Prescribing information

 

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Cosentyx is indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults, adolescents and children from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis in adult patients, alone or in combination with MTX, when the response to previous DMARD therapy has been inadequate; active ankylosing spondylitis in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence in adults who have responded inadequately to NSAIDs.

Cosentyx is now a first line biologic treatment option for patients ≥6 years of age.1 Explore the data below to understand how Cosentyx has shown fast and long-lasting improvements in skin clearance.2–7

 

Click the icons below to find out more about Cosentyx efficacy and tailored dosing for your paediatric PsO patients:

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Tailored dosing

 

Paediatric study 1

Adapted from Bodemar C, et al. 20213

Co-primary endpoints: 80% of patients achieved PASI 75 and 70% achieved IGA mod 2011 0/1 at Week 12 vs. 15% and 5% in the placebo group, respectively.2,3

Skin clearance responses were sustained for up to 52 weeks with Cosentyx*2,3

Study design

Paediatric Study 1 was a randomised, double-blind, placebo and etanercept-controlled, Phase III study in paediatric patients from 6 to <18 years of age with severe PsO* designed to assess the safety and efficacy of Cosentyx for up to 52 weeks’ follow-up.

Patients (n=162) were randomised to receive:

  • Low dose Cosentyx (75 mg for body weight <50 kg or 150 mg for body weight ≥50 kg) (n=40), or,
  • Placebo at Weeks 0, 1, 2, 3, and 4 followed by the same dose every 4 weeks (n=41), or,
  • Etanercept (0.8 mg/kg weekly, up to a maximum of 50 mg per dose) (n=41).
  • Data presented using NRI with extended analysis visit window at Week 123

 

The safety profile reported in this study was consistent with the safety profile reported in adult PsO patients.

 

Cosentyx demonstrates a consistent safety profile in adult PsO patients, with no new safety concerns observed in children2-4,6,8 

 

Adverse events from pooled paediatric trials at Week 52§8

Secukinumab (N=98)

Etanercept (N=41)
Patients with serious or significant AEs
Serious AEs 7 (7.1) 5 (12.2)
Discontinued study treatment due to any AE 2 (2.0) 1 (2.4)
Most frequent AEs (by SOC)
Infections and infestations 58 (59.2) 27 (65.9)
Skin and subcutaneous tissue disorders 23 (23.5) 10 (24.4)
Gastrointestinal disorders 18 (18.4) 14 (34.1)
Most frequent AEs (by PT)
Nasopharyngitis 23 (23.5) 11 (26.8)
Headache 10 (10.2) 4 (9.8)
Pharyngitis 8 (8.2) 3 (7.3)

 

Injection site inflammation and erythema9

No weight restriction2,9

Immunogenicity up to 52 weeks7,10

Summary of adverse reactions in clinical studies** and post-marketing experience2

System organ class Frequency†† Adverse reaction
Infections and infestations

Very Common

 

Common

 

 

Uncommon

 

 

 

 

Not known

Upper respiratory tract infections

Oral herpes

Tinea Pedis

Oral candidiasis

Otitis externa

Lower respiratory tract infections

Mucosal and cutaneous candidiasis (including oesophageal candidiasis)
Blood and lymphatic system disorders Uncommon Neutropenia
Immune system disorder Rare Anaphylactic reaction
Nervous system disorders Common Headache
Eye disorders Uncommon Conjunctivitis
Respiratory, thoracic and mediastinal disorders Common Rhinorrhoea
Gastrointestinal disorders

Common

Common

Uncommon

Diarrhoea

Nausea

Inflammatory bowel disease
Skin and subcutaneous tissue disorders Uncommon

Rare
Urticaria

Exfoliative dermatitis‡‡
General disorders and administration site conditions  Common Fatigue

Recommended dosing in paediatric PsO patients ≥6 years of age

 

  • Each 75 mg dose is given as one subcutaneous injection of 75 mg
  • Each 150 mg dose is given as one subcutaneous injection of 150 mg
  • Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg
  • The 150 mg and 300 mg solution for injection in pre-filled syringe and in pre-filled pen are not indicated for administration to paediatric patients with a weight <50 kg
  • Cosentyx may be available in other strengths and/or presentations depending on the individual treatment needs

 

Footnotes and abbreviations

*Data is for low dose secukinumab in a severe patient population (N=40) from an ongoing, multicentre, double-blind placebo- and active-controlled study in patients aged 6–<18 years (NCT02471144). Low dose defined as: <25 kg: 75 mg; 25 to <50 kg: 75 mg; ≥50 kg: 150 mg.2
Data is for low dose secukinumab in a moderate to severe population (N=42) from an ongoing, open label, parallel-group, multicentre study in patients aged 6–<18 years (NCT03668613).2,4 Low dose defined as: <25 kg: 75 mg; 25 to <50 kg: 75 mg; ≥50 kg: 150 mg.2-4
Based on patient responses to Children’s Dermatology Life Quality Index (CDLQI) questions about the impact of their skin trouble on swimming and other sports, playing, and doing hobbies and on questions about how itchy, scratchy, sore, or painful their skin was.11
§Week 52 pooled safety data from two Phase 3 studies in paediatric patients with moderate to severe psoriasis.8
AEs ordered according to paediatric population.8
**Placebo-controlled clinical studies (Phase 3) in plaque psoriasis, PsA, AS and nr-axSpA patients exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA, AS and nr-axSpA) treatment duration.
††Frequency is categorised as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
‡‡Cases were reported in patients with psoriasis diagnosis.

BSA, body surface area; CDLQI, Children’s Dermatology Life Quality Index; CRP, C-reactive protein; DMARD, disease-modifying anti-rheumatic drugs; IGA, Investigators Global Assessment; MRI, magnetic resonance imaging; MTX, methotrexate; NICE, National Institute for Health and Care Excellence, NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index.

References

  1. NICE. Cosentyx Technical Appraisal Guidance [TA734]. Available at: https://www.nice.org.uk/guidance/ta734/chapter/1-Recommendations[Accessed November 2021].
  2. Cosentyx Summary of Product Characteristics.
  3. Bodemer C, et al. J Eur Acad Dermatol Venereol 2021;35(4):938–947.
  4. Magnolo N, et al. J Am Acad Dermatol 2021. Online ahead of print. doi: 10.1016/j.jaad.2021.08.066
  5. Beissert S, et al. ESPC 2021. Poster P080
  6. Krasowska D, et al. WCPD 2021. Poster SP09
  7. Novartis data on file. UK_DOF_Sec001
  8. Sticherling M, et al. EADV 2021. Poster 1420
  9. Reich K, et al. ESPD 2021. Poster P121
  10. Bodemer C, et al. AAD VMX 2021. Poster 25482
  11. Lewis-Jones MS, et al. Br J Dermatol 1995;132:942–949
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UK | November 2021 | 172054
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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