Efficacy and safety of ruxolitinib under maximum-use conditions in people with atopic dermatitis

Summaries 3 min 392

Font Size

Created On: 09/05/2022

An open-label, maximum-use phase I study [maximum-use trial (MUsT)] was carried out to assess tolerability, safety, and bioavailability of ruxolitinib cream under maximum-use conditions in people with extensive atopic dermatitis lesions. Efficacy was evaluated as an exploratory objective.

See All

Key take away

In adolescents and adults with atopic dermatitis, the use of 1.5% ruxolitinib cream was well-tolerated, with most adverse effects of mild or moderate severity. Furthermore, it displayed a high level of efficacy in people with atopic dermatitis involving ≥ 25% affected body surface area.

Background

Method

In this study, patients (age ≥ 12-65 years) having atopic dermatitis, and an Investigator’s Global Assessment (IGA) score ≥ 2, and ≥ 25% affected body surface area were recruited. The participants applied 1.5% ruxolitinib cream twice daily to lesions detected at the baseline for the first twenty-eight days and continued use only on active lesions for an extra 28 days (extension period).

With the aid of duration, frequency, and severity of treatment-emergent adverse events, an assessment of safety was done. The plasma concentrations of ruxolitinib and pharmacokinetic parameters were evaluated as secondary outcomes.

Result

In total, 41 people (51% men; median age 17 years) were recruited and 37 (90.2%) entered the extension period, all of whom finished the study. In 13 people (31.7%), treatment-emergent adverse events were witnessed while in 4 people (9.8%), treatment-related adverse events were reported.

The mean (standard deviation) steady-state plasma concentration was found to be 104 (309) nM during the initial 28 days. This concentration was well below the half-maximal inhibitory concentration of Janus kinase-mediated myelosuppression in bone marrow (281 nM), and reduced further during extension period.

The higher plasma concentrations were detected in a few people who were treated for a very high affected body surface area. On day 56, 94.6% of people attained ≥ 75% improvement in the Eczema Area and Severity Index (EASI).

Conclusion

Under maximum-use conditions, ruxolitinib cream (a topical formulation of ruxolitinib) showed good tolerability, with nearly one-third of people experiencing treatment-emergent adverse events and few treatment-linked adverse events. Ruxolitinib cream significantly decreased itch and inflammation in atopic dermatitis people with ≥ 25% affected body surface area.