Disease burden among patients with atopic dermatitis treated with systemic therapy for 4–12 months: results from the CorEvitas Atopic Dermatitis Registry

Abstract

Background

Real-world data on the effectiveness of systemic therapy in atopic dermatitis (AD) are limited.

Methods

Adult patients with AD in the CorEvitas AD registry (2020–2021) who received systemic therapies for 4–12 months prior to enrollment were included based on disease severity: body surface area (BSA) 0%–9% and BSA ≥10%. Demographics, clinical characteristics, and outcomes were assessed using descriptive statistics. Pairwise effect sizes (ES) were used to compare BSA groups.

Results

The study included 308 patients (BSA 0%–9%: 246 [80%]; BSA ≥10%: 62 [20%]). Despite systemic therapy, both BSA groups reported the use of additional topical therapy and the presence of lesions at difficult locations. Moderate-to-severe AD (vIGA-AD^®) was reported by 11% (BSA 0%–9%) and 66% (BSA ≥10%; ES = 0.56) of patients. Mean disease severity scores: total BSA (2% and 22%; ES = 3.59), EASI (1.1 and 11.1; ES = 2.60), and SCORAD (12.1 and 38.0; ES = 1.99). Mean scores for PROs: DLQI (3.7 and 7.5; ES = 0.75), and peak pruritus (2.2 and 4.5; ES = 0.81). Inadequate control of AD was seen in 27% and 53% of patients (ES = 0.23).

Conclusions

Patients with AD experience a high disease burden despite systemic treatment for 4–12 months. This study provides potential evidence of suboptimal treatment and the need for additional effective treatment options for AD.

KEY POINTS

• This real-world study assessed clinical characteristics and overall disease burden in adult patients with atopic dermatitis (AD) who were receiving systemic therapy for 4–12 months.

• Patients reported greater involvement of back and anterior trunk, and lesions at difficult locations. Irrespective of body surface area involvement, patients continued to experience inadequate control of AD, varied disease severity, and impact on quality of life.

• The study provides potential evidence of suboptimal treatment and the need for effective treatment options for the management of AD. Besides clinical outcomes, treating dermatologists and dermatology practitioners should include patient-reported outcomes in routine clinical care to determine the best treatment options for their patients.

Keywords:

• Atopic dermatitis
• systemic therapy
• disease burden

Acknowledgments

The authors would like to thank all the investigators, their clinical staff, and patients who participated in the CorEvitas Atopic Dermatitis Registry. The authors thank Moksha Shah of Eli Lilly Services India Private Limited, Bengaluru, India, for providing medical writing support.

Ethical approval

The study was performed following Good Pharmacoepidemiology Practices (GPPs). All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review was obtained through a central Institutional Review Board (IRB), the New England Independent Review Board (NEIRB; no. 120160610). For academic investigative sites that did not receive a waiver to use the central IRB, full board approval was obtained from the respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC prior to the initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization prior to participating.

Informed consent was obtained from all patients. This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GPPs and the applicable laws and regulations of the country or countries where the study was being conducted, as appropriate.

Author contributions

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Jonathan I. Silverberg: Data collection, data analysis, and editing of publication.

Evangeline Pierce: Conception and design of the work, analysis and interpretation of data for the work, and critical revision of the work for important intellectual content.

Meghan Feely: Data analysis and editing of publication.

Amber Reck Atwater: Data analysis and editing of publication.

Amy Schrader: Design of the work, analysis and interpretation of data for the work, and critical revision of the work for important intellectual content.

Eric A. Jones: Conception and design of the work, analysis and interpretation of data for the work, and drafting and critical revision of the work for important intellectual content.

Swapna S. Dave: Interpretation of data for the work and critical revision of the work for important intellectual content.

Eric L. Simpson: Interpretation of data for the work and critical revision of the work for important intellectual content.

Disclosure statement

Jonathan I. Silverberg: Honoraria as a consultant and/or advisory board member for AbbVie, Alamar, Aldena, Amgen, AObiome, Arcutis, Arena, Asana, Aslan, BioMX, Biosion, Bodewell, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara, Castle Biosciences, Celgene, Connect Biopharma, CorEvitas, Dermavant, Dermtech, Eli Lilly, Galderma, GlaxoSmithKline, Incyte, Kiniksa, Leo Pharma, My-Or Diagnostics, Nektar, Novartis, Optum, Pfizer, RAPT, Recludix, Regeneron, Sanofi-Genzyme, Shaperon, TARGET-RWE, Union, UpToDate; speaker for AbbVie, Eli Lilly, Leo Pharma, Pfizer, Regeneron, Sanofi-Genzyme; institution received grants from Galderma, Incyte, Pfizer.

