Table 1.

Safety Profile During the Transition Period (From Week 54 to Week 78)

Number of patients withINF/SB2INF/INFSB2/SB2
(N=94)(N=101)(N=201)
n(%)n(%)n(%)
At least 1 treatment-emergent adverse event34(36.2)36(35.6)81(40.3)
At least 1 serious adverse event6(6.4)3(3.0)7(3.5)
Serious infections2(2.1)1(1.0)1(0.5)
Active tuberculosis0(0.0)0(0.0)0(0.0)
Infusion-related reaction3(3.2)2(2.0)7(3.5)
Malignancy0(0.0)0(0.0)0(0.0)
Death0(0.0)0(0.0)0(0.0)
Overall ADA positive43(45.7)51(50.5)104(53.6)a
Newly ADA positiveb6711
  • aPercentage is based on 194 patients with available ADA results. bNewly developed ADA in patients with negative overall ADA up to Week 54.