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. 2020 Apr 28;6(1):e000987. doi: 10.1136/rmdopen-2019-000987

Table 4.

Summary of antidrug antibody status: safety analysis set

F-F-F N=216 n (%) F-RP-F N=108 n (%) RP-F-F N=108 n (%) RP-RP-F N=213 n (%)
Period 2, Week 0
 Total 216 108 108 212
 Positive 133 (61.6) 69 (63.9) 67 (62.0) 123 (58.0)
Week 12
 Total 202 103 103 202
 Positive 107 (53.0) 60 (58.3) 54 (52.4) 101 (50.0)
Week 24
 Total 197 100 96 199
 Positive 99 (50.3) 58 (58.0) 47 (49.0) 100 (50.3)
Period 3, Week 30*
 Total 187 100 93 190
 Positive 97 (51.9) 61 (61.0) 42 (45.2) 98 (51.6)
Week 54
 Total 181 93 89 181
 Positive 103 (56.9) 49 (52.7) 41 (46.1) 77 (42.5)
Week 76
 Total 176 90 81 174
 Positive 90 (51.1) 49 (54.4) 39 (48.1) 74 (42.5)
Week 80
 Total 173 87 80 170
 Positive 91 (52.6) 48 (55.2) 37 (46.3) 72 (42.4)

*Week 30 is end of Period 2.

Percentages are based on the number of patients in the safety analysis set with an assay result obtained at each planned relative time (Week).

F, FKB327; N, number of patients in the safety analysis set; n, total number of patients with observation; RP, reference product.