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Adjudication committee
- First opponent: Associate Professor Michael Eberhardson, Karolinska University Hospital, Sweden
- Second opponent: Senior Advisor Venke Skibeli, The Norwegian Medicines Agency
- Third member and chair of the evaluation committee: Professor II Egil Johnson, Faculty of Medicine, University of Oslo
Chair of the Defence
Associate Professor Anne-Marie Aas, Faculty of Medicine, University of Oslo
Principal Supervisor
Associate Professor Marte Lie Høivik, Faculty of Medicine, University of Oslo
Summary
Inflammatory bowel diseases (IBD) are chronic and disabling diseases that affect the gastrointestinal tract, often in young individuals. The incidence has been increasing over the last decades. Fortunately new therapies are evolving, and today biological medicines are the cornerstone in the treatment of moderate to severe IBD. During the recent decade, new biological medicines have been introduced, including less expensive biosimilars and medicines with novel mechanisms of action. In this thesis we have evaluated the clinical effectiveness and safety of novel biological medicines and strategies in real-world clinical practice.
We have followed IBD-patients that switched from originator infliximab to the first biosimilar version. The patients were followed prospectively from switch and for 18 months. No change in clinical disease activity scores or biochemical markers of inflammation was seen during follow-up. A low number of patients discontinued treatment and few patients developed antidrug antibodies.
Further we describe the follow-up of IBD-patients that recieved the recently approved anti-integrin vedolizumab. For patients with ulcerative colitis an improvement of clinical disease activity score was seen. For patients with Crohn’s disease biochemical markers of inflammation improved over time. We found a negative correlation between CRP at baseline and the plasma concentration of vedolizumab during maintenance treatment.
Finally, we have described the follow-up of patients receiving a combination of anti-TNF-α therapy and vedolizumab. This is a new strategy barely described in the literature. All the patients had a complicated disease course. The patients were followed from start of combination treatment and for at least one year. For the majority of patients this strategy served as an effective transition from one therapy to another, but two patients with Crohn’s disease needed both medicines in order to maintain remission.
The main conclusion of this thesis is that the new treatment strategies discussed are effective and important in the treatment of IBD. There is need for early predictive biomarkers indicating which therapy is best suited for the individual patient.
Additional information
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