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氘可来昔替尼(Deucravacitinib)治疗银屑病的效果如何？
The efficacy and safety of SOTYKTU 6 mg once daily were evaluated in two multicenter, randomized, double-blind, placebo- and active-controlled clinical trials, PSO-1 (NCT03624127) and PSO-2 (NCT03611751), in subjects 18 years and older with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Subjects had ≥10% body surface area (BSA) involvement and Psoriasis Area and Severity Index (PASI) score
≥12 and static physician global assessment (sPGA) ≥3 (moderate or severe).
In PSO-1 and PSO-2, efficacy was evaluated in 1,684 subjects who were randomly assigned to deucravacitinib (6 mg orally once daily), placebo, or apremilast (30 mg orally twice daily).
Results: Across both trials, the average age was 47 years, the average weight was 91 kg, 67% of subjects were male, 13% were Hispanic or Latino, 87% were white, 2% were black, and 10% were Asian. At baseline, subjects had a median affected BSA of 20% and a median PASI score of 19. The proportions of subjects with baseline sPGA scores of 3 (moderate) and 4 (severe) were 80% and 20%, respectively. About 18% of the subjects had a history of psoriatic arthritis.
In both trials, 40% of subjects had received prior phototherapy, 42% had not received any systemic therapy (including biologic and/or nonbiologic therapy), 41% had previously received nonbiologic systemic therapy, and 35% had previously received biologic therapy.
Table 1 presents the efficacy results of (Deucravacitinib) compared with apremilast and placebo in PSO-1. Table 2 presents the efficacy results in PSO-2.
Table 1: Efficacy Results in Adult Patients with Moderate to Severe Plaque Psoriasis PSO-1 (NRI a)
|
Endpoint |
SOTYKTUDeuterated colexitinib(N = 330)N(%) |
Placebo (N = 166)N(%) |
Aprester (N = 168) n (%) |
Difference, % (95%CI)b |
|
|
Differences from Placebo |
Differences from Aprester |
||||
|
sPGA response is 0/1 (clear or almost clear) |
|||||
|
Week 16 c |
178 (54) |
12 (7) |
54 (32) |
47 (40, 53) |
22 (13, 30) |
|
Week 24 |
194 (59) |
- |
52 (31) |
- |
27 (19, 36) |
|
sPGA response is 0 |
|||||
|
Week 16 |
58 (18) |
1 (1) |
8 (5) |
17 (13, 21) |
13 (8, 18) |
|
PASI 75 response |
|
|
|||
|
Week 16 c |
193 (58) |
21 (13) |
59 (35) |
46 (39, 53) |
23 (14, 32) |
|
Week 24 |
228(69) |
- |
64 (38) |
- |
31 (22, 40) |
|
PASI 90 response |
|||||
|
Week 16 |
118 (36) |
7 (4) |
33 (20) |
32 (26, 38) |
16 (8, 24) |
|
Week 24 |
140 (42) |
- |
37 (22) |
- |
20 (12, 28) |
|
PASI 100 response |
|||||
|
Week 16 |
47 (14) |
1 (1) |
- |
14 (10, 18) |
- |
|
ss-PGA response is 0/1 (scalp)d |
(N = 209) |
(N = 121) |
(N = 110) |
|
|
|
Week 16 |
147 (70) |
21 (17) |
43 (39) |
53 (44, 62) |
30 (19, 41) |
CI = confidence interval; PASI = Psoriasis Area and Severity Index; sPGA = static physician global assessment; ss-
PGA = Scalp Specific Physician Global Assessment
aNRI = non-responder imputation
b Adjusted differences in proportions are the weighted average of treatment differences by region, weight, and previous biologic use with Cochran-Mantel-Haenszel weights.
c Co-primary endpoint comparing Deucravacitinib with placebo
d Only included subjects with baseline ss-PGA score ≥3
Table 2: Efficacy Results in Adult Patients with Moderate to Severe Plaque Psoriasis (NRI a), PSO-2 Medium
|
Endpoint |
Deuterated colexitinib(N = 511) n (%) |
Placebo (N = 255) n (%) |
Aprester (N = 254) n (%) |
Difference, % (95%CI)b |
|
|
Differences from Placebo |
Differences from Aprester |
||||
|
sPGA response is 0/1 (clear or almost clear) |
|||||
|
Week 16 c |
253 (50) |
22 (9) |
86 (34) |
41 (35, 46) |
16 (9, 23) |
|
Week 24 |
251 (49) |
- |
75 (30) |
- |
20 (13, 27) |
|
sPGA response is 0 |
|||||
|
Week 16 |
80 (16) |
3 (1) |
16 (6) |
14 (11, 18) |
9 (5, 14) |
|
PASI 75 response |
|||||
|
Week 16 c |
271 (53) |
24 (9) |
101 (40) |
44 (38, 49) |
13 (6, 21) |
|
Week 24 |
296 (58) |
- |
96 (38) |
- |
20 (13, 27) |
|
PASI 90 response |
|||||
|
Week 16 |
138 (27) |
7 (3) |
46 (18) |
24 (20, 29) |
9 (3, 15) |
|
Week 24 |
164 (32) |
- |
50 (20) |
- |
13 (6, 19) |
|
PASI 100 response |
|||||
|
Week 16 |
52 (10%) |
3 (1) |
- |
9 (6, 12) |
- |
|
ss-PGA response is 0/1 (scalp)d |
(N = 305) |
(N = 173) |
(N = 166) |
|
|
|
Week 16 |
182 (60) |
30 (17) |
61 (37) |
42 (34, 50) |
23 (14, 33) |
CI = confidence interval; PASI = Psoriasis Area and Severity Index; sPGA = static physician global assessment; ss-
PGA = Scalp Specific Physician Global Assessment
aNRI = non-responder imputation
b Adjusted differences in proportions are the weighted average of treatment differences by region, weight, and previous biologic use with Cochran-Mantel-Haenszel weights.
c Co-primary endpoint comparing Deucravacitinib with placebo
d Only included subjects with baseline ss-PGA score ≥3
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