Larry Green, MD: Efficacy of Halobetasol & Tazarotene Lotion

An analysis of data from a trial of halobetasol and tazarotene lotion in patients with moderate-to-severe plaque psoriasis demonstrated that both efficacy and safety results in a Hispanic population were comparable to the general population.

At weeks 4, 6, 8, and 12, the percentage change from baseline in IGAxBSA scores for the treatment arm was statistically significant compared to placebo (P <.001). Treatment stopped at week 8, so the week 12 data indicates a maintenance of efficacy.

Lawrence Green, MD, Associate Clinical Professor of Dermatology, George Washington University School of Medicine, Washington, DC, and an investigator on the trial, spoke with MD Magazine® about the study at the 2019 Annual Meeting of the American Academy of Dermatology (AAD).

“One other thing that's notable in the trial is that the Hispanic subset population performed very similarly to the general population in terms of maintenance of efficacy after the product was discontinued,” said Green. He specified that 4-week follow-up period after treatment was stopped, both Hispanic and other patients experienced maintained efficacy.

Green was an author of the poster, “Halobetasol and Tazarotene: Further Defining the Role of a Unique Fixed Combination Topical Lotion in Moderate-to-Severe Plaque Psoriasis in a Hispanic Population.” The poster was shared at the AAD Annual Meeting held March 1-5, 2019, in Washington, DC. Here is part 1 of his interview on the Duomii data.

MD Magazine: What results did you see in the sub-group analysis of Hispanic participants?

Green: So, we found that by week 8, over half the people achieved a 50% reduction in what we call IGAxBSA. That IGAxBSA is Investigator Global Assessment multiplied by Body Surface Area and that assessment's becoming used more and more to determine meaningful responses. Because looking at BSA is not enough and dermatologists in private practice don't do PASI, which is a much more involved way of determining improvements. So, we wanted to have an efficacy endpoint that's very practical for people in practice. So, it's very simple to do an Investigator Global Assessment on a 4 or 5 point scale, and then you determine the body surface area and you multiply those together and this shows, we get a clinical meaningful response. This is showing again, how this type of endpoint can really give us important information on the efficacy of a product.

Were outcomes for the Hispanic population similar to general results?

Yes, the outcomes for the Hispanic population were really similar to other population subtypes. And that's one of the nice things about Duobrii—it's an effective product, it's a combination product, which again theoretically gives it enhanced efficacy. It works just as well in the Hispanic population as it does in other skin of color populations and including non-skin of color populations.

Were there differences in adverse events between populations?

We did not see any difference in adverse events in this population as compared to other skin of color populations or as compared to non-skin of color populations. It was really the same. This product was very safe in all populations and I think part of it is due to the combination, where tazarotene and the halobetasol work well together—and theoretically, again this is in theory, can limit each other's adverse events and adverse outcomes.

Are there any other results you'd like to highlight?

One other thing that's notable in the trial is that the Hispanic subset population performed very similarly to the general population in terms of maintenance of efficacy after the product was discontinued. The study went 8 weeks and we saw an average of 51% reduction in people who had the product. When we stopped it for the duration—we had a 4-week time frame where patients received no product&mdash;the efficacy was maintained. That's really unusual, especially with a product that contains a topical steroid, because the efficacy usually wanes pretty quickly.