Table 2.
Summary of baseline demographics, medical history, and concomitant medications and extent of exposure
| Psoriasis | PsA | CD | All patients | |
|---|---|---|---|---|
| Number of randomized patients, Na | 3219 | 1073 | 1988 | 6280 |
| Baseline demographics | ||||
| Age, years [mean (SD)] | 45.6 (12.37) | 47.6 (11.87) | 38.6 (12.73) | 43.7 (12.90) |
| Male [n (%)] | 2207 (68.6) | 560 (52.2) | 871 (43.8) | 3638 (57.9) |
| White [n (%)] | 2960 (92.0) | 1038 (96.8) | 1729 (87.0) | 5727 (91.2) |
| Weight, kg [mean (SD)] | 91.8 (22.15) | 89.4 (21.07) | 72.2 (19.64) | 85.2 (22.99) |
| BMI, kg/m2 [mean (SD)] | 30.9 (6.99) | 31.0 (7.13) | 25.0 (6.22) | 29.0 (7.32) |
| Medical history and current diagnoses, b [% (n/N)] | ||||
| Congestive heart failurec [% (n/N)] | 0.2 (5/2899) | 1.1 (12/1073) | 0.4 (7/1935) | 0.4 (24/5907) |
| Peripheral vascular diseasec [% (n/N)] | 1.2 (35/2899) | 3.4 (36/1073) | 1.5 (29/1935) | 1.7 (100/5907) |
| Transient ischemic attackc [% (n/N)] | 0.8 (24/2899) | 1.0 (11/1073) | 0.8 (15/1935) | 0.8 (50/5907) |
| Strokec [% (n/N)] | 0.6 (17/2899) | 1.4 (15/1073) | 0.7 (14/1935) | 0.8 (46/5907) |
| Ischemic heart/coronary artery disease [% (n/N)] | 3.9 (125/3219) | 5.7 (61/1073) | 2.3 (44/1935) | 3.7 (230/6227) |
| Hyperlipidemia [% (n/N)] | 20.2 (649/3219) | 17.6 (189/1073) | 5.8 (113/1935) | 15.3 (951/6227) |
| Hypertension [% (n/N)] | 27.5 (886/3219) | 38.1 (409/1073) | 13.6 (264/1935) | 25.0 (1559/6227) |
| Diabetes mellitus [% (n/N)] | 10.6 (342/3219) | 12.0 (129/1073) | 3.2 (61/1935) | 8.5 (532/6227) |
| Family history of early coronary artery diseasec [% (n/N)] | 11.7 (340/2899) | 8.7 (93/1073) | 7.3 (142/1935) | 9.7 (575/5907) |
| Current smokingc [% (n/N)] | 33.2 (963/2899) | 21.4 (230/1073) | 24.7 (491/1988) | 28.3 (1684/5960) |
| Prior biologic treatmentc [% (n/N)] | 33.1 (961/2899) | 20.5 (220/1073) | 77.5 (1499/1935) | 45.4 (2680/5907) |
| Baseline concomitant therapies [n (%)]d | ||||
| Corticosteroids | – | 146 (13.6) | 728 (36.6) | 874 (13.9) |
| Immunomodulators | – | 482 (44.9) | 605 (30.4) | 1087 (17.3) |
| 6-MP/AZAe | – | – | 456 (22.9) | 456 (7.3) |
| Methotrexate | – | 482 (44.9) | 155 (7.8) | 637 (10.1) |
| Corticosteroids + immunomodulators [n (%)] | – | 100 (9.3) | 201 (10.1) | 301 (4.8) |
| Extent of ustekinumab exposure f | ||||
| Ustekinumab-treated patients (N)g | 3117 | 1018 | 1749 | 5884 |
| Ustekinumab exposure [n (%)] | ||||
| Single IVh | 0 | 0 | 1664 (95.1) | – |
| At least 6 monthsi | 2413 (77.4) | 842 (82.7) | 849 (48.5) | – |
| At least 1 yearj | 1142 (36.6) | 527 (51.8) | 464 (26.5) | – |
| Mean weeks of treatment | 26.5 | 27.7 | 19.5k | 24.6 |
| Total dose, mg [mean (SD)] | 270.4 (122.38) | 264.5 (126.34) | 432.1 (243.86) | 317.4 (184.2) |
6-MP 6-mercaptopurine, AZA azathioprine, BMI body mass index, CD Crohn’s disease, IV intravenous, PsA psoriatic arthritis, SD standard deviation
aPsoriasis: phase II, PHOENIX-1, PHOENIX-2, ACCEPT (immunomodulators and corticosteroids prohibited); PsA: phase II, PSUMMIT-1, PSUMMIT-2; CD: phase IIa (only placebo-controlled IV population), CERTIFI, UNITI-1, UNITI-2, IM-UNITI
bNot collected in CERTIFI (smoking information was collected)
cNot collected in the psoriasis phase II trial
dCorticosteroids and immunomodulators are prohibited medications for psoriasis
eNot collected in PsA studies
fCrossover patients were included in the ustekinumab columns after crossover to ustekinumab
gPsoriasis—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 placebo-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)
hOnly for CD studies
iThe duration between the first and last ustekinumab administrations was ≥ 14 weeks
jThe duration between the first and last ustekinumab administrations was ≥ 38 weeks
kIncludes periods of placebo treatment among some ustekinumab responders who were re-randomized to placebo at maintenance and subsequently resumed ustekinumab treatment following loss of response