Table 5.
Key safety events/100 PYS of follow-up through year 1 in PsA and CD studies, by baseline MTX and CS use
| PsA | CD | PsA and CD combined | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placeboa | Ustekinumabb | Placeboc | Ustekinumabd | Placebo | Ustekinumab | |||||||
| +MTX | −MTX | +MTX | −MTX | +MTX | −MTX | +MTX | −MTX | +MTX | −MTX | +MTX | −MTX | |
| Number of patients treated | 160 | 219 | 465 | 553 | 76 | 867 | 139 | 1610 | 236 | 1086 | 604 | 2163 |
| Mean weeks of follow-up | 20.78 | 19.25 | 44.28 | 42.65 | 17.16 | 19.29 | 33.36 | 32.84 | 19.62 | 19.28 | 41.77 | 35.35 |
| Mean weeks of treatment | 13.93 | 10.51 | 29.32 | 26.25 | 7.23 | 10.08 | 19.67 | 18.72 | 12.02 | 10.18 | 27.10 | 20.65 |
| D/C study drug due to AEs [n (%)] | 8 (5.0) | 14 (6.4) | 16 (3.4) | 15 (2.7) | 3 (3.9) | 42 (4.8) | 9 (6.5) | 99 (6.1) | 11 (4.7) | 56 (5.2) | 25 (4.1) | 114 (5.3) |
| PYs of follow-up | 64 | 81 | 396 | 454 | 25 | 322 | 89 | 1017 | 89 | 403 | 485 | 1470 |
| Event rate/100 PYS | ||||||||||||
| AEs | 381.5 | 313.3 | 255.6 | 253.1 | 849.5 | 701.5 | 647.0 | 641.2 | 513.3 | 632.3 | 327.5 | 521.5 |
| 95% CIe | 335.2–432.5 | 276.0–354.3 | 240.1–271.8 | 238.7–268.2 | 739.2–971.5 | 672.8–731.0 | 595.2–702.0 | 625.7–656.9 | 467.3–562.6 | 599.2–648.2 | 311.6–344.0 | 509.9–533.3 |
| SAEs | 20.3 | 8.6 | 6.8 | 11.5 | 79.8 | 41.0 | 40.4 | 34.9 | 37.1 | 34.5 | 13.0 | 27.7 |
| 95% CIe | 10.8–34.8 | 3.5–17.8 | 4.5–9.9 | 8.6–15.0 | 48.7–123.2 | 34.3–48.7 | 28.3–55.9 | 31.4–38.7 | 25.5–52.1 | 29.0–40.8 | 10.0–16.6 | 25.1–30.5 |
| Infectionsf | 104.8 | 101.2 | 82.3 | 74.3 | 139.6 | 145.5 | 137.9 | 133.6 | 114.6 | 136.6 | 92.5 | 115.3 |
| 95% CIe | 81.2–133.1 | 80.5–125.6 | 73.6–91.8 | 66.6–82.7 | 97.2–194.1 | 132.6–159.3 | 114.6–164.6 | 126.6–140.9 | 93.4–139.1 | 125.4–148.5 | 84.2–101.5 | 109.9–121.0 |
| Serious infectionsf | 1.6 | 0.0 | 0.0 | 1.8 | 16.0 | 6.2 | 13.5 | 5.8 | 5.6 | 5.0 | 2.5 | 4.6 |
| 95% CIh | 0.0–8.7 | 0.0–3.7 | 0.0–0.8 | 0.8–3.5.5 | 4.4–40.9 | 3.8–9.6 | 7.0–23.5 | 4.4–7.5 | 1.8–13.1 | 3.0–7.7 | 1.3–4.3 | 3.5–5.8 |
| Adjudicated serious MACE | 0.0 | 1.2 | 0.3 | 1.1 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.3 | 0.2 | 0.4 |
| 95% CIe | 0.0–4.7 | 0.0–6.9 | 0.0–1.4 | 0.4–2.6 | 0.0–12.0 | 0.0–0.9 | 0.0–3.4 | 0.0–0.6 | 0.0–3.4 | 0.0–1.4 | 0.0–1.2 | 0.2–0.9 |
| Deaths | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| 95% CIe | 0.0–4.7 | 0.0–3.7 | 0.0–0.8 | 0.0–0.7 | 0.0–12.0 | 0.0–0.9 | 0.0–3.4 | 0.0–0.3 | 0.0–3.4 | 0.0–0.7 | 0.0–0.6 | 0.0–0.2 |
| Malignancies (excluding NMSC) | 0.0 | 0.0 | 0.0 | 0.2 | 0.0 | 0.0 | 0.0 | 0.4 | 0.0 | 0.0 | 0.0 | 0.3 |
| 95% CIe | 0.0–4.7 | 0.0–3.7 | 0.0–0.8 | 0.0–1.2 | 0.0–12.0 | 0.0–0.9 | 0.0–3.4 | 0.1–1.0 | 0.0–3.4 | 0.0–0.7 | 0.0–0.6 | 0.1–0.8 |
| PsA | CD | PsA and CD combined | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placeboa | Ustekinumabb | Placeboc | Ustekinumabd | Placebo | Ustekinumab | |||||||
| +CS | −CS | +CS | −CS | +CS | −CS | +CS | −CS | +CS | −CS | +CS | −CS | |
| Number of patients treated | 45 | 334 | 141 | 877 | 351 | 592 | 643 | 1106 | 396 | 926 | 784 | 1983 |
| Mean weeks of follow-up | 21.17 | 19.73 | 43.71 | 43.35 | 18.86 | 19.27 | 32.69 | 33.00 | 19.12 | 19.44 | 34.67 | 37.58 |
