Table 2. Efficacy Outcomes at Week 60 and Week 108.
All ixekizumab populations at combined treatment perioda | ||
---|---|---|
Week 60 | Week 108 | |
Response, No./total No. of responders (%) | ||
PASI | ||
50 | 90/94 (95.7) | 89/94 (94.5) |
75 | 85/94 (90.0) | 86/94 (91.7) |
90 | 76/94 (80.3) | 74/94 (79.0) |
100 | 50/94 (53.2) | 52/94 (55.1) |
sPGA score | ||
0 or 1 | 75/94 (80.0) | 74/94 (78.3) |
0 | 51/94 (54.2) | 49/94 (52.4) |
Itch NRS score ≥4 | 58/70 (82.9) | 55/70 (78.5) |
CDLQI or DLQI 0 or 1b | 63/80 (67.0) | 57/75 (60.6) |
PatGA score 0 or 1 | 79/94 (83.9) | 79/94 (83.5) |
NAPSI = 0 | 18/28 (65.3) | 19/28 (68.1) |
PSSI = 0 | 61/83 (73.4) | 63/83 (76.2) |
PPASI 100b | 9/11 (81.8) | 9/10 (90.0) |
Clearance of genital psoriasisb | 24/27 (88.9) | 21/24 (87.5) |
Response, LSM change from baseline (SE) [NX]c | ||
PASI | −19.48 (0.4) [83] | −19.39 (0.4) [75]d |
Itch NRS score | −3.46 (0.6) [83] | −3.21 (0.6) [75]d |
NAPSI | −31.57 (2.3) [21] | −31.12 (2.2) [17]d |
PSSI | −26.75 (1.4) [72] | −27.02 (1.3) [68]d |
PPASI | −10.47 (0.1) [11] | −10.47 (0.1) [10]d |
Abbreviations: CDLQI, Children’s Dermatology Life Quality Index; DLQI, Dermatology Life Quality Index; LSM, Least Squares Mean; NAPSI, Nail Psoriasis Severity Index; NRS, Numeric Rating Scale; NX, No. of patients with data; PASI, Psoriasis Area and Severity Index; PatGA, Patient’s Global Assessment of Disease Severity; PPASI, Palmoplantar Psoriasis Area and Severity Index; PSSI, Psoriasis Scalp Severity Index; sPGA, static Physician’s Global Assessment.
All patients who were randomized to ixekizumab at week 0 (visit 2) and who received ixekizumab throughout their study participation. Missing data were imputed using modified nonresponder imputation, unless otherwise specified. For results imputed by modified nonresponders imputation, response rates were obtained through the average response rate of imputation data.
Observed data.
Continuous mixed model for repeated measures, a likelihood-based mixed-effects model, was used.
Significantly greater mean change from baseline at week 108 after ixekizumab treatment is denotated by P < .001.