New treatment options in IBD: today and the future. Silvio Danese Istituto Clinico Humanitas, Milan, Italy
|
|
- Griselda Shaw
- 6 years ago
- Views:
Transcription
1 New treatment options in IBD: today and the future Silvio Danese Istituto Clinico Humanitas, Milan, Italy Date of preparation: October 2014 GLO/EYV/ h
2 Overview of the late-stage IBD drug pipeline* Anti-Smad7 Anti-MAdCAM-1 Anti-IP-10 Stem cells Anti- α E β 7 IL inhibitors Anti-α 4 β 7 Anti-α 4 Anti-TNFα Biologics Phase II Phase III Pre-reg Launched Small molecules Anti-α 4 JAK inhibitors Anti-CCR-9 *Some classes of drugs are not yet approved/licensed CCR-9, chemokine receptor 9; IBD, inflammatory bowel disease; IL, interleukin; IP-10, Interferon-γ-inducible protein-10; JAK, Janus kinase; MAdCAM-1, mucosal vascular addressin cell adhesion molecule 1; Pre-reg, pre-registration; TNF, tumour necrosis factor Adapted from: Danese S. Gut 2012;61: ; Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: /j.gastro ). 2
3 Gut selectivity: a key to therapeutic success α L β 2 α M β 2 α 4 β 7 α 4 β 1 α L β 2 α M β 2 α 4 β 7 α 4 β 1 ICAM-2 ICAM-1 MAdCAM-1 VCAM-1 Natalizumab, AJM300 ICAM-2 ICAM-1 MAdCAM-1 VCAM-1 Vedolizumab, AMG 181, etrolizumab, PF ICAM, intercellular adhesion molecule; MAdCAM-1, mucosal vascular addressin cell adhesion molecule-1; VCAM-1, vascular cell adhesion molecule-1 Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: /j.gastro ). 3
4 GEMINI I: vedolizumab in UC Maintenance phase: outcomes at Week 52 Primary outcome: maintenance ITT population Patients (%) Adjusted difference, percentage points (95% CI) VDZ Q8W vs. PBO VDZ Q4W vs. PBO p<0.001 p< Clinical remission 26.1 (14.9, 37.2) 29.1 (17.9, 40.4) 44.8 VDZ/PBO (n=126) VDZ Q8W (n=122) VDZ Q4W (n=125) CI, confidence interval; ITT, intent to treat; PBO, placebo; Q4W, every 4 weeks; Q8W, every 8 weeks UC, ulcerative colitis; VDZ, vedolizumab Adapted from: Feagan BG, et al. N Engl J Med 2013;369:
5 GEMINI I: vedolizumab in UC Key safety results Incidence, n (%) Combined PBO Combined VDZ (n=275) (n=620) Any AE 220 (80) 497 (80) Serious AE 37 (13.5) 77 (12.4) Common AEs in 10% UC exacerbation 58 (21.1) 97 (15.6) Headache 28 (10.2) 80 (12.9) Nasopharyngitis 26 (9.5) 80 (12.9) Arthralgia 25 (9.1) 56 (9.0) Upper respiratory tract infection 21 (7.6) 52 (8.4) Nausea 19 (6.9) 38 (6.1) Cough 13 (4.7) 36 (5.8) Anaemia 16 (5.8) 35 (5.6) Abdominal pain 10 (3.6) 35 (5.6) Fatigue 10 (3.6) 33 (5.3) Influenza 6 (2) 30 (5) Infections 155 (56) 371 (60) Serious infection 8 (2.9) 12 (1.9) Malignant neoplasm 3 (1.1) 1 (0.2) AE, adverse event; PBO, placebo; UC, ulcerative colitis; VDZ, vedolizumab Feagan BG, et al. N Engl J Med 2013;369:
6 GEMINI II: vedolizumab in CD Maintenance phase: outcomes at Week 52 Patients (%) Mean % VDZ vs. VDZ/PBO Primary outcome p=0.004 p< Maintenance ITT population p=0.005 p= Secondary outcomes p=0.04 p= Clinical remission CDAI-100 response GC-free remission Durable remission CD, Crohn s disease; CDAI, Crohn s Disease Activity Index; GC, glucocorticoid; ITT, intent to treat; PBO, placebo; VDZ, vedolizumab Adapted from: Sandborn WJ, et al. N Engl J Med 2013;369: VDZ/PBO (n=153) VDZ Q8W (n=154) VDZ Q4W (n=154)
7 GEMINI II: vedolizumab in CD Maintenance phase: key safety results VDZ induction responders VDZ induction Incidence, n (%) VDZ/PBO VDZ Q8W VDZ Q4W Non-responders PBO/PBO (n=153) (n=154) (n=154) (n=506) (n=148) Any AE 128 (84) 135 (88) 130 (84) 441 (87) 118 (80) Serious AE 23 (15) 28 (18) 25 (16) 146 (29) 23 (16) Common AEs in 10% Crohn s disease 29 (19) 25 (16) 24 (16) 115 (23) 36 (24) Abdominal pain 18 (12) 15 (10) 19 (12) 45 (9) 21 (14) Nausea 18 (12) 18 (12) 22 (14) 50 (10) 12 (8) Upper respiratory tract infection 29 (19) 35 (23) 43 (28) 106 (21) 27 (18) Arthralgia 21 (14) 17 (11) 21 (14) 72 (14) 19 (13) Pyrexia 23 (15) 18 (12) 29 (19) 56 (11) 17 (11) Headache 28 (18) 20 (13) 26 (17) 51 (10) 19 (13) Infections 64 (42) 69 (45) 71 (46) 219 (43) 57 (39) Serious infection 5 (3) 6 (4) 9 (6) 30 (6) 4 (3) Infusion reaction 6 (4) 7 (5) 10 (6) 16 (3) 8 (5) Malignant neoplasm 0 (0) 1 (<1) 0 (0) 3 (<1) 1 (<1) AE, adverse event; CD, Crohn s disease; PBO, placebo; VDZ, vedolizumab Sandborn WJ, et al. N Engl J Med 2013;369: (Supplementary appendix: Table S6). 7
