@article {Honap517, author = {Sailish Honap and Lulia Al-Hillawi and Samantha Baillie and Aaron Bancil and Lawrence Matini and Rebecca Lau and Klaartje Bel Kok and Kamal Patel and Alissa Walsh and Peter M Irving and Mark A Samaan}, title = {Ustekinumab for the treatment of moderate to severe ulcerative colitis: a multicentre UK cohort study}, volume = {13}, number = {6}, pages = {517--523}, year = {2022}, doi = {10.1136/flgastro-2022-102168}, publisher = {British Medical Journal Publishing Group}, abstract = {Objective Ustekinumab is an interleukin-12/interleukin-23 receptor antagonist licensed for the treatment of ulcerative colitis (UC). Clinical trial data were promising; however, real-world data are limited. We assessed the safety and effectiveness of ustekinumab in UC in a real-world setting.Design/method This was a multicentre, retrospective, observational cohort study between February 2020 and January 2022. Disease activity was assessed using the Simple Clinical Colitis Activity Index (SCCAI). Clinical remission was defined as a SCCAI<=2. The primary endpoints were rates of corticosteroid-free remission (CSFR) at week 16 and at week 26. Objective outcomes, including faecal calprotectin (FCAL), were also collected.Results 110 patients with UC (65\% male; median age 40 (IQR range 29{\textendash}59); 96\% with prior biologic and/or tofacitinib exposure) had a median follow-up of 28 weeks (IQR 17{\textendash}47). CSFR was 36\% (18/50) at week 16\% and 33\% (13/39) at week 26, corresponding with a significant fall in SCCAI from 6 (IQR 4{\textendash}8) at baseline to 3 (IQR 0{\textendash}5) at week 26, p\<0.001. By week 16, there was improvement of median FCAL measurements, which fell from a baseline of 610 {\textmu}g/g (IQR 333{\textendash}1100) to 102 {\textmu}g/g (IQR 54{\textendash}674) at week 16. At the end of follow-up, 15\% (17/110) had discontinued treatment; 13 patients due to primary non-response or loss of response, and 1 patient for family planning. Treatment was discontinued in three patients due to adverse events.Conclusion In the largest real-world study to date, ustekinumab was effective with a reassuring safety profile in a refractory cohort of patients.No data are available. Individual patient data cannot be shared for confidentiality reasons.}, issn = {2041-4137}, URL = {https://fg.bmj.com/content/13/6/517}, eprint = {https://fg.bmj.com/content/13/6/517.full.pdf}, journal = {Frontline Gastroenterology} }