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
Papp, K.A. (Alliance Clinical Research and Probity Medical Research)
Blauvelt, Andrew (Oregon Medical Research Center)
Puig Sanz, Lluís (Institut d'Investigació Biomèdica Sant Pau)
Ohtsuki, M. (Jichi Medical University)
Beissert, Stefan (University Hospital Carl Gustav Carus)
Gooderham, Melinda (Queen's University)
Amin, A.Z. (Northwestern Medicine Dermatology)
Liu, J. (AbbVie Inc.)
Wu, T. (AbbVie Inc.)
Azam, T. (AbbVie Inc.)
Stakias, V. (AbbVie Inc.)
Espaillat, R. (AbbVie Inc.)
Sinvhal, R. (AbbVie Inc.)
Soliman, Ahmed M. (AbbVie Inc.)
Pang, Y. (AbbVie Inc.)
Chen, M.M. (AbbVie Inc.)
Lebwohl, M. G. (Icahn School of Medicine at Mount Sinai (Nova York, Estats Units d'Amèrica))
Universitat Autònoma de Barcelona

Data:	2023
Resum:	Psoriasis is a chronic, inflammatory skin disease often requiring long-term therapy. 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. 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. Long-term continuous risankizumab treatment for up to 5 years was well tolerated and demonstrated high and durable efficacy.
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, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Interleukin 23 ; Plaque psoriasis ; Psoriasis ; Risankizumab
Publicat a:	Journal of the American Academy of Dermatology, Vol. 89 Núm. 6 (december 2023) , p. 1149-1158, ISSN 1097-6787

DOI: 10.1016/j.jaad.2023.07.1024
PMID: 37553030

10 p, 1.5 MB

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