Plaque Psoriasis Adult Safety | COSENTYX® (secukinumab)

For your adult patients with PsO at risk for developing PsA The largest number of patients studied among IL antagonists1* Nadia, actual patient with PsO on COSENTYX®, and Gary, actual patient with PsO and PsA on COSENTYX, were compensated for their time. Individual results may vary.

Trust in the well-studied clinical profile

161 completed studies and >87,700 patients²

.

NO Boxed WARNING³
NO warning for suicidal ideation and behavior³
COSENTYX PsO trials did not screen out patients with depression or suicidal ideation^4-8†
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 Candida infections, IBD, MACE, or malignancy through Year 5⁹
<1% of patients had immunogenicity over 5 years¹⁰
Neutralizing antibodies developed in 0.6% of patients with PsO and were not associated with loss of efficacy^‡

*Based on number of patients studied in completed clinical trials with IL-17 antagonists, IL-23 antagonists, and IL-12/23 antagonists.¹
^†Protocol permitted investigator discretion to exclude any individuals with any medical or psychiatric condition that, in the investigator's opinion, would preclude the patient from adhering to the protocol or completing the study.^4-8
^‡The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.³

An established clinical profile³

Pooled PsO safety in pivotal trials in adults through Week 12
AEs >1% in ERASURE, FIXTURE, FEATURE, JUNCTURE	COSENTYX 300 mg (n=691)	Placebo (n=694)
Nasopharyngitis	11.4%	8.6%
Diarrhea	4.1%	1.4%
URTI	2.5%	0.7%
Rhinitis	1.4%	0.7%
Oral herpes	1.3%	0.3%
Pharyngitis	1.2%	0.0%
Urticaria	0.6%	0.1%
Rhinorrhea	1.2%	0.1%

No new cases of CD and 3 cases of exacerbation (in which 1 patient received COSENTYX); 2 new cases of UC and 2 cases of exacerbation; no cases of IBD in patients with placebo
29% of patients experienced infections (n=1382) vs 19% with placebo (n=694)
0.1% of patients reported serious infections (n=1382) vs 0.3% with placebo (n=694)
If a serious infection develops, discontinue COSENTYX until the infection resolves

A robust long-term safety profile⁹

PsO safety data from the 5-year uncontrolled SCULPTURE extension study in adults

Treatment-emergent AEs 300 mg (FI) (EAIR per 100 patient-years)^§	Year 1 300-mg extension subgroup only	Year 2 to Year 5 300-mg FI arm from extension only
	n=168	n=168	n=157	n=142	n=134
Most frequent AEs
Nasopharyngitis	20.1	18.1	18.8	13.5	11.1
Hypertension	6.8	5.1	2.0	5.3	3.6
Back pain	4.3	5.7	6.2	2.2	2.1
URTI	7.5	7.1	3.5	3.8	3.6
Headache	6.2	4.4	2.7	2.2	0.7
Selected AEs
Opportunistic infections (other than TB and candidiasis)	0.0	0.0	0.0	0.0	0.0
Tuberculosis	0.0	0.0	0.0	0.0	0.0
Candida infections
Vulvovaginal candidiasis	1.8	1.9	0.7	0.0	0.0
Oral candidiasis	0.0	0.6	0.0	0.7	0.0
Neutropenia^\|\|	0.0	0.0	0.0	0.0	0.0
MACE	0.0	0.0	0.0	0.7	0.7
Inflammatory bowel disease
CD	0.0	0.0	0.0	0.0	0.0
UC	0.0	1.2^¶	0.7	0.0	0.0
Malignant or unspecified tumors (excluding NMSC)	0.0	1.2^#	0.0	0.0	0.7**

Safety data up to Year 1 based on a post hoc analysis of the SCULPTURE core study in patients treated with 300 mg who achieved PASI 75 at Week 12, who were rerandomized to 300-mg FI arm, and reconsented at Week 52 to enter the SCULPTURE extension study.  Year 2 to Year 5 safety data are presented in this same patient subpopulation; thus, not all patients who started with 300 mg in the SCULPTURE core study were included.

^§Patient exposure is calculated as a sum of individual subject durations in days divided by 365 for each interval. A patient with multiple occurrences of the same AE in a 1-year interval was counted only once, while a patient with multiple occurrences of the same AE in different-year intervals was counted for each year.⁷
^||Includes neutropenia adverse events reported by investigators in the SCULPTURE study; does not include lab reports of neutropenia.⁷
^¶Of the 2 cases of UC in Year 2, 1 case was an exacerbation of previously existing UC.
^#1 case of cholangiocarcinoma, 1 case of invasive ductal breast carcinoma.
**1 case of breast cancer.

