Baricitinib appears to be safe, effective in phase IIb study
Baricitinib has shown consistent safety and tolerability up to 128 weeks, with no unexpected late signals, according to the results of a phase IIb study in rheumatoid arthritis (RA). In addition, clinical improvements during the 24-week blinded period persist during the open-label extension (OLE).
Treatment-emergent adverse events (AEs) occurred in 63 percent of patients in the 4-mg group and 67 percent in the 8-mg group. Furthermore, serious AE presented in 16 percent and 13 percent, infections in 35 percent and 40 percent, and serious infections in 5 percent and 3 percent of patients, respectively.
All baricitinib groups in the second OLE had similar or lower exposure-adjusted incidence rates for AE compared with the first OLE. There were no opportunistic infections, tuberculosis cases or lymphomas seen through week 128, but there was one death during the first OLE.
In addition, the proportions of patients in both OLE who achieved disease improvement at week 24 were either similar or greater at weeks 76 and 128.
To evaluate the safety and efficacy of baricitinib in RA patients up to 128 weeks, researchers enrolled eligible patients in an initial 52-week OLE following a 24-week blinded period. Patients administered 8-mg baricitinib once daily (QD; n=93) continued with that dose and all others received 4 mg QD (n=108).
Depending on researcher discretion, doses could be increased to 8 mg QD at week 28 or 32 when ≥6 tender and ≥6 swollen joints were present. Those who completed the first OLE were allowed to enter a second 52-week OLE and receive 4 mg QD irrespective of previous dose.