Boni E Elewski1, Tracey C Vlahovic2, Andrew Korotzer3. 1. Department of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama. 2. Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania. 3. Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.
Abstract
Background: The current definition of complete cure is considered too stringent to reflect the true benefit of onychomycosis treatment seen in general practice and may limit the use of newer topical agents in mild-to-moderate disease. In addition, outcomes reported in clinical trials do not consistently report secondary endpoints, making data comparison difficult. Methods: The authors review the clinical data reported on two new topical antifungals, efinaconazole and tavaborole, in light of the latest thinking of more practical approaches to assess improvement and treatment success. Results: Almost 20 percent (19.7%) of patients treated with efinaconazole had absence of clinical signs, and almost a third (31.6%) had ≤10 percent affected toenail and mycologic cure at Week 52. Cure rates for tavaborole (<10% affected toenail and mycologic cure) were 15.3 percent and 17.9 percent at week 52. With both topical treatments, cure rates were higher when only negative culture was considered. Conclusion: These clinical cure rates likely better reflect the efficacy we see in practice. It is probable that efficacy would be further improved with longer treatment courses and/or longer follow-up periods and appropriate prophylactic strategies. This clinical judgment is predicated by any risk of nonadherence or disease recurrence.
Background: The current definition of complete cure is considered too stringent to reflect the true benefit of onychomycosis treatment seen in general practice and may limit the use of newer topical agents in mild-to-moderate disease. In addition, outcomes reported in clinical trials do not consistently report secondary endpoints, making data comparison difficult. Methods: The authors review the clinical data reported on two new topical antifungals, efinaconazole and tavaborole, in light of the latest thinking of more practical approaches to assess improvement and treatment success. Results: Almost 20 percent (19.7%) of patients treated with efinaconazole had absence of clinical signs, and almost a third (31.6%) had ≤10 percent affected toenail and mycologic cure at Week 52. Cure rates for tavaborole (<10% affected toenail and mycologic cure) were 15.3 percent and 17.9 percent at week 52. With both topical treatments, cure rates were higher when only negative culture was considered. Conclusion: These clinical cure rates likely better reflect the efficacy we see in practice. It is probable that efficacy would be further improved with longer treatment courses and/or longer follow-up periods and appropriate prophylactic strategies. This clinical judgment is predicated by any risk of nonadherence or disease recurrence.
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