A	B	C
1	Main
2		Brand Name	Stelara, fka CNTO 1275
3		Generic Name	ustekinumab
4		Mechanism	Anti-IL-12/23 antibody. Mab to p40 sub-unit of IL-12 and IL-23.
5		Administration	Subcutaneous q3m, IV
6		Indication	Psoriasis, Crohn's Disease, Ulcerative Colitis
7			Ulcerative colitis (positive CHMP opinion 7/26/19), 2.6m UC in Europe.
8		IP	NCE antibody. 7,491,391 and 7,479.479 issued in 2009. Late 2023 "LOE" -- Wolk
9			SB17 biosimilar, Alvotech/Stada, Fresenius/Formycon, Dong-A, Amgen
10		Economics	MEDX antibody, low single digit royalty?
11		Efficacy	Superior to previous market leader Enbrel.
12		Side Effects	Theoretical cancer concern.
13		Timeline	9/25/2009: FDA approval on 11/28/2007 BLA. 1/23/09: EU approval.
14		Competition	briakinumab/ABT-874 same mechanism of action, but withdrawn from registration
15			Skyrizi (risankizumab) IL-23A mab
16			Taltz (ixekizumab) IL-17A mab
17		Clinical Studies
18			Phase III "UNIFI-I" ulcerative colitis induction - ACGA meeting 2018
19			IV dosing
20			Beat placebo on clinical remission
21			62% clinical response vs. 31% for placebo at 8 weeks
22
23			Phase III "UNIFI-M" ulcerative colitis maintenance - 14th Congress of European Crohn's & Colitis Organization (2019)
24			44-week maintenance trial from IV induction responders
25			q8w, q12w, placebo by subcutaneous
26			57.4%, 48.3% vs. 35.4% for placebo had Mayo remission
27
28			Phase III ACCEPT vs Enbrel
29			68%-74% PASI 75% vs 57% for Enbrel p<0.001. q6w dosing.
30			15% injection site reactions for Enbrel vs 1% for Stelara.
31
32			Phase III PHOENIX I - AAD 2008 presentation
33			87%/91% on 45mg/90mg maintained PASI 75% at 52 weeks.
34			64%/62% had PASI 75% at 52 weeks after having discontinued at 40wks
35
36			Psoriatic arthritis study not successful? --Leerink
37
38			Phase II/III n=500 Crohn's
39
40
41			Phase II Sarcoidosis