Week 16

Sunshine | Q4W^1,2

FILTER DATA

{ "sunshine":{"label":"SUNSHINE","callback":"onFiltersChanged"}, "sunrise":{"label":"SUNRISE","callback":"onFiltersChanged"} }

{ "q2w":{"label":"Q2W","callback":"onFiltersChanged"}, "q4w":{"label":"Q4W","callback":"onFiltersChanged"} }

{ "week 16":{"label":"Week 16","callback":"onFiltersChanged"}, "week 52":{"label":"Week 52","callback":"onFiltersChanged"} }

Click to see what achieving HiSCR50 could look like

KEY

SEC Q2W

SEC Q4W

PBO

PBO-SEC Q2W

PBO-SEC Q4W

{ "AN count":{"label":"AN count^†","class":"widget-title","callback":"onAn50Toggled"}, "AN50":{"label":"AN50^‡","class":"widget-title","callback":"onAn50Toggled"} }

Secukinumab
Q4W

Secukinumab
Q2W

decrease

Placebo

decrease

{ "Baseline":{"label":"Baseline","callback":"onAnCountToggled"}, "Week 16":{"label":"Week 16","callback":"onAnCountToggled"} }

Secukinumab
Q4W

Secukinumab
Q2W

decrease

Placebo

decrease

IBD

^§

Candida infections

^§

Infections and infestations

^§

End points FDA-requested analyses

Primary
Proportion of patients achieving HiSCR50 at week 16

HiSCR50 defined as ≥50% decrease in AN count, with no increase in the number of abscesses and/or in the number of draining fistulae relative to baseline at week 16

Secondary
Proportion of patients achieving an AN50 response at week 16

Defined as ≥50% decrease in AN count relative to baseline

Proportion of patients with HS flares over 16 weeks

Defined as ≥25% increase in AN count with a minimum increase of 2 AN relative to baseline

Reduction in HS-related skin pain using NRS30 in patients who entered the study with an initial baseline score of 3 or greater

Defined as a ≥30% reduction from baseline and a ≥2-unit reduction in Patient’s Global Assessment of Skin Pain at worst

Prespecified per protocol analyses

Primary
Proportion of patients achieving HiSCR50 at week 16

Secondary
Mean percentage change in AN count at week 16
Proportion of patients with HS flares over week 16
Reduction in HS-related skin pain using NRS30 in patients who entered the study with an initial baseline score of 3 or greater

Key exploratory
Safety and tolerability of SEC over 52 weeks
Proportion experiencing a ≥5-point decrease in DLQI vs baseline
Primary and secondary end point criteria up to 52 weeks for HiSCR50, AN count, flares, and NRS30*

Key inclusion criteria

Adult patients with moderate to severe HS
Selected antibiotics permitted

Key exclusion criteria

Total fistula count ≥20 at baseline
Active skin disease that may interfere with HS assessment
Pregnant or lactating women
Other active ongoing inflammatory disease requiring treatment with prohibited medications
Previous exposure to secukinumab or other IL-17–targeting biologic

For full study design details, please see Kimball AB et al Lancet. 2023;401(10378):747-761¹ and Kimball AB et al [Supplementary Appendix]. Lancet. 2023;401(10378):747-761.⁴
*Multiple imputation was applied for the 16-week data. Data for weeks 16 to 52 are reported as observed.

Acronyms

AE, adverse event
AN, abscess and inflammatory nodule
BMI, body mass index
DLQI, Disease Quality of Life Index
HiSCR, hidradenitis suppurativa clinical response
HLGT, High-Level Group Term
HLT, High-Level Term
HS, hidradenitis suppurativa
IBD, inflammatory bowel disease
IL, interleukin
MACE, major adverse cardiovascular events
MedDRA, Medical Dictionary for Regulatory Activities
n, number of patients with outcome
N, number of patients in group
NMQ, Novartis MedDRA Query
NRS30, ≥30% reduction in Numeric Rating Scale
PBO, placebo
Q2W, every 2 weeks
Q4W, every 4 weeks
SEC, secukinumab 300 mg
SAE, serious adverse event
SOC, System Organ Class
SMQ, Standardised MedDRA Query
URTI, upper respiratory tract infection

References

1. Cosentyx. Prescribing Information. Novartis Pharmaceuticals Corp.

2. Data on file. FDA-requested analysis. Novartis Pharmaceuticals Corp; October 2023.

3. Kimball AB et al. Lancet. 2023;4019(10378):747-761.

4. Kimball AB et al. [Supplementary Appendix]. Lancet. 2023;401(10378):747-761.

5. Kimball AB et al. Poster presented at: American Academy of Dermatology 2023 Annual Meeting; March 17-21, 2023; New Orleans, LA. Poster P42640.

6. Data on file. SUNSHINE Clinical Study Report. Novartis Pharmaceuticals Corp; 2023.

7. Data on file. SUNRISE Clinical Study Report. Novartis Pharmaceuticals Corp; 2023.

8. ClinicalTrials.gov. NCT03713619. Accessed November 15, 2023. https://www.clinicaltrials.gov/study/NCT03713619

9. ClinicalTrials.gov. NCT03713632. Accessed November 15, 2023. https://www.clinicaltrials.gov/study/NCT03713632

10. Hsiao JL et al. Poster presented at: Maui Derm Hawaii 2023;
January 23-27, 2023; Maui, HI.

11. Kokolakis G et al. Poster presented at: American Academy of Dermatology 2023 Annual Meeting; March 17-21, 2023; New Orleans, LA. Poster P42981.

12. Zouboulis CC et al. Poster presented at: American Academy of Dermatology 2023 Annual Meeting; March 17-21, 2023; New Orleans, LA. Poster P42652.

Secukinumab in HS

Visualizing SUNSHINE and SUNRISE Trial Data

Week 16

Sunshine | Q4W^1,2

Secukinumab in HS

Visualizing SUNSHINE and SUNRISE Trial Data

Week 16

Sunshine | Q4W1,2

Illustrative Example of HiSCR50

Acronyms

References

Sunshine | Q4W^1,2