Selection and use of the non-anti- TNF biological therapies: Who? When? How?
|
|
- Meagan Preston
- 5 years ago
- Views:
Transcription
1 Selection and use of the non-anti- TNF biological therapies: Who? When? How? Asher Kornbluth, MD Clinical Professor of Medicine The Henry D. Janowitz Division of Gastroenterology The Icahn School of Medicine New York, New York
2 Non Anti-TNF Biologics: Who, When, How As first line therapy: UC Crohn s disease As 2 nd line therapy: UC Crohn s disease In combination with a thiopurine
3 Non Anti- TNF Biologics: Is There a Need?
4 ACT 1 Clinical Remission with Infliximab in UC Proportion of Patients (%) *p < p= at Week * 32.0 Placebo 5 mg/kg Infliximab 10 mg/kg Infliximab Rutgeerts P et al. NEJM. 2005;353(23):30-44.
5 ACT 1 Sustained Remission in UC at Week 8, 30 and Proportion of Patients (%) *p = * 20.5* 0 Placebo 5 mg/kg Infliximab 10 mg/kg Infliximab Rutgeerts P et al. NEJM. 2005;353(23):30-44.
6 How effective is treatment with anti-tnf therapy in CD? (infliximab, adalimumab, certolizumab) Within a few weeks of starting treatment of an anti-tnf drug 40% do not have improvement in their symptoms 60% do have improvement in their symptoms Continued anti-tnf or placebo For those who improve, after 1 year of either continued treatment with the anti-tnf medication or placebo, this is what happens: Anti-TNF Placebo How many people were free from symptoms and off of prednisone? 29% 7%
7 Vedolizumab in UC and Crohn s disease: An alpha 4, Beta 7 Anti- Integrin Antibody
8 Artist s rendition
9 Vedolizumab in UC: Study Design Induction Weeks 0 6 Maintenance Week 6 52 Cohort 1 Blinded Induction Randomization n=374 (3:2 VDZ:PBO) NO Placebo n=149 Vedolizumab n=225 NO Placebo n=149 Vedolizumab every 4 wks n=373 Screening and Enrollment (Days -21 to -1) Cohort 1 Enrollment Complete? # Week 6: Achieved primary endpoint? YES Cohort 2* Open Label Induction Treatment n=521 Vedolizumab n=521 VDZ dose = 300 mg IV at weeks 0 and 2 for induction phase # Filled first with no more than 50% prior exposure to anti-tnf *Filled second for patients previously exposed to anti-tnf; Opened for anti-tnf naïve patients after completion of Cohort 1 enrollment Reduction in complete Mayo score of 3 points and 30% from baseline with an accompanying decrease in rectal bleeding subscore of 1 point or absolute rectal bleeding subscore of 1 point) Responders began tapering regimen at 6 weeks; others, as soon as a clinical response was achieved YES Maintenance Randomization (1:1:1) Forced Corticosteroid Tapering Placebo n=126 Vedolizumab every 4 wks n=125 Vedolizumab every 8 wks n=122 Feagan B, et al. DDW2012
10
11
12 Vedolizumab 300 mg Q8 weeks (n=70)
13 VDX ( n=220)dz VDZ VDZ (n=747) VDZ Open label VDZ q 4 weeks (non-itt)
14 Vedolizumab in Crohn s disease in anti-tnf exposed vs Anti- TNF Naïve Patients: Increased Remissions Between Weeks 6 and 10
15 Vedolizumab 300 mg Q8 weeks (n=154) Vedolizumab 300 mg Q8 weeks (n=154)
16 Vedolizumab 300 mg Q8 weeks (n=82)
17 Vedolizumab is Effective for Fistula Closure in CD: Post-Hoc Analysis of GEMINI 2 57 (12%) patients* with 1 draining fistula at study entry By Week 14 28% closure rate (VDZ) vs 11% (placebo) At Week 52 Treatment difference maintained through Week 52 (31% vs 11%) *72% patients had perianal fistulae; 4/57 patients had 3 fistulae. Feagan 17 B et al. Presented at DDW; May 16, Abstract Sa1261.
