Imperial College Health Partners (ICHP)

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Utilisation of real-world evidence in profiling the efficacy and safety for Ustekinumab (Stelara) in treating IBD patients in North West London

Currently, there is no cure for Inflammatory bowel disease (IBD). IBD diseases are characterized by a relapsing and remitting course. The aim when treating inflammatory bowel disease is either to heal the inflammation and so reduce symptoms during a flare-up ('inducing remission') or to prevent flare-ups happening in the future ('maintaining remission') in order to improve quality of life. The most common available treatments are medications and surgery. Patients with active disease typically have increased utilization of secondary care services and increased hospital visits with increased costs to the system. Relapsing Crohn's disease (CD) patients cost the NHS over five-times as much as patients in remission. Because of these characteristic alternating periods of relapse and remission clinical management of IBD is complex, with a broad range of therapies available for induction and maintenance of disease control. Pharmacologic treatment for mild to moderate disease begins with aminosalicylates (for Ulcerative Colitis (UC)), corticosteroids, thiopurines, and antibiotics, with therapies optimized based on disease location, patient preference, and comorbidities. However, conventional treatments are ineffective in 20%–40% of patients with UC and CD. For patients who do not respond, lose response or are intolerant of conventional therapy, clinical guidelines recommend using biologic therapy, particularly for patients with moderate to severe UC or CD. If remission is not achieved despite optimisation (switching) of biologics, surgery is the only remaining option. However, surgery may result in complications such as infertility, impotence, or intestinal failure. Utilization of real-world evidence can inform healthcare professionals of the effectiveness and safety of medicines for their patients. Approximately two thirds of patients seen in the clinics would routinely be excluded from clinical trials. Therefore, real world evidence is of high value to understand the true profile of the medicine, given there is limited safety data available from clinical trials, especially for the biologic therapies.

15/04/2021

TRE