Evangeline Pierce: Employment and stockholder, Eli Lilly and Company.

Meghan Feely: Associate staff member, Mount Sinai Hospital; current employment and shareholder, Eli Lilly and Company; consulting, travel, or speaker fees, American Academy of Dermatology, Aerolase, Castle Biosciences, CeraVe – L’Oréal, DREAM USA, Galderma Aesthetics, Glow Recipe, La Roche-Posay-L’Oréal, Revian, Sonoma Pharmaceuticals, Sun Pharma, and Suneva Medical.

Amber Reck Atwater: Employment and stockholder, Eli Lilly and Company; Pfizer Independent Learning and Change Grant (for fellow salary support; ended 5/2021); Patents planned, issued or pending, Eli Lilly and Company; President (2019–2021), American Contact Dermatitis Society (Board); Immediate Past President (2021–2023), American Contact Dermatitis Society (Board); Associate Editor, Contact Dermatitis, Dermatitis Journal (Board); Associate Editor, Cutis Journal (Board).

Amy Schrader: Employment, CorEvitas LLC, MA, USA.

Eric A. Jones: Former employment, CorEvitas LLC, MA, USA. Work related to the study was performed during his tenure at CorEvitas.

Swapna S. Dave: Former employment, CorEvitas LLC, MA, USA. Work related to the study was performed during her tenure at CorEvitas.

Eric Simpson: Grants/Research/Investigator (payments to OHSU), Kyowa HakkoKirin Pharma, Inc., AbbVie, Leo Pharma Inc., Merck, Eli Lilly and Company, Pfizer Inc., Novartis, Regeneron, Galderma Laboratories, LP, Sanofi, Incyte Corporation, Tioga Pharmaceuticals, Inc., Vanda Pharmaceuticals Inc., Amgen, Arcutis Inc, ASLAN Pharmaceuticals, Castle Biosciences, CorEvitas, Dermavant Sciences Inc, Dermira, National Jewish Health, Sanofi Genzyme, Target RWE, Arcotech Biopharma Inc, Kymab; Consulting fees (self), Boehringer Ingelheim, Forte Biosciences, Incyte Corporation, Regeneron, Sanofi Genzyme, Pfizer Inc., AbbVie, Eli Lilly and Company, Leo Pharma Inc., Dermira, Benevolent AI Bio Limited, Excerpta Medica B.V., Pierre Fabre, Roivant Sciences, Trevi Therapeutics, ASLAN, Valeant Pharmaceuticals International, Amgen, Arena Pharmaceuticals, BiomX Ltd., Bluefin Biomedicine, Coronado Biosciences, Janssen Research & Development, LLC, Kyowa Hakko Kirin Pharma Inc., Medscape, Ortho Dermatologics, Boston Consulting Group, Evidera, Collective Acumen LLC, Advances in Cosmetic Medical Derm Hawaii LLC, AOBiome, LLC, Arcutis Biotherapeutics, Bristol-Myers Squibb, CorEvitas, Evelo Biosciences, Inc., Gesellschaft Z, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, Physicians World LLC, WebMD, Med Learning Group, MJH Holding Company Inc.; Honoraria (self), AbbVie, Eli Lilly, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin, Leo, Pfizer, Regeneron, Sanofi, Medscape; Lecture fees (self), FIDE, Prime Education, Revolutionizing Atopic Dermatitis, Vindico Medical Education, Maui Derm; Reimbursement or travel costs cover (self), FIDE, Maui Derm, Sanofi-Regeneron; Advisory board (self), Merck, Arena Eli Lilly, GlaxoSmithKline, Incyte, Janssen, Kyowa Kirin, Leo, Pfizer, Regeneron, Sanofi; Honorarium, Chair of Sanofi-Genzyme and Regeneron US Medical Advisory Board; Chair of Research, Scientific Advisory Committee of the National Eczema Association; Chair of Atopic Dermatitis Expert Resource Group for the AAD; Board Member, International Society for Atopic Dermatitis (ISAD); Executive Member for the international Harmonizing Outcome Measures in Eczema (HOME) Working Group.

Data availability statement

Data are available from CorEvitas, LLC through a commercial subscription agreement and are not publicly available. No additional data are available from the authors.

Additional information

Funding

This study was sponsored by CorEvitas, LLC, and the analysis was funded by Eli Lilly and Company. Access to study data was limited to CorEvitas and CorEvitas statisticians completed all the analyses; all authors contributed to the interpretation of the results.