4CPS-193 Effectiveness and safety of intravenous ustekinumab intensification in Crohn’s disease with loss of response or partial response to subcutaneous therapy

Background and Importance Ustekinumab is approved for adult patients with moderately-severe active Crohn's disease (CD) at a usual dosing schedule of 90 mg every 8 to 12 weeks subcutaneously. Some patients may experience a partial response or secondary loss of response. There is increasing evidence for patient rescue by shortening the subcutaneous administration interval, but very little evidence for intravenous intensification. Aim and Objectives To evaluate the effectiveness and safety of treatment intensification with intravenous ustekinumab in adults with CD and loss of response to the standard subcutaneous regimen. Material and Methods Single-centre, descriptive, retrospective study including CD patients who intensified ustekinumab treatment to receive 130 mg intravenously every 4–6 weeks from January 2020 to August 2022. The clinical remission rate (defined as a Harvey-Bradshaw index (HBI) Results Forty-one patients were included; 61.0% were male, with a median age at intensification of 44.9 years (interquartile range (IQR): 37.8–59.6), a median disease progression of 16.6 years (IQR: 8.1–22.3) and a median time to intensification from ustekinumab initiation of 19.6 months (IQR: 10.8–31.3). The most frequent phenotypes were L3 (53.7%) and B2 (43.9%). Perianal involvement was present in 46.3% of patients. Of the total, 31 (75.6%) patients had a baseline HBI ≥5, of whom 18 (58.1%) achieved early clinical response. Clinical remission was achieved by 39.0% of patients at 12 weeks and by 58.5% at 52 weeks. The persistence rate at 52 weeks was 90.2%. Median laboratory parameter values improved at each time cut-off from baseline. No serious adverse effects were reported and no patient discontinued treatment due to adverse effects. One episode of urinary tract infection and one episode of nasopharyngitis were documented. Conclusion and Relevance Intravenous ustekinumab at 130 mg every 4–6 weeks improves CD inflammatory activity in patients with loss of response or partial response to the standard subcutaneous regimen. References and/or Acknowledgements Conflict of Interest No conflict of interest.