivariate Cox regression adjusting for potential baseline confounding factors was conducted. In patients receiving corticosteroids (CS), the influence of steroid tapering on the occurrence of new or worsening ar/ar was explored, with prednisone equivalent dose (≤30 mg) as a time-dependent ***:Patients (pts) received VDZ (n=814), VDZ/placebo (VDZ/PLA; VDZ to Week 6, PLA Week 6–52; n=153) or PLA only (n=148). Baseline EIM incidence was similar across treatment groups (Table). Further analyses focussed on ar/ar as the most common EIM. Predicted annual rates of sustained resolution of ar/ar were 51% (VDZ), 41% (VDZ/PLA) and 36% (PLA; Figure). VDZ pts were 32% more likely to achieve sustained resolution of ar/ar versus PLA (not significant [NS], Table) and 21% less likely to have a worsening/new occurrence (NS, Table). In pts receiving CS (n=530), adjustment for CS withdrawal resulted in ∼4% increased likelihood of new or worsening ar/ar in all groups over time (30 mg dose reduction HR 1.04 [95% CI: 0.67–1.60], NS). Hazard reduction for the VDZ groups versus those on PLA was similar (VDZ, 0.73 [95% CI: 0.44–1.22], NS; VDZ/PLA, 0.72 [95% CI: 0.37–1.39], NS).Conclusions:In this post hoc exploratory ana

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DOP026 Sustained remission with vedolizumab in patients with moderately to severely active ulcerative colitis: a GEMINI 1 post hoc analysis of week 14 remitters

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S42-S43页

作者： Stallmach, A. Bokemeyer, B. Axler, J. Curtis, R. Ehehalt, R. Feagan, B. Geransar, P. James, A. Kaviya, A. Khalid, J.M. Wolf, D. Schreiber, S. University hospital Jena Department of Internal Medicine IV Jena Germany Gastroenterology Practice Private practice Minden Germany TDDA (Toronto Digestive Disease Associates Inc.) Toronto Canada Takeda Development Centre Europe Ltd Global Medical Affairs London United Kingdom Praxis für Gastroenterologie Gastroenterology Heidelberg Germany Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada Takeda Pharmaceuticals International AG Global Medical Affairs Zurich Switzerland Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Development Centre Europe Ltd Clinical Development London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Atlanta Gastroenterology Associates Emory Saint Joseph's Atlanta United States University Hospital Schleswig-Holstein Institute for Clinical Molecular Biology Kiel Germany

Background:Sustained remission is a key therapeutic goal in ulcerative colitis (UC). Vedolizumab (VDZ) was more effective than placebo as induction and maintenance therapy in patients (pts) with moderately to severely active UC in the GEMINI 1 study (NCT00783718). This post hoc analysis assessed sustained remission during the maintenance phase of GEMINI ***:Analyses included pts enrolled in GEMINI 1, who received 6 weeks (wks) of induction with placebo or VDZ and entered 46 wks of maintenance continuing placebo or VDZ, respectively; eligible pts could then enrol into an open-label extension (OLE) to receive VDZ every 4 wks. The primary aim was to assess sustained remission (remission at Wks 26, 38 and 52) in pts who achieved remission at Wk 14. Remission was defined as 1) clinical remission (partial Mayo Score [PMS] ≤2 points with no individual subscore >1 point) or 2) rectal bleeding subscore =0. For the analyses, pts who received VDZ maintenance, discontinued before Wk 52 and then entered the OLE had missing maintenance data imputed using OLE ***:In total, 620 pts received VDZ (Wk 6 responders and non-responders) and 149 received placebo throughout GEMINI 1. Patient characteristics were broadly similar between treatment groups. From Wk 4 onwards, a significantly higher proportion of pts receiving VDZ were in clinical remission versus placebo in the overall and anti-TNF-naïve populations; significance was achieved at Wk 26 in the anti-TNF failure population. At Wk 14, 203 (33%) pts receiving VDZ and 30 (20%) pts receiving placebo were in clinical remission based on PMS, and 293 (47%) pts receiving VDZ and 43 (29%) pts receiving placebo were in remission based on rectal bleeding subscore. Of pts in remission at Wk 14, the VDZ group had a higher proportion of pts with sustained remission versus placebo according to both PMS and rectal bleeding definitions (Table); significance was reached in both the overall and anti-TNF-naïve populations, and a simila

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P209 Long-term effectiveness and safety of vedolizumab in patients with ulcerative colitis: 5-year cumulative exposure of GEMINI 1 completers rolling into the GEMINI open-label extension studyGet access

