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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung


  • Kim A. Papp - , Alliance Clinical Research and Probity Medical Research (Autor:in)
  • Andrew Blauvelt - , Oregon Medical Research Center (Autor:in)
  • Lluís Puig - , Autonomous University of Barcelona (Autor:in)
  • Mamitaro Ohtsuki - , Jichi Medical University (Autor:in)
  • Stefan Beissert - , Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus Dresden (Autor:in)
  • Melinda Gooderham - , Queen's University Kingston (Autor:in)
  • Ahmad Z. Amin - , Northwestern Medicine (Autor:in)
  • Jie Liu - , AbbVie (Autor:in)
  • Tianshuang Wu - , AbbVie (Autor:in)
  • Tofial Azam - , AbbVie (Autor:in)
  • Vassilis Stakias - , AbbVie (Autor:in)
  • Ramon Espaillat - , AbbVie (Autor:in)
  • Ranjeeta Sinvhal - , AbbVie (Autor:in)
  • Ahmed M. Soliman - , AbbVie (Autor:in)
  • Yinuo Pang - , AbbVie (Autor:in)
  • Michael M. Chen - , AbbVie (Autor:in)
  • Mark G. Lebwohl - , Icahn School of Medicine at Mount Sinai (Autor:in)


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.


Seiten (von - bis)1149-1158
FachzeitschriftJournal of the American Academy of Dermatology
PublikationsstatusVeröffentlicht - Dez. 2023

Externe IDs

Scopus 85170410016



  • interleukin 23, plaque psoriasis, psoriasis, risankizumab