Sabhan H1, Lördal M2, Johansson F3, Bello F4, Muhsen S2, Wennerström C5, Forsberg O5, Borin A6, Höög C7, Almer S4, Söderman C1

Affiliates

1 Gastroenterology Unit, Medical Department, S:t Göran’s Hospital, Stockholm, Sweden 2 Division of Gastroenterology and Hepatology, Department of Medicine, Danderyd Hospital, Danderyd, Sweden 3 Medical library at Danderyd Hospital, Danderyd, Sweden 4 Division of Gastroenterology, Karolinska university hospital, Stockholm, Sweden 5 Janssen Cilag AB, Stockholm, Sweden 6 Department of Medicine, South Hospital, Stockholm, Sweden 7 Department of Medicine, Huddinge, Karolinska Institutet, Stockholm, Sweden

Abstract

Background: Ustekinumab (UST) is an anti-interleukin-12/23 antibody for treatment of inflammatory bowel disease (IBD), mainly used in patients failing anti-TNF-agents. The STOCUSTE study includes patients treated at four hospitals in Stockholm to provide long-term real-world data.

Methods: This was a retrospective study including patients diagnosed with ulcerative colitis and treated with UST between 2016 and 2021. The patients were followed from start of UST until withdrawal of treatment for any reason, or until end of the study period, July 31, 2021. We assessed disease activity; Physician Global Assessment (PGA), laboratory parameters and drug persistence. The primary outcome was remission (PGA = 0) and response (decrease PGA ≥ 1 from baseline) at 3 and 12 months, respectively.

Results: 96 patients, 44 women and 52 men were included. The patients had either extensive colitis (68%), left-sided colitis (29%) or proctitis (3%). 69/96 (71%) had previously failed 1 or 2 anti-TNF-drugs. In addition, 19/69 (28%) had failed vedolizumab, 8 patients were bio-naive. At inclusion 92 patients (96%) had active disease and 4 patients were in remission. 48 (50%) patients were on oral or topical corticosteroids, and 13 (14%) had thiopurines. At 12 months, UST drug persistence were 60/96 (63%) and 9% were on corticosteroids. Among patients treated with UST, 9/71 (13%) were in remission at 3 months, 34/37 (92%) had responded, and 27/37 (73%) patients were in remission at 12 months, as observed. Withdrawal from treatment during the first 12 months occurred for 36 (38%) of patients, mainly due to persisting disease activity 20%; 8% were withdrawn due to adverse events, 2% needed bowel surgery, and 2% were lost to follow up.

Conclusions: In this group of difficult-to-treat patients with ulcerative colitis, UST was shown to be effective in the majority, with high drug persistence at 12 months in combination with a favorable safety profile.