Hidradenitis suppurativa safety data | COSENTYX® (secukinumab)

For adults with moderate to severe HS

Trust in the well-studied clinical profile

~90 completed studies and >74,000 patients²

NO boxed WARNING³
NO warning for suicidal ideation and behavior³
NO routine lab monitoring, including liver enzymes, during treatment³
- Evaluate patients for TB prior to initiating treatment
NO trend toward increased AE incidence rates of IBD, Candida infections, MACE, or malignancy through Year 5⁴
<1% of patients had immunogenicity over 5 years⁵

Safety in HS¹

Week 16

Year 1

IBD prevalence^6,7
General population=1.3% | Patients with HS=3.3%

In the SUNNY clinical program (N=1084), <0.3% of new-onset IBD cases at Year 1 in COSENTYX¹^¶
SUNSHINE=0 | SUNRISE=3

In the SUNNY Clinical Study Program (SUNSHINE and SUNRISE), patients were randomized to COSENTYX 300 mg or placebo at baseline and given loading doses of their study drug QW for 5 weeks, followed by a Q2W or Q4W regimen. At Week 16, patients in the placebo group were randomized to either COSENTYX Q2W or Q4W.¹

*Fungal infectious disorders include the following preferred terms: Vulvovaginal mycotic infection, oral candidiasis, fungal skin infection, fungal infection, tinea infection, tinea pedis, body tinea, dermatophytosis, genital candidiasis, oral fungal infection, vulvovaginal candidiasis, Candida infection, ear infection fungal, tinea versicolor, skin Candida, tinea cruris, and esophageal candidiasis.¹
^†Candida infections include the following preferred terms: Vulvovaginal candidiasis, Candida infection, mucocutaneous candidiasis, urinary tract candidiasis, skin Candida, oral candidiasis, genital candidiasis, and esophageal candidiasis.¹
^‡Any COS Q4W=COS Q4W AND PBO-COS Q4W.¹
^§Any COS Q2W=COS Q2W AND PBO-COS Q2W.
^||One case of IBD, 1 case of ulcerative colitis, and 1 case of Crohn's disease.¹
^¶Incidence includes both Q2W and Q4W dosing.

The FIRST and ONLY FDA-approved IL-17A antagonist for your adult patients with moderate to severe HS³

COSENTYX is covered as a 1st- or 2nd-line biologic in HS across Private insurance, Medicaid, and Medicare^8#**

^#Certain payers have carve-outs that restrict utilization of manufacturer support programs.
^**COSENTYX for subcutaneous use is present on formularies as either a first-, second-, third-, fourth-, or fifth-line biologic. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Coverage information is subject to change by the relevant payer. Be sure to review the COSENTYX coverage criteria outlined by your patients' insurance providers.

Get your patients started on COSENTYX

Access and Support

Lasting relief from HS³

Efficacy

Studied in the largest clinical trial program for HS^1,4

SUNNY

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

Trust in the well-studied clinical profile

~90 completed studies and >74,000 patients2

Safety in HS1

Get your patients started on COSENTYX

Lasting relief from HS3

Studied in the largest clinical trial program for HS1,4

Definitions and references

~90 completed studies and >74,000 patients²

Safety in HS¹

Lasting relief from HS³

Studied in the largest clinical trial program for HS^1,4