LISBON – Long-term treatment of severe acne using a fixed-dose combination of adapalene 0.1%/benzoyl peroxide 2.5% results in substantially lower future medication costs, according to a randomized, double-blind, multicenter clinical trial.

The same study also demonstrated greater improvements in quality of life and patient satisfaction after 12 weeks of topical fixed-dose adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo) plus anti-inflammatory–dose doxycycline at 100 mg/day than with doxycycline plus vehicle, Dr. Maria Jose Rueda reported at the annual congress of the European Academy of Dermatology and Venereology.

The 34-center North American study included 479 patients with severe acne (defined as an Investigator Global Assessment score of at least 4 on a 6-point scale). Participants were randomized in a double-blind manner to 12 weeks of Epiduo plus doxycycline or to vehicle plus doxycycline. After 12 weeks, 242 patients showed at least good improvement (defined as an IGA score of 0-3). At that point, the good responders were randomized in a double-blind manner to 24 weeks of Epiduo or vehicle.

At the end of the 36-month study, the group on 12 weeks of Epiduo plus doxycycline followed by 24 weeks of Epiduo had a "clear or almost clear" rate of 50%, as well as a mean 76% reduction in total lesion count. In contrast, subjects who received only vehicle for the final 24 weeks had a high relapse rate, and only one-quarter of them were rated clear or almost clear.

The primary study question posed to the treating physicians after 36 weeks of therapy was this: Based upon the patient’s acne history and outcome during the study, what acne medications do you intend to prescribe for this patient during the next 3 months?

Long-term therapy with Epiduo during the study period reduced the intended use of oral antibiotics by roughly half. Only 19% of patients in the Epiduo arm were slated to receive an oral antibiotic–containing regimen for the next 3 months, compared with 39% of controls. Physicians planned to prescribe topical therapy alone in 55% of the Epiduo group, compared with 35% of controls. Fewer than one-quarter of patients in each study arm were slated to receive no follow-up therapy.

Based upon prescription costs that were calculated using U.S. prices, the mean cost of intended follow-up therapy using brand-name topical agents was $571 in the Epiduo group, which was a 23% reduction compared with the $739 cost for controls. When the analysis was done using generic topicals, the cost saving in the Epiduo group was even greater, at $415 for the intended 3 months of therapy; this represented a 29% lower cost compared with the $583 in vehicle controls, according to Dr. Rueda, a dermatologist in Paris and a medical expert at Galderma, which manufactures Epiduo.

The average intended prescription costs were 34% lower in patients who had completed 36 weeks on Epiduo than in those on Epiduo for 12 weeks followed by 24 weeks of vehicle.

This study also included quality-of-life end points that were assessed via the validated Acne-QoL (Acne-Specific Quality of Life Questionnaire) and a 6-item patient satisfaction questionnaire.

At the 12-week point, patients who had been randomized to Epiduo plus doxycycline reported significantly greater across-the-board satisfaction than did those assigned to vehicle plus doxycycline. All four domains on the Acne-QoL (self-perception, acne symptoms, emotional role, and social role) were significantly improved at 12 weeks compared with baseline in both study arms, and scores on the acne symptoms domain were 11% better in the Epiduo-plus-doxycycline group than in those treated with doxycycline plus vehicle, a significant difference.