A Phase IIIb, Multicentre, Interventional, Randomised, Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Guselkumab for the Treatment of Nonpustular Palmoplantar Psoriasis (G-PLUS)

Table 3

Primary and other clinical and quality-of-life efficacy endpoints by visit through week 48 using multiple imputation and including nonresponse of discontinuations (full analysis set).

	Double-blind phase (week 16)		Open-label phase (week 24)		Open-label phase (week 48)
	Placebo	Guselkumab 100 mg q8w	Placebo-crossover	Guselkumab 100 mg q8w	Placebo-crossover	Guselkumab 100 mg q8w
ppPASI response
ppPASI75, n/N (%)	11/39 (28.2)	28/78 (35.9)	19/39 (48.7)	40/78 (51.3)	25/39 (64.1)	43/78 (55.1)
95% CI^†	15.55, 45.10	25.57, 47.62	32.71, 64.97	39.78, 62.66	47.15, 78.32	43.49, 66.26
ppPASI90, n/N (%)	6/39 (15.4)	19/78 (24.4)	8/39 (20.5)	28/78 (35.9)	16/39 (41.0)	30/78 (38.5)
95% CI^†	6.41, 31.21	15.65, 35.63	9.87, 36.94	25.57, 47.62	25.98, 57.81	27.87, 50.20
ppPASI100, n/N (%)	2/39 (5.1)	11/78 (14.1)	5/39 (12.8)	20/78 (25.6)	8/39 (20.5)	21/78 (26.9)
95% CI^†	0.89, 18.63	7.59, 24.26	4.82, 28.23	16.72, 37.00	9.87, 36.94	17.79, 38.36
ppIGA 0/1 response and ≥2-point reduction from baseline in ppIGA score, n/N (%)	6/39 (15.4)	27/78 (34.6)	9/39 (23.1)	28/78 (35.9)	19/39 (48.7)	33/78 (42.3)
95% CI^†	6.41, 31.21	24.44, 46.32	11.71, 39.72	25.57, 47.62	32.71, 64.97	31.37, 54.01
PASI response
PASI75, n/N (%)	10/39 (25.6)	23/78 (29.5)	15/39 (38.5)	35/78 (44.9)	22/39 (56.4)	42/78 (53.8)
95% CI^†	13.60, 42.43	19.97, 41.04	23.81, 55.35	33.74, 56.51	39.77, 71.81	42.24, 65.07
PASI90, n/N (%)	2/39 (5.1)	11/78 (14.1)	4/39 (10.3)	24/78 (30.8)	12/39 (30.8)	27/78 (34.6)
95% CI^†	0.89, 18.63	7.59, 24.26	3.34, 25.16	21.08, 42.38	17.55, 47.73	24.44, 46.32
PASI100, n/N (%)	1/39 (2.6)	7/78 (9.0)	3/39 (7.7)	16/78 (20.5)	6/39 (15.4)	15/78 (19.2)
95% CI^†	0.13, 15.08	3.99, 18.17	2.01, 21.97	12.53, 31.46	6.41, 31.21	11.51, 30.05
DLQI 0/1 score, n/N (%)	3/39 (7.7)	14/73 (19.2)	9/39 (23.1)	16/73 (21.9)	15/39 (38.5)	25/73 (34.2)
95% CI^†	2.01, 21.97	11.25, 30.42	11.71, 39.72	13.41, 33.42	23.81, 55.35	23.79, 46.37

^†95% CIs are based on Wilson with continuity correction. ppPASI75/90/100 response is defined as ≥75/90/100% improvement in the ppPASI score from the baseline. ppIGA response is defined as a ppIGA score of 0 (cleared) or 1 (almost clear/minimal) AND ≥ 2-grade reduction from the baseline in the IGA score. PASI75/90/100 response is defined as ≥75/90/100% improvement in PASI score from baseline. In the calculation of the ppPASI, the pustules score is considered 0 and the index has a maximum score of 48. CI, confidence interval; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; ppIGA, palmoplantar Investigator’s Global Assessment; ppPASI, palmoplantar PASI; q8w, every 8 weeks.