The Addition of an Immunosuppressant After Loss of Response to Anti-TNFα Monotherapy in Inflammatory Bowel Disease: A 2-Year Study
Abstract Background The addition of an immunosuppressant (IM) after loss of response to anti-TNFα monotherapy is an emerging strategy of therapeutic optimization in patients with inflammatory bowel disease (IBD). However, few clinical data have been reported to date. We aimed to evaluate the efficac...
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| Veröffentlicht in: | Inflammatory bowel diseases 2018-01, Vol.24 (2), p.394-401 |
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| creator | Macaluso, Fabio Salvatore Sapienza, Chiara Ventimiglia, Marco Renna, Sara Rizzuto, Giulia Orlando, Rosalba Di Pisa, Marta Affronti, Marco Orlando, Emanuele Cottone, Mario Orlando, Ambrogio |
| description | Abstract
Background
The addition of an immunosuppressant (IM) after loss of response to anti-TNFα monotherapy is an emerging strategy of therapeutic optimization in patients with inflammatory bowel disease (IBD). However, few clinical data have been reported to date. We aimed to evaluate the efficacy and safety of this selective combination therapy in patients with IBD.
Methods
All consecutive patients with loss of response to anti-TNFα monotherapy despite an intensive dose optimization who added an IM from October 2014 to October 2016 were entered into a prospective database.
Results
Among 630 patients treated with anti-TNFα agents during the study period, 46 (7.3%) added an IM. A total of 31 patients (67.4%) were treated with an intravenous anti-TNFα (infliximab, as originator or biosimilar), while 15 (32.6%) were treated with a subcutaneous anti-TNFα agent (10 adalimumab and 5 golimumab). The mean duration of follow-up was 12.8 ± 7.3 months. Twenty-one patients (45.7%) remained on combination therapy at the end of follow-up: 15 (32.6%) maintained a steroid-free remission, and 6 (13.0%) achieved a clinical response. In patients who experienced treatment success, the median value of C-reactive protein decreased from baseline to the end of follow-up (13.2 vs 3.0, P = 0.01; normal values |
| doi_str_mv | 10.1093/ibd/izx010 |
| format | Article |
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Background
The addition of an immunosuppressant (IM) after loss of response to anti-TNFα monotherapy is an emerging strategy of therapeutic optimization in patients with inflammatory bowel disease (IBD). However, few clinical data have been reported to date. We aimed to evaluate the efficacy and safety of this selective combination therapy in patients with IBD.
Methods
All consecutive patients with loss of response to anti-TNFα monotherapy despite an intensive dose optimization who added an IM from October 2014 to October 2016 were entered into a prospective database.
Results
Among 630 patients treated with anti-TNFα agents during the study period, 46 (7.3%) added an IM. A total of 31 patients (67.4%) were treated with an intravenous anti-TNFα (infliximab, as originator or biosimilar), while 15 (32.6%) were treated with a subcutaneous anti-TNFα agent (10 adalimumab and 5 golimumab). The mean duration of follow-up was 12.8 ± 7.3 months. Twenty-one patients (45.7%) remained on combination therapy at the end of follow-up: 15 (32.6%) maintained a steroid-free remission, and 6 (13.0%) achieved a clinical response. In patients who experienced treatment success, the median value of C-reactive protein decreased from baseline to the end of follow-up (13.2 vs 3.0, P = 0.01; normal values <5 mg/L). Adverse events leading to treatment discontinuation were reported in 8 out of 46 patients (17.4%).
Conclusions
In the largest cohort on this argument reported to date, the addition of an IM was an effective and safe optimization strategy after loss of response to anti-TNFα monotherapy. Low doses of IM were sufficient to achieve a clinical response.
10.1093/ibd/izx010_video1
izx010.video1
5721597581001</description><identifier>ISSN: 1078-0998</identifier><identifier>EISSN: 1536-4844</identifier><identifier>DOI: 10.1093/ibd/izx010</identifier><identifier>PMID: 29361087</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adalimumab - therapeutic use ; Adult ; Antibodies, Monoclonal - therapeutic use ; C-Reactive Protein - analysis ; Databases, Factual ; Drug Administration Schedule ; Drug Therapy, Combination - adverse effects ; Female ; Humans ; Immunosuppressive Agents - administration & dosage ; Inflammatory Bowel Diseases - drug therapy ; Infliximab - therapeutic use ; Male ; Middle Aged ; Prospective Studies ; Remission Induction ; Treatment Outcome ; Tumor Necrosis Factor-alpha - antagonists & inhibitors</subject><ispartof>Inflammatory bowel diseases, 2018-01, Vol.24 (2), p.394-401</ispartof><rights>2018 Crohn's & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. 2018</rights><rights>2018 Crohn’s & Colitis Foundation of America. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-2edb26be7163e5d978a6fc17ff251413c77f575c5a309701723957a7911785bf3</citedby><cites>FETCH-LOGICAL-c353t-2edb26be7163e5d978a6fc17ff251413c77f575c5a309701723957a7911785bf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,778,782,1581,27907,27908</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29361087$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Macaluso, Fabio Salvatore</creatorcontrib><creatorcontrib>Sapienza, Chiara</creatorcontrib><creatorcontrib>Ventimiglia, Marco</creatorcontrib><creatorcontrib>Renna, Sara</creatorcontrib><creatorcontrib>Rizzuto, Giulia</creatorcontrib><creatorcontrib>Orlando, Rosalba</creatorcontrib><creatorcontrib>Di Pisa, Marta</creatorcontrib><creatorcontrib>Affronti, Marco</creatorcontrib><creatorcontrib>Orlando, Emanuele</creatorcontrib><creatorcontrib>Cottone, Mario</creatorcontrib><creatorcontrib>Orlando, Ambrogio</creatorcontrib><title>The Addition of an Immunosuppressant After Loss of Response to Anti-TNFα Monotherapy in Inflammatory Bowel Disease: A 2-Year Study</title><title>Inflammatory bowel diseases</title><addtitle>Inflamm Bowel Dis</addtitle><description>Abstract
Background
The addition of an immunosuppressant (IM) after loss of response to anti-TNFα monotherapy is an emerging strategy of therapeutic optimization in patients with inflammatory bowel disease (IBD). However, few clinical data have been reported to date. We aimed to evaluate the efficacy and safety of this selective combination therapy in patients with IBD.
Methods
All consecutive patients with loss of response to anti-TNFα monotherapy despite an intensive dose optimization who added an IM from October 2014 to October 2016 were entered into a prospective database.
Results
Among 630 patients treated with anti-TNFα agents during the study period, 46 (7.3%) added an IM. A total of 31 patients (67.4%) were treated with an intravenous anti-TNFα (infliximab, as originator or biosimilar), while 15 (32.6%) were treated with a subcutaneous anti-TNFα agent (10 adalimumab and 5 golimumab). The mean duration of follow-up was 12.8 ± 7.3 months. Twenty-one patients (45.7%) remained on combination therapy at the end of follow-up: 15 (32.6%) maintained a steroid-free remission, and 6 (13.0%) achieved a clinical response. In patients who experienced treatment success, the median value of C-reactive protein decreased from baseline to the end of follow-up (13.2 vs 3.0, P = 0.01; normal values <5 mg/L). Adverse events leading to treatment discontinuation were reported in 8 out of 46 patients (17.4%).
Conclusions
In the largest cohort on this argument reported to date, the addition of an IM was an effective and safe optimization strategy after loss of response to anti-TNFα monotherapy. Low doses of IM were sufficient to achieve a clinical response.
10.1093/ibd/izx010_video1
izx010.video1
5721597581001</description><subject>Adalimumab - therapeutic use</subject><subject>Adult</subject><subject>Antibodies, Monoclonal - therapeutic use</subject><subject>C-Reactive Protein - analysis</subject><subject>Databases, Factual</subject><subject>Drug Administration Schedule</subject><subject>Drug Therapy, Combination - adverse effects</subject><subject>Female</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Inflammatory Bowel Diseases - drug therapy</subject><subject>Infliximab - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Remission Induction</subject><subject>Treatment Outcome</subject><subject>Tumor Necrosis Factor-alpha - antagonists & inhibitors</subject><issn>1078-0998</issn><issn>1536-4844</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMFO3DAQQK2KqrulvfAByBekqlKKHcdxzC1QoEgLSLA9cIqcZKw1SuxgOyrbK1_UH-k3EbQLRzSHmcPTk-YhtEfJD0okOzR1e2j-PhJKPqA55SxPsiLLdqabiCIhUhYz9DmEe0LSaeQnNEslyykpxBw9LVeAy7Y10TiLncbK4ou-H60L4zB4CEHZiEsdweOFC-EFuYEwOBsAR4dLG02yvDr7_w9fOuviCrwa1thMFqs71fcqOr_Gx-4PdPinCaACHOESp8kdKI9v49iuv6CPWnUBvm73Lvp9dro8-ZUsrs8vTspF0jDOYpJCW6d5DYLmDHgrRaFy3VChdcppRlkjhOaCN1wxIgWhImWSCyUkpaLgtWa76NvGO3j3MEKIVW9CA12nLLgxVFRKUnAmMzmh3zdo46enPehq8KZXfl1RUr1Er6bo1Sb6BO9vvWPdQ_uGvlaegIMN4MbhPdEzit2K4w</recordid><startdate>20180118</startdate><enddate>20180118</enddate><creator>Macaluso, Fabio Salvatore</creator><creator>Sapienza, Chiara</creator><creator>Ventimiglia, Marco</creator><creator>Renna, Sara</creator><creator>Rizzuto, Giulia</creator><creator>Orlando, Rosalba</creator><creator>Di Pisa, Marta</creator><creator>Affronti, Marco</creator><creator>Orlando, Emanuele</creator><creator>Cottone, Mario</creator><creator>Orlando, Ambrogio</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20180118</creationdate><title>The Addition of an Immunosuppressant After Loss of Response to Anti-TNFα Monotherapy in Inflammatory Bowel Disease: A 2-Year Study</title><author>Macaluso, Fabio Salvatore ; Sapienza, Chiara ; Ventimiglia, Marco ; Renna, Sara ; Rizzuto, Giulia ; Orlando, Rosalba ; Di Pisa, Marta ; Affronti, Marco ; Orlando, Emanuele ; Cottone, Mario ; Orlando, Ambrogio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-2edb26be7163e5d978a6fc17ff251413c77f575c5a309701723957a7911785bf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adalimumab - therapeutic use</topic><topic>Adult</topic><topic>Antibodies, Monoclonal - therapeutic use</topic><topic>C-Reactive Protein - analysis</topic><topic>Databases, Factual</topic><topic>Drug Administration Schedule</topic><topic>Drug Therapy, Combination - adverse effects</topic><topic>Female</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Inflammatory Bowel Diseases - drug therapy</topic><topic>Infliximab - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Remission Induction</topic><topic>Treatment Outcome</topic><topic>Tumor Necrosis Factor-alpha - antagonists & inhibitors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Macaluso, Fabio Salvatore</creatorcontrib><creatorcontrib>Sapienza, Chiara</creatorcontrib><creatorcontrib>Ventimiglia, Marco</creatorcontrib><creatorcontrib>Renna, Sara</creatorcontrib><creatorcontrib>Rizzuto, Giulia</creatorcontrib><creatorcontrib>Orlando, Rosalba</creatorcontrib><creatorcontrib>Di Pisa, Marta</creatorcontrib><creatorcontrib>Affronti, Marco</creatorcontrib><creatorcontrib>Orlando, Emanuele</creatorcontrib><creatorcontrib>Cottone, Mario</creatorcontrib><creatorcontrib>Orlando, Ambrogio</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Inflammatory bowel diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Macaluso, Fabio Salvatore</au><au>Sapienza, Chiara</au><au>Ventimiglia, Marco</au><au>Renna, Sara</au><au>Rizzuto, Giulia</au><au>Orlando, Rosalba</au><au>Di Pisa, Marta</au><au>Affronti, Marco</au><au>Orlando, Emanuele</au><au>Cottone, Mario</au><au>Orlando, Ambrogio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Addition of an Immunosuppressant After Loss of Response to Anti-TNFα Monotherapy in Inflammatory Bowel Disease: A 2-Year Study</atitle><jtitle>Inflammatory bowel diseases</jtitle><addtitle>Inflamm Bowel Dis</addtitle><date>2018-01-18</date><risdate>2018</risdate><volume>24</volume><issue>2</issue><spage>394</spage><epage>401</epage><pages>394-401</pages><issn>1078-0998</issn><eissn>1536-4844</eissn><abstract>Abstract
Background
The addition of an immunosuppressant (IM) after loss of response to anti-TNFα monotherapy is an emerging strategy of therapeutic optimization in patients with inflammatory bowel disease (IBD). However, few clinical data have been reported to date. We aimed to evaluate the efficacy and safety of this selective combination therapy in patients with IBD.
Methods
All consecutive patients with loss of response to anti-TNFα monotherapy despite an intensive dose optimization who added an IM from October 2014 to October 2016 were entered into a prospective database.
Results
Among 630 patients treated with anti-TNFα agents during the study period, 46 (7.3%) added an IM. A total of 31 patients (67.4%) were treated with an intravenous anti-TNFα (infliximab, as originator or biosimilar), while 15 (32.6%) were treated with a subcutaneous anti-TNFα agent (10 adalimumab and 5 golimumab). The mean duration of follow-up was 12.8 ± 7.3 months. Twenty-one patients (45.7%) remained on combination therapy at the end of follow-up: 15 (32.6%) maintained a steroid-free remission, and 6 (13.0%) achieved a clinical response. In patients who experienced treatment success, the median value of C-reactive protein decreased from baseline to the end of follow-up (13.2 vs 3.0, P = 0.01; normal values <5 mg/L). Adverse events leading to treatment discontinuation were reported in 8 out of 46 patients (17.4%).
Conclusions
In the largest cohort on this argument reported to date, the addition of an IM was an effective and safe optimization strategy after loss of response to anti-TNFα monotherapy. Low doses of IM were sufficient to achieve a clinical response.
10.1093/ibd/izx010_video1
izx010.video1
5721597581001</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>29361087</pmid><doi>10.1093/ibd/izx010</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Inflammatory bowel diseases, 2018-01, Vol.24 (2), p.394-401 |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adalimumab - therapeutic use Adult Antibodies, Monoclonal - therapeutic use C-Reactive Protein - analysis Databases, Factual Drug Administration Schedule Drug Therapy, Combination - adverse effects Female Humans Immunosuppressive Agents - administration & dosage Inflammatory Bowel Diseases - drug therapy Infliximab - therapeutic use Male Middle Aged Prospective Studies Remission Induction Treatment Outcome Tumor Necrosis Factor-alpha - antagonists & inhibitors |
| title | The Addition of an Immunosuppressant After Loss of Response to Anti-TNFα Monotherapy in Inflammatory Bowel Disease: A 2-Year Study |
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