18 Vedolizumab in UC: Adverse Events Through Week 52 Placebo* N=126 Maintenance ITT Population VDZ Q8Wks N=122 VDZ Q4Wks N=125 Safety Population Placebo* N=275 VDZ N=620 Any adverse event (AE), % Drug-related AEs, % AE resulting in discontinuation, % Serious AEs, % Serious infection AEs, % Deaths, n (%) (<1%) *Includes patients who never received VDZ (n=149) and patients who received 2 VDZ induction doses followed by Pbo maintenance (n=126) Feagan B, et al. DDW2012
19 Infections With Vedolizumab and Placebo in UC and CD Trials Patients treated with Vedolizumab are at increased risk for developing infections
20 Adverse reactions in 3% of Vedolizumab-treated patients and 1% higher than in placebo (UC Trials I & II 3 and CD Trials I & III 3 Vedolizumab b
21 Vedolizumab Safety Issues No baseline TB testing required No baseline measurement of hepatitis B No baseline JC antibody measurement required
22 Should Vedolizumab Be Used With Thiopurines? In vedo trials 11% of patients developed antivedo antibodies on consecutive measurements None of these patients maintained a response No patients on thiopurines developed antibodies No increased toxicity with combination of vedolizumab and thiopurines? Infections Lymphoma HSTCL
23 Ustekinumab, an Anti- Interleukin 12 and 23 Antibody in Crohn s disease
24 Proportion of Subjects (%) Ustekinumab in Crohn s disease, Primary Endpoint: Clinical Response Week 6 CERTIFI Number of Subjects in 100 point Clinical Response a,b at Week 6; Randomized Subjects in Induction Phase p=0.021 p=0.057 p=0.005 p=0.005 N=132 N=131 N=132 N=131 N=394 Ustekinumab
25 Proportion of Subjects (%) Ustekinumab in Crohn s disease, Major Secondary Endpoint: Clinical Remission at Week 22 Number of Subjects in Clinical Remission a,b at Week 22; Subjects Randomized as Responders to UST Induction CERTIFI p= /73 30/72 a Subjects who discontinued study agent due to lack of efficacy, had a prohibited CD-related surgery, or had prohibited concomitant medication changes after Week 8 are considered not to be in clinical remission, regardless of their CDAI score b Subjects who had insufficient data to calculate the CDAI score are considered not to be in clinical remission
26 Open Label Ustekinumab is Effective in CD Refractory to Conventional and Anti-TNF Therapy 26 Wils P et al. Presented at DDW; May 18, Abstract 595.
27 Non- Anti-TNF Biologics: Take Home Messages Still significant unmet need in both UC and Crohn s disease even in the age of effective anti-tnf therapy Vedolizumab effective in UC for induction and maintenance Slow onset of action in Crohn s disease, effective maintenance Excellent safety profile Positioning as first line therapy still in evolution More likely in UC With steroid jump start in Crohn s disease?
Gionata Fiorino VEDOLIZUMAB E IBD. Un nuovo target terapeutico
Gionata Fiorino VEDOLIZUMAB E IBD Un nuovo target terapeutico Anti cell adhesion molecules Danese S, NEJM 2011 6 Steps leukocyte recruitment Fiorino G. et al. 2010 Vedolizumab Blocks Fewer Biological Pathways
More informationPredicting response to anti - integrin therapy: long term efficacy and roles for optimisation with vedolizumab.
Predicting response to anti - integrin therapy: long term efficacy and roles for optimisation with vedolizumab. Dr Peter Irving Guy s and St Thomas Hospital, London King s College London Response to vedolizumab
More informationEmerging g therapies for IBD: A practical approach to positioning. Sequential Therapies for IBD
Emerging g therapies for IBD: A practical approach to positioning Stephen B. Hanauer, MD Sequential Therapies for IBD Disease Severity at Presentation Severe Anti-TNF +/IS Cyclosporine (UC) Colectomy (UC)
More informationRecent Advances in the Management of Refractory IBD
Recent Advances in the Management of Refractory IBD Raina Shivashankar, M.D. Assistant Professor of Medicine Division of Gastroenterology and Hepatology Thomas Jefferson University Philadelphia, PA Outline
More informationAn Update on the Biologic Treatment for Patients with Inflammatory Bowel Disease. David A. Schwartz, MD
An Update on the Biologic Treatment for Patients with Inflammatory Bowel Disease David A. Schwartz, MD Director, Inflammatory Bowel Disease Center Associate Professor of Medicine Vanderbilt University
More informationBiologic Therapy for Ulcerative Colitis in 2015
5/6/215 Biologic Therapy for Ulcerative Colitis in 215 John K. Marshall MD MSc FRCPC AGAF Division of Gastroenterology McMaster University Bressler B, Marshall JK, et al. Gastroenterology 215;148: 135-58
More informationUpdate on Biologics in Ulcerative Colitis. Scott Plevy, MD University of North Carolina Chapel Hill, NC