8 Conclusions We have a new class of drug in our therapeutic armamentarium! Vedolizumab provides us with a new option for the first-line biologic treatment of ulcerative colitis and Crohn s disease Vedolizumab can also be used as a second-line biologic in patients who have not responded to, or are intolerant to TNFα inhibitors Safety and tolerability reflect gut-selective mechanism of action Vedolizumab will be a valuable addition for prescribers and patients to consider when they fail conventional therapy TNFα, tumour necrosis factor alpha 8
9 Clinical positioning of current biologics Anti-TNFα Anti-integrin Ulcerative colitis Induction / maintenance UC / / Steroid-refractory fulminant UC Steroid-refractory UC (post-hoc) Early UC / Late UC (post-hoc) Safety in UC Crohn s disease Induction / maintenance luminal CD / / Perianal fistulising CD Infliximab Early luminal / Late luminal CD (post-hoc) / / Favourable efficacy and/or safety profile Less favourable profile CD, Crohn s disease; IBD, inflammatory bowel disease; UC, ulcerative colitis Danese S, Panés J. Gastroenterology 2014; Epub 14 September (DOI: /j.gastro ). 9
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 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 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 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 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 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 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 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 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 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 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 informationSelection and use of the non-anti- TNF biological therapies: Who? When? How?
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
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 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 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 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 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 informationFOR UK NURSING MEDIA Embargoed until: 00:01 GMT, Friday 13 March 2015
Contact: Ross Selby Takeda UK Ltd Email ross.selby@takeda.com News Release FOR UK NURSING MEDIA Embargoed until: 00:01 GMT, Friday 13 March 2015 World s first gut-selective treatment for ulcerative colitis
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 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 clinical study also provides data for Entyvio in inducing complete mucosal healing and endoscopic remission, particularly in bio-naïve patients
News Release Embargoed until February 16, 2018 at 17:00 CET Entyvio (vedolizumab) Shows Higher Rates of Mucosal Healing Versus TNFα-Antagonist Therapy in Ulcerative Colitis and Crohn s Disease Patients
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 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 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 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 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 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 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 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 informationI nuovi farmaci biologici: anche nell'anziano?
