ADVERTISEMENT

Efinaconazole Solution 10% for Treatment of Toenail Onychomycosis in Latino Patients

Cutis. 2017 April;99(4):286-289
April 3, 2017|Cutis
Fran E. Cook-Bolden, MD;Tina Lin, PharmD
Author and Disclosure Information

Dr. Cook-Bolden is from Skin Specialty Dermatology, New York, New York. Dr. Lin is from Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey.

Dr. Cook-Bolden was a principle investigator in the study and has served as an advisory board member, researcher, and speaker for Valeant Pharmaceuticals North America LLC. Dr. Lin is an employee and shareholder of Valeant Pharmaceuticals North America LLC.

Correspondence: Fran E. Cook-Bolden, MD, Skin Specialty Dermatology, 150 E 58th St, New York, NY 10155 (skinspecialtydermatology@gmail.com).

Onychomycosis is a common progressive fungal infection of the nail bed, matrix, or plate leading to destruction and deformity of the toenails and fingernails. The prevalence of onychomycosis is increasing in the United States, particularly in the growing population of Latino patients. In this study, we evaluated the efficacy and safety of efinaconazole solution 10% in Latino patients with onychomycosis. Once-daily application of efinaconazole solution 10% may be an effective topical option for treatment of onychomycosis in this patient population.

Practice Points

  • Onychomycosis is a common disease of importance in the increasing Latino population of the United States, especially due to predisposing factors such as obesity and diabetes mellitus. Specific data on the treatment of this patient population are lacking.
  • Two large phase 3 studies with topical efinaconazole treatment included a notable number of Latino patients.
  • Complete cure rates with efinaconazole in Latino participants were notably greater than those observed in the non-Latino population, and treatment was well tolerated in both groups.
  • Treatment of onychomycosis is important to possibly prevent a more serious infectious disease involving the lower extremities, especially in those with comorbidities such as obesity, diabetes, and peripheral vascular disease.

Primary Efficacy End Points (Observed Case [OC])

At week 52, 25.6% of Latino participants in the efinaconazole group achieved complete cure versus 0% in the vehicle group (P<.001)(Figure 1). The efficacy of efinaconazole was statistically superior in Latino participants versus non-Latino participants (17.2% [P=.012]). The net effect (calculated by active treatment minus vehicle) for Latino participants also was superior to non-Latino participants (25.6% vs 11.6%).

Figure 1. Primary efficacy end point of complete cure at week 52 (intention-to-treat pooled data) for Latino and non-Latino subpopulations. Asterisk indicates P<.001 vs vehicle; dagger, P=.012 between the 2 efina-conazole groups.

Secondary Efficacy End Points (OC)

At week 52, 61.5% of Latino participants in the efina-conazole group achieved mycologic cure versus 15.3% in the vehicle group (P<.001)(Figure 2). The net effect for Latino participants was superior to non-Latino participants (46.2% vs 38.5%). More Latino participants in the efinaconazole group compared to vehicle group achieved complete/almost complete cure (32.7% vs 1.7%) or treatment success (49.4% vs 5.1%)(all P<.001)(Figure 3). Although there was no significant difference between the 2 groups for secondary efficacy end points, the net effect of efinaconazole was greater for all end points.

Figure 2. Secondary efficacy end point of mycologic cure at week 52 (intention-to-treat pooled data) for Latino and non-Latino subpopulations. Asterisk indicates P<.001 vs vehicle; dagger, P=.154 between the 2 efina-conazole groups.
Figure 3. Secondary efficacy end point of treatment success (≤10% clinical involvement of target toenail) at week 52 (intention-to-treat pooled data) for Latino and non-Latino subpopulations. Asterisk indicates P<.001 vs vehicle; dagger, P=.559 between the 2 efinaconazole groups.

Safety

Adverse event rates were higher in the efinaconazole group than the vehicle group (65.3% vs 54.4%) and were similar in both populations; they were generally mild (61.8% vs 54.5%) or moderate (35.3% vs 45.5%) in severity, not related to study medication (96.8% vs 98.0%), and resolved without sequelae. Only 3 Latino participants (1.6%) discontinued efinaconazole treatment compared to 29 (2.8%) in the non-Latino population.

,

ADVERTISEMENT
ADVERTISEMENT
ADVERTISEMENT