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

Kim A. Papp*, Andrew Blauvelt, Lluís Puig, Mamitaro Ohtsuki, Stefan Beissert, Melinda Gooderham, Ahmad Z. Amin, Jie Liu, Tianshuang Wu, Tofial Azam, Vassilis Stakias, Ramon Espaillat, Ranjeeta Sinvhal, Ahmed M. Soliman, Yinuo Pang, Michael M. Chen, Mark G. Lebwohl

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1149-1158
Number of pages10
JournalJournal of the American Academy of Dermatology
Volume89
Issue number6
DOIs
StatePublished - Dec 2023

Funding

AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. AbbVie and authors thank all the trial investigators and the patients who participated in this clinical trial. AbbVie acknowledges Sven Richter (AbbVie) and Estefania Hidalgo (AbbVie) for developing the enhanced content videos. Medical writing support was provided by Melissa Julyanti, PharmD, and Callie A S Corsa, PhD, of JB Ashtin, and funded by AbbVie . No honoraria or payments were made for authorship. Funding sources: This study was funded by AbbVie Inc. , North Chicago, Illinois.

Keywords

  • interleukin 23
  • plaque psoriasis
  • psoriasis
  • risankizumab

ASJC Scopus subject areas

  • Dermatology

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