Table 2

Step-down safety (weeks 0–48) RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON analysis set

n (EAIR/100 PYE)Continued baricitinib 4 mg (n=281)
PYE=254.9
Step-down baricitinib 2 mg (n=278)
PYE=236.7
Step-down-emergent adverse event170 (66.7)140 (59.2)
 Infection78 (30.6)59 (24.9)
Serious adverse event19 (7.5)15 (6.3)
 Serious infection5 (2.0)4 (1.7)
Adverse event leading to discontinuation7 (2.7)8 (3.4)
  • Patients completed 48 weeks in the step-down substudy, or would have completed 48 weeks if not discontinued.

  • EAIR, exposure-adjusted incidence rate; PYE, patient-years of exposure.