Efficacy and safety of ustekinumab in treating perianal fistulizing Crohn′s disease: a meta-analysis

doi:10.3877/cma.j.issn.2095-2015.2023.06.031

Abstract

Abstract:

Objective

To systematically evaluate the efficacy of ustekinumab(UST)in treating perianal fistulizing Crohn′s disease(CD), so as to provide a theoretical basis for its clinical application.

Methods

Randomized controlled and non-randomized controlled studies of UST in the treatment of CD related perianal fistulas published in PubMed and Web of Science databases from the establishment of the database to June 2022 were searched.The literatures were screened according to inclusion and exclusion criteria.Quality analysis were performed on the 8 articles finally included, and statistical software RevMan5.4 was used for meta-analysis of the collected data.

Results

A total of 8 randomized and non-randomized controlled studies(including 427 patients with active perianal fistulizing CD)were included in this study.Analysis showed that UST treated perianal fistulizing CD with a fistula response rate of 21%(I²=47%, P<0.01)and a fistula relief rate of 20%(I²=46%, P<0.01). In terms of safety, systematic analysis of adverse events that UST treated perianal fistulizing CD showed that OR=1.10, 95% CI: 1.07-1.13, Z=7.54, P<0.01, and I²=0%.

Conclusion

According to the available literatures, UST is effective and safe in the treatment of perianal fistulizing CD.

Key words: Crohn′s disease, Ustekinumab, Perianal fistula, Meta-analysis

Xiu Wang, Yiguo Wang. Efficacy and safety of ustekinumab in treating perianal fistulizing Crohn′s disease: a meta-analysis[J]. Chinese Journal of Digestion and Medical Imageology(Electronic Edition), 2023, 13(06): 514-519.

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Figures/Tables 10

References 21

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作者	时间	文献类型	活动性肛周瘘(例)	观察时间	观察指标	Minors量表(分)
Sands^[11]	2017	随机对照试验	150	8周	瘘管反应率26%(39/150)	13
					瘘管缓解率24.7%(37/150)
Khorrami^[12]	2016	开放性队列研究	18	10个月	临床改善率61%(11/18)	7
Plevris^[13]	2021	回顾性队列研究	37	6个月	瘘管反应率12.5%	9
				12个月	瘘管反应率53.1%
					手术率35.14%(13/37)
Biemans^[14]	2019	前瞻性队列研究	28	12周	临床缓解率14.3%(4/28)	8
					瘘管反应率14.3%(4/28)
				24周	瘘管缓解率35.7%(10/28)
					临床反应率14.3%(4/28)
					手术率14.3%(4/28)
Attauabi^[15]	2020	双中心队列研究	18	8周	瘘管反应率16.7%(3/18)	10
			13	16周	瘘管反应率53.8%(7/13)
			12	24周	瘘管反应率50.0%(6/12)
			11	52周	瘘管反应率63.6%(7/11)
Chapuis-Biron^[16]	2020	回顾性队列研究	148	52周	瘘管完全缓解率38.5%(57/148)	16
				12周	临床有效率61.5%(91/148)
				24周	临床有效率48.6%(72/148)
				48周	临床有效率36.5%(54/148)
Tsistrakis^[17]	2017	回顾性队列研究	9	12周	瘘管愈合率11%(1/9)	9
Peyrin-Biroulet^[18]	2022	随机对照试验	19	48周	瘘管完全消失率47.4%(9/19)	10
			13	52周	瘘管完全消失率53.8%(7/13)

作者	时间	文献类型	活动性肛周瘘(例)	观察时间	观察指标	Minors量表(分)
Sands^[11]	2017	随机对照试验	150	8周	瘘管反应率26%(39/150)	13
					瘘管缓解率24.7%(37/150)
Khorrami^[12]	2016	开放性队列研究	18	10个月	临床改善率61%(11/18)	7
Plevris^[13]	2021	回顾性队列研究	37	6个月	瘘管反应率12.5%	9
				12个月	瘘管反应率53.1%
					手术率35.14%(13/37)
Biemans^[14]	2019	前瞻性队列研究	28	12周	临床缓解率14.3%(4/28)	8
					瘘管反应率14.3%(4/28)
				24周	瘘管缓解率35.7%(10/28)
					临床反应率14.3%(4/28)
					手术率14.3%(4/28)
Attauabi^[15]	2020	双中心队列研究	18	8周	瘘管反应率16.7%(3/18)	10
			13	16周	瘘管反应率53.8%(7/13)
			12	24周	瘘管反应率50.0%(6/12)
			11	52周	瘘管反应率63.6%(7/11)
Chapuis-Biron^[16]	2020	回顾性队列研究	148	52周	瘘管完全缓解率38.5%(57/148)	16
				12周	临床有效率61.5%(91/148)
				24周	临床有效率48.6%(72/148)
				48周	临床有效率36.5%(54/148)
Tsistrakis^[17]	2017	回顾性队列研究	9	12周	瘘管愈合率11%(1/9)	9
Peyrin-Biroulet^[18]	2022	随机对照试验	19	48周	瘘管完全消失率47.4%(9/19)	10
			13	52周	瘘管完全消失率53.8%(7/13)

作者	活动性肛周瘘(例)	观察时间	瘘管反应率
Sands^[11]	150	8周	26%(39/150)
Plevris^[13]	37	6个月	12.5%(5/37)
Biemans^[14]	28	12周	14.3%(4/28)
Attauabi^[15]	13	8周	16.7%(3/18)
Tsistrakis^[17]	9	12周	44%(4/9)

作者	活动性肛周瘘(例)	观察时间	瘘管反应率
Sands^[11]	150	8周	26%(39/150)
Plevris^[13]	37	6个月	12.5%(5/37)
Biemans^[14]	28	12周	14.3%(4/28)
Attauabi^[15]	13	8周	16.7%(3/18)
Tsistrakis^[17]	9	12周	44%(4/9)

作者	活动性肛周瘘(例)	观察时间	瘘管缓解率
Sands^[11]	150	8周	24.7%(37/150)
Biemans^[14]	28	24周	35.7%(10/28)
Chapuis-Biron^[16]	148	52周	38.5%(57/148)
Tsistrakis^[17]	9	12周	11%(1/9)
Peyrin-Biroulet^[18]	19	48周	47.4%(9/19)

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