4CPS-193 Effectiveness and safety of intravenous ustekinumab intensification in Crohn’s disease with loss of response or partial response to subcutaneous therapy

Background and ImportanceUstekinumab is approved for adult patients with moderately-severe active Crohn’s disease (CD) at a usual dosing schedule of 90 mg every 8 to 12 weeks subcutaneously. Some patients may experience a partial response or secondary loss of response. There is increasing evidence f...

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Published in:European journal of hospital pharmacy. Science and practice 2024-03, Vol.31 (Suppl 1), p.A144-A145
Main Authors: Herrero Bermejo, S, Lobato Matilla, E, Gómez Costas, D, Somoza Fernández, B, Ruiz Briones, P, Ferris Villanueva, M, Montero Antón, MDP, Rioja Díez, Y, Carrillo Burdallo, A, Herranz Alonso, A, Sanjurjo Sáez, M
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Crohn's disease
Monoclonal antibodies
Patients
Remission (Medicine)
Section 4: Clinical pharmacy services
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container_issue Suppl 1
container_start_page A144
container_title European journal of hospital pharmacy. Science and practice
container_volume 31
creator Herrero Bermejo, S
Lobato Matilla, E
Gómez Costas, D
Somoza Fernández, B
Ruiz Briones, P
Ferris Villanueva, M
Montero Antón, MDP
Rioja Díez, Y
Carrillo Burdallo, A
Herranz Alonso, A
Sanjurjo Sáez, M
description Background and ImportanceUstekinumab is approved for adult patients with moderately-severe active Crohn’s disease (CD) at a usual dosing schedule of 90 mg every 8 to 12 weeks subcutaneously. Some patients may experience a partial response or secondary loss of response. There is increasing evidence for patient rescue by shortening the subcutaneous administration interval, but very little evidence for intravenous intensification.Aim and ObjectivesTo evaluate the effectiveness and safety of treatment intensification with intravenous ustekinumab in adults with CD and loss of response to the standard subcutaneous regimen.Material and MethodsSingle-centre, descriptive, retrospective study including CD patients who intensified ustekinumab treatment to receive 130 mg intravenously every 4–6 weeks from January 2020 to August 2022.The clinical remission rate (defined as a Harvey-Bradshaw index (HBI)
doi_str_mv 10.1136/ejhpharm-2024-eahp.297
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Some patients may experience a partial response or secondary loss of response. There is increasing evidence for patient rescue by shortening the subcutaneous administration interval, but very little evidence for intravenous intensification.Aim and ObjectivesTo evaluate the effectiveness and safety of treatment intensification with intravenous ustekinumab in adults with CD and loss of response to the standard subcutaneous regimen.Material and MethodsSingle-centre, descriptive, retrospective study including CD patients who intensified ustekinumab treatment to receive 130 mg intravenously every 4–6 weeks from January 2020 to August 2022.The clinical remission rate (defined as a Harvey-Bradshaw index (HBI) &lt;5) at 12, 24 and 52 weeks and the early clinical response rate (defined as a reduction in HBI by ≥3 points or by a 30% from baseline) at 12 weeks were analysed. The evolution of inflammatory laboratory parameters such as C-reactive protein (CRP) and faecal calprotectin (FC) was assessed. Adverse effects developed during the follow-up period were collected.ResultsForty-one patients were included; 61.0% were male, with a median age at intensification of 44.9 years (interquartile range (IQR): 37.8–59.6), a median disease progression of 16.6 years (IQR: 8.1–22.3) and a median time to intensification from ustekinumab initiation of 19.6 months (IQR: 10.8–31.3). The most frequent phenotypes were L3 (53.7%) and B2 (43.9%). Perianal involvement was present in 46.3% of patients.Of