Infliximab doseren op basis van serumconcentraties bij ernstig sarcoidose: slimmer doseren

Rationale: Sarcoidosis is a granulomatous disease that primarily affects the
lung. Severe cases are treated with infliximab. Problems met in daily clinical
practice are that the optimal infliximab dose in sarcoidosis is not known and
the very high drug cost. This study aims to improve cost effectiveness and
safety.

Objective: To determine whether serum concentration guided dosing of infliximab
is not inferior to standard dosing based on bodyweight in patients with severe
sarcoidosis in terms of FVC change at 26 weeks.

Study design: Randomized, controlled, double blind study with a follow up of
one year.

Intervention: The intervention group will receive infliximab 3 mg/kg, week 0 and 2. Based on measured serum concentrations, for every patient a dose, to be given at week 6, resulting in a concentration within the target window, will be calculated. Thereafter, patients will receive infliximab every 4 weeks. Additional dose adjustments will be made based on infliximab serum concentrations. The control group will receive infliximab at the standard dose of 5 mg/kg at week 0, 2, 6 and thereafter every 4 weeks.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The burden and risks are minimal and consists of
several venipunctures, patients have to fill out questionnaires at 4
timepoints. Patients in the intervention arm will receive lower infliximab
dosages. However, at any time during the study the treating pulmonologist can
indicate that an individual patient must receive the maximal dose of 5 mg/kg
e.g. in case of rapid progression of the disease.
Revenues: It is expected that drug cost will decrease by approximately 2
million Euro*s per year in The Netherlands and drug safety might improve.