TABLE 4.
Safety During Randomized Maintenance Period: Patients With Safety Events Per 100 Patient-Years of Follow-Up (Maintenance Week 0 Through Week 44; Phase 3 Studies Onlya)
| Ulcerative Colitis | Crohn’s Diseasec | Inflammatory Bowel Diseasec | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Ustekinumab | Ustekinumab | Ustekinumab | |||||||
| Placebo SCb | 90 mg SC 12qw | 90 mg SC 8qw | Placebo SCb | 90 mg SC 12qw | 90 mg SC 8qw | Placebo SCb | 90 mg SC 12qw | 90 mg SC 8qw | |
| Patients Treated | 175 | 172 | 176 | 133 | 132 | 131 | 308 | 304 | 307 |
| Average follow-up (weeks) | 42.30 | 41.80 | 42.20 | 31.96 | 36.73 | 35.21 | 37.84 | 39.60 | 39.22 |
| Patient-years of follow-up | 142 | 138 | 143 | 82 | 93 | 89 | 224 | 231 | 232 |
| Key Safety Events, Rate (N) | |||||||||
| Adverse events | 96.94 (138) | 86.07 (119) | 95.22 (136) | 135.77 (111) | 113.70 (106) | 120.65 (107) | 111.10 (249) | 97.20 (225) | 104.96 (243) |
| Serious adverse events | 11.94 (17) | 9.40 (13) | 10.50 (15) | 24.46 (20) | 17.16 (16) | 14.66 (13) | 16.51 (37) | 12.53 (29) | 12.09 (28) |
| Infectionsd | 56.90 (81) | 41.95 (58) | 60.21 (86) | 80.73 (66) | 66.50 (62) | 71.03 (63) | 65.59 (147) | 51.84 (120) | 64.36 (149) |
| Serious infectionsd | 2.81 (4) | 4.34 (6) | 2.10 (3) | 3.67 (3) | 7.51 (7) | 3.38 (3) | 3.12 (7) | 5.62 (13) | 2.59 (6) |
| Discontinuation due to adverse event | 14.05 (20) | 6.51 (9) | 3.50 (5) | 12.23 (10) | 10.73 (10) | 4.51 (4) | 13.39 (30) | 8.21 (19) | 3.89 (9) |
| Death | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) |
| Malignancies (excluding NMSC) | 0.00 (0) | 0.72 (1) | 0.70 (1) | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.00 (0) | 0.43 (1) | 0.43 (1) |
| ≥10 Adverse events occurring in any treatment group | |||||||||
| Nasopharyngitis | 19.67 | 22.42 | 18.20 | 12.23 | 18.23 | 15.79 | 16.96 | 20.74 | 17.28 |
| Upper respiratory tract infection | 5.62 | 3.62 | 11.20 | 25.69 | 9.65 | 14.66 | 12.94 | 6.05 | 12.53 |
| Abdominal pain | 2.81 | 4.34 | 5.60 | 20.79 | 12.87 | 12.40 | 9.37 | 7.78 | 8.21 |
| Ulcerative Colitis | 35.12 | 13.74 | 12.60 | 0.00 | 0.00 | 0.00 | 22.31 | 8.21 | 7.77 |
| Crohn’s disease | 0.00 | 0.00 | 0.00 | 23.24 | 17.16 | 18.04 | 8.48 | 6.91 | 6.91 |
| Diarrhea | 1.40 | 3.62 | 4.90 | 8.56 | 11.80 | 5.64 | 4.02 | 6.91 | 5.18 |
| Nausea | 2.81 | 2.89 | 4.20 | 11.01 | 10.73 | 4.51 | 5.80 | 6.05 | 4.32 |
| Vomiting | 4.21 | 0.72 | 1.40 | 11.01 | 5.36 | 4.51 | 6.69 | 2.59 | 2.59 |
| Arthralgia | 10.54 | 10.85 | 5.60 | 23.24 | 23.60 | 20.30 | 15.17 | 15.98 | 11.23 |
| Pyrexia | 4.92 | 0.72 | 6.30 | 13.45 | 11.80 | 10.15 | 8.03 | 5.18 | 7.77 |
| Headache | 4.92 | 7.96 | 12.60 | 18.35 | 16.09 | 16.91 | 9.82 | 11.23 | 14.25 |
Abbreviations: SC, subcutaneous; NMSC, non-melanoma skin cancer.
aUlcerative Colitis: CNTO1275UCO3001; Crohn’s disease: CNTO1275CRD3003.
bPatients who were in clinical response to ustekinumab IV induction dosing and were randomized to placebo SC on entry into this maintenance study.
cIncludes data up to the time of meeting loss of response criteria for patients who had a dose adjustment in Crohn’s disease.
dInfection as assessed by the investigator.