Treatment of Onychomycosis with Efinaconazole 10% Topical Solution and Quality of Life

Objective: To evaluate the benefits of efinaconazole topical solution, 10% on quality of life in onychomycosis patients. Methods: An analysis of 1,655 patients, aged 18 to 70 years, randomized to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled, 48-week studies evaluating safety and efficacy. The primary endpoint was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture); clinical improvement defined as ≤ 10-percent improvement in nail involvement both at Week 52. Quality of life was assessed using a validated OnyCOE-t™ questionnaire. Improvement in quality of life was compared in those patients clinically and not clinically improved. Results: Efinaconazole topical solution, 10%, was significantly more effective than vehicle irrespective of QoL domain. Greatest improvement in mean score was seen in those domains with the lowest baseline scores. All mean scores in the group considered to have clinically improved with efinaconazole exceeded 80.0 at Week 52. Mean treatment satisfaction scores with efinaconazole in those patients who were clinically improved increased from 79.9 (Week 24) to 89.2 (Week 52), compared to a corresponding drop in those patients considered not improved from 65.3 to 58.0. The correlation between change in percent affected nail and change in mean domain scores was significant with efinaconazole for all domains. Limitations: A period of 52 weeks may be too brief to evaluate improvement in quality of life in onychomycosis patients. Some of the questions in the OnyCOE-t questionnaire may be more relevant than others to the study population and the onychomycosis population as a whole. Conclusion: Once-daily efinaconazole topical solution, 10%, provided statistically greater improvement in all aspects of quality of life compared to vehicle. Improvement was most marked in those patients considered clinically improved and correlated with a change in percent affected nail.Onychomycosis is a common, growing problem in dermatology practice, most frequently seen in toenails and difficult to treat successfully.1,2 It is a progressive disease, not self-healing, and occasionally the source of more widespread infection.3 Many patients suffer long-standing disease affecting several toenails.4Onychomycosis can have significant impact on the individual and other family members.5-7 The unsightly appearance of the toenail is a real concern, and often the initial reason why patients seek medical help. Indeed, the appearance of the toenail may have a more significant impact on quality of life (QoL) than the severity of the disease.8It can disrupt daily activities, negatively impact QoL, and occasionally results in significant pain and discomfort.5 The symptoms of onychomycosis and their impact on personal appearance are important determinants of patients’ perceptions of their own health. The effect of onychomycosis is greater on psychosocial than physical functioning and is directly related to the extent of nail involvement.9 Data are conflicting as to whether nail appearance or disease severity are the more important from a patient’s perspective of QoL. Area alone does not necessarily predict disease severity, and a thick nail with limited involvement may have a poor prognosis.10 Commonly reported psychosocial factors include embarrassment, low self-esteem, and social withdrawal.11The true burden of disease is unknown, but patients’ desire to have their affected nails cured is clear.5,12 Patient surveys have noted a substantial impact in several QoL domains including physical functioning (associated with foot-related activities), social functioning (affected by pain and discomfort restricting social activities and embarrassment associated with the nail appearance), and emotional well-being affected by negative feedback received from their social environment.13-15A number of disease-targeted questionnaires have been developed to assess the impact of onychomycosis and its treatment on health-related QoL. The instruments differ considerably in the extent to which they have been psychometrically tested. The generic and disease-targeted scales of most of the available questionnaires exhibit poor variability, which may limit their responsiveness to clinically important change.9 As a result; there is a lack of data to demonstrate the true QoL response to onychomycosis treatment.Improvements in QoL have been reported to correlate with the improvement or cure of infected nails.16-20 As a result, patients satisfied with their treatment had better health-related QoL;21 although patients with recurrent disease had significantly poorer QoL than those with onychomycosis for the first time that had not previously been treated.22 A significant portion of patients feel unattractive and stigmatized by onychomycosis and antimycotic therapy has been reported to result in a significant reduction of stigmatization of about 60 percent from baseline levels.23A toenail-specific questionnaire, the OnyCOE-t™, and objective clinical measures have been used to assess responsiveness of patients in a prospective onychomycosis trial.24,25 Patients were treated with terbinafine (± aggressive debridement) and comparisons made between those patients who were judged to have clinically improved and those who had not improved.The objective of this current study was to utilize this validated OnyCOE-t questionnaire to assess differences in QoL response in onychomycosis patients following treatment with efinaconazole topical solution, 10%, or vehicle. In addition, the authors compared results in those patients who were considered clinically improved (≤10% nail involvement) with those who were not clinically improved at Week 52 following active treatment, to assess the clinical meaningfulness of their results.