Other biologicals used in transplantation
Some of the drugs listed in Table 1 are used in very short courses in
organ transplantation. According to definition (FDA
https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf),
anti-thymocyte globulin preparations (ATG) are biological drugs although
not designed and produced like current biologicals. In the US
immunosuppressive protocols frequently include ATG for induction
therapy, while in most of Europe the specific IL-2R antagonist
basiliximab is preferred. In these regimens only one or two doses are
given, leaving limited space for personalized dosing except if one would
try to individualize the initial dose more than current practice. In
steroid resistant rejections ATG is an important treatment option. To
reverse the rejection repeated doses will often be required, and in this
setting the dosing intervals are adjusted based in part on the absolute
CD3 cell counts –which may be considered a form of pharmacodynamics
monitoring [29].
Imlifidase is an enzyme which rapidly degrades and depletes IgG from
circulation. This drug is approved for desensitization in highly
sensitized patients awaiting kidney transplantation. It is also in
trials for treatment of ABMR [30]. For desensitization a single dose
is recommended pretransplant while a small study also explored the use
of one repetition [31]. Dosage is BW adjusted, otherwise no further
personalization has been discussed. Of specific note is that several
other mAbs may be degraded by imlifidase if administered concurrently.