MMF relatively safe for off-label use in children, adults with severe AD

For pediatric and adult patients with severe atopic dermatitis (AD), treatment with the systemic immunomodulator methotrexate mycophenolate mofetil (MMF) is a relatively safe and well-tolerated as a long-term maintenance therapy option, according to a review of the drug in severe AD in the June 2016 Journal of Drugs in Dermatology.

Topical therapies, phototherapy and emollient use provide adequate relief for most AD patients. For those whose disease is not controlled by these conventional treatments, however, dermatologists might prescribe systemic immunomodulators. While dermatologists prescribe systemic immunomodulators, such as cyclosporine, MMF and azathioprine, to adults and children with severe AD, these drugs have not been FDA approved for AD treatment.

The authors looked at the available evidence for MMF use in children and adults with AD, and report that MMF is a potent inhibitor of the type II isoform of inosine monophosphate dehydrogenase, which is expressed in activated B and T cells. As a result, the drug, which is used to manage organ transplant patients and off-label for some autoimmune diseases, selectively inhibits B and T lymphocyte proliferation.

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MMF has been shown in multiple studies to be a promising treatment for refractory AD. But the drug was given a “C” rating and level of evidence II in the American Academy of Dermatology’s guidelines for AAD management and treatment because there are no randomized placebo-controlled studies.

AAD guidelines recommend using 1.0-1.5 g orally, twice daily for adults and 600 to 1,200 mg/m² or 30 to 50 mg/kg a day for children. MMF is usually well tolerated at those doses. Reported cytopenia cases require that dermatologists do regular blood count monitoring. Use of enteric-coated MMF might reduce gastrointestinal adverse reactions. Reports of infection, as well as cancer, which was highlighted by a 2008 FDA safety report suggesting an association between MMF and progressive multifocal leukoencephalopathy, are mostly based on the treatment of organ transplant patients who take multiple immunosuppressant drugs, according to the authors.

Large prospective randomized controlled trials are needed to study MMF’s long-term safety, efficacy and optimal dosing, in order to establish a standardized regimen for dermatologist’s use of MMF in severe adult and pediatric AD, the authors write. 

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“We use MMF a lot for severe atopic dermatitis and other chronic dermatologic conditions at Tufts Medical Center. It was very helpful to review and summarize research literature available to provide our patients more information regarding expected rates of clinical response and side effects of MMF compared to other systemic treatment options,” study author Natalia Plotnikova, M.D., dermatology resident at Tufts Medical Center in Boston, tells Dermatology Times.

Disclosure: Dr. Plotnikova has no conflicts, however, one of the study’s authors has related industry ties.