Young children with moderate-to-severe atopic dermatitis treated with dupilumab had reduced infection rates, including severe and serious cases, compared to placebo, according to a recent study.

The study evaluated the long-term safety of dupilumab in children aged six months to five years with moderate-to-severe atopic dermatitis (AD). This open-label extension (OLE) study analyzed infection rates following a median of 52 weeks of dupilumab treatment and compared outcomes with those observed in a prior 16-week randomized controlled trial (RCT).

Results, published in Pediatric Dermatology, indicated that infection rates were reduced but not eliminated during the OLE study, with 101.0 patients per 100 patient-years (PY) experiencing infections compared with 245.7 patients per 100PY in the placebo group and 185.2 patients per 100PY in the dupilumab group of the RCT. Severe and serious infections were rare in the OLE study (3.1 patients per 100PY), similar to the low rate observed in the dupilumab group of the RCT, and substantially lower than the rate in the placebo group (17.1 per 100PY). No infections in the OLE study necessitated treatment discontinuation. Rates of nonherpetic skin infections were also lower during the OLE study (22.7 per 100PY) compared with the placebo (92.7 per 100PY) and dupilumab groups (42.7 per 100PY) in the RCT.

Use of systemic anti-infective medications declined during the OLE study, with 58.9 patients per 100PY requiring such treatments compared with 203.0 per 100PY in the placebo group. Researchers attributed these reductions in infections and medication use to the ability of dupilumab to restore skin barrier function and normalize immune responses. Viral, bacterial, and fungal infections remained uncommon and generally mild.

Despite limitations such as the open-label design, non-standardized concomitant treatments, and a small sample size for patients younger than two years, the findings provide evidence for the safety of dupilumab in reducing infection risks over the long term. This study adds to the evidence supporting dupilumab’s role in reducing infection risks in young children with moderate-to-severe atopic dermatitis.

Full disclosures can be found in the published study.