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S182–S183页

作者： Loftus, E.V. Colombel, J.-F. Feagan, B. Vermeire, S. Sandborn, W. Sands, B. Danese, S. D'Haens, G. Kaser, A. Panaccione, R. Rubin, D. Shafran, I. O'Byrne, S. Geransar, P. James, A. Kaviya, A. Khalid, J.M. Mayo Clinic College of Medicine Gastroenterology and Hepatology Rochester United States Icahn School of Medicine at Mount Sinai Gastroenterology New York United States Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada University hospitals Leuven Department of clinical and experimental medicine Leuven Belgium University of California - San Diego Division of Gastroenterology La Jolla United States Icahn School of Medicine at Mount Sinai Division of Gastroenterology New York United States Humanitas University Italy Gastrointestinal Immunopathology Milan Italy University of Cambridge Division of Gastroenterology and Hepatology Cambridge United Kingdom University of Calgary Department of Medicine Calgary Canada University of Chicago Medicine Inflammatory Bowel Disease Center Section of Gastroenterology Hepatology and Nutrition Chicago United States Shafran Gastroenterology Research center Gastroenterology Winter Park United States Takeda Pharmaceuticals International AG Global Medical Affairs Zurich Switzerland Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Development Centre Europe Ltd Clinical Development London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom

Background:Approval of vedolizumab (VDZ) for moderately to severely active ulcerative colitis (UC) was based on the phase 3 GEMINI 1 study. 【1】 The GEMINI open-label extension (OLE) trial is an ongoing study investigating the long-term safety of VDZ (NCT00790933). Here we report the 5-year exploratory analyses of effectiveness and safety in patients (pts) with UC who had completed GEMINI 1 and were enrolled in GEMINI ***:Analyses included pts who responded to VDZ induction at Week (Wk) 6 and had received VDZ maintenance (every 8 or 4 wks; data were combined) to Wk 52 of GEMINI 1, followed by VDZ every 4 wks in GEMINI OLE. Pts with 248 wks of cumulative VDZ treatment (data were collected from 22 May 2009 to 21 May 2015) were assessed for clinical response (decrease in partial Mayo Score 【PMS】 of ≥2 points and ≥25% change from baseline 【BL】, with an accompanying decrease in rectal bleeding subscore of ≥1 point from BL or absolute rectal bleeding subscore of ≤1 point), clinical remission (PMS of ≤2 with no individual subscore >1) and health-related quality of life (HRQoL), including IBD Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Safety was also ***:Of 247 pts in GEMINI 1 who responded to VDZ induction at Wk 6 and received VDZ in maintenance, 154 (62%) completed VDZ maintenance and were enrolled in GEMINI OLE (anti-TNFα-naïve n=107; anti-TNFα failure n=42). At the time of this analysis, 63 pts had completed 248 wks of cumulative VDZ treatment; 54 had discontinued (n=19 【35%】 due to lack of continued benefit) and 37 are ongoing (have not yet reached 248 wks of treatment). Of pts with data at Wk 248 (n=63), 98% had clinical response and 90% were in remission (Table). HRQoL improvements were observed at Wk 248, with mean change from BL IBDQ and EQ-5D-VAS scores of 58.7 and 24.0, respectively. In the safety population, 137 pts had adverse (AEs); 17 discontinued due to AEs. Serious AEs were reported in 44 pts (in

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DOP021 Long-term effectiveness and safety of vedolizumab in patients with Crohn's disease: 5-year cumulative exposure of GEMINI 2 completers rolling into the GEMINI open-label extension study

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S39-S39页

作者： Vermeire, S. Loftus, E.V. Colombel, J.-F. Feagan, B. Sandborn, W. Sands, B. Danese, S. D'Haens, G. Kaser, A. Panaccione, R. Rubin, D. Shafran, I. O'Byrne, S. Geransar, P. Previtali, A. Khalid, J.M. Kaviya, A. University Hospitals Leuven Dpt of Gastroenterology Leuven Belgium Mayo Clinic College of Medicine Gastroenterology and Hepatology Rochester United States Icahn School of Medicine at Mount Sinai Gastroenterology New York United States Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada University of California - San Diego Division of Gastroenterology La Jolla United States Icahn School of Medicine at Mount Sinai Division of Gastroenterology New York United States Humanitas University Italy Gastrointestinal Immunopathology Milan Italy Academic Medical Centre Dept. of Gastroenterology Amsterdam Netherlands University of Cambridge Division of Gastroenterology and Hepatology Cambridge United Kingdom University of Calgary Department of Medicine Calgary Canada University of Chicago Medicine Inflammatory Bowel Disease Center Section of Gastroenterology Hepatology and Nutrition Chicago United States Shafran Gastroenterology Research center Gastroenterology Winter Park United States Takeda Pharmaceuticals International AG Global Medical Affairs Zurich Switzerland Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Takeda Development Centre Europe Ltd Clinical Development London United Kingdom

