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; Ivette Alarcon; Bruno Bieth; Shoba Ravichandran; Alexa B Kimball

doi:10.1111/ijd.70025

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
, Ivette Alarcon
, Bruno Bieth
, Shoba Ravichandran
, Alexa B Kimball

^*Corresponding author for this work

Dermatology

Research output: Contribution to journal › Article › Research › peer-review

Abstract

BACKGROUND: Secukinumab, 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.

METHODS: An 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.

RESULTS: Mean 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.

CONCLUSION: Secukinumab 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 REGISTRATION: NCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302).

Original language	English
Pages (from-to)	289-298
Number of pages	10
Journal	International Journal of Dermatology
Volume	65
Issue number	2
Early online date	21 Aug 2025
DOIs	https://doi.org/10.1111/ijd.70025
Publication status	Published - Feb 2026

Funding

The study was sponsored by Novartis Pharma AG, Basel, Switzerland.

Funders
Novartis

Keywords

C-reactive protein
Biological products
Hidradenitis suppurativa
Interleukin-17
Monoclonal antibodies
Severity of Illness Index
Body Weight
Humans
Middle Aged
Hidradenitis Suppurativa/drug therapy
Interleukin-17/antagonists & inhibitors
Male
Treatment Outcome
Antibodies, Monoclonal, Humanized/pharmacokinetics
Clinical Trials, Phase III as Topic
Female
Adult
C-Reactive Protein/metabolism

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10.1111/ijd.70025Licence: CC BY-NC

Cite this

Alavi, A., Reguiai, Z., Jemec, G. B. E., Gottlieb, A. B., Wozniak, M. B., Uhlmann, L., Fan, H., Llobet Martinez, A., Bruin, G., Thomas, N., Alarcon, I., Bieth, B., Ravichandran, S., & Kimball, A. B. (2026). Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies. International Journal of Dermatology, 65(2), 289-298. https://doi.org/10.1111/ijd.70025

@article{ee58a715e7614d29811c168422633b17,

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

abstract = "BACKGROUND: Secukinumab, 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.METHODS: An 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.RESULTS: Mean serum trough concentration at Weeks 16, 24, and 52 was \textasciitilde{}2-fold higher with SECQ2W vs. SECQ4W. At Week 16, exposure overlap was high, with an estimated numerical increase in HiSCR of \textasciitilde{}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.CONCLUSION: Secukinumab 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 REGISTRATION: NCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302).",

keywords = "C-reactive protein, Biological products, Hidradenitis suppurativa, Interleukin-17, Monoclonal antibodies, Severity of Illness Index, Body Weight, Humans, Middle Aged, Hidradenitis Suppurativa/drug therapy, Interleukin-17/antagonists \& inhibitors, Male, Treatment Outcome, Antibodies, Monoclonal, Humanized/pharmacokinetics, Clinical Trials, Phase III as Topic, Female, Adult, C-Reactive Protein/metabolism",

author = "Afsaneh Alavi and Ziad Reguiai and Jemec, \{Gregor B E\} and Gottlieb, \{Alice B\} and Wozniak, \{Magdalena B\} and Lorenz Uhlmann and Heng Fan and \{Llobet Martinez\}, Angela and Gerard Bruin and Nicolas Thomas and Ivette Alarcon and Bruno Bieth and Shoba Ravichandran and Kimball, \{Alexa B\}",

note = "{\textcopyright} 2025 The Author(s). International Journal of Dermatology published by Wiley Periodicals LLC on behalf of the International Society of Dermatology.",

year = "2026",

month = feb,

doi = "10.1111/ijd.70025",

language = "English",

volume = "65",

pages = "289--298",

journal = "International Journal of Dermatology",

issn = "0011-9059",

publisher = "John Wiley \& Sons Inc.",

number = "2",

}

Alavi, A, Reguiai, Z, Jemec, GBE, Gottlieb, AB, Wozniak, MB, Uhlmann, L, Fan, H, Llobet Martinez, A, Bruin, G, Thomas, N, Alarcon, I, Bieth, B, Ravichandran, S & Kimball, AB 2026, 'Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies', International Journal of Dermatology, vol. 65, no. 2, pp. 289-298. https://doi.org/10.1111/ijd.70025

Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies. / Alavi, Afsaneh; Reguiai, Ziad; Jemec, Gregor B E et al.
In: International Journal of Dermatology, Vol. 65, No. 2, 02.2026, p. 289-298.

Research output: Contribution to journal › Article › Research › peer-review

TY - JOUR

T1 - Secukinumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa

T2 - Pooled Pharmacokinetics and Safety Results From the SUNSHINE and SUNRISE Phase 3 Studies

AU - Alavi, Afsaneh

AU - Reguiai, Ziad

AU - Jemec, Gregor B E

AU - Gottlieb, Alice B

AU - Wozniak, Magdalena B

AU - Uhlmann, Lorenz

AU - Fan, Heng

AU - Llobet Martinez, Angela

AU - Bruin, Gerard

AU - Thomas, Nicolas

AU - Alarcon, Ivette

AU - Bieth, Bruno

AU - Ravichandran, Shoba

AU - Kimball, Alexa B

PY - 2026/2

Y1 - 2026/2

N2 - BACKGROUND: Secukinumab, 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.METHODS: An 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.RESULTS: Mean 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.CONCLUSION: Secukinumab 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 REGISTRATION: NCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302).

AB - BACKGROUND: Secukinumab, 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.METHODS: An 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.RESULTS: Mean 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.CONCLUSION: Secukinumab 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 REGISTRATION: NCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302).

KW - C-reactive protein

KW - Biological products

KW - Hidradenitis suppurativa

KW - Interleukin-17

KW - Monoclonal antibodies

KW - Severity of Illness Index

KW - Body Weight

KW - Humans

KW - Middle Aged

KW - Hidradenitis Suppurativa/drug therapy

KW - Interleukin-17/antagonists & inhibitors

KW - Male

KW - Treatment Outcome

KW - Antibodies, Monoclonal, Humanized/pharmacokinetics

KW - Clinical Trials, Phase III as Topic

KW - Female

KW - Adult

KW - C-Reactive Protein/metabolism

U2 - 10.1111/ijd.70025

DO - 10.1111/ijd.70025

M3 - Article

C2 - 40839197

SN - 0011-9059

VL - 65

SP - 289

EP - 298

JO - International Journal of Dermatology

JF - International Journal of Dermatology

IS - 2

ER -

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

Abstract

Funding

Keywords

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