Managing Assessments and Expectations: Patient Responses Following Therapy With Efinaconazole Topical Solution, 10%

baseline tended to do slightly better (P<.001 active versus vehicle from week 24 [non-diabetic population only] see Figure 2C). Disease duration seemed to have more of an impact on treatment success. Those patients with more recent onychomycosis faired better than those with long-standing disease of more than 5 years (P<.001 active versus vehicle of patients with disease duration one year or more, see Figure 2D). Figures 3 show the percent change in percent affected toenail from baseline to week 52 by baseline severity. The percent change in percent-affected toenail was similar following efinaconazole, irrespective of baseline severity. Percent change ranged from 43.6% to 50.8% by week 52. In contrast, with vehicle, there was no appreciable improvement with a mean target toenail involvement of 30% or greater at baseline. Only in patients with less than 30% target toenail involvement at baseline was some improvement seen with vehicle, although not apparent before week 36.

Patients suffering from onychomycosis can often face many weeks of treatment before noticeable improvement in their toenails is seen. Being able to provide patients with both reassurance and realistic expectations in the early weeks of treatment are important if we are to ensure longer-term success.

Clinical trial data can provide the dermatologists with guidance in terms of which treatments are likely to be the more successful, but efficacy outcomes based on complete cure are felt by some to be unrealistic and not so helpful in the real world.^16,17

In this study we assessed the degree of improvement over time and aimed to identify factors that might influence the appearance of the toenail. Our study suggests that patients might expect a 50% improvement in their affected target toenail within one year irrespective of baseline severity. Clinical data suggests almost 1 in 5 patients (18.5%) will be recognized as complete cures.¹⁸ Over the duration of the studies, treatment with efinaconazole led to a 43% mean improvement of the target toenail, which will be seen as significant by many patients. In contrast, the mean percent involvement of the target toenail treated with vehicle did not change, apart from in the group of patients with relatively mild disease (less than 30% target toenail involvement) where there was some small improvement from week 36. Mean data suggest that the degree of improvement was not influenced by baseline severity; with almost half of the affected nail growing out at the end of the study in patients treated with efinaconazole.

Improvement in the appearance of the nail did seem to be influenced by gender and disease duration, so it is likely that female patients and those with more recent disease will see improvement much quicker. The greater efficacy of efinaconazole in

females has already been reported, although the reasons are less clear.¹⁸ Male patients may be more difficult to treat, or are more likely to present with more severe disease. They may also be less compliant. It may be that their toenails just take longer to grow out and therefore require longer therapy as suggested by the trajectories in our analysis. Although the benefit seen in females by week 52 is greater, the net benefit (active minus vehicle) is similar to that seen in males.

The importance of treating early onychomycosis (when it may be less severe) has been highlighted by other workers.19 Our analysis showed greatest benefit with efinaconazole in those patients who had suffered from onychomycosis for less than a year. Although baseline severity was similar to that of patients with long-standing disease (mean % nail involvement of 33.5% compared to 37.2%), it is recognized that patients with long-standing disease had more non-target toenails affected.¹⁹

So what guidance can we provide our onychomycosis patients being treated with a topical antifungal such as efinaconazole topical solution, 10%? Firstly, it is important to emphasize that it is a long-term solution, aiming to reverse a disease process that has been progressively worse for several years. While it could take many months for the diseased nail to grow out completely, improvements are likely to be noticed as early as 12 weeks, especially in females and those with more recent disease. In addition, patients must be aware of the concomitant management strategies essential to keep the disease under control. Aside from the confirmation of the diagnosis, this includes proper nail care, treatment of recurrent tinea pedis and eradication of the nail reservoir of dermatophytes, use of nail polish and potential issues with therapies, and the potential for recurrence with non-adherence to the extent of the treatment course.

The author acknowledges Brian Bulley, MSc, of Inergy Limited for medical writing support. Valeant Pharmaceuticals North America LLC funded Inergy’s activities pertaining to this manuscript.

Dr. Bhatia is a consultant and/or speaker for Actavis, Allergan, Aqua, Bayer, Dusa, Exeltis, Ferndale, Galderma, Leo, Nerium, Novartis, PharmaDerm, Promius, and Valeant.