Table 1.

Clinical studies of ustekinumab in psoriasis, psoriatic arthritis, Crohn’s disease, and multiple sclerosis

Study	Immune-mediated disease	Study design	Primary endpoint	Results
Krueger et al20	Psoriasis	Phase II randomized placebo-controlled study	PASI75 at week 12	Ustekinumab: 52%–81% Placebo: 2%
Leonardi et al21 (PHOENIX 1)	Psoriasis	Phase III, randomized, doubleblind, parallel-group, placebo-controlled study	PASI75 at week 12	Ustekinumab: 67% Placebo: 3%
Papp et al22 (PHOENIX 2)	Psoriasis	Phase III randomized, doubleblind, parallel-group, placebo-controlled study	PASI75 at week 12	Ustekinumab: 67%–76% Placebo: 4%
Griffiths et al23 (ACCEPT)	Psoriasis	Phase III head to head comparative study	PASI75 at week 12	Ustekinumab: 68%–74% Etanercept: 57%
Gottlieb et al25	Psoriatic arthritis	Phase II randomized, placebo crossover study	ACR20 at week 12	Group 1 (ustekinumab then placebo) versus group 2 (placebo then ustekinumab) 42% versus 14%
Sandborn et al31	Crohn’s disease	Phase II randomized, placebo crossover study	Clinical response according to CDAI at week 8	Ustekinumab: 49% Placebo: 40%
Sandborn et al32	Crohn’s disease	Phase III randomized, placebo-controlled study	Clinical response according to CDAI at week 6	Ustekinumab: 36%–39% Placebo: 23.5%
Segal et al35	Multiple sclerosis	Phase II randomized, placebo-controlled study	New gadolinium enhancing T1-weighted brain MRI lesions at week 23	No difference between any ustekinumab groups versus placebo

Abbreviations: ACR20, American College of Rheumatology 20% improvement criteria; CDAI, Crohn’s Disease Activity Index; MRI, magnetic resonance imaging; PASI75, a 75% reduction in the Psoriasis Area and Severity Index score.