Evidence map›Paper›PMID 39101698›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

New insights on hidradenitis suppurativa phenotypes and treatment response: An exploratory automated analysis of the SUNSHINE and SUNRISE trials.

Anna Passera, Elisa Muscianisi, David Demanse, Ginette A Okoye, Gregor B E Jemec, Tiffany Mayo, Jennifer Hsiao, Vivian Y Shi, Angel S Byrd, Xiaoling Wei and 4 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03713619 phase3completednot on this map

A Randomized, Double-blind, Multi-center Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNSHINE).

TypeinterventionalSponsorNovartis PharmaceuticalsRan2019 to 2022Enrolled544ConditionsHidradenitis SuppurativaArmssecukinumab, Placebo
NCT03713632 phase3completednot on this map

A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2019 to 2022Enrolled545ConditionsHidradenitis SuppurativaArmsSecukinumab, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. 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.

Anna PasseraNovartis Pharma AG, Basel, Switzerland.
Elisa MuscianisiNovartis Gene Therapies, Bannockburn, Illinois, USA.
David DemanseNovartis Pharma AG, Basel, Switzerland.
Ginette A OkoyeDepartment of Dermatology, Howard University College of Medicine, Washington, D.C., USA.
Gregor B E JemecUniversity of Copenhagen, Copenhagen, Denmark.
Tiffany MayoUniversity of Alabama at Birmingham, Birmingham, Alabama, USA.
Jennifer HsiaoUniversity of Southern California, Los Angeles, California, USA.
Vivian Y ShiDepartment of Dermatology, University of Washington, Seattle, Washington, USA.
Angel S ByrdDepartment of Dermatology, Howard University College of Medicine, Washington, D.C., USA.
Xiaoling WeiNovartis Pharma Shanghai, Shanghai, China.
Lorenz UhlmannNovartis Pharma AG, Basel, Switzerland.
Marc VandemeulebroeckeNovartis Pharma AG, Basel, Switzerland.ORCID https://orcid.org/0000-0002-6407-3140
Shoba RavichandranNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Martina L PorterDepartment of Dermatology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-4738-4385

Funding

Novartis Pharma AG
6 · The paper itself

Abstract

backgroundDefining hidradenitis suppurativa (HS) subtypes was previously limited by small sample sizes and poor interrater reliability; no study has investigated subtype treatment responses. The objective of this analysis was to characterize HS clusters in adult patients with moderate to severe HS and evaluate secukinumab treatment responses between clusters.

methodsClusters were identified via an unsupervised machine learning clustering analysis using baseline data from the randomized, placebo-controlled SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) phase 3 trials. To assess treatment responses, patients received secukinumab every 2 (SECQ2W) or 4 weeks (SECQ4W) or placebo, for 16 weeks, after which, placebo patients randomly switched to SECQ2W/SECQ4W, and SECQ2W/SECQ4W patients maintained their original treatment, until week 52. Baseline outcomes included patient characteristics, disease characteristics and severity, HS-associated comorbidities and previous treatment exposures. Treatment response was assessed via the HS clinical response (HiSCR), abscess and inflammatory nodule (AN) count, flares and NRS30 (skin pain).

resultsBased on baseline data, three clusters were identified from 1084 patients (Cluster 1: 54.1%, Cluster 2: 17.8%, Cluster 3: 28.1%). Cluster 1 was predominantly female (65.4%) and was characterized by milder HS. Cluster 2 had more patients from the Asia Pacific, Middle East and Africa region (58.5%) and was characterized by moderate HS. Cluster 3 had the highest rates of previous exposure to biologics (45.9%) and prior HS-related surgeries (47.5%) and was characterized by severe HS. SECQ2W and SECQ4W demonstrated efficacy versus placebo in all clusters at week 16; SECQ2W and SECQ4W efficacy was maintained to week 52. SECQ2W treatment showed a trend for greater efficacy versus SECQ4W in Cluster 3 through week 52.

conclusionsThree HS clusters were identified. Secukinumab demonstrated benefit over placebo in all clusters. However, patients with more severe disease may take longer to respond and more frequent secukinumab dosing may be required for these patients.

trial registrationSUNSHINE (NCT03713619) and SUNRISE (NCT03713632).

Indexed as

Antibodies, Monoclonal, HumanizedDermatologic AgentsHidradenitis SuppurativaAdultCluster AnalysisFemaleHumansMaleMiddle AgedPhenotypeSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic Agentssecukinumab

Identifiers

PMID39101698
PMCPMC12290999

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.