Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials
Por:
Simpson E.L., Pink A.E., Blauvelt A., Gooderham M., Armstrong A.W., Worm M., Katoh N., Peris K., Puig L., Barbarot S., Mark T., Steffensen L.A., Tindberg A.-M., Wollenberg A.
Publicada:
1 ene 2023
Ahead of Print:
1 ene 2023
Resumen:
BACKGROUND: Two phase III trials, ECZTRA 1 and 2, confirmed the efficacy and safety of tralokinumab versus placebo in adults with moderate-to-severe atopic dermatitis (AD). To further explore the long-term efficacy of tralokinumab for AD, a pooled analysis of these trials was conducted. METHODS: ECZTRA 1 and 2 patients (n = 1596 total) were randomized to tralokinumab 300 mg or placebo every 2 weeks (q2w) over 16 weeks. Patients achieving Investigator's Global Assessment of clear/almost clear skin (IGA 0/1) and/or 75% improvement in the Eczema Area and Severity Index (EASI-75) at Week 16, were re-randomized to tralokinumab q2w, every 4 weeks (q4w), or placebo (tralokinumab withdrawal) for another 36 weeks. Patients not achieving the response criteria at Week 16 received open-label tralokinumab q2w plus optional topical corticosteroids (TCS). A pooled, prespecified analysis assessed the proportions of Week 16 responders that maintained IGA 0/1 and/or EASI-75 at Week 52. Pooled data from all patients initiated with tralokinumab, regardless of the response at Week 16 or dosing regimen received thereafter, were analyzed post hoc. RESULTS: In patients who achieved the primary endpoints at Week 16, IGA 0/1 responses were maintained at Week 52 without rescue treatment (including TCS) by 55.9%, 42.4%, and 34.0% of patients re-randomized to tralokinumab q2w, q4w, or placebo (tralokinumab withdrawal), respectively, while EASI-75 responses were maintained by 57.3%, 50.4%, and 26.4%, respectively (prespecified analysis). In a post hoc analysis of all patients initiated with tralokinumab, response rates improved over time with continued tralokinumab treatment beyond Week 16 to Week 52 for EASI-50 (63.1-82.7%), EASI-75 (37.6-61.8%), EASI-90 (20.4-37.3%), and IGA 0/1 (23.0-36.2%). CONCLUSIONS: Tralokinumab treatment provides progressive and sustained improvement over 1 year in the extent and severity of AD in patients with moderate-to-severe AD. CLINICAL TRIAL REGISTRATION: NCT03131648 (ECZTRA 1); study start date: 30 May 2017; primary completion date: 7 August 2018; study completion date: 10 October 2019. NCT03160885 (ECZTRA 2); study start date: 12 June 2017; primary completion date: 4 September 2019; study completion date: 14 August 2019. INFOGRAPHIC.
Filiaciones:
Simpson E.L.:
Department of Dermatology, Oregon Health and Science University, Portland, OR, United States
Pink A.E.:
St. John’s Institute of Dermatology, Guy’s and St, Thomas’ NHS Foundation Trust, London, United Kingdom
Blauvelt A.:
Oregon Medical Research Center, Portland, OR, United States
Gooderham M.:
SKiN Centre for Dermatology, Department of Dermatology, Queen’s University, and Probity Medical Research, Peterborough, ON, Canada
Armstrong A.W.:
Keck School of Medicine, University of Southern California, Los Angeles, CA, United States
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 L.A.:
LEO Pharma A/S, Ballerup, Denmark
Tindberg A.-M.:
LEO Pharma A/S, Ballerup, Denmark
Wollenberg A.:
Department of Dermatology and Allergy, Ludwig Maximilian University of Munich, Munich, Germany
Department of Dermatology, Free University Brussels, University Hospital Brussels, Brussels, Belgium
Green Published, hybrid, All Open Access, Hybrid Gold, Green
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