the total, 31 (75.6%) patients had a baseline HBI ≥5, of whom 18 (58.1%) achieved early clinical response. Clinical remission was achieved by 39.0% of patients at 12 weeks and by 58.5% at 52 weeks. The persistence rate at 52 weeks was 90.2%. Median laboratory parameter values improved at each time cut-off from baseline.No serious adverse effects were reported and no patient discontinued treatment due to adverse effects. One episode of urinary tract infection and one episode of nasopharyngitis were documented.Conclusion and RelevanceIntravenous ustekinumab at 130 mg every 4–6 weeks improves CD inflammatory activity in patients with loss of response or partial response to the standard subcutaneous regimen.References and/or AcknowledgementsConflict of InterestNo conflict of interest.</description><identifier>ISSN: 2047-9956</identifier><identifier>EISSN: 2047-9964</identifier><identifier>DOI: 10.1136/ejhpharm-2024-eahp.297</identifier><language>eng</language><publisher>London: British Medical Journal Publishing Group</publisher><subject>Conflicts of interest ; Crohn's disease ; Monoclonal antibodies ; Patients ; Remission (Medicine) ; Section 4: Clinical pharmacy services</subject><ispartof>European journal of hospital pharmacy. Science and practice, 2024-03, Vol.31 (Suppl 1), p.A144-A145</ispartof><rights>European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2024 European Association of Hospital Pharmacists 2024. No commercial re-use. See rights and permissions. Published by BMJ.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27915,27916</link.rule.ids></links><search><creatorcontrib>Herrero Bermejo, S</creatorcontrib><creatorcontrib>Lobato Matilla, E</creatorcontrib><creatorcontrib>Gómez Costas, D</creatorcontrib><creatorcontrib>Somoza Fernández, B</creatorcontrib><creatorcontrib>Ruiz Briones, P</creatorcontrib><creatorcontrib>Ferris Villanueva, M</creatorcontrib><creatorcontrib>Montero Antón, MDP</creatorcontrib><creatorcontrib>Rioja Díez, Y</creatorcontrib><creatorcontrib>Carrillo Burdallo, A</creatorcontrib><creatorcontrib>Herranz Alonso, A</creatorcontrib><creatorcontrib>Sanjurjo Sáez, M</creatorcontrib><title>4CPS-193 Effectiveness and safety of intravenous ustekinumab intensification in Crohn’s disease with loss of response or partial response to subcutaneous therapy</title><title>European journal of hospital pharmacy. Science and practice</title><addtitle>Eur J Hosp Pharm</addtitle><description>Background and ImportanceUstekinumab is approved for adult patients with moderately-severe active Crohn’s disease (CD) at a usual dosing schedule of 90 mg every 8 to 12 weeks subcutaneously. Some patients may experience a partial response or secondary loss of response. There is increasing evidence for patient rescue by shortening the subcutaneous administration interval, but very little evidence for intravenous intensification.Aim and ObjectivesTo evaluate the effectiveness and safety of treatment intensification with intravenous ustekinumab in adults with CD and loss of response to the standard subcutaneous regimen.Material and MethodsSingle-centre, descriptive, retrospective study including CD patients who intensified ustekinumab treatment to receive 130 mg intravenously every 4–6 weeks from January 2020 to August 2022.The clinical remission rate (defined as a Harvey-Bradshaw index (HBI) &lt;5) at 12, 24 and 52 weeks and the early clinical response rate (defined as a reduction in HBI by ≥3 points or by a 30% from baseline) at 12 weeks were analysed. The evolution of inflammatory laboratory parameters such as C-reactive protein (CRP) and faecal calprotectin (FC) was assessed. Adverse effects developed during the follow-up period were collected.ResultsForty-one patients were included; 61.0% were male, with a median age at intensification of 44.9 years (interquartile range (IQR): 37.8–59.6), a median disease progression of 16.6 years (IQR: 