Update on Biologics in Ulcerative Colitis Scott Plevy, MD University of North Carolina Chapel Hill, NC Objectives Discuss the latest advances in the pharmacologic management of ulcerative colitis Describe
More informationDisclosures. What Do I Do When Anti-TNF Therapy Is Not Working Anymore? Fadi Hamid, M.D. Saint Luke s GI Specialists
What Do I Do When Anti-TNF Therapy Is Not Working Anymore? Fadi Hamid, M.D. Saint Luke s GI Specialists Disclosures No financial relationships to disclose. 1 Learning Objectives Case 24M with ileocolonic
More information2nd Nottingham IBD Masterclass, 2017
2nd Nottingham IBD Masterclass, 217 Positioning IL12/IL23 blockade in the Crohn s disease treatment algorithm Prof James Lindsay, Consultant Gastroenterologist, Barts Health NHS Trust Professor in Inflammatory
More informationNew treatment options in IBD: today and the future. Silvio Danese Istituto Clinico Humanitas, Milan, Italy
New treatment options in IBD: today and the future Silvio Danese Istituto Clinico Humanitas, Milan, Italy Date of preparation: October 2014 GLO/EYV/2014-00010h Overview of the late-stage IBD drug pipeline*
More informationModerately to severely active ulcerative colitis
Adalimumab in the Treatment of Moderate-to-Severe Ulcerative Colitis: ULTRA 2 Trial Results Sandborn WJ, van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients
More informationPositioning New Therapies
Positioning New Therapies Stephen Hanauer, MD Professor of Medicine Medical Director, Digestive Disease Center Northwestern Medicine Chicago, Illinois Speaker Disclosure Stephen Hanauer, MD has disclosed
More informationSeptember 12, 2015 Millie D. Long MD, MPH, FACG
Update on Biologic Therapy in 2015 September 12, 2015 Millie D. Long MD, MPH, FACG Assistant Professor of Medicine Inflammatory Bowel Disease Center University of North Carolina-Chapel Hill Outline Crohn
More informationChoosing and Positioning Biologic Therapy for Crohn s Disease: (Still) Looking for the Crystal Ball
Choosing and Positioning Biologic Therapy for Crohn s Disease: (Still) Looking for the Crystal Ball Siddharth Singh, MD, MS Assistant Professor of Medicine Division of Gastroenterology Division of Biomedical
More informationIBD Updates. Themes in IBD IBD management journey. New tools for therapeutic monitoring. First-line treatment in IBD
IBD Updates Maria T. Abreu, MD University of Miami Miller School of Medicine Miami, Florida Themes in IBD 213 First-line treatment in IBD New tools for therapeutic monitoring Biologic therapy for CD and
More informationNew and Future Adhesion Molecule Based Therapies in IBD
New and Future Adhesion Molecule Based Therapies in IBD Brian G. Feagan Professor of Medicine, Epidemiology and Biostatistics University of Western Ontario Robarts Clinical Trials London, Ontario, Canada
More informationU of Cape Town, South Africa, 10 U of Washington, Seattle, WA,USA, 11 CHRU de Lille, Hôpital Claude Huriez, Lille, France, 12
A Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Ustekinumab, a Human IL-12/23p40 Monoclonal Antibody, in Moderate-severe Crohn s Disease Refractory to Anti-TNFα: UNITI-1 WJ Sandborn 1,
More informationBiologic Therapy for Inflammatory. Is Top-Down Too Top-Heavy? S. Devi Rampertab, MD, FACG, AGAF Associate Professor of Medicine University of Florida
Biologic Therapy for Inflammatory Bowel Disease: Is Top-Down Too Top-Heavy? S. Devi Rampertab, MD, FACG, AGAF Associate Professor of Medicine University of Florida Learning Objectives Evaluate evidence
More informationBiologics in IBD. Brian P. Bosworth, MD, NYSGEF Associate Professor of Medicine Weill Cornell Medical College
Biologics in IBD Brian P. Bosworth, MD, NYSGEF Associate Professor of Medicine Weill Cornell Medical College Case 30 year old man diagnosed with ulcerative proctitis diagnosed in 2003 Had been maintained
More informationSYNOPSIS. Issue Date: 25 Oct 2011
SYNOPSIS Issue Date: 25 Oct 2011 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Janssen Research & Development STELARA Ustekinumab Protocol No.: Title of Study: Study Name:
More informationModern Management of Perianal Fistulas in Crohn s Disease (PFCD): Future Directions
Modern Management of Perianal Fistulas in Crohn s Disease (PFCD): Future Directions Rami Ismail, Pharm.D., BCPS, BCCCP, CACP Lead Clinical staff Pharmacist, Cleveland Clinic Abu Dhabi Disclosure Information
More informationNew treatment options in UC. Rob Bryant IBD Consultant Royal Adelaide Hospital
New treatment options in UC Rob Bryant IBD Consultant Royal Adelaide Hospital Talk Outline 1. Raising expectations 2. Optimising UC therapy 3. Clinical trials 4. What s new on the PBS? 5. Questions 1.
