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Poster presentations: Clinical: Therapy and Observation 2020

P344 Effectiveness of ustekinumab in refractory Crohn’s disease: A real-life experience in a tertiary referral centre

M. Truyens1,2,3, J. Geldof1, G. Dewitte1, E. Glorieus1, P. Hindryckx1,3, T. Lobaton Ortega1,3

1Department of Gastroenterology, University Hospital Ghent, Ghent, Belgium, 2VIB Center for Inflammation Research, Ghent University, Ghent, Belgium, 3IBD Research Unit, Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium

Background

Ustekinumab (UST) is increasingly used in Belgium for moderate to severe Crohn’s disease (CD). The aim of the current study was to describe the real-life experience with UST in our tertiary centre.

Methods

A retrospective study was performed in patients with CD who were started on UST between December 2017 and August 2019. All patients received an initial intravenous (IV) dose of 6 mg/kg body-weight, followed by 8-weekly 90 mg subcutaneous UST. The clinical and endoscopic response was assessed by the physician after induction and during the maintenance phase.

Results

In total, 67 patients were included, of which the majority was refractory to anti-TNF and/or vedolizumab (Table 1). The median duration of treatment was 15 months (IQR 7–25). The clinical and endoscopic response is shown in Table 2. UST was discontinued in 16 patients (23.9%) after a median of 27.5 weeks (IQR 12.3–52.8). Reasons for discontinuation were a loss of response (LOR), including 5 patients who were in need of surgery (n = 10), primary non response (n = 3), malignancy (n = 1), adverse event (n = 1) and patients’ wish (n = 1).

In 29 patients (43.3%) optimisation of UST was necessary due to partial response (n = 13) or due to LOR (n = 16). The optimisation consisted of an IV re-induction in 2 patients, shortening of the dosage interval in 16 patients and a combination of both in 11 patients. The effect of optimisation could be assessed in 22 patients: 10 patients regained a good clinical response and 5 patients attained clinical remission after optimisation. In 7 patients UST was stopped despite optimisation, most often due to persistent LOR.

Table 1. Baseline characteristics

Age (years), median [IQR]42 [33–55]
Gender (female/male), n [%]36 [53.7]/31 [46.3]
Duration of disease (years), median [IQR]12 [7–20]
History of resection, n [%]35 [52.2]
Extra-intestinal manifestations, n [%]23 [34.3]
Immunosuppressant at baseline, n [%]14 [20.9]
Corticosteroids at baseline, n [%]29 [43.3]
Previous biologicals, n [%]
05 [7.5]
120 [29.8]
≥ 242 [62.7]

Table 2. Intestinal disease activity

Clinical response, n [%]Week 4–8 (n = 52)Week 16–24 (n = 54)12 months (n = 33)
No response14 [26.9]11 [20.4]5 [15.2]
Response34 [65.4]32 [59.3]14 [42.4]
Remission4 [7.7]11 [20.4]14 [42.4]
Endoscopic response, n [%]Week 16–24 (n = 16)12 months (n = 16)
No response9 [56.3]7 [43.8]
Response6 [37.5]7 [43.8]
Remission1 [6.3]2 [12.5]

Conclusion

In this tertiary population of refractory CD patients, treatment with UST resulted in a clinical response in more than 70% of patients. Of note, 43.3% needed optimisation, with a good clinical response in almost half of the cases. The endoscopic response in this preliminary analysis was modest.