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氘可来昔替尼(Deucravacitinib)不良反应？
Adverse reactions in Deucravacitinib trials
The safety of (Deucravacitinib) was evaluated in two placebo- and active-controlled trials (PSO-1 and PSO-2) and in an open-label extension trial in which participants who completed PSO-1 or PSO-2 could be enrolled. In these clinical trials, a total of 1519 subjects with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy received deuterated colexitinib 6 mg orally once daily. Among them, 1141 subjects were exposed to deucravacitinib for at least 1 year.
In trials PSO-1 and PSO-2, 1681 subjects were randomized to receive deucravacitinib 6 mg (840 subjects), placebo (419 subjects), or apremilast 30 mg twice daily (422 subjects). All subjects were randomized to switch from placebo to deucravacitinib at week 16. All other subjects remained in their original treatment group until Week 24, at which time subjects could continue receiving the same treatment or switch to Deucravacitinib or placebo. The average age of the subjects was 47 years old. The majority of subjects were white (87%) and male (67%).
In the 16-week placebo-controlled period of the pooled clinical trials (PSO-1 and PSO-2), the incidence of treatment discontinuation was 2.4% of subjects receiving deucravacitinib compared with 3.8% of subjects receiving placebo.
Table 1 summarizes adverse reactions that occurred in at least 1% of subjects in the Deucravacitinib group and occurred at a higher rate than those in the placebo group during the 16-week control period.
Table 1: Adverse reactions that occurred in ≥1% of subjects with plaque psoriasis in trials PSO-1 and PSO-2 in the deucravacitinib group and were more frequent than in the placebo group by week 16.
|
Adverse reactions |
Deuterated colexitinib6 mg once daily N = 840 n (%) |
Placebo N = 419 n (%) |
|
Upper respiratory tract infection a |
161 (19.2) |
62 (14.8) |
|
Elevated blood creatine phosphokinase |
23 (2.7) |
5 (1.2) |
|
Herpes simplex b |
17 (2.0) |
1 (0.2) |
|
Oral ulcers c |
16 (1.9) |
0 (0.0) |
|
Folliculitis |
14 (1.7) |
0 (0.0) |
Acne d |
12 (1.4) |
1 (0.2) |
a Includes upper respiratory tract infections (viral, bacterial and unspecified), nasopharyngitis, pharyngitis (including viral, streptococcal and unspecified), sinusitis (including acute, viral, bacterial), rhinitis, rhinotracheitis, tracheitis, laryngitis and tonsillitis (including bacterial, streptococcal)
bIncludes oral herpes, genital herpes, herpes simplex, and herpes virus infections
c Including oral ulcers, aphthous ulcers, tongue ulcers and stomatitis
d Includes acne, cystic acne, and acneiform dermatitis
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