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An Overview of Ibd Patients on Biological Therapy at Raigmore Hospital

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An Overview of Ibd Patients on Biological Therapy at Raigmore Hospital AN OVERVIEW OF IBD PATIENTS ON BIOLOGICAL THERAPY AT RAIGMORE HOSPITAL Gathered patient data on the biological medicines infliximab, adalimumab and vedolizumab. DIPLOMA THESIS to be awarded the academic degree MAGISTRA DER PHARMAZIE at Karl-Franzens-University Graz written by: Angelika Sattler supervised by: Rhona Gunn, Head of Specialist Pharmaceutical Services at Raigmore Hospital, Inverness, Scotland permitted by: Ao.Univ.-Prof. Mag.pharm. Dr.rer.nat. Astrid Ortner submitted to: Institute of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Karl-Franzens-University Graz, Austria Graz, 2018 Affidavit I hereby confirm that the following diploma thesis entitled ”An overview of IBD patients on biological therapy at Raigmore Hospital" was written all by myself without any help and support of a third party. Further I confirm that I did not use any other sources than those indicated. Graz, 27. April 2018 Angelika Sattler I Acknowledgements First of all, I would like to thank Ao.Univ.-Prof. Mag.pharm. Dr.rer.nat. Astrid Ortner for offering me the opportunity to go to Scotland and do the project for my diploma thesis at Raigmore Hospital in Inverness. Furthermore, I would like to thank Ian Rudd, Director of Pharmacy, for the heartily welcome and making all possible in the first place. Specials thanks go to my great supervisor Rhona Gunn, Head of Specialist Pharmaceutical Services at Raigmore Hospital, for her time and support during my stay and my research work at Raigmore Hospital. Moreover, I would like to thank consultant gastroenterologist Lindsay Potts and lead advanced nurse IBD David Armour for giving me the possibility to work on this project and for their enthusiasms. Last but not least, I would like to thank my parents for their encouraging love. Thank you for strengthen my decision to write my thesis abroad. I could not have done it without your support! Dedicated to my beloved parents and grandparents. II Content Affidavit .................................................................................................................... I Acknowledgements .................................................................................................. II Abstract .................................................................................................................. VI Kurzfassung ........................................................................................................... VII 1. Introduction ...................................................................................................... 1 1.1. Aetiology of IBD .................................................................................................. 2 1.2. Epidemiology of IBD ........................................................................................... 2 1.3. Crohn’s Disease .................................................................................................. 3 1.3.1. Symptoms ................................................................................................... 3 1.3.2. Classification ............................................................................................... 4 1.3.3. Diagnosis ..................................................................................................... 4 1.4. Ulcerative Colitis ................................................................................................ 5 1.4.1. Symptoms ................................................................................................... 5 1.4.2. Classification ............................................................................................... 5 1.4.3. Diagnosis ..................................................................................................... 7 1.5. Drug Therapy ...................................................................................................... 7 1.5.1. Aminosalicylates ......................................................................................... 8 1.5.2. Corticosteroids ............................................................................................ 9 1.5.3. Immunomodulators .................................................................................. 10 1.5.4. Antibiotics ................................................................................................. 12 1.5.5. Biologicals ................................................................................................. 12 1.6. Surgery ............................................................................................................. 12 1.7. Treatment pathway .......................................................................................... 13 1.8. Remission ......................................................................................................... 14 1.8.1. Harvey-Bradshaw Index ............................................................................ 14 1.8.2. Faecal calprotectin .................................................................................... 15 2. Biological Therapy ............................................................................................ 17 III 2.1. Monoclonal Antibodies .................................................................................... 18 2.2. TNFα- Inhibitors ............................................................................................... 18 2.2.1. Antidrug- antibodies ................................................................................. 20 2.2.2. Infliximab .................................................................................................. 20 2.2.3. Adalimumab .............................................................................................. 21 2.3. Vedolizumab ..................................................................................................... 22 2.4. Biosimilars ........................................................................................................ 23 3. Research Question, Aim and Objectives ............................................................ 25 3.1. Research Question ........................................................................................... 25 3.2. Aim ................................................................................................................... 25 3.3. Objectives ......................................................................................................... 25 4. Methods .......................................................................................................... 26 4.1. Literature Review ............................................................................................. 26 4.2. Research Methods ........................................................................................... 26 4.2.1. Inclusion Criteria ....................................................................................... 26 4.2.2. Exclusion Criteria ...................................................................................... 27 4.2.3. Ethical consideration ................................................................................ 27 4.2.4. Sample Size ............................................................................................... 27 4.3. Data Analysis .................................................................................................... 27 4.3.1. Infliximab .................................................................................................. 27 4.3.2. Adalimumab .............................................................................................. 29 4.3.3. Vedolizumab ............................................................................................. 30 4.3.4. Reason for switching treatment ............................................................... 30 4.3.5. Investigations of duration and response .................................................. 31 5. Results ............................................................................................................. 33 5.1. Study Settings ................................................................................................... 33 5.2. Infliximab .......................................................................................................... 33 5.2.1. Stopped Treatment ................................................................................... 34 5.2.2. Maintenance ............................................................................................. 35 5.2.3. Switched biological ................................................................................... 36 5.3. Adalimumab ..................................................................................................... 36 5.3.1. Stopped treatment ................................................................................... 37 IV 5.3.2. Maintenance ............................................................................................. 38 5.3.3. Switched biological ................................................................................... 39 5.4. Vedolizumab third-line treatment ................................................................... 39 5.4.1. Stopped treatment ................................................................................... 40 5.4.2. Maintenance ............................................................................................. 41 5.5. Vedolizumab second-line treatment ..............................................................
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