| Release date: November 2009 Expiration date: November 30, 2010 Estimated time to complete activity: 1.5 hours |
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Co-sponsored by the University of Chicago Pritzker School of Medicine and Curatio CME Institute
Support for this activity has been provided through an independent educational grant from Abbott and Warner Chilcott.
Activity Overview
The inflammatory bowel diseases—Crohn’s disease (CD) and ulcerative colitis (UC)—are chronic, idiopathic, inflammatory disorders of the gastrointestinal tract that are associated with considerable morbidity and a negative impact on patient quality of life. Inflammatory bowel disease (IBD) research is a dynamic area, with our understanding of the mechanisms underlying IBD and the spectrum of effective therapies continually evolving. Given the constantly changing landscape of IBD research, it is essential that clinicians be aware of the most recent data regarding the optimal and appropriate use of both conventional and biologic agents for the treatment of mild, moderate, and severe IBD. In this activity, the faculty shares relevant and important data regarding the indications and contraindications of available therapies for the treatment of IBD. Additionally, each faculty member provides perspectives on the optimal use of these agents. The presentations and interactive panel discussions are intended to translate evidence and experience into meaningful and practical information that will enable gastroenterologists to improve their daily care of patients with IBD.
Target Audience
This activity has been designed to meet the educational needs of gastroenterologists and other health care professionals involved in the care of patients with IBD.
Learning Objectives
After completing this activity, participants should be able to:
- Explain the impact of disease severity on quality of life in UC and CD
- Discuss the appropriate indications and contraindications for the use of foundational and biologic agents in the treatment of UC and CD
- Design optimal treatment strategies that use foundational or biologic agents to induce and maintain remission of UC and CD
Stephen B. Hanauer, MD—Program Chair View biography
Professor of Medicine and Clinical Pharmacology
Chief, Section of Gastroenterology, Hepatology and Nutrition
University of Chicago Pritzker School of Medicine
Chicago, Illinois
Brian G. Feagan, MD View biography
Professor of Medicine, Epidemiology and Biostatistics
University of Western Ontario
London Health Sciences Centre
Director, Robarts Clinical Trials, Robarts Research Institute
London, Ontario, Canada
Daniel H. Present, MD View biography
Clinical Professor of Medicine
Mount Sinai School of Medicine
New York, New York
William J. Sandborn, MD View biography
Dorothy A. Adair Professor of Gastrointestinal Research
Vice Chair, Division of Gastroenterology and Hepatology
Mayo Clinic
Rochester, Minnesota
Accreditation Statement
The University of Chicago Pritzker School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Credit Designation
The University of Chicago Pritzker School of Medicine designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Participants should not claim credit for this activity if credit was previously claimed for attending the June 1, 2009, live CME symposium in Chicago, Illinois, on which this activity is based.
Method of Participation
There are no fees for participating in this CME activity. To receive credit during the period November 2009 to November 30, 2010, participants must (1) read the learning objectives and disclosure statements, (2) study the educational activity, (3) complete the posttest, and (4) complete the activity evaluation form, including the certificate information section.
To obtain a certificate, participants must receive a score of 70% or better on the posttest. The posttest can be accessed at the end of the activity. Please e-mail any questions to cmeinfo@curatiocme.com.
Medium
The Internet was selected as the instructional format to accommodate the learning preferences of a significant portion of the target audience.
Disclosure
The University of Chicago Pritzker School of Medicine and Curatio CME Institute adhere to the ACCME Essential Areas, Standards for Commercial Support, and Policies regarding industry support of continuing medical education. Disclosure of the commercial relationships of everyone in a position to control the content of this educational activity is shown below. Speakers are also required to openly disclose discussion of any off-label, experimental, or investigational use of drugs or devices in their presentations.
