Evidence map›Paper›PMID 39425517›Full record

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

Secukinumab efficacy in patients with hidradenitis suppurativa assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4): A post hoc analysis of the SUNSHINE and SUNRISE trials.

Christos C Zouboulis, Athanassios Kyrgidis, Afsaneh Alavi, Gregor B E Jemec, Antonio Martorell, Angelo V Marzano, Hessel H van der Zee, Magdalena B Wozniak, Angela Llobet Martinez, Torben Kasparek and 6 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
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 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.

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

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Review
  6. 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

16 authors.

Christos C ZouboulisEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.ORCID https://orcid.org/0000-0003-1646-2608
Athanassios KyrgidisEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.ORCID https://orcid.org/0000-0003-3896-0309
Afsaneh AlaviEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.ORCID https://orcid.org/0000-0003-1171-4917
Gregor B E JemecEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.
Antonio MartorellEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.
Angelo V MarzanoEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.ORCID https://orcid.org/0000-0002-8160-4169
Hessel H van der ZeeEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.
Magdalena B WozniakNovartis Ireland Limited, Dublin, Ireland.
Angela Llobet MartinezNovartis Pharma AG, Basel, Switzerland.
Torben KasparekNovartis Pharma AG, Basel, Switzerland.
Teresa BachhuberNovartis Pharma AG, Basel, Switzerland.
Christine-Elke OrtmannNovartis Pharma AG, Basel, Switzerland.
Iryna LobachNovartis Ireland Limited, Dublin, Ireland.
Nicolas ThomasNovartis Pharma AG, Basel, Switzerland.
Shoba RavichandranNovartis Pharmaceuticals, East Hanover, New Jersey, USA.
Thrasyvoulos TzellosEuropean Hidradenitis Suppurativa Foundation (EHSF), Dessau, Germany.

Funding

Novartis
6 · The paper itself

Abstract

introductionThe International Hidradenitis Suppurativa Severity Score System (IHS4) is a validated tool that measures inflammatory lesions, including draining tunnels, in hidradenitis suppurativa (HS).

objectiveTo evaluate secukinumab efficacy using IHS4 in patients with moderate to severe HS.

methodsData from the SUNSHINE and SUNRISE trials, which assessed subcutaneous secukinumab 300 mg every 2 (SECQ2W) and 4 (SECQ4W) weeks in adults with moderate to severe HS, were analyzed. Assessments included changes from baseline in IHS4 and severity classification up to Week 52; IHS4-55, IHS4-75, IHS4-90 responses (55%, 75% and 90% reduction in IHS4) and concordance between IHS4-55 and HS clinical response (HiSCR), at Weeks 16 and 52.

resultsIn total, 1084 patients (SECQ2W = 361; SECQ4W = 360; placebo = 363) were analyzed. At Week 16, SECQ2W and SECQ4W demonstrated a numerically higher reduction in IHS4 from baseline versus placebo (adjusted mean [95% CI]: -10.80 [-12.30 to -9.30] and -9.46 [-10.96 to -7.96] vs. -4.92 [-6.43 to -3.41]); the reduction was maintained until Week 52 in both dose regimens. A greater proportion of patients achieved IHS4-55 with SECQ2W (43.4%) and SECQ4W (39.5%) versus placebo (31.5%) at Week 16, with further improvement at Week 52. Similar trends were observed for IHS4-75 and IHS4-90 responses. While no patients had mild disease based on IHS4 (80.7% had severe and 19.3% had moderate HS) at baseline, a greater proportion of patients were categorized as having mild disease at Week 16 in the SECQ2W (25.9%) and SECQ4W (24.0%) groups versus placebo (16.4%); this trend continued up to Week 52 in both dose regimens. Strong concordance (>85%) was observed between IHS4-55 and HiSCR.

conclusionsBoth SECQ2W and SECQ4W demonstrated efficacy in improving treatment response as measured by IHS4 and reducing disease severity versus placebo at Week 16 and these improvements were sustained through Week 52. These findings support that the dynamic and dichotomous IHS4 can efficiently detect treatment response changes in clinical trial settings. CLINICAL TRIALS REGISTRATION: SUNSHINE (NCT03713619); SUNRISE (NCT03713632).

Indexed as

Antibodies, Monoclonal, HumanizedDermatologic AgentsHidradenitis SuppurativaSeverity of Illness IndexAdultFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedDermatologic Agentssecukinumab

Identifiers

PMID39425517
PMCPMC12291009

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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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.