Efficacy of Ustekinumab Optimization by 2 Initial Intravenous Doses in Adult Patients With Severe Crohn's Disease

Haixia Ren; Jian Kang; Jing Wang; Juan Su; Liping Zou; Anning Yin; Jiao Li; Qian Zhou; Wei Wang; Zhishun Tang; Jing Zhang; Yueyue Lu; Yuanping Yang; Chengen Qiu; Yijuan Ding; Weiguo Dong; Ping An

doi:10.1093/ibd/izad184

Efficacy of Ustekinumab Optimization by 2 Initial Intravenous Doses in Adult Patients With Severe Crohn's Disease

Inflamm Bowel Dis. 2023 Aug 24:izad184. doi: 10.1093/ibd/izad184. Online ahead of print.

Authors

Haixia Ren^{1

2

3}, Jian Kang^{1

2

3}, Jing Wang^{1

2

3}, Juan Su^{1

2

3}, Liping Zou⁴, Anning Yin^{1

2

3}, Jiao Li^{1

2

3}, Qian Zhou^{1

2

3}, Wei Wang⁵, Zhishun Tang⁶, Jing Zhang⁷, Yueyue Lu⁸, Yuanping Yang⁹, Chengen Qiu¹⁰, Yijuan Ding^{1

2

3}, Weiguo Dong^{1

2

3}, Ping An^{1

2

3}

Affiliations

¹ Department of Gastroenterology, Renmin Hospital of Wuhan University, 99 Zhangzhidong Road, Wuhan 430060, Hubei Province, China.
² Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei Province, China.
³ Hubei Provincial Clinical Research Center for Digestive Disease Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei Province, China.
⁴ Department of Pathology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei Province, China.
⁵ Department of Gastroenterology, Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science, Xiangyang 441021, Hubei Province, China.
⁶ Sports Rehabilitation, College of Sport Medicine, Wuhan Sports University, Wuhan 430079, Hubei Province, China.
⁷ Department of Gastroenterology, Wuhan NO.9 Hospital, NO.20 Jilin Street, Qingshan District, Wuhan 430080, Hubei Province, China.
⁸ Department of Gastroenterology, First Hospital of Yangtze University, Jingzhou 434000, Hubei Province, China.
⁹ Department of Gastroenterology, Yichang Central People's Hospital, Institute of Digestive Disease China Three Gorges University, Yichang 443000, Hubei Province, China.
¹⁰ Sichuan Provincial People's Hospital, Chengdu 610031, China.

PMID: 37619248
DOI: 10.1093/ibd/izad184

Abstract

Background: Although increasing studies have reported that dose escalation can improve treatment response to ustekinumab in patients with Crohn's disease (CD), their strategies mainly focus on maintenance regimen. Evidence of ustekinumab dose escalation in induction regimen, particularly in severe CD, remains limited. This study evaluated the efficacy and safety of intravenous ustekinumab with 2 initial doses in patients with severely active CD.

Methods: A retrospective observational study of 99 adult patients with severe CD treated with ustekinumab from 3 IBD centers included 48 patients with standard and 51 with optimized induction treatment. Clinical outcomes, inflammatory biomarkers including fecal calprotectin (FC) normalization, and endoscopic outcomes were evaluated at weeks 16 and 48. Adverse events and treatment decisions after initial induction were also collected.

Results: Compared with the standard group, 2 initial intravenous injections of ustekinumab achieved higher clinical response (92.2%, 47 of 51, P = .656), clinical remission (88.2%, 45 of 51, P = .221), endoscopic response (75.8%, 25 of 33, P = .125), and FC normalization (70.6%, 36 of 51, P = .138) at week 16. The mucosal healing rate at week 16 (63.6%, P = .022) was statistically higher in the optimization group. At week 48, patients with optimized treatment achieved higher clinical response (80.4%, 41 of 51, P = .003), clinical remission (70.6%, 36 of 51, P = .007), FC normalization (66.7%, 34 of 51, P = .031), endoscopic response (72.7%, 24 of 33, P = .006), and mucosal healing (57.6%, 19 of 33, P = .004). At the last follow-up, 82.4% of optimally treated patients adhered to continued treatment with ustekinumab (P < .001).

Conclusions: Optimization of ustekinumab by 2 initial intravenous inductions is more effective than standard therapy for adult patients with severe CD.

Keywords: effectiveness; optimization; safety; severe Crohn’s disease; ustekinumab.

Plain language summary

This study used an optimization strategy in severe adult Crohn’s disease with 2 initial intravenous doses of ustekinumab. This new strategy proved to be effective and safe.

Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation 2023.

Abstract

Plain language summary

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