LE MALATTIE INFIAMMATORIE CRONICHE INTESTINALI NELL ANZIANO I nuovi farmaci biologici: anche nell'anziano? ANNA KOHN (Roma) increasing incidence Jeuring SFG, Inflamm Bowel Dis 2016 IBD Prevalence on December
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 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 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 informationUNC INFLAMMATORY BOWEL DISEASE DRUG PROTOCOL VEDOLIZUMAB (ENTYVIO)
UNC INFLAMMATORY BOWEL DISEASE DRUG PROTOCOL VEDOLIZUMAB (ENTYVIO) TREATMENT PROTOCOL: Vedolizumab is a humanized immunoglobulin G1 monoclonal antibody that targets 41 integrin and blocks its interaction
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 informationSelby Inflamm Bowel Dis. 2008:14:
Medical Management of Inflammatory Bowel Disease Freddy Caldera D.O. Assistant Professor Division of Gastroenterology Objectives Discuss Crohn s disease and Ulcerative Colitis Discuss Medications for Inflammatory
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 informationClinical Policy: Vedolizumab (Entyvio) Reference Number: CP.PHAR.265
Clinical Policy: (Entyvio) Reference Number: CP.PHAR.265 Effective Date: 07/16 Last Review Date: 07/17 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory
More informationINFLAMMATORY BOWEL DISEASE
1. Medical Condition INFLAMMATORY BOWEL DISEASE (IBD) specifically includes Crohn s disease (CD) and ulcerative colitis (UC) but also includes IBD unclassified (IBDu), seen in about 10% of cases. These
More informationHow do I choose amongst medicines for inflammatory bowel disease. Maria T. Abreu, MD
How do I choose amongst medicines for inflammatory bowel disease Maria T. Abreu, MD Overview of IBD Pathogenesis Bacterial Products Moderately Acutely Inflamed Chronic Inflammation = IBD Normal Gut Mildly
More informationCurrent and Emerging Biologics for Ulcerative Colitis
Gut and Liver, Vol. 9, No. 1, January 2015, pp. 18-27 Review Current and Emerging Biologics for Ulcerative Colitis Sung Chul Park* and Yoon Tae Jeen *Division of Gastroenterology and Hepatology, Department
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 informationSUPPLEMENTAL MATERIALS
SUPPLEMENTAL MATERIALS Intensity of Adverse Events The intensity for each adverse (AE) was defined by the study investigator as mild, moderate, or severe according to the following criteria: Mild: Awareness
More informationEmerging Therapies in IBD 2006
Overview Emerging Therapies in IBD 26 David T. Rubin, MD Assistant Professor of Medicine Inflammatory Bowel Disease Center University of Chicago Describe the unmet needs of therapy in IBD Emerging biologic
More informationResearch Update: Looking for the Answers
Research Update: Looking for the Answers Ted Denson, M.D. Schubert-Martin Inflammatory Bowel Disease Center Research Support: NIH/NIDDK, CCFA, BMRP Figure 2 Approach to Improve Outcomes for our IBD Patients
More informationSUPPLEMENTARY MATERIAL. Journal: Clinical Drug Investigation
SUPPLEMENTARY MATERIAL Journal: Clinical Drug Investigation Title: Safety profile of biologic drugs in the treatment of inflammatory bowel diseases: a systematic review and network meta-analysis of randomized
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 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 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 informationADHESION MOLECULES AS A THERAPEUTIC TARGET IN IBD
ADHESION MOLECULES AS A THERAPEUTIC TARGET IN IBD Raquel F. Leal, Azucena Salas Institut d investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Center Esther Koplowitz, Barcelona, Spain Disclosure: No
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 informationCADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION
CADTH CANADIAN DRUG EXPERT COMMITTEE FINAL RECOMMENDATION VEDOLIZUMAB (Entyvio Takeda Canada Inc.) Indication: Ulcerative Colitis Recommendation: The CADTH Canadian Drug Expert Committee (CDEC) recommends
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 informationvedolizumab 300mg powder for concentrate for solution for infusion (Entyvio ) SMC No. (1064/15) Takeda UK Ltd
vedolizumab 300mg powder for concentrate for solution for infusion (Entyvio ) SMC No. (1064/15) Takeda UK Ltd 05 June 2015 The Scottish Medicines Consortium (SMC) has completed its assessment of the above
