Ruxolitinib cream is associated with improvement in work productivity and daily activity compared with vehicle and may lower the indirect cost burden for patients with atopic dermatitis (AD), according to findings from a study in the American Journal of Clinical Dermatology.
The post hoc analysis of the TRuE-AD1 and TRuE-AD2 phase 3 studies aimed to determine the effects of ruxolitinib cream on work productivity and activity impairment in adolescent and adult patients with AD.
The randomized, double-blind studies included patients 12 years of age and older with AD for 2 or more years, an Investigator’s Global Assessment score of 2 or 3, and an affected body surface area of 3% to 20%, excluding the scalp. The participants were randomly assigned 2:2:1 to 0.75% or 1.5% ruxolitinib cream or vehicle cream applied twice daily in an 8-week double-blind period.
Patient self-reported productivity was assessed with the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem version 2.0 (WPAI:SHP v2.0) at weeks 2, 4, and 8. The analysis was performed in the efficacy-evaluable population using pooled data from the 2 studies, and the statistical significance of changes from baseline in WPAI:SHP scores at weeks 2, 4, and 8 was assessed.
A total of 1249 patients (median age, 32 years; 61.7% female) were randomly assigned in the 2 trials (vehicle, n=250; 0.75% ruxolitinib cream, n=500; 1.5% ruxolitinib cream, n=449), and 1208 patients were included in the efficacy analysis. Among this group, 678 patients (56.1%) completed 1 or more of the work-related questions, and 1205 (99.8%) completed the daily activity impairment question of the WPAI:SHP.
Patients who received 0.75% or 1.5% ruxolitinib cream had improved WPAI:SHP scores at weeks 2, 4, and 8 for domains of presenteeism, overall work impairment, and daily activity impairment. Investigators found statistically significant differences regarding the percentage change from baseline vs vehicle at week 8 for presenteeism (-19.2%/-19.8% for 0.75%/1.5% strength vs -12.3% for vehicle; P <.0001 for both), overall work impairment (-17.9%/-15.0% vs -5.7%; P <.0001 for both), and daily activity impairment (-20.6%/-21.5% vs -10.6%; P <.0001 for both). In addition, significant differences were observed at week 8 for rates of absenteeism with 0.75% ruxolitinib cream vs vehicle (1.3% vs 7.4%; P <.05), and 1.5% ruxolitinib cream (4.8%) had a trend toward a difference compared with vehicle.
The total estimated indirect cost savings per patient during the 8-week period for 0.75% and 1.5% ruxolitinib cream vs vehicle were $695 and $766, respectively. For a 1-year period, decreases in indirect costs owing to treatment were estimated to be $2127 for vehicle cream, $7428 for 0.75% ruxolitinib cream, and $6355 for 1.5% ruxolitinib cream. The incremental indirect cost savings were estimated to be $5302 ($5126-$5477) and $4228 ($3987-$4469) for patients randomly assigned to 0.75% and 1.5% ruxolitinib cream, respectively, compared with those who received vehicle.
Study limitations include the specified population that excluded patients with severe AD. In addition, extrapolation from the short-term vehicle-controlled period to annual costs may not account for potential disease progression in which ruxolitinib cream may no longer be effective. Also, indirect cost comparisons were made compared with vehicle rather than an active topical agent because data were limited on the use of topical agents for AD, and the model does not account for all indirect costs, such as impaired quality of life.
“Patients randomized to ruxolitinib cream reported reduced work time missed, work impairment, and daily activity impairment compared with vehicle,” stated the investigators. “Results of the indirect cost analysis showed that ruxolitinib cream may also significantly reduce the annual indirect cost burden on patients with AD.”
Disclosure: The study was funded by Incyte Corporation. Several of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Bloudek L, Eichenfeld LF, Silverberg JI, et al. Impact of ruxolitinib cream on work productivity and activity impairment and associated indirect costs in patients with atopic dermatitis: pooled results from 2 phase III studies. Am J Clin Dermatol. Published online October 20, 2022. doi:10.1007/s40257-022-00734-8