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Efficacy of Intravenous Ustekinumab Reinduction in Patients With Crohn’s Disease With a Loss of Response

Abstract Background/Aims In patients receiving ustekinumab (UST) for treatment of Crohn’s disease, there is no proven strategy to enhance or re-capture response. We assessed the utility of UST intravenous (IV) reinduction (~6 mg/kg) to achieve clinical, biochemical and endoscopic response or remissi...

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Published in:Journal of the Canadian Association of Gastroenterology 2022-10, Vol.5 (5), p.208-213
Main Authors: Heron, Valerie, Li Fraine, Steven, Panaccione, Nicola, Restellini, Sophie, Germain, Pascale, Candido, Kristina, Bernstein, Charles N, Bessissow, Talat, Bitton, Alain, Chauhan, Usha K, Lakatos, Peter L, Marshall, John K, Michetti, Pierre, Seow, Cynthia H, Rosenfeld, Greg, Panaccione, Remo, Afif, Waqqas
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cited_by cdi_FETCH-LOGICAL-c390t-8bcb6a365e8174c6f423623af40f72efd9ac589856b1760b057d38c78fb611da3
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container_issue 5
container_start_page 208
container_title Journal of the Canadian Association of Gastroenterology
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creator Heron, Valerie
Li Fraine, Steven
Panaccione, Nicola
Restellini, Sophie
Germain, Pascale
Candido, Kristina
Bernstein, Charles N
Bessissow, Talat
Bitton, Alain
Chauhan, Usha K
Lakatos, Peter L
Marshall, John K
Michetti, Pierre
Seow, Cynthia H
Rosenfeld, Greg
Panaccione, Remo
Afif, Waqqas
description Abstract Background/Aims In patients receiving ustekinumab (UST) for treatment of Crohn’s disease, there is no proven strategy to enhance or re-capture response. We assessed the utility of UST intravenous (IV) reinduction (~6 mg/kg) to achieve clinical, biochemical and endoscopic response or remission, in patients with partial or loss of response to UST maintenance therapy. Methods A multicentre, retrospective cohort study was performed. Adults who received an IV reinduction dose of UST for either partial response or secondary loss of response to UST were assessed. The primary outcome was clinical remission off corticosteroids (Harvey Bradshaw Index
doi_str_mv 10.1093/jcag/gwac017
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We assessed the utility of UST intravenous (IV) reinduction (~6 mg/kg) to achieve clinical, biochemical and endoscopic response or remission, in patients with partial or loss of response to UST maintenance therapy. Methods A multicentre, retrospective cohort study was performed. Adults who received an IV reinduction dose of UST for either partial response or secondary loss of response to UST were assessed. The primary outcome was clinical remission off corticosteroids (Harvey Bradshaw Index &lt;5), with biochemical response (defined as ≥ 50% decrease of CRP or FCP and/or endoscopic response (defined as a decrease in Simple Endoscopic Score-CD ≥ 50%). Secondary outcomes included clinical, biomarker and endoscopic response/remission, as well as safety. Results Sixty-five patients (median age 38 years, 54.7% women) underwent IV UST reinduction between January 2017 and April 2019. Most patients (88.3%) were already on escalated maintenance dosing of UST 90 mg subcutaneous every 4 weeks. Clinical outcomes were assessed at a median of 14 weeks (IQR: 12–19) post-reinduction. The primary outcome of clinical remission off corticosteroids with biochemical and/or endoscopic response was achieved in 31.0% (n = 18). Pre-reinduction UST concentrations were ≥1 μg/mL in 88.6% (mean 3.2 ± 2.0 μg/mL). No serious adverse events were reported. Conclusions UST IV reinduction can be effective in patients with Crohn’s disease with partial or loss of response to UST maintenance therapy. Further studies evaluating this strategy are warranted.</description><identifier>ISSN: 2515-2084</identifier><identifier>EISSN: 2515-2092</identifier><identifier>DOI: 10.1093/jcag/gwac017</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Original</subject><ispartof>Journal of the Canadian Association of Gastroenterology, 2022-10, Vol.5 (5), p.208-213</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of the Canadian Association of Gastroenterology. 