P1-38　Evaluation of Potential Drug-Drug Interactions with Baricitinib

抄録

  The purpose was to confirm whether clinically relevant drug-drug interactions (DDIs) with baricitinib (bari) were seen in clinical pharmacology (CP) studies.

  7 CP studies in healthy subjects (HS) examined potential interactions between bari and various drug transporter and CYP substrates, inhibitors, and inducers. MTX was studied in combination with bari in RA patients (pts).

  In HS, co-administration of the CYP3A inhibitor, the CYP2C19/CYP2C9/CYP3A inhibitor, the CYP3A inducer or the Pgp inhibitor with bari had no significant effects on the pharmacokinetics (PK) of bari. A potent OAT3 inhibitor had no effect on bari C_max, but increased AUC by 2-fold. When tested as a Pgp inhibitor or CYP3A inducer, bari had no effect on the PK of substrates. When tested as a CYP3A inhibitor, bari decreased the exposure of simvastatin and its active metabolite but the differences were small. The combination of MTX and bari in RA pts had no significant effect on the PK of bari or MTX.

  No clinically relevant DDIs were observed except with a strong OAT3 inhibitor. The data indicate a low risk of clinically significant DDIs between bari and other drugs that may be concomitantly administered to RA pts.