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Evaluation of effectiveness and safety of new systemic treatments for atopic dermatitis (AD) after approval is important. There are few published data exceeding 52-week therapy with dupilumab.
To examine the safety, effectiveness and drug survival of dupilumab in a Danish nationwide cohort with moderate-to-severe AD up to 104 weeks exposure.
We included 347 adult patients with AD who were treated with dupilumab and registered in the SCRATCH registry during 2017-2022.
At all visits, we observed improvement in AD severity measured by Eczema Area and Severity Index (EASI) [median (IQR)]. EASI score at baseline was 18.0 (10.6-25.2), at week 4: 6.5 (3.5-11.6), at week 16: 3.7 (1.2-6.2), at week 52: 2.0 (0.8-3.6), at week 104: 1.7 (0.8-3.8). While drug survival was high (week 52: 90%; week 104: 86%), AD in the head-and-neck area remained present in most patients at high levels; proportion with head-and-neck AD at baseline was 76% and 68% at week 104. 35% of patients reported any AE. Conjunctivitis was the most frequent (25% of all patients) and median time to first registration of conjunctivitis was 201 days.
While 2-year drug survival was 86%, dupilumab was unable to effectively treat AD in the head-and-neck area, and conjunctivitis was found in 25% of patients.
Disclosure statements are available on the authors' profiles:
A nationwide 104 weeks real-world study of dupilumab in adults with atopic dermatitis: Ineffectiveness in head-and-neck dermatitisJ Eur Acad Dermatol Venereol 2023 Jan 06;[EPub Ahead of Print], I Vittrup, NS Krogh, HHP Larsen, J Elberling, L Skov, KS Ibler, GBE Jemec, CG Mortz, RO Bach, C Bindslev-Jensen, MG Dalager, A Egeberg, T Agner, M Deleuran, C Vestergaard, JP Thyssen
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Phase III trials demonstrate safety and efficacy of new therapies over a circumscribed study period, often 12–16 weeks for dermatologic medications. We must, however, rely on post-marketing investigation to paint a more realistic portrait of real-life risks and benefits. Vittrup and colleagues assessed a Danish cohort of 347 adults with atopic dermatitis followed for up to 104 weeks to address some of these issues relating to dupilumab.
First, Eczema Area and Severity Index (EASI) scores continued to improve throughout the study period, with a mean baseline EASI of 18 (10.6–25.12), 3.7 (1.2–6.2) at 1 year, and 2.0 (0.8–3.6) at 2 years. Patients should know that improvement is most dramatic during the first 4 to 16 weeks, but gains may yet occur and effects are durable. Second, dupilumab is not a good medication for everyone with atopic dermatitis. Nearly 5% dropped out due to adverse effects (25% developed conjunctivitis first presenting at a mean of 201 days) and 2% due to lack of efficacy. Third, there were no new safety signals. Finally, and perhaps most intriguingly, a striking percentage of patients with head and neck dermatitis reported refractoriness to dupilumab (76% reported head and neck dermatitis at baseline vs 68% at 2 years). New-onset facial erythema, a vexing adverse effect reported in some dupilumab-treated patients, was rarely seen in this cohort.
As new medications for atopic dermatitis come online — three have been approved in the past year alone — providers will have an abundance of choices, previously unheard of in AD therapy. Shared decision–making must take into consideration individual patient characteristics to optimally match patient and therapy. Granular analysis of this sort will lead the way.