| Mean weeks of treatment | 13.76 | 11.72 | 29.84 | 27.30 | 9.46 | 10.10 | 18.32 | 19.07 | 10.02 | 10.72 | 20.39 | 22.71 |
| D/C study drug due to AEs [n (%)] | 3 (6.7) | 19 (5.7) | 7 (5.0) | 24 (2.7) | 17 (4.8) | 28 (4.7) | 48 (7.5) | 60 (5.4) | 20 (5.1) | 47 (5.1) | 55 (7.0) | 84 (4.2) |
| PYs of follow-up | 18 | 127 | 119 | 731 | 127 | 219 | 404 | 702 | 146 | 346 | 523 | 1,433 |
| Event rate/100 PYs | ||||||||||||
| AEs | 185.6 | 366.2 | 210.1 | 261.4 | 706.2 | 715.6 | 646.5 | 638.8 | 640.7 | 587.7 | 547.5 | 446.3 |
| 95% CIe | 128.5–259.4 | 333.7–401.1 | 184.8–237.9 | 249.8–273.4 | 660.8–754.0 | 680.6–751.9 | 621.9–671.7 | 620.3–657.8 | 600.3–683.2 | 562.4–613.8 | 527.7–568.0 | 435.4–457.4 |
| SAEs | 10.9 | 14.2 | 7.6 | 9.6 | 47.9 | 41.5 | 39.1 | 33.2 | 43.3 | 31.5 | 32.0 | 21.2 |
| 95% CIe | 1.3–39.4 | 8.4–22.5 | 3.5–14.4 | 7.5–12.1 | 36.7–61.6 | 33.4–50.9 | 33.2–45.7 | 29.1–37.7 | 33.3–55.4 | 25.9–38.0 | 27.3–37.2 | 18.8–23.7 |
| Infectionsf | 49.1 | 110.5 | 52.3 | 82.2 | 157.1 | 138.1 | 135.1 | 133.4 | 143.5 | 128.0 | 116.3 | 107.3 |
| 95% CIe | 22.5–93.3 | 93.0–130.4 | 40.1–67.1 | 75.8–89.1 | 136.1–180.5 | 123.0–154.6 | 124.0–146.9 | 124.9–142.2 | 124.7–164.4 | 116.4–140.5 | 107.3–125.9 | 102.0–112.8 |
| Serious infectionsf | 0.0 | 0.8 | 0.8 | 1.0 | 8.6 | 5.9 | 6.4 | 6.4 | 7.6 | 4.1 | 5.2 | 3.6 |
| 95% CIe | 0.0–16.4 | 0.0–4.4 | 0.0–4.7 | 0.4–2.0 | 4.3–15.5 | 3.2–10.1 | 4.2–9.4 | 4.7–8.6 | 3.8–13.5 | 2.2–6.8 | 3.4–7.5 | 2.7–4.8 |
| Adjudicated serious MACE | 0.0 | 0.8 | 0.8 | 0.7 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.3 | 0.2 | 0.4 |
| 95% CIe | 0.0–16.4 | 0.0–4.4 | 0.0–4.7 | 0.2–1.6 | 0.0–2.4 | 0.0–1.4 | 0.0–0.7 | 0.0–0.8 | 0.0–2.1 | 0.0–1.6 | 0.0–1.1 | 0.2–0.9 |
| Deaths | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| 95% CIe | 0.0–16.4 | 0.0–2.4 | 0.0–2.5 | 0.0–0.4 | 0.0–2.4 | 0.0–1.4 | 0.0–0.7 | 0.0–0.4 | 0.0–2.1 | 0.0–0.9 | 0.0–0.6 | 0.0–0.2 |
| Malignancies (excluding NMSC) | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | 0.0 | 0.6 | 0.0 | 0.0 | 0.0 | 0.4 |
| 95% CIe | 0.0–16.4 | 0.0–2.4 | 0.0–2.5 | 0.0–0.8 | 0.0–2.4 | 0.0–1.4 | 0.0–0.7 | 0.2–1.5 | 0.0–2.1 | 0.0–0.9 | 0.0–0.6 | 0.1–0.8 |
PsA—phase II (through week 36), PSUMMIT-1 (through week 52), PSUMMIT-2 (through week 60); CD—phase II (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)
AEs adverse events, CD Crohn’s disease, CI confidence interval, CS corticosteroid, D/C discontinuation, IV intravenous, MACE major adverse cardiovascular event, MTX methotrexate, NMSC non-melanoma skin cancer, PsA psoriatic arthritis, PYs patient-years, SAEs serious adverse events
aIncludes data up to the time of early escape or crossover
bIncludes data from the first ustekinumab dose onward for patients who escaped early or crossed over from placebo
cIncludes 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
dIncludes data up to 16 weeks from the first ustekinumab dose for patients who were crossed over or re-randomized to placebo
eCIs based on an exact method assuming that the observed number of events follows a Poisson distribution
fInfection as assessed by the investigator