Stelara: how long were the pivotal tox studies?

“CNTO 1275 (STELARA, ustekinumab) was dosed SC twice weekly to 3 dose groups of cynomolgus monkeys of 8/sex/group at doses of 22.5 or 45 mg/kg for 13 or 26 weeks.”

“Repeat-dose toxicity studies showed that CNTO 1275 (STELARA, ustekinumab) is generally well tolerated following IV doses up to 45 mg/kg/week for up to 1 month (Studies T-099-003 and T-099-004), and following twice-weekly SC doses up to 45 mg/kg for 6 months (Study T-2001-004).”

“Repeat-dose toxicity studies showed that CNTO 1275 (STELARA, ustekinumab) is generally well tolerated following IV doses up to 45 mg/kg/week for up to 1 month (Studies T-099-003 and T-099-004), and following twice-weekly SC doses up to 45 mg/kg for 6 months (Study T-2001-004).”