More informationPersonalized Medicine. Selecting the Right First-line Biologic Agent. Gene Expression Profiles Crohn s Disease. The Right Treatment
Personalized Medicine Selecting the Right First-line Biologic Agent William Tremaine, M.D. Maxine and Jack Zarrow Professor Mayo Clinic Rochester, MN, USA The Right Treatment Pretreatment Genomic Analysis
More informationOptimizing Therapies for Severe Ulcerative Colitis October 19, 2014
Optimizing Therapies for Severe Ulcerative Colitis October 19, 2014 Ellen J. Scherl, MD, FACP, FACG, AGAF, FASGE, NYSGEF Director Jill Roberts Center for Inflammatory Bowel Disease Jill Roberts IBD Research
More informationImmunogenicity of Biologic Agents and How to Prevent Sensitization
Immunogenicity of Biologic Agents and How to Prevent Sensitization William J. Sandborn, MD Professor and Chief, Division of Gastroenterology Director, UCSD IBD Center La Jolla, California, USA Learning
More informationTumor necrosis factor-alpha antibody for maintenace of remission in Crohn s disease (Review)
Tumor necrosis factor-alpha antibody for maintenace of remission in Crohn s disease (Review) Behm BW, Bickston SJ This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration
More informationSevere IBD: What to Do When Anti- TNFs Don t Work?
Severe IBD: What to Do When Anti- TNFs Don t Work? David T. Rubin, MD, FACG Professor of Medicine Co-Director, Inflammatory Bowel Disease Center Interim Chief, Section of Gastroenterology, Hepatology and
More informationPharmacotherapy of Inflammatory Bowel Disorder
PHARMACY / MEDICAL POLICY 5.01.563 Pharmacotherapy of Inflammatory Bowel Disorder Effective Date: Feb. 14, 2018 Last Revised: April 1, 2018 Replaces: Extracted from 5.01.550 RELATED MEDICAL POLICIES: 11.01.523
More informationPharmacotherapy of Inflammatory Bowel Disorder
PHARMACY / MEDICAL POLICY 5.01.563 Pharmacotherapy of Inflammatory Bowel Disorder Effective Date: June 9, 2019* Last Revised: Feb. 12, 2019 Replaces: Extracted from 5.01.550 RELATED MEDICAL POLICIES: 11.01.523
More informationSelective leucocyte trafficking inhibitors for treatment of IBD
Selective leucocyte trafficking inhibitors for treatment of IBD Séverine Vermeire MD, PhD Department of Gastroenterology University Hospitals Leuven Belgium Migration of Leucocytes plays a key role in
More informationIndications for use of Infliximab
Indications for use of Infliximab Moscow, June 10 th 2006 Prof. Dr. Dr. Gerhard Rogler Klinik und Poliklinik für Innere Medizin I Universität Regensburg Case report 1989: Diagnosis of Crohn s disease of
More informationPositioning Biologics in Ulcerative Colitis
Positioning Biologics in Ulcerative Colitis Bruce E. Sands, MD, MS Acting Chief, Gastrointestinal Unit Massachusetts General Hospital Associate Professor of Medicine Harvard Medical School Sequential Therapies
More informationBiologics in 2016: How Do We Select the Most Appropriate Agent? Gary R. Lichtenstein, MD, FACG University of PA School of Medicine Philadelphia, PA
Biologics in 2016: How Do We Select the Most Appropriate Agent? Gary R. Lichtenstein, MD, FACG University of PA School of Medicine Philadelphia, PA Overview Indications and Drug Selection Contraindications
More informationPharmacotherapy of Inflammatory Bowel Disorder
PHARMACY / MEDICAL POLICY 5.01.563 Pharmacotherapy of Inflammatory Bowel Disorder Effective Date: May 1, 2018 Last Revised: April 18, 2018 Replaces: Extracted from 5.01.550 RELATED MEDICAL POLICIES: 11.01.523
More informationLong-term Efficacy of Vedolizumab for Crohn s Disease
Journal of Crohn's and Colitis, 217, 412 424 doi:1.193/ecco-jcc/jjw176 Advance Access publication September 28, 216 Original Article Original Article Long-term Efficacy of Vedolizumab for Crohn s Disease
More informationINFLIXIMAB FOR PREVENTION OF POST-OPERATIVE CROHN S DISEASE RECURRENCE: THE PREVENT TRIAL
INFLIXIMAB FOR PREVENTION OF POST-OPERATIVE CROHN S DISEASE RECURRENCE: THE PREVENT TRIAL A. Hillary Steinhart, MD MSc FRCP(C) Medical Lead, Mount Sinai Hospital IBD Centre Professor of Medicine University
More informationMedical Therapy for Pediatric IBD: Efficacy and Safety
Medical Therapy for Pediatric IBD: Efficacy and Safety Betsy Maxwell, MD Assistant Professor of Clinical Pediatrics Division of Gastroenterology, Hepatology, and Nutrition Pediatric IBD: Defining Remission
More informationThe following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only.
