Abstract SAT0267 – Table 1

54 w safety data

BCD-055, n(%)Infliximab, n(%)p value
Any AE/SAE82 (62.12)43 (64.18)0.898
Any SAE7 (5.30)5 (7.46)0.376
Therapy-related AE/SAE40 (30.30)26 (38.81)0.296
Therapy-related SAE5 (3.79)4 (5.97)0.489
Any SAE/AE grade 3–518 (13.64)11 (16.42)0.754
Therapy-related AE grade 3–511 (8.33)7 (10.45)0.818
Treatment withdrawal due to SAE/AE11 (8.33)7 (10.45)0.818
Deaths1 (0.76)0 (0)1.000
ADA positive27 (21.26)13 (20,63)0.920
ADA positive, confirmed by neutralisation assay4 (3.15)4 (6.35)0.443