Atopic dermatitis is a chronic, inflammatory illness that puts sufferers and carers under a lot of stress. SHR0302 is a Janus kinase 1 inhibitor that is being studied for inflammatory skin conditions. It is an oral, highly selective inhibitor. For a review, researchers had to determine how well SHR0302 worked and how safe it was in Chinese patients with moderate to severe atopic dermatitis. Between October 2019 and August 2020, a multicenter, randomized, double-blind, placebo-controlled phase II study was undertaken in China. Patients with moderate to severe dermatitis who were unresponsive or intolerant to topical or conventional systemic therapies (n = 105) were included in the study. For 12 weeks, patients were randomly randomized to receive SHR0302 4 mg once daily, SHR0302 8 mg once daily, or placebo in a 1:1:1 ratio. The proportion of patients who achieved an Investigator’s Global Assessment (IGA) response (IGA of 0 [clear] or 1 [nearly clear] with a 2-grade improvement) at week 12 was the main efficacy goal. Eczema Area and Severity Index (EASI) and pruritus Numerical Rating Scale (NRS) scores were used as secondary effectiveness measures.
Nine patients (25.7% ; 90% confidence interval [CI] 13.6–37.9%; P= 0.022) in the SHR0302 4 mg group, 19 patients (54.3%; 90% CI: 40.4–68.1%; P <0.001) in the SHR0302 8 mg group, and two patients (5.7%; 90% CI 0.0–12.2%) in the placebo group achieved IGA response at week 12. In the SHR0302 4 mg, SHR0302 8 mg, and placebo groups, EASI75 was achieved in 51.4% (P = 0.013), 74.3% (P < 0.001), and 22.9% of patients, respectively, while an NRS 3-point improvement was seen in 65.7% (P <0.001), 74.3% (P <0.001), 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 had treatment-emergent adverse events. In most cases, the side effects were minor. There were three major side effects documented, all of which were a worsening of atopic dermatitis. There were no significant infections recorded.
In adult patients with moderate to severe atopic dermatitis, oral SHR0302 was efficacious and well-tolerated.