8.1–22.3) and a median time to intensification from ustekinumab initiation of 19.6 months (IQR: 10.8–31.3). The most frequent phenotypes were L3 (53.7%) and B2 (43.9%). Perianal involvement was present in 46.3% of patients.Of the total, 31 (75.6%) patients had a baseline HBI ≥5, of whom 18 (58.1%) achieved early clinical response. Clinical remission was achieved by 39.0% of patients at 12 weeks and by 58.5% at 52 weeks. The persistence rate at 52 weeks was 90.2%. Median laboratory parameter values improved at each time cut-off from baseline.No serious adverse effects were reported and no patient discontinued treatment due to adverse effects. One episode of urinary tract infection and one episode of nasopharyngitis were documented.Conclusion and RelevanceIntravenous ustekinumab at 130 mg every 4–6 weeks improves CD inflammatory activity in patients with loss of response or partial response to the standard subcutaneous regimen.References and/or AcknowledgementsConflict of InterestNo conflict of interest.</description><subject>Conflicts of interest</subject><subject>Crohn's disease</subject><subject>Monoclonal antibodies</subject><subject>Patients</subject><subject>Remission (Medicine)</subject><subject>Section 4: Clinical pharmacy services</subject><issn>2047-9956</issn><issn>2047-9964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpFUctOwzAQjBBIVNBfQJY4p8SPxPERVeUhVQIJOEebZq24tHawHRA3LnwEH8CP8SUk4tHT7s7Ozkg7SXJCsxmlvDjDddu14Lcpy5hIEdpuxpTcSyYsEzJVqhD7_31eHCbTEEyd5ZyXSnA1ST7F_PYupYp_vb0vtMZVNM9oMQQCtiEBNMZX4jQxNnoYNq4PpA8RH43tt1CPONpgtFlBNM4OM5l719qvt49AGhMQApIXE1uycYPooOQxdM4OqPOkAx8NbHZYdCT09aqPYHG0ii166F6PkwMNm4DT33qUPFws7udX6fLm8np-vkxrSpVMNYqaaSWbJqs15A1ASSEveUFXFICrjGvWCJlzJopSNKKRTML4F8o1KIr8KDn90e28e-oxxGrtem8Hy4qpopS8KGk5sNgPq96udwSaVWMi1V8i1ZhINSYy3Er-DXhniGs</recordid><startdate>20240320</startdate><enddate>20240320</enddate><creator>Herrero Bermejo, S</creator><creator>Lobato Matilla, E</creator><creator>Gómez Costas, D</creator><creator>Somoza Fernández, B</creator><creator>Ruiz Briones, P</creator><creator>Ferris Villanueva, M</creator><creator>Montero Antón, MDP</creator><creator>Rioja Díez, Y</creator><creator>Carrillo Burdallo, A</creator><creator>Herranz Alonso, A</creator><creator>Sanjurjo Sáez, M</creator><general>British Medical Journal Publishing Group</general><general>BMJ Publishing Group LTD</general><scope>K9.</scope></search><sort><creationdate>20240320</creationdate><title>4CPS-193 Effectiveness and safety of intravenous ustekinumab intensification in Crohn’s disease with loss of response or partial response to subcutaneous therapy</title><author>Herrero Bermejo, S ; Lobato Matilla, E ; Gómez Costas, D ; Somoza Fernández, B ; Ruiz Briones, P ; Ferris Villanueva, M ; Montero Antón, MDP ; Rioja Díez, Y ; Carrillo Burdallo, A ; Herranz Alonso, A ; Sanjurjo Sáez, M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b1197-fe4b2f97dd0bfa5daa81a58361c1aa3903f2d475324684d4d727a995613fa91e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Conflicts of interest</topic><topic>Crohn's disease</topic><topic>Monoclonal antibodies</topic><topic>Patients</topic><topic>Remission (Medicine)</topic><topic>Section 4: Clinical pharmacy services</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Herrero Bermejo, S</creatorcontrib><creatorcontrib>Lobato Matilla, E</creatorcontrib><creatorcontrib>Gómez Costas, D</creatorcontrib><creatorcontrib>Somoza Fernández, B</creatorcontrib><creatorcontrib>Ruiz Briones, P</creatorcontrib><creatorcontrib>Ferris Villanueva, M</creatorcontrib><creatorcontrib>Montero Antón, MDP</creatorcontrib><creatorcontrib>Rioja Díez, Y</creatorcontrib><creatorcontrib>Carrillo Burdallo, A</creatorcontrib><creatorcontrib>Herranz Alonso, A</creatorcontrib><creatorcontrib>Sanjurjo Sáez, M</creatorcontrib><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><jtitle>European journal of hospital pharmacy. Science and practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Herrero Bermejo, S</au><au>Lobato Matilla, E</au><au>Gómez Costas, D</au><au>Somoza Fernández, B</au><au>Ruiz Briones, P</au><au>Ferris Villanueva, M</au><au>Montero Antón, MDP</au><au>Rioja Díez, Y</au><au>Carrillo Burdallo, A</au><au>Herranz Alonso, A</au><au>Sanjurjo Sáez, M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>4CPS-193 Effectiveness and safety of intravenous ustekinumab intensification in Crohn’s disease with loss of response or partial response to subcutaneous therapy</atitle><jtitle>European journal of hospital pharmacy. Science and practice</jtitle><stitle>Eur J Hosp Pharm</stitle><date>2024-03-20</date><risdate>2024</risdate><volume>31</volume><issue>Suppl 1</issue><spage>A144</spage><epage>A145</epage><pages>A144-A145</pages><issn>2047-9956</issn><eissn>2047-9964</eissn><abstract>Background and ImportanceUstekinumab is approved for adult patients with moderately-severe active Crohn’s disease (CD) at a usual dosing schedule of 90 mg every 8 to 12 weeks subcutaneously. Some patients may experience a partial response or secondary loss of response. There is increasing evidence for patient rescue by shortening the subcutaneous administration interval, but very little evidence for intravenous intensification.Aim and ObjectivesTo evaluate the effectiveness and safety of treatment intensification with intravenous ustekinumab in adults with CD and loss of response to the standard subcutaneous regimen.Material and MethodsSingle-centre, descriptive, retrospective study including CD patients who intensified ustekinumab treatment to receive 130 mg intravenously every 4–6 weeks from January 2020 to August 2022.The clinical remission rate (defined as a Harvey-Bradshaw index (HBI) &lt;5) at 12, 24 and 52 weeks and the early clinical response rate (defined as a reduction in HBI by ≥3 points or by a 30% from baseline) at 12 weeks were analysed. The evolution of inflammatory laboratory parameters such as C-reactive protein (CRP) and faecal calprotectin (FC) was assessed. Adverse effects developed during the follow-up period were collected.ResultsForty-one patients were included; 61.0% were male, with a median age at intensification of 44.9 years (interquartile range (IQR): 37.8–59.6), a median disease progression of 16.6 years (IQR: 8.1–22.3) and a median time to intensification from ustekinumab initiation of 19.6 months (IQR: 10.8–31.3). The most frequent phenotypes were L3 (53.7%) and B2 (43.9%). Perianal involvement was present in 46.3% of patients.Of the total, 31 (75.6%) patients had a baseline HBI ≥5, of whom 18 (58.1%) achieved early clinical response. Clinical remission was achieved by 39.0% of patients at 12 weeks and by 58.5% at 52 weeks. The persistence rate at 52 weeks was 90.2%. Median laboratory parameter values improved at each time cut-off from baseline.No serious adverse effects were reported and no patient discontinued treatment due to adverse effects. One episode of urinary tract infection and one episode of nasopharyngitis were documented.Conclusion and RelevanceIntravenous ustekinumab at 130 mg every 4–6 weeks improves CD inflammatory activity in patients with loss of response or partial response to the standard subcutaneous regimen.References and/or AcknowledgementsConflict of InterestNo conflict of interest.</abstract><cop>London</cop><pub>British Medical Journal Publishing Group</pub><doi>10.1136/ejhpharm-2024-eahp.297</doi><oa>free_for_read</oa></addata></record>
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subjects Conflicts of interest
Crohn's disease
Monoclonal antibodies
Patients
Remission (Medicine)
Section 4: Clinical pharmacy services
title 4CPS-193 Effectiveness and safety of intravenous ustekinumab intensification in Crohn’s disease with loss of response or partial response to subcutaneous therapy
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