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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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