Evidence map›Paper›PMID 36892753›Full record

ArticleDermatology and therapy2023

Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial.

Alexa B Kimball, Errol P Prens, Thierry Passeron, Emanual Maverakis, Irina Turchin, Stefan Beeck, Leonidas Drogaris, Ziqian Geng, Tianyu Zhan, Izabella Messina and 1 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03926169 (A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
15.1field-weighted citation impact, top 1% of its field
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.

NCT03926169 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa

TypeinterventionalSponsorAbbVieRan2019 to 2021Enrolled243ConditionsHidradenitis SuppurativaArmsRisankizumab, Placebo for risankizumab
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. European S2k guidelines for hidradenitis suppurativa/acne inversa part 2: Treatment.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Guideline
  3. Australasian hidradenitis suppurativa management guidelines.The Australasian journal of dermatology · 2025
    Guideline
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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

11 authors at 7 institutions in 5 countries.

Alexa B KimballClinical Laboratory for Epidemiology and Applied Research in Skin (CLEARS), Department of Dermatology, Beth Israel Deaconess Medical Center-Harvard Medical School, 330 Brookline Avenue, Shapiro 2, Boston, MA, 02215, USA. CLEARS@bidmc.harvard.edu.ORCID http://orcid.org/0000-0001-9405-0479
Errol P PrensDepartment of Dermatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Thierry PasseronDepartment of Dermatology, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.
Emanual MaverakisDepartment of Dermatology, University of California, Davis, Sacramento, CA, USA.
Irina TurchinBrunswick Dermatology Center, Fredericton, NB, Canada.
Stefan BeeckAbbVie Inc., North Chicago, IL, USA.
Leonidas DrogarisAbbVie Inc., North Chicago, IL, USA.
Ziqian GengAbbVie Inc., North Chicago, IL, USA.
Tianyu ZhanAbbVie Inc., North Chicago, IL, USA.
Izabella MessinaAbbVie Inc., North Chicago, IL, USA.
Falk G BecharaDepartment of Dermatology, Venereology and Allergology, St Josef Hospital, Ruhr-University, Bochum, Germany.
AbbVie (United States) · USBeth Israel Deaconess Medical Center · USDalhousie University · CAErasmus MC · NLInserm · FRSt. Josef-Hospital · DEUniversity of California, Davis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHidradenitis suppurativa (HS) is a chronic, immune-mediated skin condition characterized by inflammatory lesions that can cause pain, impaired physical activity, and reduced quality of life. This study evaluated the efficacy and safety of risankizumab, a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to its p19 subunit, for the treatment of HS.

methodsThis phase II multicenter, randomized, placebo-controlled, double-blind study investigated the efficacy and safety of risankizumab in patients with moderate-to-severe HS. Patients were randomized 1:1:1 to receive subcutaneous risankizumab 180 mg; risankizumab 360 mg; or placebo at weeks 0, 1, 2, 4, and 12. Patients initially randomized to placebo received blinded risankizumab 360 mg at weeks 16, 17, and 18; patients initially randomized to risankizumab received blinded matching placebo at the same time points. From weeks 20-60, all patients received open-label risankizumab 360 mg every 8 weeks. The primary endpoint was the achievement of HS Clinical Response (HiSCR) at week 16. Safety was assessed by monitoring of treatment-emergent adverse events (TEAEs).

resultsA total of 243 patients were randomized (risankizumab 180 mg, n = 80; risankizumab 360 mg, n = 81; placebo, n = 82). HiSCR was achieved by 46.8% of patients with risankizumab 180 mg, 43.4% with risankizumab 360 mg, and 41.5% with placebo at week 16. The primary endpoint was not met, and the study was terminated early. Incidence of TEAEs, severe TEAEs, TEAEs considered possibly related to study drug, and TEAEs leading to discontinuation of study drug were generally low and comparable across treatment groups.

conclusionRisankizumab does not appear to be an efficacious treatment for moderate-to-severe HS. Future studies to understand the complex molecular mechanisms underlying HS pathogenesis and develop improved therapies are warranted.

trial registrationClinicalTrials.gov identifier: NCT03926169.

Indexed as

Hidradenitis suppurativaInterleukin 23 inhibitorRisankizumab

Identifiers

PMID36892753
PMCPMC9997424
OpenAlexW4323653185

What OpenQuestion holds

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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 OpenQuestion graph.