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Publications

Journal Article Epublish

PubMed: 42593155 DOI: 10.2340/actadv.v106.adv-2026-0542

Real-world Effectiveness and Safety of Lebrikizumab in Atopic Dermatitis: A TREATgermany Analysis.

Acta Derm Venereol 106

Authors: Barbara Kind, Christina Pham, Luise Heinrich, Tatjana Honstein, Annice Heratizadeh, Inken Harder, Dora Stölzl, Petra Staubach-Renz, Thomas Schaefer, Susanne Abraham, Matthias Augustin, Jutta Ramaker-Brunke, Andreas Pinter, Kathrin Meinhardt, Sven Quist, Sabine Anders, Beate Schwarz, Michael Schulz-Kiesow, Sabine Steinke, Nicole Adler, Christiane Handrick, Knut Schaekel, Michael Sticherling, Anne Bong, Felix D Jacobs, Bernd Großmann, Maren Stahl, Carl-Philipp Buerkle, Hannah L Gorriahn-Maiterth, Tilo Biedermann, Jochen Schmitt, Stephan Weidinger, Thomas Werfel

Affiliations

  • Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universitaet Dresden, Dresden, Germany.
  • Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany.
  • Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universitaet Dresden, Dresden, Germany.
  • Department of Dermatology and Allergy, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
  • Clinic for Dermatology, University Hospital, Mainz, Germany.
  • Practice Dr. med. Thomas Schaefer and Dr. med. Doreen Belz, Derma Koeln, Cologne, Germany.
  • Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universitaet Dresden, Dresden, Germany; Department of Dermatology, University Allergy Center, Carl Gustav Carus Faculty of Medicine, Technische Universitaet Dresden, Dresden, Germany.
  • Institute for Health Services Research in Dermatology Hamburg, University Medical Center Hamburg Eppendorf, Hamburg, Germany.
  • Practice 'Die Hautärzte' Braunschweig, Braunschweig, Germany.
  • Department of Dermatology, Venereology and Allergology, Clinical Research, University Hospital, Frankfurt am Main, Germany.
  • Practice Kathrin Meinhardt, Beckum, Germany.
  • Dermatology Clinic, Helix Medical Ecellence Center Mainz, Mainz, Germany.
  • Practice Dr. med. Sabine Anders, Munich, Germany.
  • Practice Dr. med. Beate Schwarz, Langenau, Germany.
  • Practice Dr. med. Michael Schulz-Kiesow and Dr. med. Inken Reimers, Lübeck, German.
  • Hohenzollernring Dermatology Practice, Münster, Germany.
  • Hautärzte am Fastnachtsbrunnen, FÄ Nicole Adler, Mainz, Germany.
  • Practice Dr. med. Christiane Handrick, Berlin, Germany.
  • Department of Dermatology, University Hospital, Heidelberg, Germany.
  • Department of Dermatology, University, German Center for Immunotherapy, Erlangen, Germany.
  • Practice Dr. med. Anne Bong, Emmerich, Germany.
  • Practice DERMAKULM, Kulmbach, Germany.
  • Practice Dr. med. Bernd Großmann, Koblenz, Germany.
  • Stahl, M. Practice Dr. med. Maren Stahl, Osterode, Germany.
  • Skin and laser medicine Kinzigtal, Practice Dr. med. Bürkle, Haslach, Germany.
  • Practice Dermasana, Karlsruhe, Germany.
  • Department of Dermatology and Allergy, School of Medicine, Technical University of Munich, Munich, Germany.

Abstract

Atopic dermatitis (AD) is driven by type 2 inflammation, with interleukin-13 (IL-13) as one of the central operators. Lebrikizumab is a monoclonal antibody that inhibits IL-13 signalling. Adult patients with moderate-to-severe AD who received lebrikizumab in the TREATgermany registry until 12/2024 were selected, and patient characteristics as well as effectiveness and safety outcomes after 1, 3 and 6 months were evaluated. A total of 108 patients were initiated on lebrikizumab, with 80 having follow-up data available for this analysis ("registry cohort"). Forty-one patients were switched to lebrikizumab without a "washout period" from another advanced systemic therapy ("switchers"). The mean Eczema Area and Severity Index (EASI) decreased from 14.8 at baseline to 5.6 and 3.0 at month 3 and month 6 and was comparable between switchers and nonswitchers. Clinically meaningful improvements were also seen across all patient reported outcomes (PROs) equally in both groups, e.g. a decrease of the mean peak pruritus numeric rating scale (PP-NRS) from 6.6 to 3.8 and 3.4 and the Dermatology Life Quality Index (DLQI) from 11.9 to 4.9 and 4.8. Overall, adverse events (AEs) were reported for 26.6% of patients within the first 3. The most frequently reported AE was conjunctivitis or other ocular complications, reported in 13 patients (20.3%). 32 patients (40%) had an initial EASI≥16 and were comparable to patients in lebrikizumab phase 3 studies. In this "trial-like" cohort, EASI-75 and EASI-90 response rates were 60% and 26.7% at month 3 and 70% and 50% at month 6. Lebrikizumab shows effectiveness in routine care well comparable to observations made in randomized controlled trials.

MeSH

Registries, Interleukin-13, Sexually Transmitted Diseases, Safety, Dermatitis, Dermatology, Dermatitis, Atopic