Skip to main content

Clinically meaningful results and a demonstrated safety profile in adults with bullous pemphigoid1

ADEPT was a phase 2/3 pivotal study that evaluated DUPIXENT for sustained disease remission, impact on itch, and safety1,2

At Week 361
  • More patients achieved sustained remission with DUPIXENT + oral corticosteroid (OCS) taper vs placebo + OCS taper (18% vs 6%; primary endpoint; 95% CI: 12.2% [-0.8, 26.1])a,b
  • Clinically meaningful itch improvement in 38% vs 11% of patients, respectively (secondary endpoint; 95% CI: 27.8% [11.6, 43.4])c
  • Median cumulative dose of OCS at Week 36 was 2.8 g in patients treated with DUPIXENT vs 4.1 g with placebo
VIEW DATA

aThis data analysis for the primary endpoint did not meet statistical significance.

bThe primary endpoint of sustained remission consisted of 3 components: complete remission and off OCS by Week 16, no rescue therapy from baseline to Week 36, and no disease relapse after completing OCS taper to Week 36. Complete remission was defined as the absence of new lesions and epithelialization of old lesions. During OCS taper, participants were permitted to increase their OCS dose once (subsequent dose increases were considered rescue therapy). Rescue therapy could include a second increase of OCS dose during the taper period, use of OCS after completion of the OCS taper/Week 16, or initiation of high-potency TCS, systemic nonsteroidal immunosuppressive medication, or immunomodulating biologic therapy. Disease relapse was defined as appearance of ≥3 new lesions/month (blisters, eczematous lesions, or urticarial plaques) or ≥1 large (>10 cm in diameter) eczematous lesion or urticarial plaque that did not heal within 1 week.1,2

cDefinitive conclusions cannot be made for these results. Data were not multiplicity controlled.

Demonstrated long-term safety profile through Week 521,a

The most common adverse reactions (incidence ≥2%) in patients with bullous pemphigoid are arthralgia, conjunctivitis, vision blurred, herpes viral infections, and keratitis.1

A case of acute generalized exanthematous pustulosis (AGEP) was reported in 1 subject with bullous pemphigoid treated with DUPIXENT compared with 0 subjects in the placebo group.1

aAt the time of safety analysis, 87 subjects had completed Week 36, and 65 subjects had completed Week 52.1

Explore images of real patients with BP

IDENTIFYING PATIENTS

BP, bullous pemphigoid.