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Please see ERASURE, FIXTURE, and SCULPTURE Core and Extension primary end points and study design details

COSENTYX clinical trial end points

Pivotal ERASURE trial in adults with moderate to severe PsO¹

Coprimary end points: PASI 75 and IGA 0/1 at Week 12.
For COSENTYX 300 mg (n=245)

82% achieved PASI 75
65% achieved IGA 0/1

Adult patients on COSENTYX 150 mg (n=245) or placebo (n=248) achieving PASI 75 (71% vs 4%) and IGA 0/1 (51% vs 2%) at Week 12, respectively. P<0.001 for all comparisons.^1,2

Pivotal FIXTURE trial in adults with moderate to severe PsO¹

Coprimary end points: PASI 75 and IGA 0/1 at Week 12.
For COSENTYX 300 mg (n=327)

76% achieved PASI 75
62% achieved IGA 0/1

Adult patients on COSENTYX 150 mg (n=327) or placebo (n=326) achieving PASI 75 (67% vs 5%) and IGA 0/1 (51% vs 3%) at Week 12, respectively. P<0.001 for all comparisons.^1,2

SCULPTURE Core and SCULPTURE Extension in adults with moderate to severe PsO³

SCULPTURE Core: The primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 in patients who were PASI 75 responders at Week 12.^3*

5-year results for patients treated with COSENTYX 300 mg FI (n=168)³:

75% of patients who entered the extension study at Year 1 completed the study at  Year 5
89% had PASI 75 at Year 5 (89% at Year 1)
41% had PASI 100 at Year 5 (44% at Year 1)

In the COSENTYX 300-mg FI group of the core study, patients received COSENTYX 300 mg every 4 weeks. At Week 12, 90% of patients in the 300-mg FI arm achieved PASI 75. PASI 75 responders at Week 12 were eligible to enter the maintenance period. 78% of patients who continued COSENTYX 300-mg FI maintained PASI 75 and 60% achieved PASI 90 at Week 52. At Week 52, patients could continue in the extension study regardless of PASI 75 response and received the same blinded maintenance regimen and dose up to the end of Year 3. Extension study was unblinded from Year 3 through Year 5.^3,4

Data presented are as observed—patients with missing data at a specific time point are not included in the analysis. The as-observed analysis included patients who completed an assessment at each visit only³
As with open-label extensions, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may raise the proportion of responders in the overall population

*Maintenance of PASI 75 response was assessed at Week 52 for patients on the FI regimen. For patients on the retreatment-as-needed regimen, PASI 75 response was assessed at Week 52 for those who required active treatment at Week 40, or at Week 40 for those who did not require active treatment at Week 40.³

Study designs

ERASURE and FIXTURE were multicenter, randomized, double-blind, placebo-controlled trials. ERASURE evaluated 738 adult patients who received subcutaneous COSENTYX 150 mg (n=245), COSENTYX 300 mg (n=245), or placebo (n=248). FIXTURE evaluated 1306 adult patients who received COSENTYX 150 mg (n=327), COSENTYX 300 mg (n=327), placebo (n=326), or a biologic active control: etanercept (n=323). All patients were adults with moderate to severe plaque psoriasis who had BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy. Patients received treatment at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter. Patients randomized to receive placebo who were nonresponders at Week 12 and did not achieve PASI 75 were then rerandomized to receive COSENTYX 300 mg or 150 mg. Coprimary end points were PASI 75 and IGA 0 or 1 (clear or almost clear).^1,5,6

SCULPTURE Core was a randomized, double-blind, multicenter trial assessing PASI response and maintenance of response in patients with moderate to severe plaque psoriasis on either an FI regimen (every 4 weeks) or on a retreatment at SoR regimen. All patients had a BSA of ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy. Primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 in patients who were PASI 75 responders at Week 12. Initial dosing (weekly) was at baseline and Weeks 1, 2, 3, 4, and 8. In the SoR arms, patients received COSENTYX at Week 12 and then every 4 weeks from the start of relapse (≥20% loss of maximum PASI improvement vs baseline and a loss of PASI 75 response) until they achieved PASI 75 again.⁷

SCULPTURE Extension was a multicenter, double-blind, and open-label (from Week 156 through Week 260) extension study. Patients who completed 52 weeks of the SCULPTURE Core study were eligible to continue the same COSENTYX dose and regimen in the extension to Week 156. At Week 156, the study was unblinded and, based on investigator judgment, patients could switch dosing regimens (from SoR to FI regimen and from COSENTYX 150 mg to 300 mg). Primary objective was to assess long-term safety and tolerability of COSENTYX in patients who completed treatment in the core studies. Other objectives included efficacy over time with respect to PASI 50/75/90.⁸

BSA, body surface area; FI, fixed interval; IGA, Investigator’s Global Assessment; IGA mod 2011, Investigator's Global Assessment modified 2011; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis; SoR, start of relapse.

