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.
Results
These analyses included data from the 628 patients enrolled in the 2 phase 3 trials. Patients had similar baseline characteristics across treatment groups (Table 2). Itching was the most common cutaneous symptom at baseline, reported by almost two-thirds (n=392, 62.4%) of patients. Of the 628 patients, 236 (37.6%) had a target lesion located on the elbow or knee selected for assessment. The mean baseline body surface area was 13% to 14% across groups.
A post hoc analysis was performed on the subgroup of patients who reported itching at baseline (N=392)(eFigure 1). For these patients, almost half were itch free by day 4 across all groups (49.3% BD spray, 48.2% AugBD lotion, and 47.4% vehicle). By the end of treatment, 65.9% of patients using BD spray and 58.3% of patients using vehicle were itch free at day 29, with 56.9% of AugBD lotion patients itch free at day 15.
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Application-site pruritus recorded as a treatment-emergent adverse event was seen in low numbers and was similar in proportion between the 2 steroid treatments (7.7% BD spray, 6.7% AugBD lotion, and 14.4% vehicle).
Psoriasis Individual Sign Scores for Knee and Elbow Plaques
Target lesions located on the knee or elbow represented 37.6% of all target lesions assessed. Efficacy analysis of the pooled data on knee and elbow lesions revealed that BD spray was similar to AugBD lotion in reducing sign scores to 0 or 1 (Figures 1 and 2).
The percentage of patients reporting improvements in erythema, scaling, and plaque elevation scores at day 4
The proportion of patients achieving treatment success (defined as a score of 0 or 1) was comparable for the2 products on day 15 for erythema (66.2% BD spray vs 62.5% AugBD lotion), scaling (70.7% BD spray vs 62.5% AugBD lotion), and plaque elevation (65.4% BD spray vs 62.5% AugBD lotion)(Figure 1). From day 8, BD spray reduced erythema and scaling in significantly more patients than vehicle (P=.003 for both), and BD spray reduced erythema, scaling, and plaque elevation in more patients than vehicle from day 15 (P<.001 for all). No statistically significant difference was found between BD spray and AugBD lotion on erythema, scaling, and plaque elevation scores.
Total Sign Score
Total sign score results showed that the mean percentage of patients achieving a TSS of 0 or 1 for all signs for lesions located on the knees or elbows was numerically higher for BD spray vs AugBD lotion at day 4, but this difference was not statistically significant (Figure 2). Day 15 outcomes for TSS also showed a numerically greater success rate for BD spray, but again this difference was not statistically significant (53.4% BD spray vs 43.8% AugBD lotion). At days 15 and 29, significantly more patients treated with BD spray achieved TSS of 0 or 1 for all 3 signs compared to those treated with vehicle (P<.001). Improvement in TSS with BD spray continued through to day 29 of the study.
