Table 7.
Patients with one or more malignancies/100 PYs through year 1 in psoriasis, PsA, and CD studies
| Psoriasis | PsA | CD | All patients | |||||
|---|---|---|---|---|---|---|---|---|
| Comparatora | Ustekinumabb | Placeboc | Ustekinumabd | Placeboe | Ustekinumabf | Comparator | Ustekinumab | |
| Number of patients treated | 733 | 3117 | 379 | 1018 | 943 | 1749 | 2055 | 5884 |
| NMSC | ||||||||
| Total (median) PYs of follow-up | 182 (0.2) | 2558 (0.9) | 145 (0.4) | 849 (1.0) | 346 (0.2) | 1105 (0.6) | 673 (0.2) | 4512 (0.8) |
| Patients with event/incidence/100 PYs | 2/1.1 | 24/0.9 | 0/0.0 | 2/0.2 | 2/0.6 | 4/0.4 | 4/0.6 | 30/0.7 |
| 95% CIg | (0.1–4.0) | (0.6–1.4) | (0.0–2.1) | (0.0–0.9) | (0.1–2.1) | (0.1–0.9) | (0.2–1.5) | (0.5–1.0) |
| Malignancies excluding NMSC and in situ cervical cancer | ||||||||
| Total (median) PYs of follow-up | 182 (0.2) | 2563 (0.9) | 145 (0.4) | 849 (1.0) | 347 (0.2) | 1106 (0.6) | 674 (0.2) | 4519 (0.8) |
| Patients with event/incidence/100 PYs | 1/0.6 | 11/0.4 | 0/0.0 | 1/0.1 | 0/0.0 | 3/0.3 | 1/0.2 | 15/0.3 |
| 95% CIg | (0.0–3.1) | (0.2–0.8) | (0.0–2.1) | (0.0–0.7) | (0.0–0.9) | (0.1–0.8) | (0.0–0.8) | (0.2–0.6) |
| All malignancies | ||||||||
| Total (median) PYs of follow-up | 181 (0.2) | 2556 (0.9) | 145 (0.4) | 849 (1.0) | 346 (0.2) | 1105 (0.6) | 673 (0.2) | 4510 (0.8) |
| Patients with event/incidence/100 PYs | 3/1.7 | 35/1.4 | 0/0.0 | 3/0.4 | 2/0.6 | 7/0.6 | 5/0.7 | 45/1.0 |
| 95% CIg | (0.3–4.8) | (1.0–1.9) | (0.0–2.1) | (0.1–1.0) | (0.1–2.1) | (0.3–1.3) | (0.2–1.7) | (0.7–1.3) |
| Patients included in SEER analysish | 722 | 3033 | 373 | 1005 | 914 | 1689 | 2009 | 5727 |
| Total (median) PYs of follow-up | 179 (0.2) | 2497 (0.9) | 143 (0.5) | 839 (1.0) | 334 (0.2) | 1068 (0.6) | 656 (0.2) | 4403 (0.8) |
| Observed/expectedi patients with event | 1/1.0 | 10/13.2 | 0/0.9 | 1/4.9 | 0/1.2 | 2/3.6 | 1/3.0 | 13/21.7 |
| SIRj | 1.1 | 0.8 | 0.0 | 0.2 | 0.0 | 0.6 | 0.3 | 0.6 |
| SIR 95% CIg | (0.0–5.8) | (0.4–1.4) | (0.0–3.5) | (0.0–1.1) | (0.0–2.6) | (0.1–2.0) | (0.0–1.9) | (0.3–1.0) |
Psoriasis—phase II, PHOENIX-1, PHOENIX-2, ACCEPT (all through week 52); PsA—phase II (through week 36), PSUMMIT-1 (through week 52), PSUMMIT-2 (through week 60); CD—phase IIa (only controlled IV population in population 1; through week 28), CERTIFI (through week 36), UNITI-1 and UNITI-2 (through week 8 for patients who entered IM-UNITI; through week 20 for patients who did not enter IM-UNITI), IM-UNITI (through week 44)
CD Crohn’s disease, CI confidence interval, IV intravenous, NMSC non-melanoma skin cancer, PsA psoriatic arthritis, PYs patient-years, SEER Surveillance, Epidemiology, and End Results, SIR standardized incidence ratio
aIncludes data up to the time of crossover
bIncludes data from the first ustekinumab dose onward for patients who crossed over from placebo
cIncludes data up to the time of early escape or crossover
dIncludes data from the first ustekinumab dose onward for patients who escaped early or crossed over from placebo
eIncludes data up to the first ustekinumab dose for patients who were initially treated with placebo; includes data on or after 16 weeks from the first ustekinumab dose for patients who were initially treated with ustekinumab and were crossed over or re-randomized to placebo
fIncludes data up to 16 weeks from the first ustekinumab dose for patients who were crossed over or re-randomized to placebo
gCIs based on an exact method assuming that the observed number of events follows a Poisson distribution
hOnly patients of White, Black or African American, Asian, American Indian/Alaska Native, Native Hawaiian or other Pacific Islander race were included since SEER only contains incidence rates for these populations
iExpected number of patients with malignancies is based on the SEER database (year 2013), adjusted for age, sex, and race
jSIR determined as observed, divided by the expected numbers of patients with malignancies