Betamethasone Dipropionate Spray 0.05% Alleviates Troublesome Symptoms of Plaque Psoriasis
Patients consider pruritus and scaling to be the most bothersome symptoms of psoriasis. Psoriatic plaques on the knees and elbows are widely considered difficult to treat because of the thicker stratum corneum, which reduces skin hydration and topical absorption. Betamethasone dipropionate (BD) spray 0.05% is a topical steroid with demonstrated efficacy in treating plaque psoriasis. Post hoc analyses of 2 phase 3 trials were done to assess the efficacy of BD spray in relieving the symptom of itching and improving the signs of erythema, scaling, and plaque elevation on plaques located on the knees and elbows vs its vehicle and an augmented BD (AugBD) lotion 0.05%. Betamethasone dipropionate spray reduced the incidence of pruritus, with approximately half of patients who reported itching at baseline showing complete itch relief by day 4. Betamethasone dipropionate spray also reduced the signs of psoriasis on knee and elbow plaques in more patients than AugBD lotion at day 4, though the differences were not statistically significant. Efficacy was similar between the 2 formulations on days 8 and 15. Betamethasone dipropionate spray rapidly relieved2 of the most bothersome symptoms of psoriasis and improved psoriatic signs in hard-to-treat knee and elbow plaques.
Practice Points
- Pruritus is one of the most bothersome symptoms of psoriasis; plaques located on the knees and elbows remain hard to treat.
- Topical corticosteroids are the initial form of treatment of localized plaque psoriasis.
- The choice of vehicle can change the penetration of the medication, alter the efficacy, and minimize side effects of the drug.
- Betamethasone dipropionate spray 0.05% is a mid-potent corticosteroid that provides fast symptom relief and early efficacy in clearing plaques, similar to a high-potency topical corticosteroid but with less potential for systemic absorption and adverse events.
Comment
In these post hoc analyses, mid-potency BD spray demonstrated early relief of itching and early efficacy in the treatment of psoriasis plaques on the elbows and knees with minimal systemic absorption and a low rate of adverse events.
Betamethasone dipropionate spray and its vehicle formulation relieved psoriatic itching with similar efficacy to the superpotent AugBD steroid lotion. Notably, relief was rapid, with approximately half of responding patients reporting relief of itching by day 4. The results seen with vehicle suggest that the emollient formulation of BD spray is responsible for hydrating dry skin, contributing to the relief of this cutaneous symptom. Dry skin can exacerbate itching, and emollients are recognized as being able to alleviate itching by hydrating and soothing the skin.7
The second set of post hoc analyses reported here demonstrated that BD spray was efficacious in clearing the signs of psoriatic lesions on the difficult-to-treat areas of the knees and elbows. Efficacy with BD spray was similar to the superpotent steroid AugBD lotion, with no statistical difference between the 2 products at any time point. Betamethasone dipropionate spray was significantly more effective than its vehicle in reducing the signs of erythema and scaling from day 8 and plaque elevation from day 15.
,Rapid relief of symptoms is important for patient comfort and to improve treatment adherence. These analyses showed that by day 4, BD spray resulted in numerically higher percentages of patients achieving a score of 0 or 1 for the individual signs of erythema, scaling, and plaque elevation compared to AugBD lotion. Of particular note, 37.6% of patients treated with BD spray had scaling scores of clear or almost clear by day 4 compared to 25.0% of patients treated with AugBD lotion. Scaling has been consistently reported as the second most bothersome symptom experienced by patients2,3 and has been shown to be associated with decreased quality of life and work productivity.19
Betamethasone dipropionate spray has a rationally designed vehicle, with the formulation selected specifically to maximize penetration of the product through the stratum corneum and retention of BD steroid in the epidermis and upper dermis while reducing absorption into the systemic circulation.14 The reduced absorption into the systemic circulation leads to less vasoconstriction; fewer adverse events; and a “medium potent” VCA designation compared to the “superpotent” designation of the AugBD formulation, despite containing the same active ingredient.
These analyses demonstrate that BD spray is effective at addressing 2 symptoms that patients with psoriasis consider most bothersome: itching and scaling. Notably, BD spray was able to achieve these results rapidly, with many patients experiencing improvements in 4 days. In these analyses, mid-potent BD spray demonstrated similar efficacy to AugBD lotion, a superpotent steroid formulation.
This analysis is limited by being post hoc. Although the statistical methodology is valid, the AugBD lotion arm of the analyses was relatively small compared with the BD spray and vehicle arms, as it was only included in 1 of 2 studies pooled.
Conclusion
Mid-potency BD spray effectively improved the symptom of itching and cleared hard-to-treat lesions on knees and elbows with efficacy similar to a superpotent AugBD formulation but with less systemic absorption. Improvements were seen in erythema, scaling, and plaque elevation. Reductions in psoriatic signs were observed as early as day 4, with continued improvement seen throughout the study period. These findings provide evidence that BD spray can rapidly relieve 2 of the most troublesome symptoms affecting patients with psoriasis (itching and scaling), potentially improving quality of life.
Acknowledgments
The authors wish to thank Alix Bennett, PhD, formerly of Promius Pharma, a subsidiary of Dr. Reddy’s Laboratories, Inc (Princeton, New Jersey), and Jodie Macoun, PhD, of CUBE Information (Katonah, New York), for their review and assistance with the preparation of this manuscript. Manuscript preparation was supported by Promius Pharma (Princeton, New Jersey)(DRL #866).
