Background and importance Ustekinumab is a monoclonal antibody that inhibits the bioactivity of IL-12 and IL-23 causing a decrease in inflammatory markers in Crohn’s disease (CD), used in patients in whom conventional treatment or anti-TNF is insufficient to control the disease or are contraindicated.
Aim and objectives To evaluate the efficacy and safety of ustekinumab in patients diagnosed with CD in a real clinical setting.
Material and methods This was a retrospective observational study, in two regional hospitals, in patients with CD who received an induction dose of ustekinumab between January 2018 and September 2019, inclusive. The data were obtained from the PRISMA-APD outpatient care programme, and by reviewing medical records in Diraya. To assess efficacy, the Harvey–Bradshaw index (HBI) was considered, for which the following variables were recorded: general condition of the patient, abdominal pain, number of daily liquid bowel movements, presence or absence of abdominal mass and other associated symptoms. Remission of the disease was considered if HBI was 1–6. Other clinical variables included were: age, sex, previous treatments with anti-TNF, concomitant use with immunomodulators and/or corticosteroids, need for intensification and treatment interruption. To assess safety, adverse effects associated with ustekinumab were considered.
Results Thirty-seven patients were included in the study: 21 women and 16 men. Median age was 45 years. With the exception of three patients, all had received prior therapy with one or more anti-TNF. Twenty of the patients had received concomitant corticosteroid and immunosuppressive medication. In 4 patients ustekinumab was withdrawn due to lack of action but 29 patients presented with an HBI <6, of whom 23 had an intensified pattern (90 mg every 8 weeks). The only adverse reaction recorded was atypical erythema nodosum in a patient.
Conclusion and relevance Ustekinumab seemed to have good efficacy in CD with an intensified regimen, as the disease was in remission (HBI 1–6 points) in most patients. Its safety profile was optimum as only one patient experienced an adverse reaction and withdrawal of the drug was not necessary.
References and/or acknowledgements No conflict of interest.
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