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Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials.
Simpson, Eric L; Pink, Andrew E; Blauvelt, Andrew; Gooderham, Melinda; Armstrong, April W; Worm, Margitta; Katoh, Norito; Peris, Ketty; Puig, Luis; Barbarot, Sébastien; Mark, Thomas; Steffensen, Louise Abildgaard; Tindberg, Ann-Marie; Wollenberg, Andreas.
Afiliação
  • Simpson EL; Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.
  • Pink AE; St. John's Institute of Dermatology, Guy's and St, Thomas' NHS Foundation Trust, London, UK.
  • Blauvelt A; Oregon Medical Research Center, Portland, OR, USA.
  • Gooderham M; SKiN Centre for Dermatology, Department of Dermatology, Queen's University, and Probity Medical Research, Peterborough, ON, Canada.
  • Armstrong AW; Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
  • Worm M; Division of Allergy and Immunology, Department of Dermatology, Venereology and Allergology, Campus Charité Mitte, Universitätsmedizin Berlin, Berlin, Germany.
  • Katoh N; Kyoto Prefectural University of Medicine, Graduate School of Medical Science, Kyoto, Japan.
  • Peris K; Department of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.
  • Puig L; Department of Dermatology, IIB SANT PAU, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
  • Barbarot S; Department of Dermatology, University Hospital of Nantes, Nantes, France.
  • Mark T; LEO Pharma A/S, Ballerup, Denmark.
  • Steffensen LA; LEO Pharma A/S, Ballerup, Denmark.
  • Tindberg AM; LEO Pharma A/S, Ballerup, Denmark.
  • Wollenberg A; Department of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany. wollenberg@lrz.uni-muenchen.de.
Am J Clin Dermatol ; 24(6): 939-952, 2023 Nov.
Article em En | MEDLINE | ID: mdl-37682422
Atopic dermatitis (AD) is a chronic inflammatory disease characterized by excessively dry and itchy skin, resulting in a considerable burden of disease. Patients with AD often require long-term treatment. Tralokinumab is an injectable antibody treatment that targets a protein called interleukin-13, which substantially contributes to the signs and symptoms of AD. In the ECZTRA 1 and 2 phase III clinical trials, funded by LEO Pharma A/S, adults with moderate-to-severe AD treated with tralokinumab every other week for 16 weeks showed significant improvement in disease extent and severity compared with patients receiving placebo. To further explore the long-term efficacy of tralokinumab for AD, we performed a new analysis combining the almost 1600 patients of ECZTRA 1 and 2. A large proportion of patients treated with tralokinumab who achieved clear or almost clear skin at Week 16 were able to maintain clear or almost clear skin at Week 52 with less frequent dosing (every 4 weeks). Additionally, combining all patients treated with tralokinumab, regardless of Week 16 response or dose frequency thereafter, showed that most patients achieved a significant reduction in disease extent and severity at Week 52. These results demonstrate that many tralokinumab-treated patients continue to improve beyond Week 16, and highlight that efficacy results at Week 16 may not be representative of the outcome of longer-term tralokinumab treatment. These findings may help health care providers better advise patients regarding when to modify treatment with tralokinumab.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Dermatite Atópica / Fármacos Dermatológicos Tipo de estudo: Clinical_trials Limite: Adult / Humans Idioma: En Revista: Am J Clin Dermatol Assunto da revista: DERMATOLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Dermatite Atópica / Fármacos Dermatológicos Tipo de estudo: Clinical_trials Limite: Adult / Humans Idioma: En Revista: Am J Clin Dermatol Assunto da revista: DERMATOLOGIA Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos