Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial
Therapeutic drug monitoring (TDM) during induction therapy with anti-tumor necrosis factor drugs has emerged as a strategy to optimize response to these biologics and avoid undesired outcomes related to inadequate drug exposure. This study aimed to describe clinical, biological, and endoscopic remis...
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MDPI AG
2023-06-01
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| Series: | Biomedicines |
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| Online Access: | https://www.mdpi.com/2227-9059/11/6/1757 |
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| author | Karoline Soares Garcia Matheus Freitas Cardoso de Azevedo Alexandre de Sousa Carlos Luísa Leite Barros Jane Oba Carlos Walter Sobrado Junior Aytan Miranda Sipahi Olívia Duarte de Castro Alves Tomás Navarro-Rodriguez Rogério Serafim Parra Júlio Maria Fonseca Chebli Liliana Andrade Chebli Cristina Flores Andrea Vieira Christianne Damasceno Arcelino do Ceará Natália Sousa Freitas Queiroz Aderson Omar Mourão Cintra Damião |
| author_facet | Karoline Soares Garcia Matheus Freitas Cardoso de Azevedo Alexandre de Sousa Carlos Luísa Leite Barros Jane Oba Carlos Walter Sobrado Junior Aytan Miranda Sipahi Olívia Duarte de Castro Alves Tomás Navarro-Rodriguez Rogério Serafim Parra Júlio Maria Fonseca Chebli Liliana Andrade Chebli Cristina Flores Andrea Vieira Christianne Damasceno Arcelino do Ceará Natália Sousa Freitas Queiroz Aderson Omar Mourão Cintra Damião |
| author_sort | Karoline Soares Garcia |
| collection | DOAJ |
| description | Therapeutic drug monitoring (TDM) during induction therapy with anti-tumor necrosis factor drugs has emerged as a strategy to optimize response to these biologics and avoid undesired outcomes related to inadequate drug exposure. This study aimed to describe clinical, biological, and endoscopic remission rates at six months in Brazilian inflammatory bowel disease (IBD) patients following a proactive TDM algorithm guided by IFX trough levels (ITL) and antibodies to IFX (ATI) levels during induction, at week six. A total of 111 IBD patients were prospectively enrolled, excluding those previously exposed to the drug. ITL ≥ 10 μg/mL was considered optimal. Patients with suboptimal ITL (<10 µg/mL) were guided according to ATI levels. Those who presented ATI ≤ 200 ng/mL underwent dose intensification in the maintenance phase, and patients with ATI > 200 ng/mL discontinued IFX. In our study, proactive TDM was associated with persistence in the IFX rate at six months of 82.9%. At that time, rates of clinical, biological, and endoscopic remission in patients under IFX treatment were 80.2%, 73.9%, and 48.1%, respectively. Applying a simplified TDM-guided algorithm during induction seems feasible and can help improve patients’ outcomes in clinical practice. |
| first_indexed | 2024-03-11T02:44:00Z |
| format | Article |
| id | doaj.art-a40212136539406fadaf057714be969e |
| institution | Directory Open Access Journal |
| issn | 2227-9059 |
| language | English |
| last_indexed | 2024-03-11T02:44:00Z |
| publishDate | 2023-06-01 |
| publisher | MDPI AG |
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| series | Biomedicines |
| spelling | doaj.art-a40212136539406fadaf057714be969e2023-11-18T09:27:46ZengMDPI AGBiomedicines2227-90592023-06-01116175710.3390/biomedicines11061757Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective TrialKaroline Soares Garcia0Matheus Freitas Cardoso de Azevedo1Alexandre de Sousa Carlos2Luísa Leite Barros3Jane Oba4Carlos Walter Sobrado Junior5Aytan Miranda Sipahi6Olívia Duarte de Castro Alves7Tomás Navarro-Rodriguez8Rogério Serafim Parra9Júlio Maria Fonseca Chebli10Liliana Andrade Chebli11Cristina Flores12Andrea Vieira13Christianne Damasceno Arcelino do Ceará14Natália Sousa Freitas Queiroz15Aderson Omar Mourão Cintra Damião16Department of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilRibeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, BrazilUniversity Hospital of the Federal University of Juiz de Fora, Juiz de Fora 36038-330, BrazilUniversity Hospital of the Federal University of Juiz de Fora, Juiz de Fora 36038-330, BrazilCrohn’s and Colitis Reference Center, Rio Grande do Sul 90560-002, BrazilIrmandade da Santa Casa de Misericórdia de São Paulo, São Paulo 01221-010, BrazilIrmandade da Santa Casa de Misericórdia de São Paulo, São Paulo 01221-010, BrazilHealth Sciences Graduate Program, Pontifícia Universidade Católica do Paraná (PUCPR), Curitiba 80215-901, BrazilDepartment of Gastroenterology, University of São Paulo, School of Medicine, São Paulo 05403-000, BrazilTherapeutic drug monitoring (TDM) during induction therapy with anti-tumor necrosis factor drugs has emerged as a strategy to optimize response to these biologics and avoid undesired outcomes related to inadequate drug exposure. This study aimed to describe clinical, biological, and endoscopic remission rates at six months in Brazilian inflammatory bowel disease (IBD) patients following a proactive TDM algorithm guided by IFX trough levels (ITL) and antibodies to IFX (ATI) levels during induction, at week six. A total of 111 IBD patients were prospectively enrolled, excluding those previously exposed to the drug. ITL ≥ 10 μg/mL was considered optimal. Patients with suboptimal ITL (<10 µg/mL) were guided according to ATI levels. Those who presented ATI ≤ 200 ng/mL underwent dose intensification in the maintenance phase, and patients with ATI > 200 ng/mL discontinued IFX. In our study, proactive TDM was associated with persistence in the IFX rate at six months of 82.9%. At that time, rates of clinical, biological, and endoscopic remission in patients under IFX treatment were 80.2%, 73.9%, and 48.1%, respectively. Applying a simplified TDM-guided algorithm during induction seems feasible and can help improve patients’ outcomes in clinical practice.https://www.mdpi.com/2227-9059/11/6/1757inflammatory bowel diseasestumor necrosis factor-alphainfliximabtherapeutic drug monitoringCrohn’s diseaseulcerative colitis |
| spellingShingle | Karoline Soares Garcia Matheus Freitas Cardoso de Azevedo Alexandre de Sousa Carlos Luísa Leite Barros Jane Oba Carlos Walter Sobrado Junior Aytan Miranda Sipahi Olívia Duarte de Castro Alves Tomás Navarro-Rodriguez Rogério Serafim Parra Júlio Maria Fonseca Chebli Liliana Andrade Chebli Cristina Flores Andrea Vieira Christianne Damasceno Arcelino do Ceará Natália Sousa Freitas Queiroz Aderson Omar Mourão Cintra Damião Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial Biomedicines inflammatory bowel diseases tumor necrosis factor-alpha infliximab therapeutic drug monitoring Crohn’s disease ulcerative colitis |
| title | Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial |
| title_full | Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial |
| title_fullStr | Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial |
| title_full_unstemmed | Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial |
| title_short | Efficacy of Early Optimization of Infliximab Guided by Therapeutic Drug Monitoring during Induction—A Prospective Trial |
| title_sort | efficacy of early optimization of infliximab guided by therapeutic drug monitoring during induction a prospective trial |
| topic | inflammatory bowel diseases tumor necrosis factor-alpha infliximab therapeutic drug monitoring Crohn’s disease ulcerative colitis |
| url | https://www.mdpi.com/2227-9059/11/6/1757 |
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