“The sample size and methods for assessment used in this study were appropriate for delivering the message about the value of this concentration of halobetasol,” Dr. Bhatia says.
Mean size of the leg target lesion at baseline for the 234 patients was 42.0 cm2; 91% of the randomized patients completed the study. A statistically significant difference in treatment success rate favoring the halobetasol group over placebo was achieved by week four for all three psoriasis signs. At week eight, treatment success rates for improving erythema, plaque elevation, and scaling severity on the leg were 52.1%, 55,5%, and 58.2%, respectively, in the halobetasol group and 15.7%, 22.9%, and 22.2%, respectively, in the controls.
A statistically significant difference favoring halobetasol was also achieved by week four in the analysis of overall success rates. At week eight, the overall success rates in the halobetasol and control groups were 37.1% and 8.4%, respectively.
Efficacy was also evaluated by calculating an IGA x BSA composite score. Analyses showed that the mean percent change in the composite score was significantly greater in the halobetasol group compared with controls (50.5% vs 13.8%, P<0.001). In addition, a significantly higher proportion of halobetasol-treated patients achieved the composite score cutoff that defines a clinically meaningful effect (≥75% reduction from baseline; 37.7% vs. 7.2%, P<0.001).
Patients also completed the 10-question Dermatology Life Quality Index (DLQI) at baseline and during follow-up. Corresponding with the improvements seen in disease severity, the DLQI results showed that by week 4, the halobetasoltreated patients achieved quality of life improvement that represents a clinically important difference. Mean DLQI score was improved further at week 8 in the halobetasol group, and at both visits, the improvement from baseline was significantly greater than in the control group.
Dr. Bhatia is an advisor and/or investigator for Bausch Health.
1. Bhatia ND, Vlahovic TC, Green LG, Martin G, Lin T. J Drugs Dermatol. 2019;18(10):1029-1036