Dupilumab Shown to Reduce Symptoms, Steroid Use in BP

ORLANDO, Fla. — The interleukin (IL)-4 and IL-13 inhibitor dupilumab improved itch symptoms and curtailed disease activity while also reducing oral corticosteroid use in older patients with bullous pemphigoid (BP), a phase 2/3 study demonstrated.

“Dupilumab demonstrated significant benefits across multiple disease aspects in BP at 36 weeks, including achieving sustained remission at week 36 while off steroids, improving disease activity and itch, reducing the risk of using rescue medications, and achieving corticosteroid-sparing benefit,” said Frédéric Caux, MD, PhD, head of dermatology at Avicenne Hospital in Bobigny, France, at the late-breakers session at the American Academy of Dermatology 2025 Annual Meeting, where he reported the results of the ADEPT trial.

Overall, safety was consistent with findings reported in clinical trials of other indications for dupilumab, Caux said.

The trial enrolled 106 patients with moderate to severe BP, randomly assigned to either a 300 mg injection of dupilumab every 2 weeks after an initial loading dose or a placebo. All patients also received standard-of-care oral corticosteroids with a defined tapering regimen if their disease activity was under control and maintained. The average age of BP onset in the study population was 71 years in both groups.

The US Food and Drug Administration (FDA) in February accepted for priority review the biologics license application for dupilumab to treat BP.

‘Corticosteroid-sparing Benefit’

By week 16, 38.4% of dupilumab patients and 26.6% of control individuals had complete remission and were off oral corticosteroid therapy (P = .2419). At week 36, Caux reported that 20.2% of patients on dupilumab had sustained disease remission vs 4% of placebo patients (P = .0114).

At 36 weeks, 42.2% of the dupilumab patients did not need any rescue therapy vs 11.8% of control individuals (P = .0004). After discontinuing oral corticosteroids at weeks 16 through 36, 58.5% of the treatment group vs 15.8% of the placebo group had no disease relapse (P = .0023).

Rescue therapy consisted of either increasing the oral corticosteroid dose or, if the patient had stopped taking them, resuming oral corticosteroid treatment, principal trial investigator Victoria Werth, MD, chief of dermatology at the Philadelphia Veterans Administration Hospital, Philadelphia, and professor of dermatology at the University of Pennsylvania in Philadelphia, told Medscape Medical News.

“The findings are important in terms of the disease activity: Improving the itching; improving the need for rescue medication was different; and the steroid-sparing effect,” Werth said.

“We know this is an older age patient, and they really don’t do well with steroids, so being able to minimize that is very critical,” she added. “They were more likely to get off steroids, so I think these are all important endpoints for a rather vulnerable population.”

Why Reducing Corticosteroids Matters

The study findings are significant because they showed that older patients with BP could reduce or even eliminate their use of oral corticosteroids, said Robert Dellavalle, MD, PhD, chair of the Department of Dermatology at the University of Minnesota, Minneapolis, and national dermatology executive program director of the US Department of Veterans Affairs.

“Steroids have multiple effects of predisposing for diabetes or elevated sugar, changing behavior, disturbing sleep, dissolving bones,” he told Medscape Medical News. “If you’re between a rock and a hard place of having blistering skin or having those side effects, probably those side effects are not as concerning as having your skin blister, but if we have a treatment that doesn’t have those side effects, like dupilumab, that’s a great alternative,” said Dellavalle, who was asked to comment on the results and was not an investigator.

The study findings make a confirmatory case for the FDA to add BP as an indication for dupilumab, he added. “It’s great support for what people are already doing in the field and will probably do more so, using dupilumab for BP,” Dellavalle said.

However, he added that the cost of biologic drugs such as dupilumab is significantly higher than oral corticosteroids. “As we use more expensive medications for more and more things in dermatology, we have to ask, how long will our health care system support that?” Dellavalle said. “That’s always the dilemma.”

The study was funded by Regeneron Pharmaceuticals. Both Caux and Werth reported financial relationships with Regeneron Pharmaceuticals. Dellavalle reported no relevant financial relationships.

Richard Mark Kirkner is a medical journalist based in Philadelphia.