Inflammatory Bowel Diseases Clinical Trial
Official title:
Comparison of the Performance of SB2-Infliximab With Originator Infliximab in the Measure of Serum Concentrations in Serum
The measurement of serum concentrations of infliximab (IFX)has now become a routine part of
optimal use of that drug. Trough values are used in two situations: (a) reactively where
there is loss of response to infliximab - therapeutic concentrations are indicate likely
non-response to the drug, whereas low levels are associated with the chance of regaining
response by increasing dosage; or (b) proactively, where dose optimisation in the maintenance
phase is performed to ensure ongoing efficacy and/or cost-effective use (where high levels
lead to reduction in dosage without loss of efficacy).
With the introduction of biosimilar infliximab into clinical practice, it is important to
demonstrate that the biosimilar behaves similarly in the assay used as does originator
infliximab to which the assays were developed. While unlikely to be different due to
identical protein core, such confirmation is needed before such assays can be used in
clinical practice with confidence.
AIMS
1. To compare the concentrations of biosimilar IFX (MSD-IFX) with that of originator IFX
(orig-IFX) when added to serum form healthy subjects and those with IBD when measured by
commonly-used commercial assays.
2. To compare the effect of freeze-thawing and storage at 4 oC on concentrations of
MSD-IFX.
EXPERIMENTAL PLAN Serum This will separated from peripheral blood taken from 2 healthy
subjects, 2 patients with ulcerative colitis (one with quiescent and the other with active
disease), and 2 patients with Crohn's disease (one with quiescent and the other with active
disease). It will be used wither fresh or freshly thawed from serum stored at -20 oC.
Infliximab
Two sources of infliximab will be used:
- Orig-IFX from Janssen
- MSD-IFX from Merck Sharp & Dome.
Preparation of simulated serum samples Fresh or thawed serum will be spiked with IFX to
obtained serum at concentrations of 0, 1, 2, 4, 6, 8, 10, 12, 15 and 20 ug/ml. This range
covers that seen in routine practice. These preparations will be used fresh or stored in
aliquots at 4 oC or -20 oC.
Assays to be evaluated These commercially-available assay kits have been chosen on the basis
that they are commonly used. They will all be used according to manufacturer's
recommendations.
- SHIKARI Q-INFLIXI from Matriks Biotech;
- LISA TRACKER Premium from Theradiag;
- Promonitor ELISA kit from Grifols;
- Quantum Blue Infliximab trough level rapid test from Buhlmann. Testing protocol The two
IFX molecules will be tested on the same plates in duplicate at the concentrations
prepared (as above). One assay plate will be sufficient for sera from 2 individuals. One
assay only will be performed on any one day.
For the direct comparisons, 3 ELISA assay kits will be required to assess 6 pairs of
IFX-spiked sera. The rapid test will be performed in duplicate in a similar way.
In order to assess the effect of storing at -20 oC followed by freeze-thawing, and storage at
4 oC, sera from two subjects will be prepared at one concentration (7 ug/ml), will tested
fresh and then again 7 days later after storage at the two temperatures. This will l be
performed with one assay kit only (the one performing the best in the comparative studies if
differences in kits emerge).
Analysis The result of MSD-IFX will be compared to those of Orig-IFX by plotting the
respective curves of concentrations and visually comparing them for each assay. The percent
deviation for each concentration will be calculated. The results will also be compared across
assays for each IFX source and then the findings compared.
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