Comparison of safety profile in patients with atopic dermatitis treated with dupilumab or conventional systemic treatment: real world data from the US network

J Dermatolog Treat. 2024 Dec;35(1):2421429. doi: 10.1080/09546634.2024.2421429. Epub 2024 Nov 3.

Abstract

Background: Safety of dupilumab in atopic dermatitis (AD) was investigated in randomized controlled trials (RCT). However, head-to-head trials comparing with conventional systemic drugs are lacking and large real-world data on the long-term safety profile as compared are scarce.

Objective: To compare long-term safety profile of dupilumab with conventional systemic drugs used in the management of moderate to severe AD.

Methods: Data from electronic health records of AD patients treated with either dupilumab, azathioprine, Cyclosporine A, mycophenolate mofetil, methotrexate, or oral glucocorticoids were retrieved from the TriNetX US Collaborative Network. Risks of adverse events and new onset of type-2-inflammatory diseases within 5 years after treatment initiation was investigated.

Results: 5 propensity-matched cohorts, up to 18,708 individuals per cohort, were created. Dupilumab treatment displayed reduced risk for diseases of the circulatory, the upper respiratory, and the musculoskeletal system, infections, and type 2 diseases as compared to all other treatment options. In contrast risk for conjunctivitis was increased in dupilumab treated patients as compared to mycophenolate mofetil and methotrexate.

Conclusion: Here presented data indicates that treatment with dupilumab for AD has reduced risk for adverse effects of conventional systemic drugs and thus might be safer. Obtained data should be verified in prospective studies.

Keywords: Atopic dermatitis; TriNetX; comorbidities; conventional systemic therapy; dupilumab; risk; safety.

Plain language summary

Moderate to severe atopic dermatitis can be treated by using conventional systemic treatments, monoclonal antibodies, or JAK inhibitors.Direct comparison on safety between conventional systemic treatments and monoclonal antibodies are lacking.Treatment with dupilumab reduced the risk for type 2 diseases and diseases affecting the upper respiratory and circulatory system in comparison to conventional systemic treatments.Dupilumab for the treatment of atopic dermatitis might have reduced risk for adverse effects of conventional systemic drugs and thus might be safer.

Publication types

  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Azathioprine / adverse effects
  • Azathioprine / therapeutic use
  • Cyclosporine / adverse effects
  • Cyclosporine / therapeutic use
  • Dermatitis, Atopic* / drug therapy
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use
  • Female
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / adverse effects
  • Glucocorticoids / therapeutic use
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Methotrexate* / adverse effects
  • Methotrexate* / therapeutic use
  • Middle Aged
  • Mycophenolic Acid / adverse effects
  • Severity of Illness Index
  • Treatment Outcome
  • United States
  • Young Adult

Substances

  • dupilumab
  • Antibodies, Monoclonal, Humanized
  • Methotrexate
  • Mycophenolic Acid
  • Cyclosporine
  • Azathioprine
  • Dermatologic Agents
  • Glucocorticoids
  • Immunosuppressive Agents