Table 2:
Demographics, UC medication history, and concomitant UC medication at induction baseline and UC disease characteristics at maintenance baseline; patients who were treated in the long-term extension
| Randomized patients † | Non-randomized patients |
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|---|---|---|---|---|---|---|---|---|
| Ustekinumab | Responders to placebo IV induction | Week 16 responders ¶ | ||||||
|
|
|
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| Placebo SC ‡ (N=115) | 90 mg SC p12w (N=141) | 90 mg SC q8w (N=143) | Combined (N=284) | Total (N=399) | Placebo SC § (N=73) | Ustekinumab 90 mg SC q8w (N=116) | Overall total (N=588) | |
| Induction baseline | ||||||||
| Male, n (%) | 73 (63.5) | 77 (54.6) | 82 (57.3) | 159 (56.0) | 232 (58.1) | 47 (64.4) | 83 (71.6) | 362 (61.6) |
| Age, Mean (SD), years | 42.9 (14.54) | 40.4 (13.22) | 39.9 (12.92) | 40.1 (13.05) | 40.9 (13.54) | 43.1 (15.03) | 43.6 (13.20) | 41.7 (13.69) |
| Weight (kg) | ||||||||
| Median (IQ range) | 72.00 (60.00; 79.40) | 71.60 (60.00; 83.80) | 70.80 (59.00; 85.30) | 71.50 (59.55; 84.25) | 71.60 (60.00; 83.20) | 71.50 (60.00; 84.00) | 73.00 (64.10; 87.10) | 72.00 (60.25; 83.65) |
| Race, n (%) | ||||||||
| White | 79 (68.7) | 111 (78.7) | 107 (74.8) | 218 (76.8) | 297 (74.4) | 62 (84.9) | 92 (79.3) | 451 (76.7) |
| Black or African American | 1 (0.9) | 0 | 2 (1.4) | 2 (0.7) | 3 (0.8) | 0 | 0 | 3 (0.5) |
| Asian | 26 (22.6) | 19 (13.5) | 22 (15.4) | 41 (14.4) | 67 (16.8) | 8 (11.0) | 17 (14.7) | 92 (15.6) |
| Other | 3 (2.6) | 8 (5.7) | 3 (2.1) | 11 (3.9) | 14 (3.5) | 1 (1.4) | 2 (1.7) | 17 (2.9) |
| Not Reported | 6 (5.2) | 3 (2.1) | 9 (6.3) | 12 (4.2) | 18 (4.5) | 2 (2.7) | 5 (4.3) | 25 (4.3) |
| Region n (%) | ||||||||
| Asia | 24 (20.9) | 18 (12.8) | 20 (14.0) | 38 (13.4) | 62 (15.5) | 8 (11.0) | 17 (14.7) | 87 (14.8) |
| Eastern Europe | 50 (43.5) | 68 (48.2) | 56 (39.2) | 124 (43.7) | 174 (43.6) | 35 (47.9) | 55 (47.4) | 264 (44.9) |
| Rest of World | 41 (35.7) | 55 (39.0) | 67 (46.9) | 122 (43.0) | 163 (40.9) | 30 (41.1) | 44 (37.9) | 237 (40.3) |
| North America | 12 (10.4) | 27 (19.1) | 28 (19.6) | 55 (19.4) | 67 (16.8) | 11 (15.1) | 12 (10.3) | 90 (15.3) |
| Western Europe | 23 (20.0) | 20 (14.2) | 32 (22.4) | 52 (18.3) | 75 (18.8) | 16 (21.9) | 26 (22.4) | 117 (19.9) |
| Other | 6 (5.2) | 8 (5.7) | 7 (4.9) | 15 (5.3) | 21 (5.3) | 3 (4.1) | 6 (5.2) | 30 (5.1) |
| Any UC medication at induction baseline | 105 (91.3) | 128 (90.8) | 128 (89.5) | 256 (90.1) | 361 (90.5) | 71 (97.3) | 110 (94.8) | 542 (92.2) |
| Immunosuppressants | 39 (33.9) | 37 (26.2) | 41 (28.7) | 78 (27.5) | 117 (29.3) | 25 (34.2) | 43 (37.1) | 185 (31.5) |
| Aminosalicylates | 86 (74.8) | 115 (81.6) | 94 (65.7) | 209 (73.6) | 295 (73.9) | 56 (76.7) | 91 (78.4) | 442 (75.2) |
| Corticosteroids use | 57 (49.6) | 69 (48.9) | 74 (51.7) | 143 (50.4) | 200 (50.1) | 40 (54.8) | 52 (44.8) | 292 (49.7) |
| Corticosteroid use (excl. budesonide and beclomethasone dipropionate) | 46 (40.0) | 58 (41.1) | 65 (45.5) | 123 (43.3) | 169 (42.4) | 34 (46.6) | 41 (35.3) | 244 (41.5) |
| Budesonide | 12 (10.4) | 11 (7.8) | 9 (6.3) | 20 (7.0) | 32 (8.0) | 7 (9.6) | 10 (8.6) | 49 (8.3) |
| Beclomethasone dipropionate | 1 (0.9) | 2 (1.4) | 0 | 2 (0.7) | 3 (0.8) | 0 | 2 (1.7) | 5 (0.9) |
|
| ||||||||
| Induction baseline | ||||||||
| Biologic naïve | 63 (54.8) | 82 (58.2) | 67 (46.9) | 149 (52.5) | 212 (53.1) | 36 (49.3) | 54 (46.6) | 302 (51.4) |
| Biologic refractory | 52 (45.2) | 53 (37.6) | 71 (49.7) | 124 (43.7) | 176 (44.1) | 35 (47.9) | 58 (50.0) | 269 (45.7) |
| Only TNF antagonist | 38 (33.0) | 36 (25.5) | 54 (37.8) | 90 (31.7) | 128 (32.1) | 24 (32.9) | 40 (34.5) | 192 (32.7) |
| Vedolizumab regardless of TNF antagonist | 14 (12.2) | 17 (12.1) | 17 (11.9) | 34 (12.0) | 48 (12.0) | 11 (15.1) | 18 (15.5) | 77 (13.1) |
| ≥1 TNF antagonist regardless of vedolizumab | 52 (45.2) | 53 (37.6) | 70 (49.0) | 123 (43.3) | 175 (43.9) | 34 (46.6) | 58 (50.0) | 267 (45.4) |
| TNF antagonist and vedolizumab | 14 (12.2) | 17 (12.1) | 16 (11.2) | 33 (11.6) | 47 (11.8) | 10 (13.7) | 18 (15.5) | 75 (12.8) |
| Maintenance baseline | ||||||||
| Mayo score (0–12) | ||||||||
| Mean (SD) | 3.2 (2.52) | 2.6 (2.07) | 2.4 (1.95) | 2.5 (2.01) | 2.7 (2.19) | 3.6 (2.48) | 3.2 (2.33) | 2.9 (2.28) |
| Clinical remission, †† n (%) | 32 (27.8) | 35 (24.8) | 32 (22.4) | 67 (23.6) | 99 (24.8) | 13 (17.8) | 15 (12.9) | 127 (21.6) |
| Endoscopic improvement, n (%) | 49 (42.6) | 57 (40.4) | 47 (32.9) | 104 (36.6) | 153 (38.3) | 28 (38.4) | 25 (21.6) | 206 (35.0) |
| C-Reactive Protein (mg/L) | ||||||||
| N | 114 | 140 | 143 | 283 | 397 | 72 | 116 | 585 |
| Median (IQ range) | 1.03 (0.47; 3.20) | 1.49 (0.51; 3.18) | 1.75 (0.73; 5.23) | 1.59 (0.62; 4.04) | 1.50 (0.56; 3.83) | 1.78 (0.58; 6.09) | 1.86 (0.74; 4.71) | 1.56 (0.60; 4.13) |
| Abnormal CRP‡‡, n (%) | 32 (28.1) | 37 (26.4) | 52 (36.4) | 89 (31.4) | 121 (30.5) | 29 (40.3) | 39 (33.6) | 189 (32.3) |
| Fecal calprotectin (mg/kg) | ||||||||
| N | 111 | 131 | 130 | 261 | 372 | 69 | 113 | 554 |
| Median (IQ range) | 316.0 (92.0; 900.0) | 431.0 (84.0; 1171.0) | 450.5 (157.0; 1515.0) | 450.0 (138.0; 1253.0) | 422.5 (109.5; 1176.0) | 332.0 (95.0; 1234.0) | 428.0 (165.0; 1183.0) | 421.5 (114.0; 1183.0) |
| Abnormal fecal calprotectin, ‡‡ n (%) | 59 (53.2) | 78 (59.5) | 85 (65.4) | 163 (62.5) | 222 (59.7) | 38 (55.1) | 76 (67.3) | 336 (60.6) |
| Maintenance baseline | ||||||||
| Fecal lactoferrin (μg/g) | ||||||||
| N | 110 | 132 | 133 | 265 | 375 | 72 | 112 | 559 |
| Median (IQ range) | 28.79 (4.30; 176.80) | 37.93 (3.78; 139.89) | 50.03 (14.25; 174.33) | 43.14 (9.17; 164.22) | 41.74 ((8.24; 169.65) | 32.13 (3.80; 184.85) | 52.58 (13.14; 171.91) | 42.88 (8.28; 172.00) |
| Abnormal fecal lactoferrin‡‡, n (%) | 78 (70.9) | 93 (70.5) | 111 (83.5) | 204 (77.0) | 282 (75.2) | 50 (69.4) | 90 (80.4) | 422 (75.5) |
Patients who were in clinical response to ustekinumab IV induction dosing based on the treatment assignment by IWRS on entry into the maintenance study, regardless whether patients had a dose adjustment during the long-term extension.
Patients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo SC on entry into the maintenance.
Patients who were in clinical response to placebo IV induction dosing and received placebo SC on entry into the maintenance study.
Patients who were not in clinical response to ustekinumab at I-8 but were in clinical response at I-16 after a SC administration of ustekinumab at I-8.
Mayo score ≤2 points, with no individual subscore >1.
Abnormal values for: CRP, >3 mg/L; fecal calprotectin, > 250 mg/kg; fecal lactoferrin, >7.24 μg/g.
Key: CRP, C-reactive protein; IQ, interquartile; I-8, induction Week 8; I-16, induction Week 16; IV, intravenous; IWRS, interactive web response system; q8w, every 8 weeks; q12w, every 12 weeks; SC, subcutaneous; SD, standard deviation; TNF, tumor necrosis factor; UC, ulcerative colitis.