Evidence map›Paper›PMID 40728772›Full record

Trial reportAmerican journal of clinical dermatology2025

Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results.

Kim A Papp, Mark G Lebwohl, Lluís Puig, Mamitaro Ohtsuki, Stefan Beissert, Melinda Gooderham, Ahmad Z Amin, Tianshuang Wu, Simone Rubant, Brenton Bialik and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in American journal of clinical dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03047395 (A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03047395 phase3completednot on this map

A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)

TypeinterventionalSponsorAbbVieRan2017 to 2023Enrolled2,170ConditionsPsoriasisArmsrisankizumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
  6. IL-23 Inhibitors in Psoriasis: What Have We Learnt so Far?Journal of inflammation research · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Kim A PappAlliance Clinical Trials and Probity Medical Research, Inc., 135 Union Street East, Waterloo, ON, N2J 1C4, Canada. kapapp@probitymedical.com.ORCID http://orcid.org/0000-0001-9557-3642
Mark G LebwohlIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Lluís PuigHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Mamitaro OhtsukiJichi Medical University, Tochigi, Japan.
Stefan BeissertDepartment of Dermatology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.
Melinda GooderhamSKiN Centre for Dermatology, Probity Medical Research, Peterborough, ON, Canada.
Ahmad Z AminDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Tianshuang WuAbbVie Inc., North Chicago, IL, USA.
Simone RubantAbbVie Inc., North Chicago, IL, USA.
Brenton BialikAbbVie Inc., North Chicago, IL, USA.
Doug AshleyAbbVie Inc., North Chicago, IL, USA.
Ahmed M SolimanAbbVie Inc., North Chicago, IL, USA.
Michael M ChenAbbVie Inc., North Chicago, IL, USA.
Andrew BlauveltBlauvelt Consulting, LLC, Lake Oswego, OR, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPsoriasis is a chronic, inflammatory disease requiring long-term therapy. Risankizumab, an anti-interleukin-23 monoclonal antibody, is approved to treat moderate-to-severe plaque psoriasis in adults.

objectiveThe aim was to assess the long-term safety and efficacy of continuous risankizumab treatment through 6 years in adults with moderate-to-severe plaque psoriasis.

methodsLIMMitless, a phase 3, open-label extension study, evaluated the long-term safety and efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis following multiple phase 2/3 base studies. Patients randomized to risankizumab 150 mg at baseline of the base studies (≤ 52 weeks) were eligible to enroll in the LIMMitless study, in which they received risankizumab 150 mg subcutaneously every 12 weeks for an additional 252 weeks. This final analysis assessed safety (treatment-emergent adverse events [TEAEs]) through 324 weeks and efficacy (including proportions of patients who achieved ≥ 90%/100% improvement from baseline in Psoriasis Area and Severity Index [PASI 90/PASI 100], static Physician's Global Assessment of clear or almost clear [sPGA 0/1], or Dermatology Life Quality Index of no effect on patient's quality of life [DLQI 0/1]) through 304 weeks.

resultsOf 897 patients enrolled in the LIMMitless study, 661 completed the study for a total of 4921.2 patient years of exposure to risankizumab. Rates of TEAEs, TEAEs leading to discontinuation, and TEAEs of safety interest were low and consistent with rates observed in previous studies. During the base studies, risankizumab treatment demonstrated high rates of rapid and durable efficacy through 52 weeks; risankizumab treatment also maintained or further improved efficacy and quality-of-life outcomes in the LIMMitless study. At week 304, 86.0% of patients achieved PASI 90, 54.2% achieved PASI 100, 84.7% achieved sPGA 0/1, and 76.3% achieved DLQI 0/1 (using modified nonresponder imputation).

conclusionsLong-term risankizumab was well tolerated and demonstrated high and durable efficacy through 6 years of continuous treatment. CLINICAL

trial registrationNCT03047395.

Indexed as

Antibodies, MonoclonalDermatologic AgentsPsoriasisAdultAgedDrug Administration ScheduleFemaleHumansInjections, SubcutaneousMaleMiddle AgedQuality of LifeSeverity of Illness IndexTime FactorsTreatment OutcomeYoung AdultAntibodies, MonoclonalDermatologic Agentsrisankizumab

Identifiers

PMID40728772
PMCPMC12436474

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.