Evidence map›Paper›PMID 40839197›Full record

Trial reportInternational journal of dermatology2026

Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies.

Afsaneh Alavi, Ziad Reguiai, Gregor B E Jemec, Alice B Gottlieb, Magdalena B Wozniak, Lorenz Uhlmann, Heng Fan, Angela Llobet Martinez, Gerard Bruin, Nicolas Thomas and 4 more

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

Trial report in International journal of dermatology, 2026. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. 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.

Afsaneh AlaviDepartment of Dermatology, Mayo Clinic, Rochester, Minnesota, USA.ORCID https://orcid.org/0000-0003-1171-4917
Ziad ReguiaiDermatology Department, Polyclinique Courlancy-Bezannes, Reims, France.ORCID https://orcid.org/0000-0003-4844-3559
Gregor B E JemecDepartment of Dermatology, Zealand University Hospital, Roskilde, Denmark.
Alice B GottliebDepartment of Dermatology, UT Southwestern Medical Center, Dallas, Texas, USA.
Magdalena B WozniakNovartis Ireland Limited, Dublin, Ireland.
Lorenz UhlmannNovartis Pharma AG, Basel, Switzerland.
Heng FanShanghai Novartis Trading Limited, Shanghai, China.
Angela Llobet MartinezNovartis Pharma AG, Basel, Switzerland.
Gerard BruinNovartis, Biomedical Research, Basel, Switzerland.
Nicolas ThomasNovartis Pharma AG, Basel, Switzerland.
Ivette AlarconNovartis Pharma AG, Basel, Switzerland.
Bruno BiethNovartis Pharma AG, Basel, Switzerland.
Shoba RavichandranNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Alexa B KimballHarvard Medical School and Clinical Laboratory for Epidemiology and Applied Research in Skin (CLEARS), Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.

Funding

Novartis Pharma
6 · The paper itself

Abstract

backgroundSecukinumab, a fully human, monoclonal antibody targeting interleukin-17A, is approved for moderate-to-severe HS in adults. This study evaluated pharmacokinetics (PK), high-sensitivity C-reactive protein (hsCRP) changes, and safety of secukinumab over 52 weeks in SUNSHINE and SUNRISE Phase 3 trials.

methodsAn exploratory analysis of pooled Phase-3 trials evaluated serum PK and safety of secukinumab 300 mg every 2 (SECQ2W) or 4 weeks (SECQ4W). A population PK model assessed the effects of body weight, disease severity, and baseline hsCRP on secukinumab serum concentration. Exposure-response analysis assessed the relationship between predicted PK and HS clinical response [HiSCR]. No confirmatory statistical testing was performed.

resultsMean serum trough concentration at Weeks 16, 24, and 52 was ~2-fold higher with SECQ2W vs. SECQ4W. At Week 16, exposure overlap was high, with an estimated numerical increase in HiSCR of ~3% for SECQ2W over SECQ4W. At Week 52, HiSCR levels plateaued. At Week 16, hsCRP decreased from 18.6 ± 26.3 mg/L to 12.8 ± 18.0 mg/L (SECQ2W), 15.9 ± 27.6 mg/L to 11.5 ± 18.4 mg/L (SECQ4W), and remained unchanged with placebo (14.4 ± 22.5 mg/L to 14.7 ± 23.8 mg/L); reductions were sustained through Week 52. Higher body weight, disease severity, and baseline hsCRP were associated with lower secukinumab serum concentrations. Secukinumab immunogenicity was low (< 1%), with no new safety signals.

conclusionSecukinumab serum concentrations in patients with HS varied with body weight, disease severity, and baseline hsCRP. SECQ2W may benefit certain patients. Secukinumab reduced hsCRP through Week 52. The safety profile of secukinumab was consistent with other approved indications, with no apparent dose-response relationship observed.

trial registrationNCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302).

Indexed as

Antibodies, Monoclonal, HumanizedHidradenitis SuppurativaAdultBody WeightClinical Trials, Phase III as TopicC-Reactive ProteinFemaleHumansInterleukin-17MaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedC-Reactive ProteinInterleukin-17secukinumabbiological productsC‐reactive proteinhidradenitis suppurativainterleukin‐17monoclonal antibodies

Identifiers

PMID40839197
PMCPMC12783437

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.