Background:Vedolizumab (VDZ), a humanised monoclonal antibody that targets α4β7integrin, is approved for moderately to severely active Crohn's disease (CD) and ulcerative colitis. The GEMINI open-label extension (OLE) trial is an ongoing study investigating the long-term safety of VDZ (NCT00790933). Here we report the 5-year exploratory analyses of effectiveness and safety in patients (pts) with CD who had completed GEMINI 2 [1] and were enrolled in GEMINI ***:Analyses included pts who had responded to VDZ induction at Week (Wk) 6 and received VDZ maintenance (every 8 or 4 wks; data were combined) to Wk 52 of GEMINI 2, followed by VDZ every 4 wks in GEMINI OLE. Pts with 248 wks of cumulative VDZ treatment (data were collected from 22 May 2009 to 21 May 2015) were assessed for clinical response (decrease in Harvey–Bradshaw Index [HBI] of ≥3 points from baseline [BL]), clinical remission (HBI ≤4) and health-related quality of life (HRQoL), including IBD Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Safety was also ***:Of 308 pts in GEMINI 2 who responded to VDZ induction at Wk 6 and received VDZ in maintenance, 146 (47%) completed VDZ maintenance and were enrolled in GEMINI OLE (anti-TNFα-naïve n=81; anti-TNFα failure n=57). At the time of this analysis, 61 pts had completed 248 wks of cumulative VDZ treatment, 58 had discontinued (n=11 [19%] due to lack of continued benefit) and 27 are ongoing (have not yet reached 248 wks of treatment). Of pts with data at Wk 248 (n=61), 95% had clinical response and 89% were in remission (Table). HRQoL improvements were observed at Wk 248, with mean change from BL IBDQ and EQ-5D-VAS scores of 59.4 and 29.8, respectively. In the safety population, 134 pts had adverse events (AEs); 15 discontinued due to AEs. Serious AEs were reported in 41 pts (in 3 pts these were drug-related; 8 pts discontinued as a consequence of serious AEs). One death (not drug-related; motor accident)

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Cognitive and Functional Profiles in Mild-to-Moderate Alzheimer’s Disease and Mild Cognitive Impairment Compared to Healthy Elderly

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Advances in Alzheimer's Disease 2014年第4期3卷 168-186页

作者： Mark Marsico Celeste A. de Jager April Grant Xingshu Zhu Arwen Markwick Julie Chandler Epidemiology Department Merck Research Laboratories North Wales USA OPTIMA Nuffield Department of Medicine University of Oxford Oxford UK Division of Geriatric Medicine Department of Medicine Faculty of Health Sciences University of Cape Town Cape Town South Africa Statistical Programming Merck Research Laboratories North Wales USA

Background: Amnestic mild cognitive impairment (aMCI) and mild-to-moderate Alzheimer’s disease (AD) are clinically distinct but impact cognitive and functional ability similarly. Comprehensive assessment of cognitive and functional deficits may prove useful in informing differential diagnosis in early stages of dementia and in informing endpoint selection in therapeutic AD trials. Objective: The objective of this study was to characterize patterns of cognitive and functional impairment in aMCI and mild-to-moderate AD subjects compared to cognitively intact healthy elderly (HE). Methods: Thirty-one healthy elderly, 20 aMCI and 19 AD participants were administered a cognitive test battery that included the ADAS-Cog and functional assessments. Z-scores were calculated for all endpoints based on the HE reference group. Results: Cognitive deficits were observed in AD and aMCI participants relative to the referent group. On average, aMCI participants performed 1 - 2 standard deviations below HE on cognitive tests, and AD participants performed 2 - 3 standard deviations below HE. Domain-specific functional deficits among AD participants (z- score -0.4 to -6.4) were consistently greater than those of aMCI participants (z-score 0 to -1.7). Conclusion: This study provides further support for comprehensive assessment and monitoring of cognitive and functional domain scores in the diagnosis and treatment of aMCI and mild AD. Domain-specific cognitive scores may be more useful than composite scores in characterizing impairment and decline. Measuring domains such as attention, processing speed and executive function may increase the sensitivity of detecting disease progression and therapeutic effects, particularly in mild-moderate AD where memory decline may be too slow to detect drug effects during a typical clinical trial.

