Table 2.

Clinical studies of ustekinumab in additional indications: psoriatic arthritis (PsA), Crohn disease (CD) and multiple sclerosis (MS)

Indication	Study Design	Results	Reference	Clinical Trial
Psoriatic arthritis	Phase2	Doses Patients with PsA, who also had active plaque psoriasis were assigned to one of 2 groups: 1) 90 mg or 63 mg ustekinumab for the first 4 weeks, followed by placebo at weeks 12 and 16; 2) placebo for the first 4 weeks, followed by 63 mg ustekinumab at weeks 12 and 16. Patients were followed up until week 36.	At week 12, 42% of the patients in Group 1 achieved an ACR20 score, compared with 14% in Group 2. 25% and 11 % of Group 1 patients achieved ACR50 and ACR70, respectively, compared with 5% and 0% in Group 2. 52% of ustekinumab treated group achieved PASI 75, compared with 5% in the placebo group.	12	NCT00267 956
Crohn's Disease	Phase2a	Two populations of patients with a CDAI between 220–450 were enrolled. Population 1 had previously received conventional treatments. Patients were divided into 4 groups: 1) Weekly placebo between weeks 0–3, plus 90 mg ustekinumab (sc) between weeks 8–11; 2) Weekly ustekinumab (sc) between weeks 0–3, plus 90 mg placebo between weeks 8–11; 3) Placebo at week 0, then 4.5 mg/kg ustekinumab (iv) at week 8; 4) 4.5 mg/kg ustekinumab (iv) at week 0, then placebo at week 8. Population 2 consisted of non-responders to infliximab, who were given either 90 mg ustekinumab (sc) weekly between weeks 0–3 or 4.5 mg/kg ustekinumab (iv) at week 0.	Population 1: At weeks 4 and 6, 53% of combined ustekinumab treated patients (Groups 2 and 4) were in clinical response, compared with 30% in the placebo treated patients (Groups 1 and 3). At week 8, the proportion of patients with a complete clinical response in the combined ustekinumab group was 49% compared with 40% in the placebo qroup. Population 2: At weeks 2 and 4, 22% and 41 % of patients in the combined ustekinumab group were in clinical response, the proportion reached 48% by week 6. At week 8, the clinical response rates were 43% for Group 1 and 54% for Group 2.	14	NCT00265 122
	Phase2/3	Patients with a history of anti-TNF therapy will be assigned to one of 4 groups receiving intravenous injections of 1 mg/kg, 3mg/kg or 6mg/kg ustekinumab (iv) or placebo at the start of the study. Ustekinumab-treated groups will be re-randomized to receive placebo or 90 mg ustekinumab (sc) at weeks 8 and 16. The placebo group will be re-randomized to receive placebo at weeks 8 and 16, or 270 mg ustekinumab (sc) at week 8 followed by 90 mg at week 16. Patients will be followed up until week 36.	On-going (Currently recruiting participants)	N/A	NCT00771 667
Multiple Sclerosis	Phase2 (Discontinued)	Patients with relapsing-remitting MS were given 27, 90, 90q8w or 180 mg ustekinumab (sc) or placebo at weeks 0,1,2,3,7,11,15 and 19; 90q8w group received placebo at weeks 7 and 15.	Ustekinumab was well tolerated, but was not effective in decreasing the cumulative number of newly formed Gd-enhancing T1-weighted lesions in MS.	15	NCT00207 727