Table 1.

A summary of the main outcomes presented in Phase II and III trials comparing ustekinumab to placebo

Outcome measure	Study	Concurrent therapy	Treatment groups				P-values
			Placebo		Ustekinumab 63 or 90 mg
ACR 20 response	Gottlieb et al25	All patients	32/76 (42%)		10/70 (14%)		0.0002
			Placebo	Ustekinumab 45 mg	Ustekinumab 90 mg	Combined ustekinumab
	McInnes et al26	All patients	47/206 (22.8%)	87/205 (42.4%)	101/204 (49.5%)	188/409 (46.0%)	<0.0001 for all comparisons versus placebo
		With MTX treatment	25/96 (26.0%)	43/99 (43.4%)	46/101 (45.5%)	89/200 (44.5%)
		Without MTX treatment	22/110 (20.0%)	44/106 (41.5%)	55/103 (53.4%)	99/209 (47.4%)
	Ritchlin et al27	All patients	21/104 (20.2%)	45/103 (43.7%)	46/105 (43.8%)	91/208 (43.8%)	<0.001 for all comparisons versus placebo
		With MTX treatment	14/49 (28.6%)	27/54 (50.0%)	21/52 (40.4%)	48/106 (45.3%)
		Without MTX treatment	7/55 (12.7%)	18/49 (36.7%)	25/53 (47.2%)	43/102 (42.2%)
			Placebo		Ustekinumab 63 or 90 mg
PASI 75 response	Gottlieb et al25	All patients	3/55 (5%)		33/63 (52%)		<0.0001
			Placebo	Ustekinumab 45 mg	Ustekinumab 90 mg	Combined ustekinumab
	McInnes et al26	All patients	16/146 (11.0%)	83/145 (57.2%)	93/149 (62.4%)	176/294 (59.9%)	<0.0001 for all comparisons versus placebo
		With MTX treatment	10/66 (15.2%)	32/66 (48.5%)	38/69 (55.1%)	70/135 (51.9%)
		Without MTX treatment	6/80 (7.5%)	51/79 (64.6%)	55/80 (68.8%)	106/159 (66.7%)
	Ritchlin et al27	All patients	4/80 (5.0%)	41/80 (51.3%)	45/81 (55.6%)	86/161 (53.4%)	<0.001 for all comparisons versus placebo
		With MTX treatment	3/29 (10.3%)	19/39 (48.7%)	22/39 (56.4%)	41/78 (52.6%)
		Without MTX treatment	1/51 (2.0%)	22/41 (53.7%)	23/42 (54.8%)	45/83 (54.2%)

Abbreviations: ACR, American College of Rheumatology; PASI, Psoriasis Area and Severity Index; MTX, methotrexate.