A Real-world Meta-analysis Study of Disease Severity in European Patients Who Received Baricitinib for Atopic Dermatitis: Data from BioDay, SCRATCH and TREATgermany

Authors

  • Celeste Boesjes Department of Dermatology, University Medical Center Utrecht, Utrecht, Netherlands
  • Marjolein de Bruin-Weller Department of Dermatology, University Medical Center Utrecht, Utrecht, Netherlands
  • Nicolaas P. A. Zuithoff Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands
  • Said el Bouhaddani Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands; Population Health Research, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia; King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia
  • Inge Haeck Department of Dermatology, Reinier de Graaf Gasthuis, Delft, Netherlands
  • Marijke Kamsteeg Department of Dermatology, Radboud University Medical Center, Nijmegen, Netherlands
  • Marie-Louise Schuttelaar Department of Dermatology, University Medical Center Groningen, Groningen, Netherlands
  • Luca Le Treust Real-World Evidence, OPEN Health, London, United Kingdom
  • Nick Denholm Real-World Evidence, OPEN Health, London, United Kingdom https://orcid.org/0009-0006-7813-5919
  • Ahmet Akkoc Zitelab, Frederiksberg, Denmark
  • Simon F. Thomsen Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark
  • Ida Vittrup Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark
  • Thomas Birkner Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
  • Luise Heinrich Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
  • Jochen Schmitt Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
  • Stephan Weidinger Center for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany
  • Thomas Werfel Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany

DOI:

https://doi.org/10.2340/actadv.v106.adv-2025-0231

Keywords:

Atopic Dermatitis, Baricitinib, EASI, Registry

Abstract

Clinical trials have demonstrated the effectiveness of baricitinib, an oral selective Janus kinase 1/2 inhibitor, for patients with moderate-severe atopic dermatitis, but data from real-world practice are limited. This non-interventional cohort study evaluated clinician- and patient-reported disease severity over 16 weeks using 3 national atopic dermatitis registries: BioDay (Netherlands), SCRATCH (Denmark) and TREATgermany (Germany). Absolute scores for Eczema Area and Severity Index (EASI) and itch Numerical Rating Scale (Itch-NRS) were assessed at baseline and follow-up (Week 13/16) for each registry and for the overall pooled cohort. Descriptive analyses, generalized linear mixed modelling and meta-analysis approaches were applied to complete-case and multiply-imputed
datasets. In total, 264 patients (89 BioDay, 117 SCRATCH, 58 TREATgermany) were included. Results showed improvements in EASI, with
58%, 68% and 62% achieving EASI≤7 at Week 13/16 in BioDay, SCRATCH and TREATgermany, respectively. In the pooled cohort, the proportion was 62% (95% CI: 50–73%). The pooled mean EASI change was -7.8 [14.4,–1.1]. Effectiveness was generally observed in both biologic-naïve and -experienced patients. Notable heterogeneity was observed, particularly for Itch-NRS, with the proportion achieving NRS≤4 ranging from 20% (BioDay) to 71% (TREATgermany). These real-world findings support the effectiveness of baricitinib while also highlighting variability in patient outcomes.

Downloads

Download data is not yet available.

References

Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol 2014; 70: 338–351. DOI: https://doi.org/10.1016/j.jaad.2013.10.010

Wollenberg A, Kinberger M, Arents B, Aszodi N, Avila Valle G, Barbarot S, et al. European guideline (EuroGuiDerm) on atopic eczema: part I - systemic therapy. J Eur Acad Dermatol Venereol 2022; 36: 1409–1431. DOI: https://doi.org/10.1111/jdv.18345

EMA. European medicines agency. Olumiant; 2018. [cited 2023 March 23].

Simpson EL, Lacour JP, Spelman L, Galimberti R, Eichenfield LF, Bissonnette R, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol 2020; 183: 242–255. DOI: https://doi.org/10.1111/bjd.18898

Reich K, Kabashima K, Peris K, Silverberg JI, Eichenfield LF, Bieber T, et al. Efficacy and safety of baricitinib combined with topical corticosteroids for treatment of moderate to severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol 2020; 156: 1333–1343. DOI: https://doi.org/10.1001/jamadermatol.2020.3260

Buhl T, Rosmarin D, Serra-Baldrich E, Fernandez-Peñas P, Igarashi A, Konstantinou MP, et al. Itch and sleep improvements with baricitinib in patients with atopic dermatitis: a post hoc analysis of 3 phase 3 studies. Dermatol Ther 2021; 11: 971–982. DOI: https://doi.org/10.1007/s13555-021-00534-8

Thyssen JP, de Bruin-Weller M, Costanzo A, Grond S, Schuster C, Liu C, et al. Baseline body surface area and itch severity define response to baricitinib in patients with moderate-to-severe atopic dermatitis at week 16. Adv Ther 2023; 40: 3574–3587. DOI: https://doi.org/10.1007/s12325-023-02528-8

Carrascosa JM, Narcisi A, Nomura T, Ständer S, Vestergaard C, Sabatino S, et al. Baricitinib improvement across regions in atopic dermatitis patients with baseline body surface area up to 40% and severe itch. Dermatol Ther 2024; 14: 1561–1573. DOI: https://doi.org/10.1007/s13555-024-01171-7

Gerbens LAA, Apfelbacher CJ, Irvine AD, Barbarot S, de Booij RJ, Boyce AE, et al. TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo- and systemic therapy registries. Br J Dermatol 2019; 180: 790–801. DOI: https://doi.org/10.1111/bjd.16714

Vermeulen FM, Gerbens LAA, Bosma AL, Apfelbacher CJ, Irvine AD, Arents BWM, et al. TREatment of ATopic eczema (TREAT) Registry Taskforce: consensus on how and when to measure the core dataset for atopic eczema treatment research registries. Br J Dermatol 2019; 181: 492–504. DOI: https://doi.org/10.1111/bjd.17715

BioDay eczema and atopic diseases registry. 2023. [cited 2023 March 24].