The following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only. If you have any ques7ons, please contact Imedex via email at:
More informationHow to use infliximab?
How to use infliximab? Séverine Vermeire, MD, PhD Division of Gastroenterology University Hospital Gasthuisberg Leuven The how to use infliximab rules Before starting IFX: try optimizing chances for response!
More information4/16/2018. Updates in Crohn s Disease. Disclosures. Learning Objectives. Crohn s Disease is Progressive and Destructive
4/16/218 Disclosures Updates in Crohn s Disease David T. Rubin, MD Joseph B. Kirsner Professor of Medicine Chief, Section of Gastroenterology, Hepatology and Nutrition University of Chicago Consultant
More informationOutline. Biologic Drugs in Inflammatory Bowel Disease Dr. Jason Etzel MD The Vancouver Clinic. Biologic Drugs. Biologic Drugs. Biologic Drugs Anti-TNF
Outline Biologic Drugs in Inflammatory Bowel Disease Dr. Jason Etzel MD The Vancouver Clinic Types of biologic drugs How do they work? How effective are they? Safety/Toxicity concerns with biologics Biologic
More informationMono or Combination Therapy with. Individualized Approach
Mono Combination Therapy with Biologics i in IBD: Developing an Individualized Approach David T. Rubin, MD, FACG Co-Direct, Inflammaty Bowel Disease Center Fellowship Program Direct University of Chicago
More informationUlcerative colitis (UC) is a chronic inflammatory
Induction and Maintenance Therapy with Vedolizumab, a Novel Biologic Therapy for Ulcerative Colitis Feagan BG, Rutgeerts P, Sands BE, et al; GEMINI 1 Study Group. Vedolizumab as induction and maintenance
More informationCAG Symposium: Management of IBD in 2018
CAG Symposium: Management of IBD in 2018 Waqqas Afif, MD, M. Sc., FRCPC, Associate Professor, Department of Medicine Division of Gastroenterology McGill University Health Center X X X X X CanMEDS Roles
More informationThe Best of IBD at UEGW (Crohn s)
The Best of IBD at UEGW (Crohn s) Iyad Issa MD Head of Gastroenterology, Rafik Hariri Univ Hosp Adjunct Faculty, School of Medicine, Leb Univ Founding Faculty, School Of Medicine, Leb Am Univ 1 The Best
More informationΑπό τη θεωρία στη πράξη: Συζήτηση κλινικών περιστατικών. Κωνσταντίνος Κατσάνος Επίκουρος Καθηγητής Γαστρεντερολογίας Πανεπιστήμιο Ιωαννίνων
Από τη θεωρία στη πράξη: Συζήτηση κλινικών περιστατικών Κωνσταντίνος Κατσάνος Επίκουρος Καθηγητής Γαστρεντερολογίας Πανεπιστήμιο Ιωαννίνων Conflict of interest By means of this, the speaker confirms that
More informationVedolizumab: policing leukocyte traffic
Oxford Inflammatory Bowel Disease MasterClass Vedolizumab: policing leukocyte traffic Dr Brian Feagan, London, Canada Vedolizumab : Policing Lymphocyte Traficking Brian G. Feagan Professor of Medicine,
More informationBeyond Anti TNFs: positioning of other biologics for Crohn s disease. Christina Ha, MD Cedars Sinai Inflammatory Bowel Disease Center
Beyond Anti TNFs: positioning of other biologics for Crohn s disease Christina Ha, MD Cedars Sinai Inflammatory Bowel Disease Center Objectives: To define high and low risk patient and disease features
More informationJohn F. Valentine, MD Inflammatory Bowel Disease Program University of Utah
John F. Valentine, MD Inflammatory Bowel Disease Program University of Utah Hawaii 1/20/2017 DISCLOSURES Research Support: NIH, Pfizer, Celgene, AbbVie, Roche/Genentech, Takeda, CCFA OBJECTIVES Review
More informationSTELARA (ustekinumab) Clinical Study Report CNTO1275CRD3001
SYNOPSIS Name of Sponsor/Company Janssen Research & Development* Name of Investigational Product STELARA (ustekinumab) * Janssen Research & Development is a global organization that operates through different
More informationMucosal Healing in Crohn s Disease. Geert D Haens MD, PhD University Hospital Gasthuisberg University of Leuven Leuven, Belgium
Mucosal Healing in Crohn s Disease Geert D Haens MD, PhD University Hospital Gasthuisberg University of Leuven Leuven, Belgium Mucosal Lesions in CD: General Features CD can affect the entire GI tract
More informationEfficacy and Safety of Treatment for Pediatric IBD
Efficacy and Safety of Treatment for Pediatric IBD Andrew B. Grossman MD Co-Director, Center for Pediatric Inflammatory Bowel Disease Associate Professor of Clinical Pediatrics Division of Gastroenterology,
More informationWHY HAVE WE NOT FINALLY FIGURED OUT COMBINATION THERAPY?
