Abstract
Abstract Background In this study we seek to add to the body of knowledge on the practical use of ustekinumab in patients with Crohns and Colitis. Patients commencing ustekinumab will mostly have failed, or are intolerant to, conventional biologic agents and therefore have a limited number of medical options available to manage their disease. Results from the IM-UNITI long-term extension study have shown that a proportion of patients will lose response to maintenance dose therapy, and a small number of studies have suggested that repeated induction doses of this therapy can prolong its effective use and allow patients a greater period of disease free remission. Shrewsbury and Telford hospital NHS trust is a multi-site UK hospital serving a large population in the west-midlands region which has established the routine use of usetkinumab therapy over 5 years ago and by reviewing data on our patient cohort we aimed to identify characteristics amongst patients who have required reinduction doses and how effective they have been in maintaining remission. Methods In this retrospective, interventional study two researchers gathered data including baseline characteristics, disease type and distribution, previous surgical and medical therapies and time from diagnosis on all patients who had received ustekinumab therapy over the past five years. We used biochemical and endoscopic data, as well as clinical records, to determine the efficacy of ustekinumab on the disease course. We identified the subgroup of patients requiring reinduction doses and noted whether this was a successful intervention and sought to describe similarities which could help identify patients at risk of failing maintenance therapy in future. Results Data from 213 patients was gathered (Crohns: 150, UC: 61, IBDU: 2) and of which 87 (Crohns: 63, UC: 24) received reinduction doses. Average time to reinduction from therapy commencement was 19.5 months (Crohns) and 16.3 months (UC) respectively. Of the reinduction group 63% showed improvement in their disease control and a variety of characteristics were noted amongst the successful patients for discussion including disease location, presence of perianal disease and time from diagnosis. Conclusion Ustekinumab reinduction is an important area for further research as it allows patients to prolong their successful therapy and delay the need for surgical intervention for difficult to manage disease. This study suggests characteristics which could inform further trials and establish protocols to aid clinicians when making decisions about switching biologic therapies.
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