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 informationAdvances in the development of new biologics in inflammatory bowel disease
INVITED REVIEW Annals of Gastroenterology (2016) 29, 1-6 Advances in the development of new biologics in inflammatory bowel disease Bella Ungar, Uri Kopylov Sheba Medical Center, Tel Hashomer and Sackler
More informationInflammatory bowel disease (IBD) Overview of the Paediatric investigation plans. Presented by: Richard Veselý. An agency of the European Union
Inflammatory bowel disease (IBD) Overview of the Paediatric investigation plans Presented by: Richard Veselý An agency of the European Union Adalimumab - Crohn s disease Indication: Treatment of severe,
More informationNew and Emerging Therapies in IBD. Sarah Streett MD, AGAF Clinical Associate Professor of Medicine Stanford University
New and Emerging Therapies in IBD Sarah Streett MD, AGAF Clinical Associate Professor of Medicine Stanford University New and Emerging Therapies in IBD I have no relevant financial disclosures. IBD is
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 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 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 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 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 informationNorthern Treatment Advisory Group. Biologic drugs for treatment-refractory moderately to severely active ulcerative colitis
Northern Treatment Advisory Group Biologic drugs for treatment-refractory moderately to severely active ulcerative colitis Lead author: Dominic McDermott Regional Drug & Therapeutics Centre (Newcastle)
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 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 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 informationFuture Therapies in IBD. William J. Sandborn, M.D. Mayo Clinic, Rochester, Minnesota
Future Therapies in IBD William J. Sandborn, M.D. Mayo Clinic, Rochester, Minnesota Korzenik et al. Nature Reviews Drug Discovery 5, 197 209 (March 2006) doi:10.1038/nrd1986 Therapies for IBD: The Pipeline
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 informationEfficacy of Vedolizumab as Induction Therapy for Inflammatory Bowell Disease in a «real-life» Study. Clinical Study
Efficacy of Vedolizumab as Induction Therapy for Inflammatory Bowell Disease in a «real-life» Study Clinical Study Q. Trefois (1), O. Descamps (2), J-C. Coche (3), M. Schapira (4) 1 Depar t m ent o f H
More informationEvidence review for Surrey Prescribing Clinical Network SUMMARY
East Surrey CCG, Guildford & Waverley CCG, North West Surrey CCG, Surrey Downs CCG, Surrey Heath CCG, Crawley CCG, Horsham & Mid-Sussex CCG Evidence review for Surrey Prescribing Clinical Network Medicine
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 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 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 informationPRODUCT MONOGRAPH ENTYVIO. Vedolizumab. powder for concentrate for solution for infusion. 300 mg/vial. Professed
PRODUCT MONOGRAPH ENTYVIO Vedolizumab powder for concentrate for solution for infusion 300 mg/vial Professed Gut-Selective Anti-Inflammatory Biologic ENTYVIO should be used by Healthcare Professionals
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 informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 3 October 2012
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 3 October 2012 REMICADE 100 mg, powder for concentrate for solution for infusion B/1 vial (CIP code: 562 070-1) Applicant:
More informationVedolizumab: an α4β7 integrin antagonist for ulcerative colitis and Crohn s disease
Virginia Commonwealth University VCU Scholars Compass VCU Health Publications VCU Health 2015 Vedolizumab: an α4β7 integrin antagonist for ulcerative colitis and Crohn s disease Lauren N. Cherry Virginia
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 informationLooking for Answers. IBD Research March 9, Dr. Benjamin Click, MD MS Associate Staff Cleveland Clinic
Looking for Answers IBD Research 2019 March 9, 2019 Dr. Benjamin Click, MD MS Associate Staff Cleveland Clinic Disclosures No relevant financial disclosures There is still no cure for IBD Why me? ETIOLOGY