WHY HAVE WE NOT FINALLY FIGURED OUT COMBINATION THERAPY? Siew Ng, Professor MBBS, FRCP, (Lon, Edin), PhD (Lond), AGAF, FHKCP, FHKAM (medicine) Department of Medicine and Therapeutics Chinese University
More informationHow to Optimize Induction and Maintenance Responses: Definitions and Dosing Advances in Inflammatory Bowel Disease December 6, 2009
How to Optimize Induction and Maintenance Responses: Definitions and Dosing 2009 Advances in Inflammatory Bowel Disease December 6, 2009 Fernando Velayos MD MPH University of California, San Francisco
More informationImproving outcome of Inflammatory Bowel Disease in children
Improving outcome of Inflammatory Bowel Disease in children Dinesh Pashankar, MD Pediatric Gastroenterologist Director- Pediatric IBD program Yale University School of Medicine Pediatric Gastroenterology
More informationMucosal healing: does it really matter?
Oxford Inflammatory Bowel Disease MasterClass Mucosal healing: does it really matter? Professor Jean-Frédéric Colombel, New York, USA Oxford Inflammatory Bowel Disease MasterClass Mucosal healing: does
More informationCOPYRIGHT. Inflammatory Bowel Disease What Every Clinician Needs to Know. Adam S. Cheifetz, MD. Director, Center for Inflammatory Bowel Disease
Inflammatory Bowel Disease What Every Clinician Needs to Know Adam S. Cheifetz, MD Director, Center for Inflammatory Bowel Disease Beth Israel Deaconess Medical Center Associate Professor of Medicine Harvard
More informationProgress in Inflammatory Bowel Disease
Progress in Inflammatory Bowel Disease Gary R Lichtenstein, MD Director, Center for IBD University of Pennsylvania School of Medicine Hospital of the University of PA Philadelphia, PA Disclosure Research,
More informationHighlights of DDW 2015: Crohn s disease
Highlights of DDW 2015: Crohn s disease Mark S. Silverberg, MD, PhD, FRCPC Associate Professor of Medicine, University of Toronto Staff Gastroenterologist, Mount Sinai Hospital Senior Investigator, Lunenfeld-Tanenbaum
More informationMedical Management of Inflammatory Bowel Disease
Medical Management of Inflammatory Bowel Disease John K. Marshall MD MSc FRCPC AGAF Division of Gastroenterology McMaster University John K. Marshall: Conflicts of Interest Speaker: AbbVie, Allergan, Ferring,
More informationOptimizing the effectiveness of anti-tnf therapy in paediatric IBD
Optimizing the effectiveness of anti-tnf therapy in paediatric IBD Anne Griffiths MD, FRCPC Co-Lead, Inflammatory Bowel Disease Center Northbridge Chair in IBD Hospital for Sick Children, Professor of
More informationENTYVIO (VEDOLIZUMAB)
ENTYVIO (VEDOLIZUMAB) UnitedHealthcare Community Plan Medical Benefit Drug Policy Policy Number: CS2017D0053F Effective Date: July 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 BENEFIT CONSIDERATIONS...
More informationManaging Complications of IBD and Its Therapies David T. Rubin, MD, AGAF
Managing Complications of IBD and Its Therapies David T. Rubin, MD, AGAF Joseph B. Kirsner Professor of Medicine Chief, Section of Gastroenterology, Hepatology and Nutrition University of Chicago Medicine
More informationCrohn's Disease. The What, When, and Why of Treatment
Crohn's Disease The What, When, and Why of Treatment Gary R. Lichtenstein, MD, FACG Professor of Medicine Director, Inflammatory Bowel Disease Program University of Pennsylvania Philadelphia, PA In my
More informationEfficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn s Disease Patients Stratified by Age
Adv Ther (2017) 34:542 559 DOI 10.1007/s12325-016-0467-6 ORIGINAL RESEARCH Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn s Disease Patients Stratified by Age Vijay Yajnik. Nabeel Khan.
More informationTitle: Author: Journal:
IMPORTANT COPYRIGHT NOTICE: This electronic article is provided to you by courtesy of Ferring Pharmaceuticals. The document is provided for personal usage only. Further reproduction and/or distribution
More informationEdward V. Loftus, Jr., M.D.
