Background Ustekinumab is a human monoclonal antibody against interleukin 12 and interleukin 23. Its use in inflammatory bowel disease (IBD) is little known.

Purpose To evaluate the effectiveness and safety of ustekinumab in adults with moderate to severe IBD resistant to anti-tumour necrosis factor (TNF) treatment.

Material and methods A retrospective observational study was carried out which included all patients with refractory IBD treated with subcutaneous ustekinumab from January 2012 to date. Data on demographic and clinical characteristics, indications, posology and duration of treatment, previous and concomitant therapies, adverse events and clinical evolution were collected from the electronic health record and the assisted electronic prescription programme. Effectiveness was defined as clinical improvement, and ineffectiveness as treatment suspension due to lack of response or clinical worsening.

Results 7 patients were included (mean age 40.7 years, 43% men). Indications for use were ulcerative colitis (UC) in 2/7 patients (28.6%) and Crohn´s disease (CD) in 5/7 patients (71.4%). The induction pattern was 90 mg weekly (4 doses) and the maintenance pattern 90 mg every 2 or 8 weeks; the mean number of administered doses was 8 (1–14). All patients had previously received infliximab, adalimumab or golimumab with inadequate response or intolerance, which placed ustekinumab in the second–fourth line of biological treatment. Currently, 3 patients continue receiving ustekinumab, showing clinical remission and therefore are considered cases in which the drug was effective. With regard to adverse events associated with ustekinumab, only 1 patient reported asthenia.

Conclusion Ustekinumab is a therapeutic approach for IBD treatment in clinical practice in patients with poor response or intolerance to other biological therapies, especially in patients not responding to anti-TNFα. Available data are still limited and therefore future prospective studies assessing its suitability in this context will be required.

No conflict of interest