Patients with Moderate-to-Severe Atopic Dermatitis Maintain Stable Response with No or Minimal Fluctuations with 1 Year of Lebrikizumab Treatment
Silverberg, Jonathan (George Washington University School of Medicine)
Wollenberg, Andreas (Comprehensive Center of Inflammation Medicine (Lübeck, Alemanya))
Stein Gold, Linda (Henry Ford Health System (Detroit, Estats Units d'Amèrica))
Del Rosso, James (JDR Dermatology Research (Las Vegas, Estats Units d'Amèrica))
Yosipovitch, Gil (University of Miami)
Lio, Peter (Northwestern University Feinberg School of Medicine(Chicago, Estats Units d'Amèrica))
Carrascosa, José Manuel (Institut Germans Trias i Pujol)
Gallo, Gaia (Eli Lilly and Company (Indianapolis, Estats Units d'Amèrica))
Ding, Yuxin (Eli Lilly and Company (Indianapolis, Estats Units d'Amèrica))
Xu, Zhenhui (CIMS Global LLC (Somerset, Estats Units d'Amèrica))
Casillas, Marta (Eli Lilly and Company (Indianapolis, Estats Units d'Amèrica))
Pierce, Evangeline (Eli Lilly and Company (Indianapolis, Estats Units d'Amèrica))
Agell, Helena (Almirall (Barcelona))
Ständer, Sonja (University Hospital Münster (Alemanya))

Data:	2024
Resum:	Lebrikizumab is a novel monoclonal antibody with established efficacy in patients with moderate-to-severe atopic dermatitis (AD) in multiple Phase 3 trials. One of the ultimate treatment goals for patients with moderate-to-severe AD is to achieve stable disease control without concern for planning future life events. In ADvocate1 and ADvocate2, lebrikizumab-treated patients meeting the protocol-defined response criteria at Week 16 were re-randomized 2:2:1 to receive lebrikizumab every 2 weeks (Q2W), lebrikizumab every 4 weeks (Q4W), or placebo Q2W (lebrikizumab withdrawal) for 36 additional weeks. In this post hoc analysis, we evaluated the proportions of patients with no or minimal fluctuations of efficacy during the 36-week maintenance period and plotted individual patient trajectories. We defined no or minimal fluctuations as achieving and maintaining the defined endpoint (≥ 75% improvement in the Eczema Area and Severity Index [EASI 75], ≥ 90% improvement in EASI, Pruritus Numeric Rating Scale [NRS] ≥ 4-point improvement, or Pruritus NRS ≥ 3-point improvement) for ≥ 80% of the study visits. If patients used rescue medication, discontinued treatment, or transferred to the escape arm, data collected at or after the event were imputed as non-response. The proportions of lebrikizumab responders who maintained EASI 75 with no or minimal fluctuations were 70. 8% (lebrikizumab Q2W), 71. 2% (lebrikizumab Q4W), and 60. 0% (lebrikizumab withdrawal). Of the patients with baseline Pruritus NRS ≥ 4 and who achieved ≥ 4-point improvement at Week 16, 66. 1% (lebrikizumab Q2W), 62. 7% (lebrikizumab Q4W), and 55. 2% (lebrikizumab withdrawal) maintained ≥ 4-point Pruritus NRS improvement with no or minimal fluctuations. Patients who met the response criteria at Week 16 and continued treatment with lebrikizumab Q2W or Q4W demonstrated a stable response with no or minimal fluctuations of efficacy in measures of skin and itch up to Week 52. NCT04146363 (ADvocate1) and NCT04178967 (ADvocate2). The online version contains supplementary material available at 10. 1007/s13555-024-01226-9. The online version contains supplementary material available at 10. 1007/s13555-024-01226-9.
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
Matèria:	Atopic dermatitis ; Eczema ; Fluctuations ; Lebrikizumab ; Response ; Stability
Publicat a:	Dermatology and Therapy, Vol. 14 (august 2024) , p. 2249-2260, ISSN 2190-9172

DOI: 10.1007/s13555-024-01226-9
PMID: 39123054

12 p, 1.5 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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