关键词： Alzheimer’s Disease Amnestic Mild Cognitive Impairment Dementia Cognition

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Merging RTF files using SAS®, MSWord®, and Acrobat Distiller®

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Pharmaceutical programming 2012年第1-2期5卷 50-56页

作者： Wirtz, Oliver Global Statistical Programming Global Data Operations Monheim Germany

Producing tables, listings, and figures (TLF) is one of the key responsibilities for programmers in the pharmaceutical industry. While SAS® Software offers a wide range of procedures to produce outputs in nearly all possible formats, collating multiple documents into an overall PDF file is not a trivial task. This paper will combine main aspects and show how you can implement this procedure within your organization. All you need is SAS, MSWord® and Acrobat Distiller®.

关键词： RTF PDF PS VBScript Acrobat Distiller

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On some "disadvantages" of the population approach

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AAPS Journal 2005年第2期7卷 E374-E382页

作者： Nedelman, Jerry R. Biostatistics and Statistical Programming Novartis Pharmaceuticals East Hanover NJ 07936 One Health Plaza United States

In a seminal article on population pharmacokinetic modeling, researchers demonstrated how means and variances of pharmacokinetic parameters for a patient population could be inferred from sparse data collected under conditions of routine patient care. But they also identified 4 potential concerns about their methodology: unobserved confounding variables may bias the inferences;conditions under which data are collected may lead to inaccuracies of reporting or recording;correlations among important predictor variables may reduce statistical efficiency;and costs cannot be controlled by principles of study design. Experiences are reviewed that relate to these potential disadvantages. A method is presented for diagnosing the possible presence of confounding. A model is constructed and applied that captures the influences of data inaccuracies. An example of selecting from among correlated covariates is summarized. Finally, a methodology for optimal study design is reviewed and applied to an example. Copyright ©2003. All Rights Reserved.

关键词： Confounding Errors in variables Noncompliance Optimal design Variable selection

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POVERTY, STATE CAPITAL, AND RECIDIVISM AMONG WOMEN OFFENDERS*

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Criminology & Public Policy 2006年第2期3卷

作者： KRISTY HOLTFRETER MICHAEL D. REISIG MERRY MORASH Kristy Holtfreter received her Ph.D. from the School of Criminal Justice Michigan State University in January 2004. Her research interests include legal responses to fraud in organizations correctional programming and research methodology. Her recent publications have appeared in Women and Criminal Justice and the Journal of Contemporary Criminal Justice. Michael D. Reisig is an Associate Professor of Criminal Justice at Michigan State University. His interests include neighborhood context and policing institutional corrections and applied statistical models. His research has appeared in such journals as Criminoalgy Justice Quarterly Journal of Research in Cromie and Delinquency and Crime and Delinquency. Merry Morash is a Professor of Criminal Justice at Michigan State University. Before obtaining her Ph.D. (University of Maryland in 1978) she worked in the adult prison system as a pre-release social worker directed programs for youthful offenders and worked in the juvenile court as a social worker. Her current research projects include programming to meet the needs of women offenders domestic violence among different racial and ethnic groups both within and outside the United States and assessment of community efforts to respond to crime victimization. She has conducted research with funding from the National Institute of Justice the National Science Foundation and with support from numerous other sources.

Research Summary: This research investigates the effects of poverty and state capital (i.e., state-sponsored support) on recidivism among women offenders. We seek also to determine whether criticisms directed at actuarial risk tools, such as the failure to take into account gender-related factors (e.g., poverty status), have merit. A community corrections sample of 134 female felony offenders from one county in the State of Oregon and in the cities of Minneapolis and St. Paul, Minnesota is used to examine self-reports of rearrest and probation or parole violations over a six-month time period. Results from the logistic regression analyses show poverty status increases the odds of rearrest by a factor of 4.6, and it increases the odds of supervision violation by a factor of 12.7. In contrast, risk scores failed to predict recidivism once poverty status was taken into account. Among poor women offenders specifically, we find providing state-sponsored support to address short-term needs (e.g., housing) reduces the odds of recidivism by 83%. Not only do community corrections officers who make available state capital promote women's empowerment, they are also less likely to have clients who reoffend. Policy Implications: Our findings suggest that a commonly used actuarial risk assessment tool (i.e., the LSI-R) does not sufficiently take into account the economic marginality of women offenders. At a minimum, existing tools should be refined or supplemented with other sources of information. During the early stages of supervision, community corrections agencies should encourage their officers to refer and advocate for poor women to receive available sources of state capital (e.g., subsidized housing) to address critical short-term needs, which can improve their economic circumstances, help move them out of poverty, and reduce the likelihood of recidivism. More broadly, recent changes in welfare policy, such as “Working Toward Independence,” will experience (at best) limite

关键词： State Capital, Poverty, Recidivism, Women Offenders, Corrections, LSI-R

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