Long-term real-world data of ustekinumab in Crohn's disease: the Stockholm ustekinumab study.

Autor:	Bello F; Karolinska Institutet, Department of Medicine Solna, Karolinska University Hospital, Centre for Digestive Health, Department of Gastroenterology, Dermatovenereology and Rheumatology, Stockholm, Sweden., Muhsen S; Division of Gastroenterology and Hepatology, Department of Medicine, Danderyd Hospital, Danderyd, Sweden., Sabhan H; Gastroenterology Unit, Medical Department, St Göran's Hospital, Stockholm, Sweden., Borin A; Department of Medicine, South Hospital, Stockholm, Sweden., Johansson F; Medical Library at Danderyd Hospital, Danderyd, Sweden., Höög C; Department of Upper Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden., Forsberg O; Janssen-Cilag AB, Stockholm, Sweden., Wennerström C; Janssen-Cilag AB, Stockholm, Sweden., Söderman C; Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden Gastroenterology Unit, Medical Department, St Göran's Hospital, Stockholm, Sweden., Lördal M; Division of Gastroenterology and Hepatology, Department of Medicine, Danderyd Hospital, Danderyd, Sweden., Almer S; Karolinska Institutet, Department of Medicine Solna, Karolinska University Hospital, Centre for Digestive Health, Department of Gastroenterology B4:09, Dermatovenereology and Rheumatology, SE-171 76 Stockholm, Sweden.
Jazyk:	angličtina
Zdroj:	Therapeutic advances in gastroenterology [Therap Adv Gastroenterol] 2024 Apr 23; Vol. 17, pp. 17562848241242700. Date of Electronic Publication: 2024 Apr 23 (Print Publication: 2024).
DOI:	10.1177/17562848241242700
Abstrakt:	Background: Ustekinumab is used to treat inflammatory bowel disease mainly in patients failing anti-tumour necrosis factor (TNF)-agents. Objectives: To provide real-world data in unselected patients with Crohn's disease (CD), treated with ustekinumab. Design: Longitudinal retrospective study at four hospitals in Stockholm, Sweden. Methods: Disease activity (Harvey-Bradshaw index and physician global assessment), laboratory parameters, endoscopic findings and drug persistence were assessed. Follow-up data were obtained in patients that stopped ustekinumab. Results: In total, 322 patients (median age 38 years, 48% women) were included. All had luminal disease and 22% also fistulizing disease. A total of 271 (84%) had failed ⩾1 and 148 (46%) ⩾2 anti-TNF drugs; 34% failed vedolizumab. At inclusion, 93% had active disease; 28% were on oral corticosteroids and 18% on thiopurines. The median follow-up on treatment was 13.5 months; overall 67% were followed at least 24 months. By intention to treat analysis, response rate at 3 and 12 months was 43% and 42%, respectively. Among patients with ongoing ustekinumab, 19% were in steroid-free remission at 3 months and 64% at 12 months. The median faecal calprotectin level decreased from 460 µg/g at baseline to 156 µg/g at 3 months and was 182 µg/g at 12 months. C-reactive protein remained stable at 4 mg/L whereas serum albumin increased slightly. About 31% of patients were withdrawn during the first 12 months, mainly due to persisting disease activity 21%, adverse events 5%, bowel surgery 0.6% or malignancy 0.3%. The overall persistence on ustekinumab was 88%, 51%, 34% and 20% at 3, 12, 24 and 36 months, respectively. Within 12 months following withdrawal of ustekinumab in 121 patients, 64% had active disease most of the time, 68% needed another biologic and 24% underwent surgery. Conclusion: Among difficult-to-treat patients with CD, ustekinumab was effective in the majority, with high drug persistence at 12 and 24 months in combination with a favourable safety profile. Competing Interests: FB, HS and AB performed part of the work during their internship in gastroenterology at Region Stockholm. FB: Speaker: Janssen, Research: Janssen. CH: speaker: Janssen, Vifor-Pharma, Takeda. OF and CW are employees of Janssen Cilag AB. SA: Scientific committee/Advisory board: Pharmacosmos, Janssen, Takeda, Consultant: Takeda, Janssen, Speaker: Galapagos, Janssen, Tillotts, Research: Janssen. The other authors have nothing to declare. (© The Author(s), 2024.)
Databáze:	MEDLINE
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