Edward V. Loftus, Jr., M.D. Professor of Medicine Faculty photo will be placed here loftus.edward@mayo.edu 2015 MFMER 3417200-1 Inflammatory Bowel Disease Therapy Edward V. Loftus, Jr., M.D. Gastroenterology
More informationTreatment Goals. Current Therapeutic Pyramids Crohn s Disease Ulcerative Colitis 11/14/10
Current Management of IBD: From Conventional Agents to Biologics Stephen B. Hanauer, M.D. University of Chicago Treatment Goals Induce and maintain response/ remission Prevent complications Improve quality
More informationTemporary Compliance Waiver Notice
Temporary Compliance Waiver Notice At the time of initial posting on August 24th, 2012, the attached PDF document may not be fully accessible to readers using assistive technology. A fully accessible version
More informationUse of extrapolation in small clinical trials:
Use of extrapolation in small clinical trials: Infliximab for pediatric ulcerative colitis Jessica J. Lee, MD, MMSc Medical Officer Division of Gastroenterology and Inborn Errors Products CDER/ FDA 1 Learning
More informationTherapies for IBD: the Pipeline. New Therapeutic Agents in IBD
Therapies for IBD: the Pipeline New Therapeutic Agents in IBD William J. Sandborn, MD Professor & Chief, Division of Gastroenterology Director, UCSD IBD Center Budesonide Oral MMX budesonide Rectal budesonide
More informationDr. Elmer Schabel, MD. Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany (No conflicts of interest)
EMA workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn s disease Overview of authorised medicines for IBD in Europe - previous regulatory positions
More informationENTYVIO (VEDOLIZUMAB)
ENTYVIO (VEDOLIZUMAB) UnitedHealthcare Oxford Clinical Policy Policy Number: PHARMACY 285.8 T2 Effective Date: November 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 CONDITIONS OF COVERAGE...
More informationAnti tumor necrosis factor (TNF) agents have
Achieving Clinical Response and Remission in Moderate-to-Severe Ulcerative Colitis With Golimumab Sandborn WJ, Feagan BG, Marano C, et al; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical
More informationSpecial Authorization Drug Products with
Effective August 1, 2008 Summary Special Authorization Drug Products with Changes to Criteria Special Authorization Drug Products with Changes to Criteria Alberta Blue Cross has been advised by Alberta
More informationPosition of Biologics in IBD Circa 2006: Top Down vs. Step Up Therapy
Position of Biologics in IBD Circa 2006: Top Down vs. Step Up Therapy Stephen B. Hanauer, MD University of Chicago Potential Conflicts: Centocor/Schering, Abbott, UCB, Elan, Berlex, PDL Goals of Treatment
More informationThe Refractory Crohn s Disease
The Refractory Crohn s Disease Patient David T. Rubin, MD, FACG Professor of Medicine Co-Director, Inflammatory Bowel Disease Center Interim Chief, Section of Gastroenterology, Hepatology and Nutrition
More informationLatest Meds Approved for IBD: What are they and how do they work?
Latest Meds Approved for IBD: What are they and how do they work? JAMES LORD, MD PHD BENAROYA RESEARCH INSTITUTE AT VIRGINIA MASON MEDICAL CENTER SEPT 30, 2018 Brief history of IBD Dr. Burrill Crohn JAMA
More informationBiologics, Novel Therapeutic Approaches in Inflammatory Bowel Diseases
Biologics, Novel Therapeutic Approaches in Inflammatory Bowel Diseases Walter Reinisch Univ-Klinik für Innere Medizin III Abt. Gastroenterologie & Hepatologie AKH Wien The Biologic s evolution From availabilitydriven
More informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION VEDOLIZUMAB (Entyvio Takeda Canada Inc.) Indication: Crohn s Disease Recommendation: The CADTH Canadian Drug Expert Committee (CDEC) recommends
More informationReferring to Part of Dossier: Volume: Page:
Synopsis Abbott Laboratories Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority
More informationENTYVIO (VEDOLIZUMAB)
ENTYVIO (VEDOLIZUMAB) UnitedHealthcare Commercial Medical Benefit Drug Policy Policy Number: 2017D0053F Effective Date: July 1, 2017 Table of Contents Page INSTRUCTIONS FOR USE... 1 BENEFIT CONSIDERATIONS...
