Long-term safety and efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis: Interim analysis of the LIMMitless open-label extension trial up to 5 years of follow-up.
Por:
Papp KA, Blauvelt A, Puig L, Ohtsuki M, Beissert S, Gooderham M, Amin AZ, Liu J, Wu T, Azam T, Stakias V, Espaillat R, Sinvhal R, Soliman AM, Pang Y, Chen MM, Lebwohl MG
Publicada:
1 dic 2023
Ahead of Print:
6 ago 2023
Resumen:
BACKGROUND: Psoriasis is a chronic, inflammatory skin disease often requiring long-term therapy. OBJECTIVE: To evaluate the long-term safety and efficacy of risankizumab in patients with psoriasis. METHODS: LIMMitless is an ongoing phase 3, open-label extension study evaluating the long-term safety and efficacy of continuous risankizumab 150 mg every 12 weeks for adults with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. This interim analysis assessed safety (ie, monitored treatment-emergent adverse events [TEAEs]) through 304 weeks. Efficacy assessments included determining the proportion of patients who achieved =90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90/100), static Physician's Global Assessment of clear/almost clear (sPGA 0/1), and Dermatology Life Quality Index of no effect on patient's life (DLQI 0/1) through 256 weeks. RESULTS: Among 897 patients randomized to risankizumab in the base studies, 706 were still ongoing at data cutoff. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low. At week 256, 85.1%/52.3% of patients achieved PASI 90/100, respectively, 85.8% achieved sPGA 0/1, and 76.4% achieved DLQI 0/1. LIMITATIONS: Open-label study with no placebo or active-comparator group. CONCLUSIONS: Long-term continuous risankizumab treatment for up to 5 years was well tolerated and demonstrated high and durable efficacy.
Filiaciones:
Papp KA:
Alliance Clinical Research and Probity Medical Research, Waterloo. Electronic address:
Blauvelt A:
Oregon Medical Research Center, Portland
Puig L:
Department of Dermatology, IIB Sant Pau, Hospital de la Santa Creu i Sant Pau, Barcelona
Ohtsuki M:
Department of Dermatology, Jichi Medical University, Tochigi
Beissert S:
Department of Dermatology, University Hospital Carl Gustav Carus, TU Dresden, Dresden
Gooderham M:
SKiN Centre for Dermatology, Probity Medical Research, and Department of Medicine, Queen's University, Ontario
Amin AZ:
Northwestern Medicine Dermatology, Chicago
Liu J:
AbbVie Inc., North Chicago
Wu T:
AbbVie Inc., North Chicago
Azam T:
AbbVie Inc., North Chicago
Stakias V:
AbbVie Inc., North Chicago
Espaillat R:
AbbVie Inc., North Chicago
Sinvhal R:
AbbVie Inc., North Chicago
Soliman AM:
AbbVie Inc., North Chicago
Pang Y:
AbbVie Inc., North Chicago
Chen MM:
AbbVie Inc., North Chicago
Lebwohl MG:
Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York
hybrid, All Open Access; Hybrid Gold
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