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Comparison of Long-Term Effectiveness and Safety of Upadacitinib for Atopic Dermatitis Between Dupilumab-Exposed and Dupilumab-Naïve Patients

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Abstract

Background and Objectives

Upadacitinib is an oral selective Janus kinase-1 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis (AD) in patients \(\ge\) 12 years of age. In real life, upadacitinib currently represents a valid therapeutic option for patients failing available systemic therapies, in particular patients who discontinued dupilumab because of lack of efficacy or occurrence of adverse events. The objectives of the present study were to compare the effectiveness and safety of upadacitinib in patients affected by AD who had previously failed dupilumab therapy versus biologic naïve patients.

Methods

A retrospective, multi-centre, observational, real-life study was conducted in four Italian dermatological referral centres (Milan, Perugia, Naples and Vicenza). Baseline characteristics included age, sex, AD history and severity, prior treatments, comorbidities and concomitant therapies. AD severity was assessed at baseline and at week 4 (W4), W16, W24 and W52, using Eczema Area Severity Index (EASI), Dermatology Life Quality Index (DLQI) and Pruritus Numerical Rating Scale (P-NRS) scores. Full blood count, hepatic and renal function, lipid panel, and muscle enzymes [lactate dehydrogenase (LDH) and creatine phosphokinase (CPK)] were assessed at baseline and at each follow-up visit.

Results

A total of 113 patients (72 males, 63.7%; mean age: 37.22 ± 16.8 years) were included in the analysis, all patients were in treatment and underwent follow-up period until W16, whilst 91 (80.5%) and 75 (66.4%) patients were in treatment and in follow-up period until W24 and W52, respectively.

Mean EASI score significantly changed from 24.30 ± 10.27 to 1.28 ± 4.34, 0.74 ± 2.31 and 0.25 ± 1.34 at W16, W24 and W52, respectively (p < 0.0001). Specifically, at W16 the percentage of patients achieving EASI-75, EASI-90 and EASI-100 was 85.21, 76.35 and 66.11%, respectively. At W24, EASI-75, EASI-90 and EASI-100 were reached by 88.54, 85.42, and 78.37% of patients, respectively. Finally, 90.1% of patients achieved EASI-75, 88.3% achieved EASI-90 and 83.0% achieved EASI-100 at W52.

Conclusions

This study confirmed the clinical effectiveness of upadacitinib treatment in adult patients in a real-world setting with moderate-to-severe AD who had discontinued dupilumab due to poor effectiveness or adverse events and who were biologic naïve; therefore, previous treatments do not seem to affect the response to upadacitinib treatment.

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Authors and Affiliations

  1. Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, 80131, Naples, Italy

    Maddalena Napolitano, Luciano Foggia & Vincenzo Picone

  2. Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy

    Silvia Mariel Ferrucci

  3. Dermatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy

    Katharina Hansel, Luca Stingeni & Elettra Antonelli

  4. Dermatology Unit, Ospedale San Bortolo, Vicenza, Italy

    Elena Pezzolo

  5. Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy

    Cataldo Patruno

Authors
  1. Maddalena Napolitano
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  2. Silvia Mariel Ferrucci
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  3. Luciano Foggia
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  4. Katharina Hansel
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  5. Elena Pezzolo
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  6. Luca Stingeni
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  7. Elettra Antonelli
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  8. Vincenzo Picone
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  9. Cataldo Patruno
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Corresponding author

Correspondence to Vincenzo Picone.

Ethics declarations

Funding

No funding was received to conduct this study. For some of the patients, AbbVie provided the drug upadacitinib through a compassionate use programme activated according to the DM 7/9/2017.

Conflict of interest

MN acted as speaker, consultant and advisory board member for Sanofi, Abbvie, Lilly, Leo Pharma and Pfizer; S.M.F. is speaker of Novartis and Sanofi Genzyme, is principal investigator for Eli Lilly, AbbVie, Sanofi Genzyme, and is an advisory member of Sanofi Genzyme; L.S. acted as speaker and board member for Sanofi-Genzyme; C.P. acted as investigator, speaker, consultant and advisory board member for AbbVie, Eli Lilly, Novartis, Pfizer, Pierre Fabre and Sanofi. The other authors have no competing interests to declare.

Ethics approval

Approval of this study was obtained by the Local Ethics Committee (Prot. N. 116/20, approved on December 5, 2022).

Consent to participate

The patients in this manuscript have given written informed consent to participate in the study.

Consent for publication

The patients in this manuscript have given written informed consent to publication of their case details.

Data availability statement

All data are reported in the current study.

Code availability

Not applicable.

Author contributions

All authors made substantial contribution to this manuscript and in detail: MN conceptualized, designed the study, analysed and interpretated the data and drafted the article; SMF, KH, EP and EA acquired data and clinically managed patients; LF and VP performed statistical analysis of data with graphical and tabular conceptualization; LS and CP reviewed the article critically for important intellectual content. All authors read and approved the final version of the manuscript.

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Napolitano, M., Ferrucci, S.M., Foggia, L. et al. Comparison of Long-Term Effectiveness and Safety of Upadacitinib for Atopic Dermatitis Between Dupilumab-Exposed and Dupilumab-Naïve Patients. Clin Drug Investig 44, 71–77 (2024). https://doi.org/10.1007/s40261-023-01336-w

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