More informationIBD Biologicals and Novel therapeutic regimes. Dr S K Sinha Additional Professor Department of Gastroenterology PGIMER, Chandigarh
IBD Biologicals and Novel therapeutic regimes Dr S K Sinha Additional Professor Department of Gastroenterology PGIMER, Chandigarh 1 Treatment aims in IBD Traditional treatment goals of IBD Control of symptoms?improvement
More informationDisease Management Strategies for Moderate to Severe IBD in Adults
Disease Management Strategies for Moderate to Severe IBD in Adults Alyssa Parian, MD Assistant Professor of Medicine Johns Hopkins University April 21, 2016 Outline Overview of IBD Treatments (Benefits/Risks)
More informationAzathioprine for Induction and Maintenance of Remission in Crohn s Disease
Azathioprine for Induction and Maintenance of Remission in Crohn s Disease William J. Sandborn, MD Chief, Division of Gastroenterology Director, UCSD IBD Center Objectives Azathioprine as induction and
More informationCROHN'S DISEASE/ULCERATIVE COLITIS TREATMENT ALGORITHM
CROHN'S DISEASE/ULCERATIVE COLITIS TREATMENT ALGORITHM Crohn's Disease Ulcerative Colitis Steroids x 2 No prior AZA/6-MP Biologic Agent AZA/6-MP STEP-UP MANAGEMENT APPROACH Advantages Patients attain remission
More informationCarefirst.+.V Family of health care plans
Carefirst.+.V Family of health care plans CVS care mark POLICY Document for ENTYVIO The overall objective of this policy is to support the appropriate and cost effective use of the medication, specific
More informationJoin the conversation at #GIFORUMCCFA
1 Join the conversation at #GIFORUMCCFA 2 Disclosures In accordance with the ACCME Standards for Commercial Support of CME, the speakers for this course have been asked to disclose to participants the
More informationTechnology appraisal guidance Published: 26 August 2015 nice.org.uk/guidance/ta352
Vedolizumab for treating moderately to severely erely active Crohn's disease after prior therapy Technology appraisal guidance Published: 26 August 2015 nice.org.uk/guidance/ta352 NICE 2017. All rights
More informationUlcerative Colitis Therapy. Faculty Disclosure. Acknowledgements 28/11/2013. Amy Morse November 30/13
Ulcerative Colitis Therapy Amy Morse November 30/13 GI for GP s Jasper AB Faculty Disclosure Faculty: Amy Morse Relationships with commercial interests: Grants/Research Support: Therapeutic Fellowship
More informationAdalimumab M Clinical Study Report Final R&D/17/0360
Methodology (Continued): Beginning at Week 8, subjects who developed a flare while receiving ew therapy or had a PCDAI 15 points higher than Baseline at any time during this study may have been discontinued
More informationCase Example: Exposure Response to Support Extrapolation of Efficacy in Pediatric Ulcerative Colitis
Case Example: Exposure Response to Support Extrapolation of Efficacy in Pediatric Ulcerative Colitis Kerry Jo Lee, MD Medical Officer Division of Gastroenterology and Inborn Error Products Office of New
More informationRisk = probability x consequence
Explaining Risks of IBD Therapy to Parents and Patients December 4, 2009 CCFA Advances in IBD Hollywood, FL Corey A. Siegel Assistant Professor of Medicine, Dartmouth Medical School Director, Dartmouth-Hitchcock
More information1. Comparative effectiveness of vedolizumab
Cost-effectiveness of vedolizumab (Entyvio ) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were
More informationInflammatory Bowel Disease Drug Therapy 2016
Inflammatory Bowel Disease Drug Therapy 206 David T. Rubin, MD, FACG Joseph B. Kirsner Professor of Medicine Chief, Section of Gastroenterology, Hepatology and Nutrition Objectives Outline the goals of
More informationEfficacy and Safety of Treatment for Pediatric IBD
Efficacy and Safety of Treatment for Pediatric IBD Andrew B. Grossman MD Co-Director, Center for Pediatric Inflammatory Bowel Disease Assistant Professor of Clinical Pediatrics Division of Gastroenterology,
More informationEpidemiology of IBD in Pediatric Patients in the US: Data from the ImproveCareNow Registry
Epidemiology of IBD in Pediatric Patients in the US: Data from the ImproveCareNow Registry Michael D. Kappelman, MD Professor of Pediatrics and Epidemiology University of North Carolina, Chapel Hill Richard
More informationCommon Questions in Crohn s Disease Therapy. Case
Common Questions in Crohn s Disease Therapy Jean-Paul Achkar, MD, FACG Kenneth Rainin Chair for IBD Research Cleveland Clinic Case 23 yo male with 1 year history of diarrhea, abdominal pain and 15 pound
More informationSCIENTIFIC DISCUSSION. London, 26 April 2007 Product name: Humira/Trudexa Procedure number: EMEA/H/C/ /II/33
SCIENTIFIC DISCUSSION London, 26 April 2007 Product name: Humira/Trudexa Procedure number: EMEA/H/C/481-482/II/33 1. Introduction Adalimumab is a recombinant human immunoglobulin (IgG 1 ) monoclonal antibody
More information