Real-world utilization patterns of systemic immunosuppressants among US adult patients with atopic dermatitis

PLoS One. 2019 Jan 25;14(1):e0210517. doi: 10.1371/journal.pone.0210517. eCollection 2019.

Abstract

At the time of this study, prior to the introduction of biologics in the US, systemic therapies used for the treatment of moderate-to-severe atopic dermatitis included off-label immunosuppressants and corticosteroids. Immunosuppressant therapy is associated with a substantial risk of side-effects, therefore needing clinical monitoring, and is likely to incur a significant healthcare burden for patients and payers. This retrospective cohort study based on claims data measured immunosuppressant use and its associated burden among US adult patients with atopic dermatitis covered under commercial or Medicare Supplemental insurance from January 01, 2010, to September 30, 2015. Overall, based on age, gender, region, and index year, 4201 control patients with atopic dermatitis without immunosuppressant use were matched with 4204 patients treated with immunosuppressants. The majority (68.5%) of patients using immunosuppressants were non-persistent with immunosuppressant treatment during the 12-month follow-up period after a mean (standard deviation) of 88.1 (70.7) days of immunosuppressant use; 72.3% required systemic steroid rescue treatment. Immunosuppressant users had higher incidence of immunosuppressant-related clinical events than controls; in addition, a larger proportion of immunosuppressant users versus controls developed cancer (0.28% vs 0.14%, respectively; P < 0.0001). Healthcare utilization and costs associated with clinical events and monitoring were also higher for immunosuppressant users compared with controls (total costs, $9516 vs $1630, respectively; P < 0.0001; monitoring costs, $363 vs $54, respectively; P < 0.0001). This study revealed that patients treated with systemic immunosuppressants often require systemic steroids or changes to treatment. The increase in immunosuppressant-related clinical events, including the need for increased monitoring with immunosuppressant treatment, compared with controls demonstrates a substantial treatment burden and highlights the unmet need for more effective long-term therapies for atopic dermatitis with improved safety profiles and reduced monitoring requirements.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Aged
  • Costs and Cost Analysis / economics
  • Costs and Cost Analysis / statistics & numerical data
  • Dermatitis, Atopic / drug therapy*
  • Female
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Insurance Claim Review / economics*
  • Insurance Claim Review / statistics & numerical data
  • Male
  • Middle Aged
  • Patient Acceptance of Health Care / statistics & numerical data
  • Retrospective Studies
  • United States

Substances

  • Adrenal Cortex Hormones
  • Immunosuppressive Agents

Grants and funding

Study funded by Sanofi and Regeneron Pharmaceuticals, Inc. No specific grants were issued to individual authors. Medical writing support was provided by Elien Moes, PhD, ISMPP CMPP™ and Sam Lewtas, MRPharmS, of Prime, Knutsford, UK, and funded by Sanofi and Regeneron Pharmaceuticals, Inc. The authors were responsible for all content and editorial decisions, and received no honoraria related to the development of this publication. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the International Committee of Medical Journal Editors criteria for authorship for this manuscript, take responsibility for the integrity of the work and have given final approval for the version to be published. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.