References

1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis—results of two phase 3 trials. N Engl J Med. 2014;371(4):326-338.
3. Mrowietz U, Leonardi CL, Girolomoni G, et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol. 2015;73(1):27-36.
4. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
5. Data on file. AIN457A2302 (ERASURE): Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
6. Data on file. AIN457A2303 (FIXTURE): Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
7. Data on file. CAIN457A2304 (SCULPTURE): Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
8. Data on file. 4-Year Interim Report. Study CAIN457A2304E1 (SCULPTURE). Novartis Pharmaceuticals Corp; December 2016.

Definitions and references

Definitions

AE, adverse event; CD, Crohn’s disease; EAIR, exposure-adjusted incidence rate (patient incidence rate per 100 patient-years); FI, fixed interval; IBD, inflammatory bowel disease; IL, interleukin; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TB, tuberculosis; UC, ulcerative colitis; URTI, upper respiratory tract infection.

References

1. Data on file. Summary of Approved IL Antagonist Trials. Novartis Pharmaceuticals Corp; February 2026.
2. ClinicalTrials.gov. Accessed March 30, 2026. https://clinicaltrials.gov/search?term=Secukinumab&aggFilters=status:com&limit=100&viewType=Table
3. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
4. Blauvelt A, Prinz JC, Gottlieb AB, et al; for the FEATURE Study Group. Secukinumab administration by pre-filled syringe: efficacy, safety, and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2015;172(2)(suppl):1-20.
5. Data on file. AIN457A2302 (ERASURE): Clinical Trial Protocol. Novartis Pharmaceuticals Corp; February 2011.
6. Data on file. AIN457A2303 (FIXTURE): Clinical Trial Protocol. Novartis Pharmaceuticals Corp; February 2011.
7. Data on file. CAIN457A2304 (SCULPTURE): Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
8. Data on file. CAIN457A2309 (JUNCTURE): Clinical Study Report. Novartis Pharmaceuticals Corp; November 2014.
9. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
10. Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a fully human anti interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years. J Eur Acad Dermatol Venereol. 2019;33(9):1733-1741.

Trust in the well-studied clinical profile

161 completed studies and >87,700 patients²

.

NO Boxed WARNING³

NO warning for suicidal ideation and behavior³

NO routine lab monitoring, including liver enzymes, during treatment³

NO trend toward increased AE incidence rates of Candida infections, IBD, MACE, or malignancy through Year 5⁹

<1% of patients had immunogenicity over 5 years¹⁰

An established clinical profile³

A robust long-term safety profile⁹

PsO safety data from the 5-year uncontrolled SCULPTURE extension study in adults

Please see ERASURE, FIXTURE, and SCULPTURE Core and Extension primary end points and study design details

COSENTYX clinical trial end points

Study designs

Definitions and references

Important Safety Information

Indications

Trust in the well-studied clinical profile

161 completed studies and >87,700 patients2

.

NO Boxed WARNING3

NO warning for suicidal ideation and behavior3

NO routine lab monitoring, including liver enzymes, during treatment3

NO trend toward increased AE incidence rates of Candida infections, IBD, MACE, or malignancy through Year 59

<1% of patients had immunogenicity over 5 years10

An established clinical profile3

A robust long-term safety profile9

PsO safety data from the 5-year uncontrolled SCULPTURE extension study in adults

Please see ERASURE, FIXTURE, and SCULPTURE Core and Extension primary end points and study design details

Definitions and references

161 completed studies and >87,700 patients²

NO Boxed WARNING³

NO warning for suicidal ideation and behavior³

NO routine lab monitoring, including liver enzymes, during treatment³

NO trend toward increased AE incidence rates of Candida infections, IBD, MACE, or malignancy through Year 5⁹

<1% of patients had immunogenicity over 5 years¹⁰

An established clinical profile³

A robust long-term safety profile⁹