Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis : Pooled Data from Two Phase III Trials
Simpson, Eric L. (Oregon Health and Science University)
Pink, Andrew E. (Guy's and St, Thomas' NHS Foundation Trust)
Blauvelt, Andrew (Oregon Medical Research Center)
Gooderham, Melinda (Centre for Dermatology and Probity Medical Research)
Armstrong, April W. (University of Southern California)
Worm, Margitta (Charité - Universitätsmedizin Berlin)
Katoh, Norito (Kyoto Prefectural University of Medicine)
Peris, Ketty (Catholic University of the Sacred Heart)
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Barbarot, Sébastien (University Hospital of Nantes)
Mark, Thomas (LEO Pharma A/S)
Steffensen, Louise Abildgaard (LEO Pharma A/S)
Tindberg, Ann-Marie (LEO Pharma A/S)
Wollenberg, Andreas (University Hospital Brussels)
Universitat Autònoma de Barcelona

Data:	2023
Resum:	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. 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. 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%). Tralokinumab treatment provides progressive and sustained improvement over 1 year in the extent and severity of AD in patients with moderate-to-severe AD. 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. The online version contains supplementary material available at 10. 1007/s40257-023-00806-3. The online version contains supplementary material available at 10. 1007/s40257-023-00806-3.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	American Journal of Clinical Dermatology, Vol. 24 (september 2023) , p. 939-952, ISSN 1179-1888

DOI: 10.1007/s40257-023-00806-3
PMID: 37682422

14 p, 2.8 MB

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