For adult patients with moderate to severe HS,

Redefine treatment with the FIRST and ONLY FDA-approved IL-17A antagonist¹

Across 2 clinical trials, the percentages of patients on COSENTYX^® experiencing ≥50% reduction in the number of inflammatory nodules and abscesses, with no increase in the number of abscesses and/or in the number of draining tunnels, at Week 16 were Q4W: 41.3% and 42.5%; Q2W: 44.5% and 38.3% vs placebo: 29.4% and 26.1%, respectively.¹

Data presented are the results of an FDA-requested analysis of the SUNSHINE and SUNRISE trials.

HiSCR50 is defined as at least a 50% decrease in abscess and inflammatory nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae compared with baseline.²
*If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks.¹

Week 2 results were as observed prespecified exploratory end points. No clinical or statistical conclusions can be drawn.³

Observed results at Year 1

Improvement in inflammatory nodules and abscesses⁵

71% of patients had an observed ≥50% reduction (AN50) in the count of abscesses and nodules^† at Year 1 in the Q4W arm (n=255)
71% of patients had an observed ≥50% reduction (AN50) in the count of abscesses and nodules^† at Year 1 in the Q2W arm (n=254)

Q4W

Q2W

AN50 at 52 weeks were as observed prespecified exploratory end points. No clinical or statistical conclusions can be drawn.
Data shown are Q4W and Q2W, pooled from the SUNSHINE and SUNRISE trials.

^†At Week 16, patients in the placebo group were randomized to either COSENTYX 300 mg Q2W or Q4W.

Patients with no new tunnel formation

83% of patients formed no new draining tunnels at Year 1 in the Q4W arm (n=218 with ≥1 draining fistula on COSENTYX 300 mg Q4W)⁷
81% of patients formed no new draining tunnels at Year 1 in the Q2W arm (n=239 with ≥1 draining tunnel Q2W 300 mg)⁷

Q4W

Q2W

Tunnels were as observed prespecified exploratory end points. No clinical or statistical conclusions can be drawn. Data shown are Q4W pooled data and Q2W pooled data from the SUNSHINE and SUNRISE trials.

Tunnels, also called fistulae or sinus tracts, are defined as raised, tender, and fluctuating longitudinal tunnels of variable length and depth, with communications to skin surface, with or without purulent discharge.²

“When draining, I have to wear all black to cover up any leaking through bandages. I used to travel a lot and was terrified I would leak onto the car seats or in meetings.”⁸

– Quote from a real patient with HS

Patients with zero flares

78% of patients had zero flares at Year 1 in the Q4W arm (n=127)²
80% of patients had zero flares at Year 1 in the Q2W arm (n=117)²

Q4W

Q2W

^‡Q4W: Data presented are from the SUNRISE trial; the same results were not seen in SUNSHINE. Q2W: Data presented are from the SUNSHINE trial; the same results were not seen in SUNRISE. Flares were as observed prespecified exploratory end points at 52 weeks. No clinical or statistical conclusions can be drawn.

Flares were defined as a 25% or greater increase in abscess and inflammatory nodule count with a minimum increase of 2 abscesses and inflammatory nodules compared with baseline.²

"I’ve had flares under my armpits that were so massive that the vibrations of my footsteps would shoot up my body and cause too much pain to walk or bend over."¹⁰

– Quote from a real patient with HS

Patients with reduced skin pain

70% of those who started with moderate to severe skin pain had mild or no pain at Year 1 in the Q4W arm¹²
65% of those who started with moderate to severe skin pain had mild or no pain at Year 1 in the Q2W arm¹²

Q4W

Q2W

Skin pain was as observed prespecified exploratory end point. No clinical or statistical conclusions can be drawn. Data shown are Q4W pooled data and Q2W pooled data from the from SUNSHINE and SUNRISE trials.
^§Based on VAS.

