Efficacy and safety of SHR0302, a highly selective Janus kinase 1 inhibitor, in patients with moderate to severe atopic dermatitis: A phase II randomized clinical trial
American Journal of Clinical Dermatology Aug 13, 2021
Zhao Y, Zhang L, Ding Y, et al. - In Chinese adult patients with moderate to severe atopic dermatitis, oral SHR0302 (a highly selective Janus kinase 1 inhibitor) was efficacious and well-tolerated.
One hundred five patients, aged 18 to 75 years, with moderate to severe dermatitis and nonresponsive or intolerant to topical or conventional systemic treatments were included in this randomized, double-blind, placebo-controlled, multicenter, phase II trial.
This trial was carried out in China between October 2019 and August 2020.
Study participants were randomly assigned in a ratio of 1:1:1 to obtain SHR0302 4 mg once daily, SHR0302 8 mg once daily, or placebo for 12 weeks.
At week 12, nine patients in the SHR0302 4 mg group, 19 patients in the SHR0302 8 mg group, and two patients in the placebo group had achieved IGA response.
In the SHR0302 4 mg, SHR0302 8 mg, and placebo groups, EASI75 was achieved in 51.4%, 74.3%, and 22.9% of patients, respectively, while an NRS ≥3-point improvement was achieved in 65.7%, 74.3%, and 22.9% of patients, respectively.
In the SHR0302 4 mg, SHR0302 8 mg, and placebo groups, respectively, 60.0%, 68.6%, and 51.4% of patients experienced treatment-emergent adverse events.
In most cases, the side effects were minor.
Three serious adverse events were documented, all of which were related to the worsening of atopic dermatitis.
There were no reports of serious infections.
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