The combination of a topical corticosteroid and a topical retinoid for the treatment of plaque psoriasis resulted in significant improvements in clinical signs, in two multicenter, double-blind, vehicle-controlled phase 3 studies.
In the two, investigators randomized a total of 418 or vehicle lotion, applied once a day to affected areas. After 8 weeks of treatment, 35.8% of adults in the first study and 45.3% of those in the second study had achieved the primary outcome of at least a two-grade improvement in the Investigator’s Global Assessment score and reaching “clear” or “almost clear,” compared with 7.0% and 12.5%, respectively, of patients treated with the vehicle (P less than .001). The report was published online in the Journal of the American Academy of Dermatology.
At 8 weeks, reduction in erythema was achieved by 44.2% and 49.6% of patients in the treatment arms, compared with 10% and 18.7% of patients in the control arms. Plaque elevation was reduced in 59.3% and 59.7% of patients in the treatment arms, compared with 17.9% and 21.3% of patients in the control arms; and scaling was reduced in 59.4% and 62.9% of those on treatment, compared with 20.6% and 21.0%, respectively. All differences between the treatment and control groups were statistically significant (P less than .001).
Participants who received the treatment also reported significantly lower scores for itching, dryness, and burning or stinging compared with those who received the vehicle lotion.
Dr. Linda Stein Gold of Henry Ford Hospital in Detroit, and her coauthors, wrote that while clinical studies have established the benefit of using a topical corticosteroid as an adjunct to tazarotene for plaque psoriasis, data on their combined use was limited. This combination “was consistently more effective than vehicle in achieving treatment success; effectively reducing affected area and psoriasis signs at the target lesion, and improving QoL [quality of life],” they wrote.
Most patients maintained these improvements over the 4-week posttreatment period.
Patients who received the halobetasol propionate/tazarotene lotion reported more adverse events than did those who received the control lotion, but most were mild to moderate and included contact dermatitis (6.3%), pruritus (2.2%) and application site pain (2.6%). Three serious adverse events were not related to treatment.
The studies were funded by Dow Pharmaceutical Sciences, a division of Valeant Pharmaceuticals North America. Four authors disclosed advisory, consultancy and speaking positions and other funding from the pharmaceutical industry, including with Valeant Pharmaceuticals. Five authors are employees of the company.
SOURCE: Gold L et al. J Am Acad Dermatol. 2018 Mar 31. pii: S0190-9622(18)30494-8.