Relationship information for the Program Chair and Faculty Presenters appears below:
Brian G. Feagan, MD, has disclosed the following relevant financial relationships:
| Research Support | Abbott, Berlex, Bristol-Myers Squibb, Boehringer Ingelheim, Novartis, Centocor Ortho Biotech, Elan/Biogen, Genentech, Millennium Pharmaceuticals, Napo Pharma, Osiris, Otsuka, Protein Design Labs, Schering Canada, Schering-Plough, Synta, Tillotts, Warner Chilcott, UCB |
| Consultant | Albireo, AstraZeneca, Berlex, Bristol-Myers Squibb, Celgene, Centocor Ortho Biotech, Cerimon Pharmaceuticals, CombinatoRx, Elan/Biogen, GeneLogic, Genentech, Given Imaging, ISIS, Janssen-Ortho, Millennium Pharmaceuticals, Napo Pharma, Ore Pharmaceuticals, Osiris, Protein Design Labs, Salix, Santarus, Schering Canada, Schering-Plough, Serono, Synta, Teva Pharmaceuticals, Tillotts, Tioga Pharmaceuticals, Warner Chilcott, UCB, Unity Pharmaceuticals |
| Speakers Bureau | AstraZeneca |
| Advisory Board | AstraZeneca, Celgene, Elan/Biogen, Given Imaging, Novartis, Protein Design Labs, Schering Canada, Synta |
Stephen B. Hanauer, MD, has disclosed the following relevant financial relationships:
| Consultant | Abbott, Bristol-Myers Squibb, Centocor Ortho Biotech, Elan, Ferring, Genentech, GlaxoSmithKline, McNeil PPC, Millennium Pharmaceuticals, Novartis, Prometheus, Salix, Shire, Warner Chilcott, UCB |
| Clinical Research | Abbott, Bristol Myers Squibb, Centocor Ortho Biotech, Elan, Ferring, Genentech, Prometheus, Salix, Shire, Warner Chilcott, UCB |
Daniel H. Present, MD, has disclosed the following relevant financial relationships:
| Grant/Research Support | Abbott, Alaven, Centocor Ortho Biotech, Crohn’s & Colitis Foundation of America, Elan, Mayo Clinic, The National Institutes of Health (University of Pennsylvania), Tech Lab, Teva Pharmaceuticals USA, Warner Chilcott, UCB |
| Consultant/Scientific Advisor | Abbott, Alaven, Axcan Pharma, Centocor Ortho Biotech, Elan, Salix, Warner Chilcott, UCB Speakers Bureau Axcan Pharma, Elan, Salix, Shire, Warner Chilcott, UCB |
William J. Sandborn, MD, has disclosed the following relevant financial relationships:
| Consultant | Abbott, Centocor Ortho Biotech, Elan, Salix, Shire, Warner Chilcott, UCB |
| Research Support | Abbott, Centocor Ortho Biotech, Elan, Shire, Warner Chilcott, UCB |
Curatio CME Institute
LJ Fiedler, RN, BSN, has disclosed no relevant financial relationships.
Julie Messick, Pharm D, has disclosed no relevant financial relationships.
Jonathan S. Simmons, ELS, has disclosed no relevant financial relationships.
University of Chicago Center for Continuing Medical Education
The staff of the Center for Continuing Medical Education has no financial arrangements or affiliations to disclose.
Disclaimer
The information presented at this activity is for continuing medical education purposes only and is not meant to substitute for the independent medical judgment of a physician regarding diagnosis and treatment of a specific patient’s medical condition.
Unapproved Product Use
This educational activity may contain discussion of published or investigational uses of agents that are not indicated by the US Food and Drug Administration. Curatio CME Institute, Abbott, Warner Chilcott, and the University of Chicago Pritzker School of Medicine do not recommend the use of any agent outside the labeled indications.
The opinions expressed in this educational activity are those of the faculty and do not represent the views of Curatio CME Institute, Abbott, Warner Chilcott, or the University of Chicago Pritzker School of Medicine. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
| Generic Name | Trade Name | Approved Use (if any) | Unapproved/ Investigational Use |
| Adalimumab | Humira® | Reducing signs and symptoms and inducing and maintaining remission in adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response to conventional therapy; reducing signs and symptoms and inducing clinical remission in patients with CD who have also lost response to or are intolerant to infliximab; rheumatoid arthritis (RA); juvenile idiopathic arthritis; psoriatic arthritis; ankylosing spondylitis; plaque psoriasis | Ulcerative colitis (UC); early treatment of CD |
| Azathioprine | Imuran® | Prevention of rejection in renal homotransplantation; severe, active RA that is unresponsive to rest, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or to agents in the class of which gold is an example | Inflammatory bowel disease (IBD); UC or CD |
| Budesonide | Entocort® EC | Treatment of mild to moderate active CD (up to 8 weeks with repeated 8-week courses as necessary); maintenance of clinical remission of CD for up to an additional 3 months | Maintenance of remission of CD (long-term) |
| Certolizumab pegol | Cimzia™ | Reducing signs and symptoms of CD and maintaining clinical response in patients with moderately to severely active CD who have had an inadequate response to conventional therapy; moderately to severely active RA | UC; early treatment of CD |
| Ciprofloxacin | Various | Urinary tract infections, acute uncomplicated cystitis in females, chronic bacterial prostatitis, lower respiratory tract infections, acute sinusitis, skin and skin structure infections, bone and joint infections, complicated intra-abdominal infections | CD |