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 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 informationEmerging Therapies in IBD: The Future is Bright October 28 th 2017
Emerging Therapies in IBD: The Future is Bright October 28 th 2017 Nirmal Kaur, MD Director, Inflammatory Bowel Disease Center Division of Gastroenterology Henry Ford Health System Disclosures Research
More informationInflammatory bowel disease: cause(s), cure(s) and prediction of disease flare NZ Society of GI: 21 st November 2018
Inflammatory bowel disease: cause(s), cure(s) and prediction of disease flare NZ Society of GI: 21 st November 2018 Dr Charlie Lees Consultant Gastroenterologist From the Edinburgh IBD Unit at the Western
More informationInflammatory bowel disease: Novel therpaies NZ November 2018
Inflammatory bowel disease: Novel therpaies NZ November 2018 Dr Charlie Lees Consultant Gastroenterologist From the Edinburgh IBD Unit at the Western General Hospital History of treatment for IBD 1950s
More informationEffectiveness and safety of vedolizumab for treatment of Crohn s disease: a systematic review and meta-analysis
Systematic review/meta-analysis Effectiveness and safety of vedolizumab for treatment of Crohn s disease: a systematic review and meta-analysis Paweł Moćko 1, Paweł Kawalec 1, Beata Smela-Lipińska 1, Andrzej
More informationFuture Directions in IBD: Treatments & Approaches JAMES LORD, MD PHD BENAROYA RESEARCH INSTITUTE AT VIRGINIA MASON MEDICAL CENTER APRIL 29, 2018
Future Directions in IBD: Treatments & Approaches JAMES LORD, MD PHD BENAROYA RESEARCH INSTITUTE AT VIRGINIA MASON MEDICAL CENTER APRIL 29, 2018 Why do pharmaceuticals dominate IBD therapy discussions?
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 informationManaging Crohn s Disease and Ulcerative Colitis
Managing Crohn s Disease and Ulcerative Colitis Samir A. Shah, MD, FACG, FASGE, AGAF Clinical Professor of Medicine, Brown University Chief of Gastroenterology, The Miriam Hospital Gastroenterology Associates,
More informationInitiation of Maintenance Treatment in Moderate to Severe New Onset Crohn s Disease
Initiation of Maintenance Treatment in Moderate to Severe New Onset Crohn s Disease The Case for Starting with Anti-TNFα Agents Maria Oliva-Hemker, M.D. Chief, Division of Pediatric Gastroenterology &
More informationustekinumab 130mg concentrate for solution for infusion and 90mg solution for injection (Stelara ) SMC No. (1250/17) Janssen-Cilag Ltd
ustekinumab 130mg concentrate for solution for infusion and 90mg solution for injection (Stelara ) SMC No. (1250/17) Janssen-Cilag Ltd 09 June 2017 The Scottish Medicines Consortium (SMC) has completed
More informationGuide to Gastroenterology Biological Therapeutic Drug Monitoring Pathway (TDM)
Guide to Gastroenterology Biological Therapeutic Drug Monitoring Pathway (TDM) Author: Responsible Lead Consultants: Endorsing Body: Implementation Date: 01/08/2018 Version Number: 1.0 Review Date: 01/08/2020
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 informationTofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis
The new england journal of medicine Original Article Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis William J. Sandborn, M.D., Chinyu Su, M.D., Bruce E. Sands, M.D., Geert R. D
More informationA Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab
Clin Pharmacokinet (2017) 56:1287 1301 DOI 10.1007/s40262-017-0546-0 REVIEW ARTICLE A Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Vedolizumab Maria Rosario 1 Nathanael
More informationEnrolling Research Studies 15 November 2017
Enrolling Research Studies 15 November 2017 Crohn s Disease/ Ulcerative Colitis Humira (AbbVie) Crohn s Disease (Eli Lilly) Ulcerative Colitis (Genentech) Crohn s Disease (Genentech) Crohn s Disease /
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 informationDENOMINATOR: All patients aged 18 and older with a diagnosis of inflammatory bowel disease
Measure #270: Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy National Quality Strategy Domain: Effective Clinical Care 2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY
More information