Introduction: For some patients with atopic dermatitis (AD), topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), and systemic therapies are inadequate to control disease or are associated with adverse events (AEs). Ruxolitinib cream monotherapy demonstrated anti-inflammatory and anti-pruritic effects among patients enrolled in two pivotal phase 3 studies (TRuE-AD1/TRuE-AD2); most patients had long-term disease control with as-needed use during the 44-week long-term safety (LTS) period. This post hoc analysis explored efficacy and safety of 1.5% ruxolitinib cream by previous medication use.
Methods: Patients aged ≥ 12 years enrolled in TRuE-AD1/TRuE-AD2 were randomized 2:2:1 to twice-daily 0.75% or 1.5% ruxolitinib cream or vehicle cream for 8 weeks, followed by a 44-week LTS period; patients initially on vehicle were re-randomized 1:1 to either ruxolitinib cream strength.
Results: Within 12 months of enrollment (N = 1249), previous AD therapies were used by 89.4% of efficacy-evaluable patients applying vehicle or ruxolitinib cream (n = 725); of these, 80.4% received TCS (n = 583), 22.2% TCI (n = 161), 20.3% TCS + TCI (n = 147), and 18.9% systemic therapies (n = 137). Across previous medication subgroups, achievement of Investigator's Global Assessment (IGA)-treatment success (IGA 0/1 with ≥ 2-grade improvement from baseline), ≥ 75% improvement in Eczema Area and Severity Index from baseline, and ≥ 4-point improvement in Itch numerical rating scale score from baseline at Week 8 did not substantially differ among patients who applied ruxolitinib cream. Outcomes were similar to those in the overall study population. At all study visits during the LTS period, > 70% of patients in each subgroup had IGA 0/1 and a low percentage (generally < 3%) of affected body surface area. Treatment-related AEs across subgroups were reported in 7.3% (n = 35/481) to 17.4% (n = 19/109) of patients.
Conclusions: Continuous-use ruxolitinib cream monotherapy for 8 weeks followed by as-needed use was effective and well tolerated, regardless of previous topical or systemic therapy, with outcomes similar to those achieved in the overall study population.
Trial registration: ClinicalTrials.gov Identifier, NCT03745638/NCT03745651.
Keywords: Atopic dermatitis; Eczema; Janus kinases; Ruxolitinib cream; Treatment outcome.
Atopic dermatitis (AD) is a skin condition resulting in itchy, dry, and inflamed skin. For some patients, medication applied to the skin (topical treatment) or medication taken by mouth or injection (systemic treatment) may not control disease or may have side effects. In the TRuE-AD1/TRuE-AD2 trials in patients with mild to moderate AD aged 12 years and older, ruxolitinib cream used twice daily for 8 weeks reduced itch and redness. As-needed ruxolitinib cream use for another 44 weeks maintained long-term disease control. Here, we assessed disease control with 1.5% ruxolitinib cream in patients with AD based on their previous AD treatments. Of the 725 patients who had used previous AD treatments, most (80.4%) used topical corticosteroids (TCS). After 8 weeks, disease control outcomes were similar across all previous treatment subgroups (i.e., TCS, topical calcineurin inhibitors [TCI], TCS + TCI, systemic treatments) and were similar to the outcomes in the overall study population. After 44 weeks of as-needed ruxolitinib cream use, over two-thirds of patients still had clear or almost clear skin. The percentage of affected body surface area also remained low. Regardless of the AD treatments previously used, twice-daily ruxolitinib cream use for 8 weeks and then as needed for 44 weeks was generally well tolerated. These results show that twice-daily 1.5% ruxolitinib cream for 8 weeks, followed by as-needed treatment for 44 weeks, provides long-term control of AD in patients regardless of previous topical or systemic treatment received.
© 2024. The Author(s).