Regulatory Decision Summary for BETEFLAM

Beteflam was demonstrated to have vasoconstrictive and anti-inflammatory properties and to be efficacious in treating mild to moderate psoriasis of the elbows and knees based on lesion remission using several psoriasis scoring systems, such as the Psoriasis Area Severity Index (PASI), Physician Global Assessment (PGA), and Total Severity Score (TSS), which evaluate psoriasis severity based on parameters such as itching, soreness, size, redness, crusting, and thickening. In pivotal clinical studies Beteflam was also shown to be non-inferior to a calcipotriol/betamethasone dipropionate gel (50 µg/g calcipotriol; 0.5 mg/g betamethasone dipropionate) and superior to a betamethasone valerate cream (0.1%) in treating psoriasis in the target population.

Having an additional choice in topical corticosteroid products may improve compliance in some patients.

The primary concerns associated with topical corticosteroids are local reactions, such as irritation and skin thinning. In clinical trials with Beteflam the incidence of local adverse events was low and no serious adverse events associated with the patch use were reported. It is expected that local adverse reactions would resolve quickly once treatment is stopped. It is unlikely that Beteflam use would lead to significant systemic effects, as only small amounts are absorbed through the skin. Children, however, would be at greater risk for systemic effects, as they have a higher skin surface area to body mass. As the use of Beteflam in children was not investigated, Beteflam is contraindicated for the pediatric population (<18 years of age).

Beteflam was tested in the Caucasian population only. This has been addressed in the Product Monograph.

The phototoxiciy of the Beteflam patch was not investigated. While it is known that betamethasone valerate is not phototoxic, it remains unknown if other components of the patch might be associated with phototoxiciy. The issue has been addressed in the Product Monograph.

Overall, the expected benefits of Beteflam outweigh the possible harms and uncertainties relating to its use.