Musters AH, Gerbens LAA, van der Gang L, Middelkamp-Hup MA, Ouwerkerk W, Hijnen DJ, et al. Baseline characteristics of atopic eczema patients enrolled in seven European registries united in the TREatment of ATopic eczema (TREAT) registry taskforce. J Eur Acad Dermatol Venereol 2025; 39: 2096–2112. DOI: https://doi.org/10.1111/jdv.20876

TREATgermany. Deutsches Neurodermitis-Register; . [cited 2025 July 21].

Boesjes CM, Kamphuis E, Zuithoff NPA, Bakker DS, Loman L, Spekhorst LS, et al. Daily practice experience of baricitinib treatment for patients with difficult-to-treat atopic dermatitis: results from the BioDay registry. Acta Derm Venereol 2022; 102: adv00820. DOI: https://doi.org/10.2340/actadv.v102.3978

Traidl S, Heinrich L, Siegels D, Heratizadeh A, Kind B, Haufe E, et al. Treatment of moderate-to-severe atopic dermatitis with baricitinib: results from an interim analysis of the TREATgermany registry. J Eur Acad Dermatol Venereol 2024; 38: e887–e891 DOI: https://doi.org/10.1111/jdv.19979

Vittrup I, Elberling J, Skov L, Ibler KS, Jemec GBE, Mortz CG, et al. Short-term real-world experience with baricitinib treatment in Danish adults with moderate-severe atopic dermatitis. J Eur Acad Dermatol Venereol 2023; 37: e543–e546. DOI: https://doi.org/10.1111/jdv.18804

Schwarzer G, Rücker G. Meta-analysis of proportions. Methods Mol Biol 2022; 2345: 159–172. DOI: https://doi.org/10.1007/978-1-0716-1566-9_10

R Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2021.

Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Softw 2010; 36: 1–48. DOI: https://doi.org/10.18637/jss.v036.i03

Harrer M, Cuijpers P, Furukawa TA, Ebert DD. Chapter 5 between-study heterogeneity. In: Doing Meta-Analysis in R.

Langan D, Higgins JPT, Jackson D, Bowden J, Veroniki AA, Kontopantelis E, et al. A comparison of heterogeneity variance estimators in simulated random-effects meta-analyses. Res Synth Methods 2019; 10: 83–98. DOI: https://doi.org/10.1002/jrsm.1316

Nederland Z. Zorginstituut Nederland. [cited 2023 May 16].

Augustin M, Serra-Baldrich E, Seneschal J, Grond S, Lampropoulou A, Elrayes M, et al. Baseline characteristics and treatment patterns of patients with atopic dermatitis treated with oral systemic therapies: an interim analysis of the AD-REAL study. Adv Ther 2025; 42: 2728–2738. DOI: https://doi.org/10.1007/s12325-025-03137-3

Kamata M, Tada Y. A literature review of real-world effectiveness and safety of dupilumab for atopic dermatitis. JID Innov 2021; 1: 100042. DOI: https://doi.org/10.1016/j.xjidi.2021.100042

Tolino E, Ambrosio L, Bernardini N, Proietti I, Skroza N, Potenza C. Effectiveness of tralokinumab in different phenotypes of atopic dermatitis: a real-world study. Dermatol Ther 2025; 15: 337–350. DOI: https://doi.org/10.1007/s13555-025-01341-1

Ibba L, Falcidia C, Di Giulio S, Bianco M, Valenti M, Facheris P, et al. Real-world effectiveness and safety of upadacitinib and abrocitinib in moderate-to-severe atopic dermatitis: a 52-week retrospective study. J Clin Med 2025; 14: 2953. DOI: https://doi.org/10.3390/jcm14092953

Li Y, Swerlick RA. Capture of patient itch scores in practice reveals disparate itch impact on the basis of age, gender, and race: a cross-sectional survey analysis. JID Innov 2025; 5: 100338. DOI: https://doi.org/10.1016/j.xjidi.2024.100338

Wei W, Anderson P, Gadkari A, Blackburn S, Moon R, Piercy J, et al. Discordance between physician- and patient-reported disease severity in adults with atopic dermatitis: a US cross-sectional survey. Am J Clin Dermatol 2017; 18: 825–835. DOI: https://doi.org/10.1007/s40257-017-0284-y

de Wijs L, Schreurs C, Schlösser A, Nijsten T, Hijnen DJ. Baricitinib for atopic dermatitis patients who responded inadequately to dupilumab treatment: first daily practice results. JEADV Clin Pract 2022; 1: 364–371. DOI: https://doi.org/10.1002/jvc2.64

Lorenc T, Felix L, Petticrew M, Melendez-Torres GJ, Thomas J, Thomas S, et al. Meta-analysis, complexity, and heterogeneity: a qualitative interview study of researchers’ methodological values and practices. Syst Rev 2016; 5: 192. DOI: https://doi.org/10.1186/s13643-016-0366-6

Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med 2002; 21: 1539–1558. DOI: https://doi.org/10.1002/sim.1186

Published

2026-05-27

How to Cite

Boesjes, C., Bruin-Weller, M. de, Zuithoff, N. P. A., Bouhaddani, S. el, Haeck, I., Kamsteeg, M., … Werfel, T. (2026). A Real-world Meta-analysis Study of Disease Severity in European Patients Who Received Baricitinib for Atopic Dermatitis: Data from BioDay, SCRATCH and TREATgermany. Acta Dermato-Venereologica, 106, adv–2025. https://doi.org/10.2340/actadv.v106.adv-2025-0231

Issue

Section

Articles

Categories