- Szepietowski J. Efficacy and safety of ruxolitinib cream among patients aged ≥65 years with atopic dermatitis: pooled results from two phase 3 studies. Presentation ID FC01.01, EADV Congress 2021, 29 Sept–2 Oct.
The results of the phase 2 trials TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) demonstrated sustained action of ruxolitinib cream on inflammation and itch in AD compared with a vehicle with a good tolerance profile. The studies tested ruxolitinib 0.75% and 1.5% cream versus vehicle with the primary endpoint of treatment success in the IGA-TS defined as a score 0/1 with at least 2 grades of improvement from baseline.
“Published literature describing patients with AD 65 years and older is limited,” said Prof. Jacek Szepietowksi (Wroclaw Medical University, Poland). Thus, Prof. Szepietowksi and collegues assessed the efficacy and safety of the topical JAK1/ JAK2 inhibitor ruxolitinib in this patient population at week 8 with pooled data of the ≥65-year old patients from TRuE-AD1 and 2.
Among the 1,249 participants (aged 12–85 years), 115 (9.2%) were included in the presented analysis. The median age of this older cohort was 70 years and 55.7% were women. The clinical characteristics showed a mean baseline Eczema Area and Severity Index (EASI) score of 7.7 and IGA of 3 in 73% of patients. Prof. Szepietowksi added that “70% of patients had an itch numeric rating scale (NRS) score of at least 4 and the median duration of AD was 20 years indicating long-standing disease.”
The primary endpoint of IGA-TS was achieved by 60.5% in the 1.5% ruxolitinib cream arm, which was statistical significantly more than the 15.4% receiving vehicle (P<0.001). The 0.75% regimen led to IGA-TS in 32% of patients. Also, the 8-week results for EASI 50, 75, and 90 reflected time-dependent and dose-dependent ameliorations. EASI 50 was reached by 64% (0.75% dosage) and 84.2% (1.5% dosage) versus 38.5% on placebo. The corresponding outcomes for EASI 75 were 44.0% and 73.7% versus 15.4%, respectively. EASI 90 was seen in 26% and 50% of the active treatment arms versus 3.8% on the vehicle.
Among the key secondary endpoints were also differences in itch NRS score and Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance. Depending on the cream concentration, a proportion of 53.8% (1.5% cream) and 36.1% (0.75% cream) had a ≥4-point score reduction in itch NRS compared with 17.6% in the placebo group. As for a decrease in sleep disturbance, about a third in the higher-dosed arm experienced ≥6-point decrease in their PROMIS score.
Prof. Szepietowksi pointed out that in terms of safety, ruxolitinib cream only led to a low rate of application site reactions and no safety findings of systemic JAK inhibition. He, furthermore, stressed that no serious treatment-emergent adverse events were observed. “These results demonstrate the potential of ruxolitinib cream as an effective and well-tolerated topical treatment for patients with atopic dermatitis aged 65y and older,” Prof. Szepietowksi concluded.