Abstract
Benzoyl peroxide gel (Bepio® Gel 2.5%, hereinafter, BPO) that has antibacterial activity and exfoliating action was approved for the treatment of acne vulgaris in December 2014. The safety and efficacy were evaluated in the Special Drug Use-Results Survey starting in July 2015 with a 12-month observation period for acne vulgaris in clinical practice.
Adverse drug reactions were observed in 15.2% (169/1109) in the safety analysis set. Application site erythema was observed in 1 patient as serious, but the other events were non-serious. All of the 169 patients experienced skin irritation symptoms which is an important identified risk in the Risk Management Plan, and 119 of these patients experienced skin irritation symptoms within 1 month of the start of the administration.
The incidence proportion of skin irritation symptoms tended to be higher in women and in patients with dry or sensitive skin, but the specific patient group that should avoid the drug use was not identified.
The number of facial skin lesions were reduced by a median of 80.0% for inflammatory, 66.7% for non-inflammatory, and 73.9% for total skin lesion count at the final evaluation within 12 months.
With regard to overall improvement at the final evaluation, “markedly improved” and “improved” accounted for 71.4% (788/1103) of facial lesions and 64.1% (59/92) of non-facial lesions. Evaluation of quality of life using the Japanese version of Skindex-16 showed a significant reduction in all of the symptoms, emotion, function, and total scores after 3 months of use of BPO versus baseline, and the reduction was maintained at 12 months following the use of BPO.
These results indicate that BPO is useful not only in the acute inflammatory phase, but also in long-term use in real clinical settings.
