HealthCert Blog

A recent study in the Netherlands was the first to look at long-term oral treatment for atopic dermatitis. It investigated long-term effectiveness, safety and drug survival of methotrexate and azathioprine.

In an open‐label follow‐up phase of a clinical trial, patients were seen every three months for five years. Methotrexate and azathioprine doses could be increased or decreased concurrent with daily clinical practice.

Primary effectiveness outcomes were mean absolute and relative reduction in SCORing Atopic Dermatitis (SCORAD) index and Investigator’s Global Assessment after five years compared with baseline. To assess safety, the type, frequency, severity and relatedness to treatment of adverse events were investigated. Drug survival was analysed by Kaplan–Meier curves.

Thirty‐five of 43 originally included patients participated, of whom 27 completed the follow‐up. At year five, the mean relative reduction in SCORAD index was similar in the methotrexate and azathioprine groups: 53% and 54% using descriptive analysis.

Twelve serious adverse events occurred in five years; for three there was a possible causal relationship. Drug survival demonstrated a longer survival for methotrexate, but survival in both groups was low after five years.

Based on this relatively small pragmatic study, methotrexate and azathioprine seem to be effective and safe as maintenance treatments in moderate‐to‐severe atopic dermatitis up to five years. Few patients in both groups survive on their originally allocated drug although some discontinued because of controlled atopic dermatitis.