05/05/2020    Bryan C. Markinson, DPM

FDA Approves JUBLIA® for Ages 6 and Older

The FDA approval of Jublia in pediatric patients
is a good development. In my practice, 90% of
patients interested in possible cure (largely
clinical) of onychomycosis are treated with
systemic therapy and 90% of those are with oral
terbinafine. This includes asymptomatic HIV
patients and patients who have been cured of Hep
C (in consultation with their hepatologist or ID
specialist), and children. Terbinafine in
children is off label use, but pediatric dosages
have been well established. Patients are also
informed about important adjunctive measures such
as cleaning of shoes, avoidance of barefoot
walking, treatment of concomitant tinea pedis
(including those they live with), and general
good hygiene practices. In 100% of patients in
whom I plan to use any FDA approved agent
treatment is NOT started until their diagnosis
has been laboratory confirmed. In my hospital
laboratory, a PAS stain and fungal culture of
deep proximal subungual material results in 95%
confirmation of dermatophyte infection. All of my
treated patients are put on topical anti-fungal
cream for life.

Here are some observations:

1) A high percentage of highly motivated patients
at the beginning become not highly motivated
within three months. Some patients bow out before
treatment starts when I am done informing them
what they need to do to maximize chances for
success.

2) Clinical success or acceptable improvement
occurs in a high percentage of patients,
especially those with less than 50% of nail
involvement

3) In the past 20 years, less than five patients
experienced any one of the well published side
effects of systemic therapy, none permanent.

4) Non adherence to adjunctive measures after
drug therapy stops, results in almost 100%
recurrence within 2-3 years.

5) 90% of patient's, when asked if they are
adhering to adjunctive measures, respond as
follows; "Not as much as I should."

When it comes to FDA approved topical agents,
such as Jublia or Kerydin, it is very unfortunate
to meet so many patients who have been prescribed
these very expensive agents for no other reason
than not to worry about systemic side effects. It
is undeniable that safety concerns (deserved or
not) are the prime driver of the topical
antifungal market. It is true however, that we do
need to provide an alternative for motivated
patients who simply won't take systemic therapy.
Along with that, there is a very high percentage
of patients who are prescribed these agents
(especially by primary care physicians and
dermatologists, as well as podiatrists) WITHOUT
laboratory confirmation of the diagnosis
(depending on insurance requirements). So if
failure occurs, we don't know if they are non-
responders or even if they have a fungal
infection of the nail in the first place. Same is
true for oral therapy. We should not be getting
laboratory confirmation when insurance requires
it, it should be standard of care always.

My concern is that approval of Jublia for use in
children will result in a high rate of use
without laboratory confirmation of diagnosis, and
without diligent explanation of the work involved
with adjunctive measures to maximize chances of
success, and the need for patience to observe
positive results. Safety is of course one
important issue, but it should not exclude
recognized best practices that enhance success.
It is not fair to the patients, and not fair to
the drug that ends up declared a failure when it
never had a chance.

Bryan C. Markinson, DPM, NY, NY

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