None listed
Conditions
Brief summary
Patients with inflammatory bowel disease (IBD) are prescribed medications used to treat inflammation. Infliximab is an effective intravenous therapy that is used in the treatment of Crohn’s disease and ulcerative colitis. Conventionally, infliximab is given as an infusion every 8 weeks. The dose of infliximab is calculated according to weight and may differ between patients. Despite initially responding to infliximab, some patients will lose response over time, such that the drug no longer continues to work as well as it once did. Studies have demonstrated that patients on a maintenance treatment are more likely to continue to show positive responses to infliximab therapy when the blood level of infliximab, measured just prior to the next scheduled infusion (referred to as a ‘trough level’), is within an optimal range (referred to as ‘therapeutic range’). Infliximab levels are measured from a blood sample. In the past we measured infliximab levels only occasionally. This is partly because the results took time to be processed and were not available on the same day. In this project a blood test will be taken to measure the infliximab level every time patients are due for your infliximab infusion. The test to be used is able to measure the drug level within an hour at the point of care. We will then be able to modify the infliximab dose immediately, in small increments, according to the infliximab level with the aim of ensuring that infliximab levels remain within the ideal therapeutic range. The infliximab blood test and dose modification, if needed, will occur at each visit for the duration of the study (for 12 months, or 6-7 infusions). At each visit, 10mL (about 2 teaspoons) of blood will be taken from your peripheral access line to measure the level of infliximab in your blood along with other blood tests normally conducted when you have your infusion. The information from the blood tests will be used by the researchers to adjust the infliximab dose and to validate the dosing guide. Participants will be asked to provide faecal samples to measure faecal calprotectin, a protein that is secreted in the intestine of patients with inflammation of the gastrointestinal tract (this is a test we currently perform periodically; during this study we will do this test at the second visit and at the end of the study). Participants will be asked to complete a brief survey that assesses quality of life at the beginning and the end of the study, and to answer some short questions about their Crohn’s disease or ulcerative colitis
Interventions
The intervention will be prospective adjustments of infliximab dosing based on infliximab blood levels tested using a new point of care (POC) test, Quantum Blue Infliximab Assay, manufactured by Buhlmann Laboratories and approved for use in the European Union.
Patients currently receive infliximab therapy on a 6- or 8-weekly schedule; POC testing and dose adjustments will occur 6-8 weekly according to this schedule. The intervention period will be 12 months from the commencement of the intervent
The intervention will be prospective adjustments of infliximab dosing based on infliximab blood levels tested using a new point of care (POC) test, Quantum Blue Infliximab Assay, manufactured by Buhlmann Laboratories and approved for use in the European Union. Patients currently receive infliximab therapy on a 6- or 8-weekly schedule; POC testing and dose adjustments will occur 6-8 weekly according to this schedule. The intervention period will be 12 months from the commencement of the intervention. All eligible patients will have undergone infliximab induction, and will now be on maintenance infliximab therapy; starting dose of infliximab for this study will be the patient’s current prescribed dose. All patients receiving infliximab infusions at this institution have established peripheral access lines, and it is routine practice for blood samples to be taken before each infusion to test biochemistry, FBE and infliximab levels via ELISA assay. Patients will have an additional 10ml of blood taken from this line, at the same time as other blood tests, by the clinic nurse, which will be applied to the POC test, which produces a result within 60 minutes. No adherence monitoring strategies are in place. The dosing algorithm used to prospectively adjust infliximab doses is as follows: Infliximab trough concentration and dose adjustments: If 0-0.9ug/ml then increase by 3mg/kg If 1-1.9ug/ml then increase by 2mg/kg If 2-2.9ug/ml then increase by 1mg/kg If 3-7ug/ml - therapeutic range, no action If 7.1-9ug/ml then decrease by 1mg/kg If >9ug/ml then decrease by 2mg/kg
Sponsors
Alfred Health Pharmacy Department
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults over 18 years. Diagnosis of moderate to severe Crohn's disease or Ulcerative Colitis Currently receiving maintenance infliximab therapy (ie have commenced infliximab therapy at least 14 weeks prior to recruitment) Receiving their infliximab therapy and disease monitoring through Alfred Health
Exclusion criteria
Unable or unwilling to provide informed consent Patients with detectable anti-drug antibodies (ADAs) and undetectable trough levels Pregnant or breastfeeding women
Outcome results
None listed