Treatment of severe pediatric atopic dermatitis with methotrexate: A retrospective review

Abstract

Background/Objectives Severe atopic dermatitis (AD) may require systemic immunomodulatory agents to control symptoms. A lack of evidence and guidelines for systemic AD therapy in children has led to variability in agents selected and uncertainty in their comparative efficacy and safety. Evaluation of the efficacy of methotrexate in children with severe AD was performed. Methods We performed a retrospective chart review of 55 pediatric patients seen at Children's Hospital of Philadelphia that measured improvement using the Investigator's Global Assessment (IGA), a scale that rates AD symptoms from 0 to 5. Results About 76% of patients showed improvement with methotrexate. Mean baseline IGA of all patients was 4.18. After 6‐9 months of treatment, this improved to 2.94. There was additional improvement to a mean IGA score of 2.39 after 12‐15 months of treatment. At the final visit before each patient stopped methotrexate, the mean IGA score was 2.71. Approximately 50% of patients experienced minor side effects with gastrointestinal side effects the most common. Conclusions In a diverse patient population, safety and efficacy of methotrexate was demonstrated. Significant improvement in IGA was noted for the majority after 6‐9 months of therapy with further improvement when continuing treatment to 12‐15 months. Methotrexate remains an important option for long‐term symptom control with a favorable side effect profile and low cost.

A phase 2, open‐label study of single‐dose dupilumab in children aged 6 months to <6 years with severe uncontrolled atopic dermatitis: pharmacokinetics, safety and efficacy

“…Non‐corticosteroid alternatives, such as the topical calcineurin inhibitors (TCI) tacrolimus and pimecrolimus, are used to minimize chronic TCS exposure in AD, but access to these medications is often limited by payers, based on labeling for children aged >2 years 14–16 . The use of systemic corticosteroids is strongly discouraged in AD, 17 while other systemic immunosuppressants such as cyclosporine, methotrexate, azathioprine, and mycophenolate mofetil have been used off‐label, despite significant potential side effects, including procarcinogenic, hepatic and renal toxicity 18–22 . Immunomodulating treatment may impact immune development in children, and the immune mechanisms underlying AD in pediatric patients may differ from those in adults; 23,24 therefore, safety and efficacy of immunomodulatory agents should be assessed in dedicated, age‐specific clinical trials.…”

Topical and Oral Therapies for Childhood Atopic Dermatitis and Plaque Psoriasis

“…Clinical improvement occurred in 76% of 55 moderate to severe AD pediatric patients with a decrease of mean Investigator’s Global Assessment from 4.2 to 3.0 after 6 to 9 months of MTX treatment. There was additional improvement after 12 to 15 months [45]. MTX provided a reduction of Psoriasis Area and Severity Index (PASI) by 50% or greater in 58% in a small prospective study [36].…”

Monitoring trough levels in cyclosporine for atopic dermatitis: A systematic review

“…Most affected patients achieve disease control with topical agents alone, but some require systemic immunosuppression. Azathioprine, methotrexate, mycophenolate, and cyclosporine have all been successfully used in the treatment of moderate to severe pediatric atopic dermatitis…”