Interim Analysis Shows Dupilumab Safe, Effective for AD Treatment at 2 Years
The findings are consistent with previously reported data.
Dupilumab was associated with improved disease control in patients with moderate-to-severe atopic dermatitis (AD) at two years, according to a new interim analysis.
The study, published in Dermatology and Therapy, examined two-year data from the PROSE AD Registry (an ongoing, prospective, observational, multicenter registry based in the U.S. and Canada that includes patients aged ≥ 12 years with moderate-to-severe AD). Dupilumab was administered according to local (country) guidelines. Researchers looked at a number of severity and patient-reported assessments, including body surface area affected by AD (BSA), Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (P-NRS), Patient-Oriented Eczema Measure (POEM), Patient Global Assessment of Disease (PGAD) questionnaire score, and adverse events (AEs). The study included 764 adult and adolescent patients, 632 (83%) of whom remained in the study at the time of the present interim analysis.
According to the results, improvements were reported at first post-baseline clinic visits, which occurred at approximately three months, and these improvements were sustained through the two-year analysis period. Patient-reported measures, such as reporting conditions as "very good/excellent" on the PGAD questionnaire in response to queries about overall quality of life with eczema, were also reported. Treatment with dupilumab was also safe and well-tolerated, which according to the authors was consistent with previously reported study results looking at dupilumab for the treatment of AD.
"Interim real-world data from the ongoing PROSE AD registry indicate that adolescent and adult patients with moderate-to-severe AD who initiated dupilumab experienced sustained improvement in disease control, symptom burden, and HRQoL; safety data were consistent with the known safety profile of dupilumab," the researchers wrote. "These results support previous findings from the dupilumab clinical trial program in AD, showing dupilumab has a risk/benefit profile suitable for the treatment of patients with moderate-to-severe AD."
The real-world design of the study (with its lack of a comparator or placebo group) was cited as a study limitation.
Source
Simpson, E., Lockshin B., Lee, LW, et al. Real-world effectiveness of dupilumab in adult and adolescent patients with atopic dermatitis: 2-Year interim data from the PROSE Registry. Dermatol Ther (Heidelb) (2024). https://doi.org/10.1007/s13555-023-01061-4
Disclosures
The authors reported the following conflicts: Eric Simpson receives/has received grants/research support from AbbVie, Acrotech Biopharma Inc., Amgen, Arcutis Biotherapeutics, Aslan Pharmaceuticals, Castle Biosciences, CorEvitas, Dermavant Sciences, Dermira, Eli Lilly and Company, Incyte, Kymab, Kyowa Kirin, National Jewish Health, LEO Pharma, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Target RWE; and is/has been a consultant for Advances in Cosmetic and Medical Dermatology Hawaii LLC, AbbVie, Amgen, AOBiome LLC, Arcutis Biotherapeutics, Arena Pharmaceuticals, Aslan Pharmaceuticals, Boehringer Ingelheim USA, Inc., Boston Consulting Group, Bristol Myers Squibb, Collective Acumen LLC (CA), CorEvitas, Dermira, Eli Lilly and Company, Evelo Biosciences, Evidera, Excerpta Medica, FIDE, Forte Biosciences, Galderma, GlaxoSmithKline, Incyte, Janssen, Johnson & Johnson, Kyowa Kirin Pharmaceutical Development, LEO Pharma, Medscape LLC, Merck, MauiDerm, MLG Operating, MJH Holdings, Pfizer, Physicians World LLC, PRImE, Regeneron Pharmaceuticals, Revolutionizing Atopic Dermatitis Inc., Roivant, Sanofi-Genzyme, Trevi Therapeutics, Valeant Pharmaceuticals, Vindico Medical Education, and WebMD. Ben Lockshin has received investigator and speaker fees from Eli Lilly and Regeneron Pharmaceuticals Inc.; investigator fees from Anacor Pharmaceuticals, Dermira, Franklin Bioscience, and LEO Pharma; and investigator/speaker/consultant fees from AbbVie. Lara Wine Lee is on the Advisory Board of Castle Creek, Eli Lilly, Pfizer, Regeneron Pharmaceuticals Inc., and Verrica; is a consultant for AbbVie, Amryt, Krystal Biotech, Novartis, and Kimberly Clark; is/has been an investigator for AbbVie, Amgen, Amryt, Arcutis, Castle Creek, Celgene, Eli Lilly, Galderma, Incyte Corp, Mayne Pharmaceuticals, Moonlake Pharmaceuticals, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi, Target Pharma, Timber Pharmaceuticals, Trevi Therapeutics, and UCB; and has received speaker fees from Amryt and Krytsal Biotech. Moataz Daoud is a Sanofi employee and may hold stock and/or stock options in the company. Zhen Chen and Andrew Korotzer are employees and shareholders of Regeneron Pharmaceuticals Inc.
The funders participated in the conception and design of the study, analysis and interpretation of the data, and drafting and critical revision of the report, and also gave approval to submit. Conceptualization: Andrew Korotzer, Moataz Daoud, Zhen Chen. Data Curation: Andrew Korotzer, Moataz Daoud, Zhen Chen. Formal analysis: Andrew Korotzer, Moataz Daoud, Zhen Chen. Investigation: Eric L. Simpson, Lara Wine Lee. Writing–review and editing: Andrew Korotzer, Ben Lockshin, Eric L. Simpson, Laura Wine Lee, Moataz Daoud, Zhen Chen.