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Influence of HLA-DQA1*05 Genotype in Adults With Anti-TNF Treatment With Proactive Therapeutic Drug Monitoring.

Recruiting
18 years of age
Both
Phase N/A

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Overview

HLA-DQA1*05 variant carriers are at risk of developing antibodies against infliximab and adalimumab with reduced TNF antagonist persistence.

The impact of proactive therapeutic drug monitoring (PTDM) on this association has been barely assessed.

Therefor, we propose a cohort study including adult patients with Crohn's disease and ulcerative colitis treated with TNF antagonists under proactive therapeutic drug monitoring.

Our hypothesis is that, proactive therapeutic drug monitoring could be an alternative to combination treatment with immunomodulators to increase TNF-antagonists' persistence in HLA-DQA1*05 carriers.

Description

Population study: patients with inflammatory bowel disease and initiation of anti-TNF therapy

Inclusion and exclusion criteria

The inclusion criteria are:

  • Patient diagnosed with inflammatory bowel disease based on clinical, endoscopic, and pathological criteria according to ECCO criteria.
  • Initiation of anti-TNf, including infliximab and adalimumab.
  • Subjects naïve to biological treatment
  • Age >18 years.

The exclusion criteria are:

  • No determination of HLA DQA1*5 allele.
  • No proactive drug monitoring
  • Initiation of anti-TNF treatment as prevention of post-surgical recurrence in Crohn's disease during the first 12 months after surgery or, after that time, with a colonoscopy with a Rutgeerts 0-1
  • Anti-TNF treatment with combined treatment with immunomodulator. Prior initiation of immunomodulator or prior use and suspension would not be a contraindication
  • Initiation of anti-TNF treatment for extraintestinal manifestation
  • Initiation of anti-TNF treatment during pregnancy.

Proactive drug monitoring was defined as standardized determination of drug levels during induction and maintenance, with optimization independently of the patient's clinical status, until reaching target levels.

Eligibility

Inclusion Criteria:

  • Diagnosis of inflammatory bowel disease according to ECCO criteria.
  • Older than 18 years
  • Subjects naïve to biological treatment
  • Anti-TNF treatment initiation (infliximab or adalimumab) due to intestinal activity and/or perianal disease.
  • Avaibility to evaluate HLA DQA1*05 status
  • Proactive therapeutic drug monitoring of anti-TNF levels

Exclusion Criteria:

  • Initiation of anti-TNF treatment as prevention of post-surgical recurrence in Crohn's disease during the first 12 months after surgery or, afterwards, if endoscopic recurrence with a Rutgeerts 0-1.
  • Initiation of anti-TNF treatment under combo treatment with immunomodulator. Prior initiation of immunomodulator or prior use and suspension would not be a contraindication.
  • Initiation of anti-TNF treatment due to extraintestinal activity.
  • Initiation of anti-TNF treatment by a non-gastroenterologist specialist.
  • Initiation of anti-TNF treatment during pregnancy.

Study details

Drug Monitoring, Inflammatory Bowel Diseases

NCT05986903

Hospital del Río Hortega

25 January 2024

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