Journal
INFLAMMATORY BOWEL DISEASES
Volume 28, Issue 1, Pages 41-47Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/ibd/izab015
Keywords
Crohn's disease; ustekinumab; re-induction; loss of response
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Intravenous re-induction with ustekinumab is an effective and safe strategy that recovers the response in approximately half of the patients with refractory Crohn's disease who experience a loss of response. Re-induction can be attempted before switching out of the therapy class.
Background:A significant percentage of patients treated with ustekinumab may lose response. Our aim was to evaluate the short-term efficacy and safety of intravenous re-induction with ustekinumab in patients with Crohn's disease who have lost the response to the treatment. Methods: This is a retrospective, observational, multicenter study. Treatment efficacy was measured at week 8 and 16; clinical remission was defined when the Harvey-Bradshaw Index was <= 4 points, and clinical response was defined as a decrease of >= 3 points in the index compared with the baseline. Adverse events and treatment decisions after re-induction were also collected. Results: Fifty-three patients from 13 centers were included. Forty-nine percent had previously failed to respond to 2 biological treatments, and 24.5% had failed to respond to 3. The average exposure time to ustekinumab before re-induction was 17.7 +/- 12.8 months. In 56.6% of patients, the administration interval had been shortened to every 4 to 6 weeks before re-induction. At week 8 and 16 after re-induction, 49.0% (n = 26) and 43.3% (n = 23), respectively, were in remission, whereas 64.1% (n = 34) and 52.8% (n = 28) had a clinical response. Patients who achieved remission at week 16 had lower C-reactive protein levels than those who did not respond (2.8 +/- 1.6 vs 12.5 +/- 9.5 mg/dL; P = 0.001). No serious adverse events related to re-induction were observed. Conclusion: Intravenous re-induction with ustekinumab is an effective and safe strategy that recovers the response in approximately half of the patients with refractory Crohn's disease who experience a loss of response. Re-induction can be attempted before switching out of the therapy class.
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