Provide patients hope for better days ahead^2,14,15

At Week 16,

~3x improvement in DLQI across both trials vs placebo, with results maintained at Year 1

Components of DLQI include:

Feelings of embarrassment or self-consciousness
Daily activities, like shopping or caring for their home
Leisure activities, including socializing or playing a sport
Working or studying
Personal relationships with partners, close friends, or family

DLQI was 1 exploratory end point and was measured using multiple domains; each listed item was not evaluated separately. No clinical or statistical conclusions can be drawn. Data shown are from both Q4W and Q2W in both trials.²

DLQI includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school.¹⁶

A robust safety profile¹

Safety

A convenient dosing schedule²

Dosing

Get your patients started on COSENTYX

Access and Support

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.

In the postmarketing setting, serious and some fatal infections have been reported in patients treated with COSENTYX.

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable caps of the COSENTYX Sensoready® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Immunizations

Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Please see Full Prescribing Information ↗, including Medication Guide ↗.

10/23 310615

Definitions
DLQI, Dermatology Life Quality Index; FDA, US Food and Drug Administration; HiSCR, Hidradenitis Suppurativa Clinical Response; HS, hidradenitis suppurativa; IL, interleukin; NRS, numeric rating scale; QoL, quality of life; Q2W, every 2 weeks; Q4W, every 4 weeks; VAS, visual analogue scale.

References
1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023;401(10378):747-761 and Supplementary Appendices. doi:10.1016/S0140-6736(23)00022-3
3. Data on file. AIN457M Summary of Clinical Efficacy in Moderate to Severe Hidradenitis Suppurativa. Novartis Pharmaceuticals Corp; September 2022.
4. Shah M, Sachdeva M, Alavi A. The importance of early diagnosis and treatment in hidradenitis suppurativa: case report and literature review. J Clin Cosmet Dermatol. 2020;4(2):1-4. doi:10.16966/2576-2826.151
5. Data on file. CAIN45M2301/2302 data tables. Novartis Pharmaceuticals Corp; October 2022.
6. Martorell A, Giovanardi G, Gomez-Palencia P, Sanz-Motilva V. Defining fistular patterns in hidradenitis suppurativa: impact on the management. Dermatol Surg. 2019;45(10):1237-1244. doi:10.1097/DSS.0000000000001916
7. Data on file. Effect of Secukinumab on Draining Tunnels in Patients with Moderate to Severe Hidradenitis Suppurativa: Post Hoc Analysis of the SUNSHINE and SUNRISE Phase 3 Randomised Trials. Novartis Pharmaceuticals Corp; February 2023.
8. Canadian Skin Patient Alliance. Scarred for life: 2020 update: a national report of patients' experiences living with hidradenitis suppurativa. May 2020.
9. Garg A, Neuren E, Cha D, et al. Evaluating patients' unmet needs in hidradenitis suppurativa: results from the Global Survey of Impact and Healthcare Needs (VOICE) Project. J Am Acad Dermatol. 2020;82(2):366-376. doi:10.1016/j.jaad.2019.06.1301
10. Liles M. What it's like to live with HS. Updated February 26, 2020. Accessed October 21, 2023. https://www.healthcentral.com/article/hs-patient-stories
11. Matusiak Ł, Szczęch J, Kaaz K, et al. Clinical characteristics of pruritus and pain in patients with hidradenitis suppurativa. Acta Derm Venereol. 2018;98(2):191-194. doi:10.2340/00015555-2815
12. Data on file. SUNNY clinical study program post hoc analysis of skin pain severity. Novartis Pharmaceuticals Corp; April 2023.
13. Krajewski PK, Matusiak Ł, von Stebut E, et al. Quality-of-life impairment among patients with hidradenitis suppurativa: a cross-sectional study of 1795 patients. Life (Basel). 2021;8;11(1):34. doi:10.3390/life11010034
14. Data on file. CAIN457M2301 (SUNSHINE). Novartis Pharmaceuticals Corp; April 2022.
15. Data on file. CAIN457M2302 (SUNRISE). Novartis Pharmaceuticals Corp; April 2022.
16. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)—a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.