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Monday Poster Session
Category: IBD
Christina Ha, MD, FACG
Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center
Los Angeles, CA, United States
Induction Cohort (8 weeks)a | Maintenance Cohort (52 weeks)a | Overall Cohort, Aug 2020 (≤7.8 years)a | ||||||
PBO (N=282; 44.8 PY) | Tofacitinib 10 mg BID (N=938; 156.2 PY) | PBO (N=198; 100.4 PY) | Tofacitinib 5 mg BID (N=198; 146.2 PY) | Tofacitinib 10 mg BID (N=196; 154.3 PY) | PD tofacitinib 5 mg BID (N=201; 776.4 PY) | PD tofacitinib 10 mg BID (N=956; 2,038.0 PY) | Tofacitinib All (N=1,157; 2,814.4 PY) | |
Infections (all) n (%), IR [95% CI] | 43 (15.2), 93.23 [67.47, 125.57] | 196 (20.9), 134.25 [116.11, 154.42] | 48 (24.2) 58.16 [42.88, 77.12] | 71 (35.9), 62.54 [48.85, 78.89] | 78 (39.8), 72.82 [57.56, 90.88] | 136 (67.7), 40.79 [34.22, 48.25] | 504 (52.7), 50.48 [46.17, 55.08] | 640 (55.3), 48.05 [44.40, 51.92] |
SIsb n (%), IR [95% CI] | 0 (0), 0.00 [0.00, 7.30] | 8 (0.9), 4.83 [2.09, 9.52] | 2 (1.0), 1.94 [0.23, 7.00] | 2 (1.0), 1.35 [0.16, 4.87] | 1 (0.5), 0.64 [0.02, 3.54] | 10 (5.0), 1.26 [0.60, 2.31] | 40 (4.2), 1.90 [1.36, 2.59] | 50 (4.3), 1.72 [1.28, 2.27] |
OIsc n (%), IR [95% CI] | 0 (0), 0.00 [0.00, 9.13]d | 3 (0.3), 1.89 [0.39, 5.53]e | 1 (0.5), 0.97 [0.02, 5.42] | 2 (1.0), 1.36 [0.16, 4.92] | 4 (2.0), 2.60 [0.71, 6.65] | 8 (4.0), 1.04 [0.45, 2.05] | 22 (2.4), 1.05 [0.66, 1.60]f | 30 (2.7),g 1.05 [0.71, 1.50]h |
Non-HZ OIsc,i n (%) IR [95% CI] | 0 (0), 0.00 [0.00, 9.13]d | 1 (0.1), 0.63 [0.02, 3.51]e | 0 (0), 0.00 [0.00, 3.57] | 0 (0), 0.00 [0.00, 2.48] | 0 (0), 0.00 [0.00, 2.35] | 1 (0.5), 0.13 [0.00, 0.70] | 4 (0.4), 0.19 [0.05, 0.48]f | 5 (0.4), 0.17 [0.06, 0.40]h |
All HZ (non-serious and serious)j n (%), IR [95% CI] | 1 (0.4), 1.98 [0.05, 11.05] | 6 (0.6), 3.62 [1.33, 7.88] | 1 (0.5), 0.97 [0.02, 5.42] | 3 (1.5), 2.05 [0.42, 6.00] | 10 (5.1), 6.64 [3.19, 12.22] | 22 (10.9), 3.02 [1.89, 4.58] | 70 (7.3), 3.51 [2.74, 4.44] | 92 (8.0), 3.38 [2.73, 4.15] |
SIsb by time interval, in the Overall Cohort (N=1,157; 2,814.4 PY) | HZ (non-serious and serious) by time interval, in the Overall Cohort (N=1,157; 2,814.4 PY) | |||||||
Time (months) 0–6 >6–12 >12–18 >18–24 >24–30 >30 | N 1,157 780 679 606 554 507 | n (%) 15 (1.3) 6 (0.8) 5 (0.7) 3 (0.5) 4 (0.7) 17 (3.4) | IR 3.02 1.66 1.57 1.03 1.51 1.45 | 95% CI 1.69, 4.98 0.61, 3.62 0.51, 3.67 0.21, 3.02 0.41, 3.86 0.85, 2.32 | N 1,157 768 654 577 519 471 | n (%) 22 (1.9) 14 (1.8) 14 (2.1) 10 (1.7) 5 (1.0) 27 (5.7) | IR 4.46 3.98 4.58 3.66 2.02 2.57 | 95% CI 2.79, 6.75 2.17, 6.67 2.51, 7.69 1.76, 6.73 0.66, 4.72 1.70, 3.75 |