Measuring infliximab and adalimumab blood levels in IBD patients, prospective observations from a single center compared to a time period before regular use of these measurements.

Therapeutic drug monitoring of TNF-alpha blockers in IBD, a prospective single center cohort experience compared to biologicals in the pre-TDM era

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29021

Enrollment

275

Registered

2018-10-10

Start date

2018-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel diseases, IBD, inflammatoire darm ziekten, Crohn's disease, Ziekte van Crohn, ulcerative colitis, colitis ulcerosa, IBD-U, IBD-unclassified, biologicals, TNFalpha blockers, anti-TNF-alfa, infliximab, IFX, adalimumab, ADM, therapeutic drug monitoring, TDM, trough levels, medicatiespiegels, dalspiegels.

Interventions

None

Eligibility

Inclusion criteria

Inclusion criteria: For the historical cohort: - All patients who were 18 years and older on 01-01-2016 and no longer being cared for by our paediatricians - Diagnosed with Crohn’s disease, ulcerative colitis or IBD-unclassified - Received infliximab or adalimumab in any dosage between 01-01-2016 and 01-01-2017 For the prospective cohort: - All patients who are 18 years and older on 01-09-2018 and no longer being cared for by our paediatricians - Diagnosed with Crohn’s disease, ulcerative colitis or IBD-unclassified - Being treated with infliximab or adalimumab in any dose on 01-09-2018 or being put on them after that date up to 01-09-2019

Exclusion criteria

Exclusion criteria: -Any IBD-patient (who was) participating in a clinical trial for one of these biologicals that dictated/s an alternative treatment regimen than was/is used in clinical practice. - Any IBD patient whose treatment indication for infliximab or adalimumab is/was not primarily for IBD during the study periods (such as rheumatoid arthritis or psoriasis).

Design outcomes

Primary

Measure	Time frame
To explore the proportion of patients needing rescue therapy in the form of steroids, surgery and/or discontinuation or switch of the TNF-alpha blocker due to refractory disease in a one year period	—

Secondary

Measure	Time frame
• Descriptive data per IFX or ADM on the number of trough level/ADA measurements and its values and indications for measurement. A comparison of these values between the three major reasons for TDM: loss of response or before intended treatment alterations or after remission induction in the fixed one year cohorts. • For participants commencing therapy during the study periods, follow-up time for registration of events will be extended to include one full year of therapy. • We will gather information on the effect of TDM on treatment decisions: on dose alterations or drug discontinuation and for the prospective cohort on adherence to the uniform treatment algorithm. • Exploratory IBD related costs, including serum trough measurement, IBD medication costs (for IFX corrected for different costs related to originator/biosimilar), hospitalization, medical visits because of suspected disease flare and diagnostics utilized to analyse possible disease flare will be compared. • Lastly the number of flares defined by physician assessment in combination with at least one of two biomarkers elevated: C-reactive protein (CRP) > 5 mg/l and faecal calprotectin (FCP) > 150 mg/kg indication disease activity or defined by endoscopy (physician assessed). • Differences between IBD sub types will be explored	—

Measure

Time frame

• Descriptive data per IFX or ADM on the number of trough level/ADA measurements and its values and indications for measurement. A comparison of these values between the three major reasons for TDM: loss of response or before intended treatment alterations or after remission induction in the fixed one year cohorts. • For participants commencing therapy during the study periods, follow-up time for registration of events will be extended to include one full year of therapy. • We will gather information on the effect of TDM on treatment decisions: on dose alterations or drug discontinuation and for the prospective cohort on adherence to the uniform treatment algorithm. • Exploratory IBD related costs, including serum trough measurement, IBD medication costs (for IFX corrected for different costs related to originator/biosimilar), hospitalization, medical visits because of suspected disease flare and diagnostics utilized to analyse possible disease flare will be compared. • Lastly the number of flares defined by physician assessment in combination with at least one of two biomarkers elevated: C-reactive protein (CRP) > 5 mg/l and faecal calprotectin (FCP) > 150 mg/kg indication disease activity or defined by endoscopy (physician assessed). • Differences between IBD sub types will be explored

—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)