NOR DRUM
The Norwegian study for therapeutic pharmacovigilance
Project managers
Postdoc
PhD fellow
ABOUT THE PROJECT
Biological drugs, including infliximab, have revolutionized the treatment of a number of chronic inflammatory immunological diseases, but a proportion of patients do not reach the goal of remission and many patients lose efficacy over time. There are large individual differences in the drug concentration in the blood of patients on standard doses, with a large proportion of patients both without measurable levels and with levels far above the assumed therapeutic level. One of the reasons for low levels is the development of antibodies to infliximab. Underdosing in the form of low serum concentrations is related to poorer treatment effect, while overdose can increase the risk of side effects and result in unnecessarily high societal costs. There was therefore reason to believe that target management of infliximab treatment based on serum concentration and measurements of drug antibodies would bring more patients into remission and prevent disease flare-ups during treatment. However, efficacy studies in this area were lacking. Therapeutic drug monitoring of infliximab treatment had therefore not been widely implemented either nationally or internationally.
In this study, we wanted to investigate whether targeting infliximab treatment using regular measurements of serum concentration and antibodies would improve disease control in patients initiating treatment with infliximab (part A) and in patients on maintenance treatment (part B).
We expected that NOR-DRUM could have a major impact on the treatment and follow-up of patients with inflammatory immunological diseases in both the short and long term.
WHO CAN JOIN?
Adults with ulcerative colitis, Crohn's disease, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis and psoriasis who are to initiate treatment with infliximab.
Recruitment of participants has ended.
WHAT DOES THE STUDY INVOLVE?
The study has now been completed.
NOR-DRUM A and NOR-DRUM B are randomized controlled trials. Patients in the intervention group received infliximab based on a treatment strategy based on regular measurements of serum concentration and drug antibodies, while the control group received standard infliximab dose.
NOR-DRUM A included 400 patients. The effect of the intervention was measured in the proportion of patients who achieved remission after 30 weeks (defined based on validated disease activity measures for each disease).
In NOR-DRUM B, 500 patients were included and the effect was measured in the proportion who did not develop disease flare-ups over 52 weeks.
Patients in NOR-DRUM A and B were followed at each infusion with, among other things, registration of patient-reported outcome measures, validated disease activity measures for the various diseases and adverse reactions. Blood samples were taken including biobank and serum concentration and antibodies.