2022</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-8bcb6a365e8174c6f423623af40f72efd9ac589856b1760b057d38c78fb611da3</citedby><cites>FETCH-LOGICAL-c390t-8bcb6a365e8174c6f423623af40f72efd9ac589856b1760b057d38c78fb611da3</cites><orcidid>0000-0002-1551-9054 ; 0000-0003-2610-1910 ; 0000-0002-7193-0657 ; 0000-0002-3948-6488</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9527659/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9527659/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,724,777,781,882,1599,27905,27906,53772,53774</link.rule.ids></links><search><creatorcontrib>Heron, Valerie</creatorcontrib><creatorcontrib>Li Fraine, Steven</creatorcontrib><creatorcontrib>Panaccione, Nicola</creatorcontrib><creatorcontrib>Restellini, Sophie</creatorcontrib><creatorcontrib>Germain, Pascale</creatorcontrib><creatorcontrib>Candido, Kristina</creatorcontrib><creatorcontrib>Bernstein, Charles N</creatorcontrib><creatorcontrib>Bessissow, Talat</creatorcontrib><creatorcontrib>Bitton, Alain</creatorcontrib><creatorcontrib>Chauhan, Usha K</creatorcontrib><creatorcontrib>Lakatos, Peter L</creatorcontrib><creatorcontrib>Marshall, John K</creatorcontrib><creatorcontrib>Michetti, Pierre</creatorcontrib><creatorcontrib>Seow, Cynthia H</creatorcontrib><creatorcontrib>Rosenfeld, Greg</creatorcontrib><creatorcontrib>Panaccione, Remo</creatorcontrib><creatorcontrib>Afif, Waqqas</creatorcontrib><title>Efficacy of Intravenous Ustekinumab Reinduction in Patients With Crohn’s Disease With a Loss of Response</title><title>Journal of the Canadian Association of Gastroenterology</title><description>Abstract Background/Aims In patients receiving ustekinumab (UST) for treatment of Crohn’s disease, there is no proven strategy to enhance or re-capture response. We assessed the utility of UST intravenous (IV) reinduction (~6 mg/kg) to achieve clinical, biochemical and endoscopic response or remission, in patients with partial or loss of response to UST maintenance therapy. Methods A multicentre, retrospective cohort study was performed. Adults who received an IV reinduction dose of UST for either partial response or secondary loss of response to UST were assessed. The primary outcome was clinical remission off corticosteroids (Harvey Bradshaw Index &lt;5), with biochemical response (defined as ≥ 50% decrease of CRP or FCP and/or endoscopic response (defined as a decrease in Simple Endoscopic Score-CD ≥ 50%). Secondary outcomes included clinical, biomarker and endoscopic response/remission, as well as safety. Results Sixty-five patients (median age 38 years, 54.7% women) underwent IV UST reinduction between January 2017 and April 2019. Most patients (88.3%) were already on escalated maintenance dosing of UST 90 mg subcutaneous every 4 weeks. Clinical outcomes were assessed at a median of 14 weeks (IQR: 12–19) post-reinduction. The primary outcome of clinical remission off corticosteroids with biochemical and/or endoscopic response was achieved in 31.0% (n = 18). Pre-reinduction UST concentrations were ≥1 μg/mL in 88.6% (mean 3.2 ± 2.0 μg/mL). No serious adverse events were reported. Conclusions UST IV reinduction can be effective in patients with Crohn’s disease with partial or loss of response to UST maintenance therapy. 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We assessed the utility of UST intravenous (IV) reinduction (~6 mg/kg) to achieve clinical, biochemical and endoscopic response or remission, in patients with partial or loss of response to UST maintenance therapy. Methods A multicentre, retrospective cohort study was performed. Adults who received an IV reinduction dose of UST for either partial response or secondary loss of response to UST were assessed. The primary outcome was clinical remission off corticosteroids (Harvey Bradshaw Index &lt;5), with biochemical response (defined as ≥ 50% decrease of CRP or FCP and/or endoscopic response (defined as a decrease in Simple Endoscopic Score-CD ≥ 50%). Secondary outcomes included clinical, biomarker and endoscopic response/remission, as well as safety. Results Sixty-five patients (median age 38 years, 54.7% women) underwent IV UST reinduction between January 2017 and April 2019. Most patients (88.3%) were already on escalated maintenance dosing of UST 90 mg subcutaneous every 4 weeks. Clinical outcomes were assessed at a median of 14 weeks (IQR: 12–19) post-reinduction. The primary outcome of clinical remission off corticosteroids with biochemical and/or endoscopic response was achieved in 31.0% (n = 18). Pre-reinduction UST concentrations were ≥1 μg/mL in 88.6% (mean 3.2 ± 2.0 μg/mL). No serious adverse events were reported. Conclusions UST IV reinduction can be effective in patients with Crohn’s disease with partial or loss of response to UST maintenance therapy. Further studies evaluating this strategy are warranted.</abstract><cop>US</cop><pub>Oxford University Press</pub><doi>10.1093/jcag/gwac017</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-1551-9054</orcidid><orcidid>https://orcid.org/0000-0003-2610-1910</orcidid><orcidid>https://orcid.org/0000-0002-7193-0657</orcidid><orcidid>https://orcid.org/0000-0002-3948-6488</orcidid><oa>free_for_read</oa></addata></record>
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title Efficacy of Intravenous Ustekinumab Reinduction in Patients With Crohn’s Disease With a Loss of Response
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