N/A
N=45
Biomarkers of Anti-TNF Treatment in Inflammatory Bowel Disease (IBD)
Inflammatory Bowel Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01971970 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Pre-treatment Serum Level of Endogenous Anti-TNF in Relation to Primary Clinical Response or Non-response — NA endogenous anti-TNF serum level (µg/mL)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Infliximab (Biological); Adalimumab (Biological)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Erasmus Medical Center
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-treatment Serum Level of Endogenous Anti-TNF in Relation to Primary Clinical Response or Non-response |
NA | — |
| PRIMARY RNA Expression Profiles in Relation to Clinical Endpoints |
180; 0; 523 | < 0.05 sig |
| SECONDARY Number of Participants With Clinical Endpoints of Interest. |
1; 1; 2; 15; 15; 30 | 0.2616 |
| SECONDARY Anti-TNF Treatment Specific Outcomes |
17; 9; 26; 14; 4; 18 | 0.0177 sig |
| SECONDARY Number of Participants With Concommitant Treatment |
5; 5; 10; 3; 0; 3 | — |
Summary
Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction (primary response) and maintenance of remission. When effective, clinical and endoscopic remission is reached within weeks. However, primary non-response is observed in 20% of pediatric patients, and in 40% of adult CD patients, suggesting a more robust acute response to anti-TNF therapy in children as compared to adults.During maintenance treatment, 60 - 80% of patients have secondary loss of response, necessitating dose adjustments to maintain clinical response. Anti-TNF treatment is also increasingly used in ulcerative colitis (UC), and has been shown to induce remission in active disease. For UC, the comparison between the efficacy in children versus adults is more difficult to report as studies in children are scarce. Anti-TNF treatment is associated with rare but potentially fatal side effects, infusion reactions, and is an expensive treatment. To avoid overtreatment it is necessary to early identify non-responders to treatment, and therefore it is important to develop predictive biomarkers of treatment response.
Eligibility Criteria
Inclusion Criteria
- Anti-TNF naïve CD patients (≥ 6 years) who initiate anti-TNF treatment (IFX or ADA) because of active luminal disease, failing treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate) and corticosteroids.
- Anti-TNF naïve UC patients (≥ 6 years) who initiate anti-TNF treatment (IFX or ADA) because of active disease despite corticosteroid treatment or because of failing of immunomodulator treatment.
- Anti-TNF naïve CD or UC patients (≥ 6 years) who initiate anti-TNF treatment (IFX or ADA) because of intolerance to treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate) or corticosteroids.
- Informed consent by patients and parents (when required).
Exclusion Criteria
- IBD patients who initiate IFX or ADA immediately after diagnosis.
- Presence of severe perianal disease as primary indication to start anti-TNF treatment.
- Age < 6 years when anti-TNF maintenance treatment is initiated.
Data sourced from ClinicalTrials.gov (NCT01971970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.