Systemic Therapies for Pediatric Atopic Dermatitis

Severe and/or refractory cases of atopic dermatitis (AD) can require systemic
immunosuppressive therapy for disease control, yet there are few studies regarding the
appropriate use of these drugs for pediatric AD and even less data comparing them. The
current observational study will observe the effect of these therapies on children with
moderate to severe atopic dermatitis as they are treated. These drugs being observed will be
cyclosporine, azathioprine, mycophenolate mofetil, and methotrexate.

Inclusion Criteria:

- Diagnosis of moderate, severe, or very severe atopic dermatitis meeting the Hanifin
and Rajka criteria

- Needs systemic therapy (e.g. cyclosporine, azathioprine, mycophenolate mofetil, or
methotrexate) for severe atopic dermatitis

- Subject has severe or recalcitrant disease interrupting daily life as evidenced by
fulfilling 2 or more of the following 4 criteria:

- Failure of multimodal therapy including emollients/barrier repair, topical
anti-inflammatory agents (medium to high potency topical corticosteroids, and/or
low-potency or topical calcineurin inhibitors if facial/intertriginous areas),
and antihistamines

- Significant impairment in quality of life (physical, psychological, emotional)
such as significant sleep disruption, poor school performance, or frequent
school absenteeism, per the judgement of the investigator.

- Inability to receive, prior failure, or the need for more than one course of
phototherapy

- Prior failure or need for more than one course of another oral immunosuppressive
medication

- No serious medical condition that precludes the use of oral immunosuppressives based
on the subject's medical history, physical examination, and safety laboratory tests.

- Negative PPD within the last year prior to study initiation.

- Female of childbearing potential has a negative pregnancy test at the time of
starting the systemic drug and who consents to be abstinent or using an effective
method of contraception during the study. Effective contraception is defined as IUD,
condom with spermicide, diaphragm with spermicide, or stable use of a hormonal
contraceptive (oral, implant, injection or transdermal patch) beginning at least 1
month prior to starting the systemic drug.

- Subject and parent/guardian are willing and able to comply with study instructions
and return to the clinic for all required visits.

Exclusion Criteria:

- Female who is pregnant, nursing, or planning a pregnancy during the study period.

- Concurrent participation in another clinical trial with an investigational drug or
device that may impact on the individual's atopic dermatitis.

- Subjects with clinically significant hepatic disease, history of lymphoma or
myelosuppression, low TMPT activity (if starting azathioprine), renal disease (if
starting cyclosporine or azathioprine), hypertension (if starting cyclosporine),
blood dyscrasias, or central nervous system disorders, such as uncontrolled seizures
or peripheral neuropathy, or taking systemic medications that could interact
adversely with the study medicine (e.g. erythromycin use with cyclosporine).

- Subjects with any underlying disease that the Investigator deems uncontrolled, and
poses a concern for subject safety while participating on the study.

- Subject has a history of clinically significant drug or alcohol abuse in the last
year.

- Subject is considered by the Investigator, for any reason, to be an unsuitable
candidate for the study.

- Active systemic infection that could worsen with systemic therapy for AD.