MONTREAL — Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis (ISAD).
“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
The rate of AD at 2 years — the primary outcome of the BEEP trial — have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice vs standard skin-care advice alone among 1394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Williams explained.
At 2 years, 23% of the emollient group vs 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention, but also with other related disorders, he explained.
“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”
The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs 28% in controls), clinical diagnosis of food allergy (15% vs 14%, respectively), or other outcomes.
“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Williams commented, adding that he does not recommend use of emollients for AD prevention.
“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University in Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well…showing a positive effect,” he added, referring to the small, single-center STOP-AD trial that was recently reported by Medscape.
“We’re always hoping and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, Toronto, Canada, told Medscape Medical News. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”
Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”
He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Drucker advised.
Williams and Drucker report no relevant financial relationships.
International Society of Atopic Dermatitis (ISAD) 2022: Abstract OL.1 Presented October 17, 2022.
Kate Johnson is a Montreal-based freelance medical journalist who has been writing for more than 30 years about all areas of medicine.