5/22 202132

Here with you to help kids be comfortable in their own skin

Please see primary and key secondary end point results and study design details for PsO6 (A2310) study

In the pivotal PsO6 (A2310) study of pediatric patients with severe PsO

Skin clearance results in children⁹

*In this study, an IRT error led to additional dosing and higher dosing of some patients (LD: n=16; HD: n=20) at Weeks 13, 14, and 15, after the primary end point (Week 12) assessment. The number of patients in the affected and not-affected patient groups was deemed to be too low for any differences to be considered clinically relevant.⁹

^†Data presented here do not account for 3 patients from the COSENTYX HD arm weighing <25 kg who received COSENTYX 75 mg, based on the recommended dosing for pediatric patients <50 kg.⁹

The PsO6 (Study A2310) study was a randomized, double-blind, placebo- and active-controlled trial to demonstrate efficacy and assess the safety and tolerability of COSENTYX vs placebo and etanercept (in a single-blinded arm) in patients from 6 to <18 years of age with severe chronic PsO (defined by a PASI score of ≥20 and an IGA modified 2011 score of 4, and involving ≥10% of the BSA) who were candidates for systemic therapy. pNRI was used to handle missing values.^1,9

See time to flare in ERA^m

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Convenient once-a-month maintenance dosing (every 4 weeks)^m

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5/22 201030

Please see the coprimary and key secondary end point results and study design details for the pivotal PsO6 (A2310) study (pediatric PsO)

Pivotal PsO6 (Study A2310) study in pediatric patients ≥6 years of age with severe PsO¹

Results by baseline weight strata for the approved doses:

PASI 75 and IGA mod 2011 0 or 1 at Week 12 (coprimary end points)

PASI 75

70% for COSENTYX 75 mg and 150mg (N=43)

15% for placebo (N=41)

55% for COSENTYX 75 mg (N=22; <50 kg)

10% for placebo (N=20)

86% for COSENTYX 150 mg (N=21; ≥50 kg)

19% for placebo (N=21)

IGA mod 2011 0 or 1

56% for COSENTYX 75 mg and 150 mg (N=43)

5% for placebo (N=41)

32% for COSENTYX 75 mg (N=22; <50 kg)

5% for placebo (N=20)

81% for COSENTYX 150 mg (N=21; ≥50 kg)

5% for placebo (N=21)

PASI 90 at Week 12 (key secondary end point)

60% for COSENTYX 75 mg and 150 mg (N=43)

2% for placebo (N=41)

41% for COSENTYX 75 mg (N=22; <50 kg)

5% for placebo (N=20)

81% for COSENTYX 150 mg (N=21; ≥50 kg)

0% for placebo (N=21)

PsO6 (Study A2310) (pediatric PsO) study design

PsO6 (Study A2310) was a global, multicenter, randomized, double-blind, placebo- and active-controlled study in 162 pediatric patients from 6 to <18 years of age with severe chronic PsO (as defined by a PASI score ≥20, an IGA modified 2011 score of 4, and involving ≥10% of the BSA) who were candidates for systemic therapy. Patients received subcutaneous COSENTYX 75 mg if weighing <25 kg, COSENTYX 75 mg or 150 mg if weighing 25 to <50 kg, COSENTYX 150 mg or 300 mg if weighing ≥50 kg, or placebo. Treatment was administered at Weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter up to Week 52, followed by an extension period up to Week 236. Patients in the etanercept arm received a weekly subcutaneous dose of 0.8 mg/kg (up to a maximum of 50 mg). At Week 12, PASI 75 nonresponders on placebo were placed on COSENTYX based on their weight (as described above) while PASI 75 responders entered the follow-up period. The coprimary end points were PASI 75 and IGA mod 2011 0 or 1 response at Week 12. The key secondary end point was PASI 90 at Week 12.^1,9

BSA=body surface area; IGA mod 2011=Investigator’s Global Assessment modified 2011; PASI=Psoriasis Area and Severity Index; PsO=plaque psoriasis.

Definitions

BSA=body surface area; HD=high dose; IGA mod 2011=Investigator’s Global Assessment modified 2011; IRT=Interactive Response Technology; LD=low dose; PASI=Psoriasis Area and Severity Index; pNRI=pure nonresponder imputation; PsO=plaque psoriasis; Q1=every 1.

References

1.
Cosentyx. Prescribing Information. Novartis Pharmaceuticals Corp; December 2021.
2.
Humira. Prescribing Information. AbbVie Inc; 2021.
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Orencia. Prescribing Information. Bristol-Myers Squibb Co; 2021.
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Actemra. Prescribing Information. Genentech Inc; 2022.
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Ilaris. Prescribing Information. Novartis Pharmaceuticals Corp; 2020.
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Simponi Aria. Prescribing Information. Janssen Biotech Inc; 2021.
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Xeljanz. Prescribing Information. Pfizer Inc; 2022.
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Taltz. Prescribing Information. Eli Lilly & Co; 2021.
9.
Data on file. CAIN457A2310 Clinical Study Report. Week 52 Analysis. Novartis Pharmaceuticals Corp; September 2019.
a.
Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e.
Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f.
Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g.
Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h.
Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
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Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j.
Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
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Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m.
Cosentyx. Prescribing Information. Novartis Pharmaceuticals Corp; December 2021.
n.
Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o.
Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p.
Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q.
Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r.
Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s.
Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t.
Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

6/22 201008

INDICATIONS

COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).

COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

Click or scroll down to see full Indications and Important Safety Information

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

COSENTYX^® (secukinumab) 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 plaque psoriasis, 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 with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo-controlled trials in subjects with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. In the postmarketing setting, serious and some fatal infections have been reported in patients receiving COSENTYX.

Click or scroll down to see full Indications and Important Safety Information

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

Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in COSENTYX treated subjects during clinical trials in plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory trial in 59 subjects with active Crohn’s disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.

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.

7/21 132185

Click or scroll down to see full Indications and Important Safety Information

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

Click or scroll down to see full Indications and Important Safety Information

WARNINGS AND PRECAUTIONS

Infections

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection.

Pre-treatment Evaluation for Tuberculosis

Inflammatory Bowel Disease

Hypersensitivity Reactions

Immunizations

MOST COMMON ADVERSE REACTIONS

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

INDICATIONS

COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).

COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

Please see full Prescribing Information, including Medication Guide.

7/21 132185

Here with you to help kids be comfortable in their own skin

In the pivotal PsO6 (A2310) study of pediatric patients with severe PsO

Skin clearance results in children9

See time to flare in ERAm

Convenient once-a-month maintenance dosing (every 4 weeks)m

Dedicated support for patients and the office

Please see the coprimary and key secondary end point results and study design details for the pivotal PsO6 (A2310) study (pediatric PsO)

Definitions and references

Definitions

References

INDICATIONS

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Infections

Pre-treatment Evaluation for Tuberculosis

Inflammatory Bowel Disease

Hypersensitivity Reactions

Immunizations

MOST COMMON ADVERSE REACTIONS

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Infections

Pre-treatment Evaluation for Tuberculosis

Inflammatory Bowel Disease

Hypersensitivity Reactions

Immunizations

MOST COMMON ADVERSE REACTIONS

INDICATIONS

Skin clearance results in children⁹

See time to flare in ERA^m

Convenient once-a-month maintenance dosing (every 4 weeks)^m

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS