Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study
Home self-injection of the human anti-tumour necrosis alpha [anti-TNFα] monoclonal adalimumab complicates prospective serial-sampling studies. Although a recent study examined adalimumab levels and immunogenicity in Crohn's disease [CD] patients, prospective real-world data from ulcerative coli...
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| Veröffentlicht in: | Journal of Crohn's and colitis 2024-03, Vol.18 (3), p.341-348 |
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| creator | Harnik, Sivan Abitbol, Chaya M Haj Natour, Ola Yavzori, Miri Fudim, Ella Picard, Orit Naftali, Timna Broide, Efrat Hirsch, Ayal Selinger, Limor Shachar, Eyal Yablecovitch, Doron Albshesh, Ahmad Coscas, Daniel Kopylov, Uri Eliakim, Rami Ben-Horin, Shomron Ungar, Bella |
| description | Home self-injection of the human anti-tumour necrosis alpha [anti-TNFα] monoclonal adalimumab complicates prospective serial-sampling studies. Although a recent study examined adalimumab levels and immunogenicity in Crohn's disease [CD] patients, prospective real-world data from ulcerative colitis [UC] patients are lacking.
A three-monthly home-visit programme from induction was established prospectively for UC patients. Clinical scores were determined at each visit, and sera were obtained for assessment of drug and anti-adalimumab antibody levels. Calprotectin was measured using a smartphone-based app. This cohort was compared to a parallel prospective cohort of adalimumab-treated CD patients [POETIC1].
Fifty UC patients starting adalimumab [median follow-up 28 weeks] were compared to 98 adalimumab-treated CD patients [median follow-up 44 weeks]. Only 11/50 UC patients [22%] continued treatment to the end of the follow-up compared with 50/98 [51%] CD patients (odds ratio [OR] = 0.27, p = 0.001). Loss of response was significantly more common in UC patients [OR = 3.2, p = 0.001]. Seventeen patients [34%] in the UC cohort developed anti-adalimumab antibodies, 9/17 [52.9%] as early as week 2. There was no difference between patient cohorts in the overall development of anti-adalimumab antibodies [34% vs 30.6%, respectively, OR = 1.67, p = 0.67], nor was there a difference in early immunogenicity [OR = 1.39, p = 0.35]. There was no difference in low drug levels [ |
| doi_str_mv | 10.1093/ecco-jcc/jjad156 |
| format | Article |
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A three-monthly home-visit programme from induction was established prospectively for UC patients. Clinical scores were determined at each visit, and sera were obtained for assessment of drug and anti-adalimumab antibody levels. Calprotectin was measured using a smartphone-based app. This cohort was compared to a parallel prospective cohort of adalimumab-treated CD patients [POETIC1].
Fifty UC patients starting adalimumab [median follow-up 28 weeks] were compared to 98 adalimumab-treated CD patients [median follow-up 44 weeks]. Only 11/50 UC patients [22%] continued treatment to the end of the follow-up compared with 50/98 [51%] CD patients (odds ratio [OR] = 0.27, p = 0.001). Loss of response was significantly more common in UC patients [OR = 3.2, p = 0.001]. Seventeen patients [34%] in the UC cohort developed anti-adalimumab antibodies, 9/17 [52.9%] as early as week 2. There was no difference between patient cohorts in the overall development of anti-adalimumab antibodies [34% vs 30.6%, respectively, OR = 1.67, p = 0.67], nor was there a difference in early immunogenicity [OR = 1.39, p = 0.35]. There was no difference in low drug levels [<3 µg/mL] between the two cohorts [OR = 0.87, p = 0.83].
Loss of response to adalimumab therapy was significantly more common in the UC compared to the CD cohort and was driven by a higher rate of non-immunogenic, pharmacodynamic parameters.</description><identifier>ISSN: 1873-9946</identifier><identifier>EISSN: 1876-4479</identifier><identifier>DOI: 10.1093/ecco-jcc/jjad156</identifier><identifier>PMID: 37691574</identifier><language>eng</language><publisher>England</publisher><subject>Adalimumab - therapeutic use ; Colitis, Ulcerative - drug therapy ; Crohn Disease - drug therapy ; Humans ; Prospective Studies ; Tumor Necrosis Factor-alpha</subject><ispartof>Journal of Crohn's and colitis, 2024-03, Vol.18 (3), p.341-348</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c299t-72c005da3d2bbee1c6e226aec91924ce93fa9926474dd9712cc3c7d5efd1a3223</citedby><cites>FETCH-LOGICAL-c299t-72c005da3d2bbee1c6e226aec91924ce93fa9926474dd9712cc3c7d5efd1a3223</cites><orcidid>0000-0001-6939-2688</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37691574$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Harnik, Sivan</creatorcontrib><creatorcontrib>Abitbol, Chaya M</creatorcontrib><creatorcontrib>Haj Natour, Ola</creatorcontrib><creatorcontrib>Yavzori, Miri</creatorcontrib><creatorcontrib>Fudim, Ella</creatorcontrib><creatorcontrib>Picard, Orit</creatorcontrib><creatorcontrib>Naftali, Timna</creatorcontrib><creatorcontrib>Broide, Efrat</creatorcontrib><creatorcontrib>Hirsch, Ayal</creatorcontrib><creatorcontrib>Selinger, Limor</creatorcontrib><creatorcontrib>Shachar, Eyal</creatorcontrib><creatorcontrib>Yablecovitch, Doron</creatorcontrib><creatorcontrib>Albshesh, Ahmad</creatorcontrib><creatorcontrib>Coscas, Daniel</creatorcontrib><creatorcontrib>Kopylov, Uri</creatorcontrib><creatorcontrib>Eliakim, Rami</creatorcontrib><creatorcontrib>Ben-Horin, Shomron</creatorcontrib><creatorcontrib>Ungar, Bella</creatorcontrib><title>Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study</title><title>Journal of Crohn's and colitis</title><addtitle>J Crohns Colitis</addtitle><description>Home self-injection of the human anti-tumour necrosis alpha [anti-TNFα] monoclonal adalimumab complicates prospective serial-sampling studies. Although a recent study examined adalimumab levels and immunogenicity in Crohn's disease [CD] patients, prospective real-world data from ulcerative colitis [UC] patients are lacking.
A three-monthly home-visit programme from induction was established prospectively for UC patients. Clinical scores were determined at each visit, and sera were obtained for assessment of drug and anti-adalimumab antibody levels. Calprotectin was measured using a smartphone-based app. This cohort was compared to a parallel prospective cohort of adalimumab-treated CD patients [POETIC1].
Fifty UC patients starting adalimumab [median follow-up 28 weeks] were compared to 98 adalimumab-treated CD patients [median follow-up 44 weeks]. Only 11/50 UC patients [22%] continued treatment to the end of the follow-up compared with 50/98 [51%] CD patients (odds ratio [OR] = 0.27, p = 0.001). Loss of response was significantly more common in UC patients [OR = 3.2, p = 0.001]. Seventeen patients [34%] in the UC cohort developed anti-adalimumab antibodies, 9/17 [52.9%] as early as week 2. There was no difference between patient cohorts in the overall development of anti-adalimumab antibodies [34% vs 30.6%, respectively, OR = 1.67, p = 0.67], nor was there a difference in early immunogenicity [OR = 1.39, p = 0.35]. There was no difference in low drug levels [<3 µg/mL] between the two cohorts [OR = 0.87, p = 0.83].
Loss of response to adalimumab therapy was significantly more common in the UC compared to the CD cohort and was driven by a higher rate of non-immunogenic, pharmacodynamic parameters.</description><subject>Adalimumab - therapeutic use</subject><subject>Colitis, Ulcerative - drug therapy</subject><subject>Crohn Disease - drug therapy</subject><subject>Humans</subject><subject>Prospective Studies</subject><subject>Tumor Necrosis Factor-alpha</subject><issn>1873-9946</issn><issn>1876-4479</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kU9v1DAQxaMKREvh3hPykUva2E7sNbcqXUqkSrsS23PkjCfFq8ReYmel_Tx8Ubx_4DTzrDdv5Pll2R0t7mmh-AMC-HwL8LDdakMrcZXd0IUUeVlK9e7U81ypUlxnH0PYFkWlKrn4kF1zKRStZHmT_VlPPuwQot0jWXUBp72O1js9kOVeD_NJEN-T-AvJxo6YP-EOnUEHh-Pzo9GDHedRd6QZx9n5N3QWbDwQ7Qx5muY3UnsH6OJ0jrKOvA6AR5U21n6w0QayTjJ5wrfTnvVquWlq0jTkZ5zN4VP2vtdDwM-Xepu9fl9u6h_5y-q5qR9fcmBKxVwySD80mhvWdYgUBDImNIKiipWAivdaKSZKWRqjJGUAHKSpsDdUc8b4bfb1nLub_O8ZQ2xHGwCHQTv0c2jZQqTDCcZ5shZnK6TzhQn7djfZUU-HlhbtEU17RNMmNO0FTRr5ckmfuxHN_4F_LPhfuGGQkQ</recordid><startdate>20240301</startdate><enddate>20240301</enddate><creator>Harnik, Sivan</creator><creator>Abitbol, Chaya M</creator><creator>Haj Natour, Ola</creator><creator>Yavzori, Miri</creator><creator>Fudim, Ella</creator><creator>Picard, Orit</creator><creator>Naftali, Timna</creator><creator>Broide, Efrat</creator><creator>Hirsch, Ayal</creator><creator>Selinger, Limor</creator><creator>Shachar, Eyal</creator><creator>Yablecovitch, Doron</creator><creator>Albshesh, Ahmad</creator><creator>Coscas, Daniel</creator><creator>Kopylov, Uri</creator><creator>Eliakim, Rami</creator><creator>Ben-Horin, Shomron</creator><creator>Ungar, Bella</creator><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><orcidid>https://orcid.org/0000-0001-6939-2688</orcidid></search><sort><creationdate>20240301</creationdate><title>Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study</title><author>Harnik, Sivan ; 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Although a recent study examined adalimumab levels and immunogenicity in Crohn's disease [CD] patients, prospective real-world data from ulcerative colitis [UC] patients are lacking.
A three-monthly home-visit programme from induction was established prospectively for UC patients. Clinical scores were determined at each visit, and sera were obtained for assessment of drug and anti-adalimumab antibody levels. Calprotectin was measured using a smartphone-based app. This cohort was compared to a parallel prospective cohort of adalimumab-treated CD patients [POETIC1].
Fifty UC patients starting adalimumab [median follow-up 28 weeks] were compared to 98 adalimumab-treated CD patients [median follow-up 44 weeks]. Only 11/50 UC patients [22%] continued treatment to the end of the follow-up compared with 50/98 [51%] CD patients (odds ratio [OR] = 0.27, p = 0.001). Loss of response was significantly more common in UC patients [OR = 3.2, p = 0.001]. Seventeen patients [34%] in the UC cohort developed anti-adalimumab antibodies, 9/17 [52.9%] as early as week 2. There was no difference between patient cohorts in the overall development of anti-adalimumab antibodies [34% vs 30.6%, respectively, OR = 1.67, p = 0.67], nor was there a difference in early immunogenicity [OR = 1.39, p = 0.35]. There was no difference in low drug levels [<3 µg/mL] between the two cohorts [OR = 0.87, p = 0.83].
Loss of response to adalimumab therapy was significantly more common in the UC compared to the CD cohort and was driven by a higher rate of non-immunogenic, pharmacodynamic parameters.</abstract><cop>England</cop><pmid>37691574</pmid><doi>10.1093/ecco-jcc/jjad156</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-6939-2688</orcidid></addata></record> |
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| ispartof | Journal of Crohn's and colitis, 2024-03, Vol.18 (3), p.341-348 |
| issn | 1873-9946 1876-4479 |
| language | eng |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adalimumab - therapeutic use Colitis, Ulcerative - drug therapy Crohn Disease - drug therapy Humans Prospective Studies Tumor Necrosis Factor-alpha |
| title | Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study |
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