Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease
ObjectivesUstekinumab (UST) optimization strategies, including shortening intervals and intravenous reinduction, should be administered to patients with partial or loss of respond. Evidence comparing these types of optimization treatments is limited. We evaluated the efficacy and safety of weight-ba...
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Frontiers Media S.A.
2023-07-01
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Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1105981/full |
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author | Jiayin Yao Jiayin Yao Xiang Peng Xiang Peng Yingkui Zhong Yingkui Zhong Tao Su Tao Su Adam Bihi Adam Bihi Junzhang Zhao Junzhang Zhao Tao Liu Tao Liu Wei Wang Wei Wang Pinjin Hu Pinjin Hu Min Zhang Min Zhang Min Zhi Min Zhi |
author_facet | Jiayin Yao Jiayin Yao Xiang Peng Xiang Peng Yingkui Zhong Yingkui Zhong Tao Su Tao Su Adam Bihi Adam Bihi Junzhang Zhao Junzhang Zhao Tao Liu Tao Liu Wei Wang Wei Wang Pinjin Hu Pinjin Hu Min Zhang Min Zhang Min Zhi Min Zhi |
author_sort | Jiayin Yao |
collection | DOAJ |
description | ObjectivesUstekinumab (UST) optimization strategies, including shortening intervals and intravenous reinduction, should be administered to patients with partial or loss of respond. Evidence comparing these types of optimization treatments is limited. We evaluated the efficacy and safety of weight-based UST intravenous reinduction in patients with refractory Crohn’s disease (CD).MethodsThis was a single-center retrospective observational study. Optimization strategies were designed for patients showing partial or loss of response to standardized UST therapy. Clinical, biochemical, and endoscopic response and remission rate were determined by Crohn’s disease activity index (CDAI), C-reactive protein (CRP) levels, and SES-CD evaluation. UST trough concentrations were detected and adverse events were recorded.ResultsA total of 128 patients receiving UST optimization therapies were included, with 105 patients administered shortening intervals of q8w or q4w, and 23 receiving intravenous reinduction followed by subcutaneous q8w or q4w. The follow-up duration for the shortening interval and reinduction cohorts were 15.0 (10.0, 31.0) and 23.0 (13.0, 70.0) weeks, respectively. A significant CDAI delta variation pre-and post-treatment could be found between groups [17.0 (−4.4, 65.9) vs. 69.0(10.7, 151.0), p = 0.013]. the trough concentration of UST increased [2.5 (1.3, 5.3) vs. 1.1 (0.5, 2.3), p = 0.001] after intravenous reinduction. Clinical and endoscopic remission were achieved in 69.6 and 31.8% of patients in the intravenous reinduction cohort, and 62.9 and 22.2% of patients in the shortening interval cohort, respectively. No significant difference was found between groups regarding safety.ConclusionIntravenous reinduction brought about favorable recapture of clinical and endoscopic remission, and should have significant priority over the strategy of merely shortening drug intervals, which should be launched before switching to other biologics targeting different inflammatory pathways.Clinical Trial Registration: identifier NCT04923100. https://classic.clinicaltrials.gov/ct2/show/NCT04923100?id=04923100&draw=2&rank=1 |
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spelling | doaj.art-65d92378ac7b4a9fb26466874f9e39292023-07-24T14:15:58ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-07-011010.3389/fmed.2023.11059811105981Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s diseaseJiayin Yao0Jiayin Yao1Xiang Peng2Xiang Peng3Yingkui Zhong4Yingkui Zhong5Tao Su6Tao Su7Adam Bihi8Adam Bihi9Junzhang Zhao10Junzhang Zhao11Tao Liu12Tao Liu13Wei Wang14Wei Wang15Pinjin Hu16Pinjin Hu17Min Zhang18Min Zhang19Min Zhi20Min Zhi21Department of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaDepartment of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaGuangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, ChinaObjectivesUstekinumab (UST) optimization strategies, including shortening intervals and intravenous reinduction, should be administered to patients with partial or loss of respond. Evidence comparing these types of optimization treatments is limited. We evaluated the efficacy and safety of weight-based UST intravenous reinduction in patients with refractory Crohn’s disease (CD).MethodsThis was a single-center retrospective observational study. Optimization strategies were designed for patients showing partial or loss of response to standardized UST therapy. Clinical, biochemical, and endoscopic response and remission rate were determined by Crohn’s disease activity index (CDAI), C-reactive protein (CRP) levels, and SES-CD evaluation. UST trough concentrations were detected and adverse events were recorded.ResultsA total of 128 patients receiving UST optimization therapies were included, with 105 patients administered shortening intervals of q8w or q4w, and 23 receiving intravenous reinduction followed by subcutaneous q8w or q4w. The follow-up duration for the shortening interval and reinduction cohorts were 15.0 (10.0, 31.0) and 23.0 (13.0, 70.0) weeks, respectively. A significant CDAI delta variation pre-and post-treatment could be found between groups [17.0 (−4.4, 65.9) vs. 69.0(10.7, 151.0), p = 0.013]. the trough concentration of UST increased [2.5 (1.3, 5.3) vs. 1.1 (0.5, 2.3), p = 0.001] after intravenous reinduction. Clinical and endoscopic remission were achieved in 69.6 and 31.8% of patients in the intravenous reinduction cohort, and 62.9 and 22.2% of patients in the shortening interval cohort, respectively. No significant difference was found between groups regarding safety.ConclusionIntravenous reinduction brought about favorable recapture of clinical and endoscopic remission, and should have significant priority over the strategy of merely shortening drug intervals, which should be launched before switching to other biologics targeting different inflammatory pathways.Clinical Trial Registration: identifier NCT04923100. https://classic.clinicaltrials.gov/ct2/show/NCT04923100?id=04923100&draw=2&rank=1https://www.frontiersin.org/articles/10.3389/fmed.2023.1105981/fullCrohn’s diseaseUstekinumaboptimization algorithmintravenous reinductionendoscopic remission |
spellingShingle | Jiayin Yao Jiayin Yao Xiang Peng Xiang Peng Yingkui Zhong Yingkui Zhong Tao Su Tao Su Adam Bihi Adam Bihi Junzhang Zhao Junzhang Zhao Tao Liu Tao Liu Wei Wang Wei Wang Pinjin Hu Pinjin Hu Min Zhang Min Zhang Min Zhi Min Zhi Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease Frontiers in Medicine Crohn’s disease Ustekinumab optimization algorithm intravenous reinduction endoscopic remission |
title | Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease |
title_full | Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease |
title_fullStr | Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease |
title_full_unstemmed | Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease |
title_short | Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease |
title_sort | extra intravenous ustekinumab reinduction is an effective optimization strategy for patients with refractory crohn s disease |
topic | Crohn’s disease Ustekinumab optimization algorithm intravenous reinduction endoscopic remission |
url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1105981/full |
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