According to the findings of phase II randomized clinical trial, people having moderate to severe atopic dermatitis attain considerable improvements in clinical symptoms, including pruritus, and improvement of skin lesions after oral administration of SHR0302 4 mg and 8 mg. Yan Zhao et al. and other researchers undertook this analysis for exploring safety and efficacy of SHR0302 (an oral and highly selective Janus kinase 1 inhibitor) for the management of dermatitis.

This placebo-controlled, double-blind, and multicenter study incorporated 105 Chinese adults having atopic dermatitis and who were intolerant or nonresponsive to conventional or topical systemic therapies. Participants (age 18-75 years) were randomized to receive SHR0302 4 mg once daily (n=35), SHR0302 8 mg once daily (n=35), or placebo (n=35) for twelve weeks.

The percentage of people attaining Investigator's Global Assessment (IGA) response (IGA of 0 or 1 [clear or almost clear] with an improvement of ≥2 grades) at 12th week was the major outcome ascertained. The secondary outcomes ascertained were pruritus numerical rating scale (NRS), and Eczema Area and Severity Index (EASI).

Table 1 denotes the percentage of people reporting IGA response at Week 12, EASI75, NRS ≥3-point improvement, and treatment-emergent adverse events.

The overall efficacy of SHR0302 at both 8 mg and 4 mg doses showed superiority to placebo, with the 8 mg dose demonstrating higher efficacy when compared to the 4 mg group. In majority of cases, there were mild adverse events. Notably, 3 severe noxious events were reported, all being deterioration of atopic dermatitis. There were no serious infections observed. Thus, orally administered SHR0302 (4 mg and 8 mg) seems beneficial for managing atopic dermatitis patients.