Table 4.
Brodalumab | |||||
---|---|---|---|---|---|
Q2W | Q4W | ||||
Placebo (n = 38) | 70 mg (n = 39) | 140 mg (n = 39) | 210 mg (n = 40) | 280 mg (n = 42) | |
Proportion of subjects with Psoriasis Symptom Inventory total score = 0 | |||||
Baseline | |||||
n/N (%) | 0/33 (0) | 0/37 (0) | 0/37 (0) | 0/39 (0) | 0/42 (0) |
P-value | N/A | N/A | N/A | N/A | |
Week 2 | |||||
n/N (%) | 0/34 (0) | 4/38 (10) | 2/36 (6) | 4/38 (10) | 6/41 (15) |
P-value | 0·047 | 0·154 | 0·043 | 0·020 | |
Week 4 | |||||
n/N (%) | 0/37 (0) | 2/38 (5) | 6/39 (15) | 14/40 (35) | 9/41 (22) |
P-value | 0·161 | 0·012 | < 0·0001 | 0·002 | |
Week 8 | |||||
n/N (%) | 0/37 (0) | 6/38 (16) | 17/39 (44) | 20/40 (50) | 7/41 (17) |
P-value | 0·012 | < 0·0001 | < 0·0001 | 0·007 | |
Week 12 | |||||
n/N (%) | 0/37 (0) | 7/38 (18) | 16/39 (41) | 22/40 (55) | 13/41 (32) |
P-value | 0·006 | < 0·0001 | < 0·0001 | 0·0001 | |
Proportion of subjects with DLQI total score = 0 | |||||
Baseline | |||||
n/N (%) | 0/37 (0) | 0/37 (0) | 0/39 (0) | 0/40 (0) | 1/42 (2) |
P-value | N/A | N/A | N/A | 0·341 | |
Week 4 | |||||
n/N (%) | 0/36 (0) | 3/38 (8) | 8/39 (20) | 14/39 (36) | 8/40 (20) |
P-value | 0·088 | 0·004 | < 0·0001 | 0·004 | |
Week 8 | |||||
n/N (%) | 0/37 (0) | 5/38 (13) | 17/39 (44) | 21/40 (52) | 10/41 (24) |
P-value | 0·023 | < 0·0001 | < 0·0001 | 0·0009 | |
Week 12 | |||||
n/N (%) | 0/37 (0) | 6/38 (16) | 18/39 (46) | 23/40 (58) | 14/41 (34) |
P-value | 0·012 | < 0·0001 | < 0·0001 | < 0·0001 | |
Proportion of subjects with DLQI total score = 0/1 | |||||
Baseline | |||||
n/N (%) | 0/37 (0) | 0/37 (0) | 2/39 (5) | 0/40 (0·0) | 2/42 (5) |
P-value | N/A | 0·161 | N/A | 0·175 | |
Week 4 | |||||
n/N (%) | 2/36 (6) | 8/38 (21) | 14/39 (36) | 22/39 (72) | 12/40 (30) |
P-value | 0·054 | 0·002 | < 0·0001 | 0·006 | |
Week 8 | |||||
n/N (%) | 2/37 (5) | 9/38 (24) | 24/39 (62) | 29/40 (72) | 18/41 (44) |
P-value | 0·026 | < 0·0001 | < 0·0001 | < 0·0001 | |
Week 12 | |||||
n/N (%) | 2/37 (5) | 10/38 (26) | 25/39 (64) | 29/40 (72) | 23/41 (56) |
P-value | 0·015 | < 0·0001 | < 0·0001 | < 0·0001 |
P-value is based on Cochran–Mantel–Haenszel test stratified by body mass index group (≤ 35, > 35) and is for comparison between each brodalumab group and placebo without multiplicity adjustment; last observation carried forward was used to impute missing data. N/A, not applicable; Q2W, every 2 weeks; Q4W, every 4 weeks.