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 2

Primary efficacy endpoint and major secondary efficacy endpoints during double-blind phase (week 16) based on the composite estimand strategy (full analysis set).

	Double-blind phase (week 16)
	Placebo	Guselkumab 100 mg q8w
Full analysis set	n = 39	n = 78
Primary efficacy endpoint
ppPASI75 response at week 16, n (%)	11 (28.2)	28 (35.9)
% Difference (95% CI)		7.7 (−11.5, 24.7)
value		0.533
Major secondary efficacy endpoints: changes from the baseline to week 16
ppPASI change from the baseline^†‡§
LS mean (95% CI)	−7.670 (−9.614, −5.727)	−6.713 (−8.083, −5.343)
LS mean difference (95% CI)		0.957 (−1.427, 3.341)
value		0.428
aPASI change from the baseline^†‡§
LS mean (95% CI)	−1.361 (−2.439, −0.283)	−2.924 (−3.686, −2.162)
LS mean difference (95% CI)		−1.563 (−2.884, −0.241)
p value		0.021
ppIGA change from the baseline^†‡§
LS mean (95% CI)	−0.865 (−1.244, −0.486)	−1.094 (−1.362, −0.826)
LS mean difference (95% CI)		−0.229 (−0.693, 0.235)
value		0.330
f-PGA change from the baseline^†‡§
LS mean (95% CI)	−0.300 (−0.629, 0.030)	−0.429 (−0.662, −0.197)
LS mean difference (95% CI)		−0.130 (−0.533, 0.274)
value		0.526
BSA change from the baseline^†‡§
LS mean (95% CI)	−1.076 (−2.247, 0.095)	−3.645 (−4.473, −2.817)
LS mean difference (95% CI)		−2.570 (−4.004, −1.135)
value		<0.001
DLQI change from the baseline^†‡§
LS mean (95% CI)	−3.892 (−6.034, −1.750)	−5.977 (−7.501, −4.453)
LS mean difference (95% CI)		−2.085 (−4.715, 0.545)
p value		0.119
ppQLI change from the baseline^†‡§
LS mean (95% CI)	−7.654 (−11.453, −3.855)	−9.417 (−12.099, −6.734)
LS mean difference (95% CI)		−1.763 (−6.421, 2.896)
value		0.455
EQ-5D-5L change from the baseline^†‡§
LS mean (95% CI)	0.128 (0.052, 0.203)	0.111 (0.057, 0.164)
LS mean difference (95% CI)		−0.017 (−0.109, 0.076)
value		0.718

^†The change from the baseline using observed data or 0 (no improvement) if a participant met treatment failure criteria prior to week 16. Participants with missing week 16 score are included with a score of “no improvement.” ^‡LS means and values are based on a mixed model for repeated measures under the missing at random assumption for missing data except for missing week 16 data. ^§95% CIs were based on the Chan–Zhang method for binary response efficacy endpoints. Note. Under the composite estimand strategy, treatment effects are assessed not only based on the variable measurements but also on intercurrent events defined in treatment failure criteria. The participant is assigned a score of no improvement for continuous variables if the participant meets any treatment failure criteria. ppPASI75 response is defined as ≥75% improvement in the ppPASI score from the baseline. In the calculation of ppPASI, the pustules score is considered 0 and the index has a maximum score of 48. aPASI, absolute Psoriasis Area and Severity Index; BSA, body surface area; CI, confidence interval; DLQI, Dermatology Life Quality Index; EQ-5D-5L, European Quality of Life, 5-Dimension, 5-Level; f-PGA, fingernail Physician’s Global Assessment; LS, least squares; ppIGA, palmoplantar Investigator’s Global Assessment; ppPASI, palmoplantar Psoriasis Area and Severity Index; ppQLI, palmoplantar Quality-of-Life Instrument; q8w, every 8 weeks.