| Corticosteroids | Various | UC and regional enteritis, endocrine disorders, rheumatic disorders, collagen disorders, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, nervous system disorders (acute exacerbations of multiple sclerosis), and miscellaneous disorders (tuberculosis meningitis, trichinosis) | CD |
| Cyclosporine | Sandimune®, Neoral® | Kidney, liver, and heart transplantation; RA; psoriasis | UC |
| Infliximab | Remicade® | Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy; fistulizing CD; moderately to severely active UC; moderately to severely active RA; ankylosing spondylitis; plaque psoriasis; psoriatic arthritis | Early treatment of CD |
| 6-Mercaptopurine | Purinethol® | Remission induction and maintenance therapy of acute lymphatic leukemia | IBD; UC or CD |
| Controlled-release mesalamine | Pentasa® | Induction of remission and for the treatment of patients with mildly to moderately active UC | CD; maintenance of remission of UC; chemoprevention of colorectal cancer; IBD in pregnancy |
| Delayed-release mesalamine | Asacol® | Treatment of mildly to moderately active UC; maintenance of remission of UC | CD; dosages >2.4 g/d for UC; chemoprevention of colorectal cancer; IBD in pregnancy |
| Delayed-release mesalamine | Asacol® HD | Treatment of moderately active UC | CD; maintenance of remission of UC; chemoprevention of colorectal cancer; IBD in pregnancy |
| Delayed-release mesalamine | Lialda™ | Induction of remission in patients with active, mild to moderate UC | CD; maintenance of remission of UC; chemoprevention of colorectal cancer; IBD in pregnancy |
| Extended-release mesalamine | Apriso™ | Maintenance of remission of UC | CD; chemoprevention of colorectal cancer; IBD in pregnancy |
| Methotrexate | Rheumatrex® | Treatment of neoplastic diseases; symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy; management of selected adults with severe, active, rheumatoid arthritis (ACR criteria) or children with active polyarticular-course juvenile rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first-line therapy including full-dose NSAIDs | CD |
| Metronidazole | Various | Trichomoniasis, aymptomatic consorts of patients with Trichomonas vaginalis infection, amebiasis, anaerobic bacterial infections, intra-abdominal infections, skin and skin structure infections, gynecologic infections, bacterial septicemia, bone and joint infections, central nervous system infections, lower respiratory tract infections, endocarditis | CD |
| Sulfasalazine | Azulfidine® | Treatment of mild to moderate UC and as adjunctive therapy in severe UC; prolongation of the remission period between acute attacks of UC | CD; chemoprevention of colorectal cancer |
| Sulfasalazine | Azulfidine-EN® | Treatment of mild to moderate UC and as adjunctive therapy in severe UC; prolongation of the remission period between acute attacks of UC; treatment of patients with RA who have responded inadequately to salicylates or other NSAIDs; treatment of pediatric patients with polyarticular-course juvenile RA who have responded inadequately to salicylates or other NSAIDs | CD; chemoprevention of colorectal cancer |
Abbreviations
| 4-ABA | 4-aminobenzoic acid |
| 5-ASA | 5-aminosalicylic acid |
| 6-MP | 6-mercaptopurine |
| ACCENT | A Crohn’s Disease Clinical Trial Evaluating Infliximab in a New Long- Term Treatment Regimen |
| ACT | Active Ulcerative Colitis Trial |
| ADA | adalimumab |
| AE | adverse events |
| ARR | absolute risk reduction |
| ASCEND | Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA |
| AZA | azathioprine |
| CCDSS | Cooperative Crohn’s Disease Study in Sweden |
| CD | Crohn’s disease |
| CDAI | Crohn’s Disease Activity Index |
| CHARM | Crohn’s Trial of the Fully Human Antibody Adalimumab for Remission Maintenance |
| COMMIT | Combination of Maintenance Methotrexate-Infliximab Trial |
| CI | confidence interval |
| D/C | discontinued |
| EBV | Epstein-Barr virus |
| ENACT | Efficacy of Natalizumab as Active Crohn’s Therapy |
| EOW | every other week |
| ESR | erythrocyte sedimentation rate |
| GCS | glucocorticoid steroids |
| HR | hazard ratio |
| IBD | inflammatory bowel disease |
| IBDQ | Inflammatory Bowel Disease Questionnaire |
| IFX | infliximab |
| ITT | intent to treat |
| MAdCAM | mucosal addressin cell adhesion molecule |
| METRO | metronidazole |
| MTX | methotrexate |
| NCCDS | National Cooperative Crohn’s Disease Study |
| NNT | number needed to treat |
| OR | odds ratio |
| Post-op | post operative |
| PRECISE | Pegylated Antibody Fragment Evaluation in Crohn’s Disease: Safety and Efficacy |
| QoL | quality of life |
| RA | rheumatoid arthritis |
| RCT | randomized controlled trial |
| RR | risk ratio |
| SC | subcutaneous |
| SF-36 | short form-36 |
| SIR | standard incidence ratio |
| SONIC | Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease |
| SPS | sulfasalazine |
| TNF | tumor necrosis factor |
| TOUCH | Tysabri Outreach: Unified Commitment to Health Prescribing Program |
| TREAT | Crohn’s Therapy, Resource, Evaluation, and Assessment Tool |
| UC | ulcerative colitis |
| US | United States |
| VCAM | vascular cell adhesion molecule |
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