The JADE Mono-2 study in adolescent and adult patients with atopic dermatitis (AD) investigated the efficacy and safety of abrocitinib. The results demonstrated significant advantages in clinical signs and symptoms over placebo [1,2].
The randomised, controlled, double-blind, phase 3 trial included 391 patients aged ≥12 years with moderate-to-severe AD from 115 centres worldwide and was presented by Dr Melinda Gooderham (Queen’s University and Probity Medical Research, Canada). Patients with prior dupilumab failure were not excluded from the trial. All participants had AD for ≥1 year, and topical medication had not been successful. The primary endpoints of the trial were the rate of patients reaching an Eczema Area and Severity Index (EASI) score of ≥75 at week 12, or an Investigator’s Global Assessment (IGA) of 0 or 1 (clear or almost clear skin) with an improvement of at least 2 grades. Secondary endpoints included a change in pruritus of at least 4 points improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) response and EASI 90. Participants were randomised 2:2:1 to receive either 200 mg abrocitinib, 100 mg abrocitinib, or placebo over 12 weeks and followed by a 4-week follow-up safety period.
Statistically significant and clinically relevant improvements compared with placebo were seen as early as week 2, which increased and stabilised by week 12. Patients taking abrocitinib reached the IGA endpoint more often: 38.1% (200 mg) and 28.4% (100 mg) versus 9.1% for placebo (P<0.0001 and P<0.05) (see Figure). Similar rates were observed for the proportion of patients achieving an EASI 75 response: 61.0% (200 mg) and 44.5% (100 mg) versus 10.4% (placebo) (P<0.0001 for both comparisons). More than one third of patients in the 200 mg group reached EASI 90 (37.7%).
Figure: Co-primary endpoints in the JADE MONO-2 study 
EASI, Eczema Area and Severity Index; FAS, full analysis set; IGA, Investigator’s Global Assessment; NRI, non-responder imputation.
*P<0.05 vs placebo.
**P<0.001 vs placebo.
Pruritus is often the symptom that bothers AD patients the most. Therefore, the PP-NRS response was also of great interest. Of patients treated with the higher dose, 55.3% responded with an improvement of ≥4 points in the PP-NRS compared with 45.2% treated with the lower dose and 11.5% in the placebo group (P<0.0001).
Regarding the safety of abrocitinib, discontinuation due to adverse events was required for 3.2% of patients in the 200 mg group, 3.8% in the 100 mg group, and 12.8% in the placebo group. Serious adverse events occurred in 1.3%, 3.2%, and 1.3% of the 200 mg, 100 mg, and the placebo group.
In conclusion, both doses of oral abrocitinib demonstrated substantial effectiveness in treating adolescent and adult patients with moderate-to severe AD while showing an acceptable safety profile.
Read our peer-reviewed Conference Report on the AAD2020 on the Medicom Conference Portal
- Silverberg JI, et al. Late-breaking Abstract, AAD Virtual Meeting Experience, 12-14 June 2020.
- Silverberg JI, et al. JAMA Dermatol. 2020 Jun 3. Doi:10.1001/jamadermatol.2020.1406.