What is Cosentyx (secukinumab)?

What is Cosentyx (Secukinumab)?

Cosentyx (secukinumab) is a fully human monoclonal IgG1 antibody that selectively binds to and neutralizes interleukin-17A (IL-17A), a pro-inflammatory cytokine involved in psoriasis, psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa. 1, 2

Mechanism of Action

• Secukinumab inhibits IL-17A's interaction with its receptor, thereby blocking the release of pro-inflammatory cytokines and chemokines that drive inflammatory disease processes 1, 2
• IL-17A is naturally occurring but becomes elevated in psoriatic plaques, inflamed joints in psoriatic arthritis, and hidradenitis suppurativa lesions 1
• By neutralizing IL-17A, secukinumab reduces epidermal neutrophils and inflammatory markers in affected tissues 1

FDA-Approved Indications

Cosentyx is approved for multiple inflammatory conditions 1:

• Moderate-to-severe plaque psoriasis in adults and children ≥6 years who are candidates for systemic therapy or phototherapy 1
• Active psoriatic arthritis in patients ≥2 years and weighing ≥15 kg 1
• Active ankylosing spondylitis in adults 1
• Active non-radiographic axial spondyloarthritis with objective signs of inflammation in adults 1
• Active enthesitis-related arthritis in patients ≥4 years and weighing ≥15 kg 1
• Moderate-to-severe hidradenitis suppurativa in adults with inadequate response to conventional systemic therapy 3, 1

Clinical Efficacy

Psoriasis

• Secukinumab 300 mg is more effective than the 150 mg dose and should be the preferred dosing regimen 4
• At week 16,79% of patients achieved PASI 90 (90% improvement in Psoriasis Area and Severity Index) with secukinumab 300 mg compared to 57.6% with ustekinumab 4
• Efficacy extends to difficult-to-treat areas including scalp, nails, and palmoplantar psoriasis 4, 2
• Continuous every-4-week dosing is superior to as-needed dosing after the initial 12-week course 4

Psoriatic Arthritis

• ACR20 response rates at 5 years were 74% with secukinumab 300 mg and 70% with 150 mg 5
• ACR50 response rates at 5 years were 52% with 300 mg and 43% with 150 mg 5
• Effective in both TNF-inhibitor-naïve patients and those who failed TNF inhibitors 6, 7
• Improves enthesitis, dactylitis, and inhibits radiographic progression of peripheral arthritis 7

Dosing Regimens

Plaque Psoriasis

• Loading phase: 300 mg subcutaneously at weeks 0,1,2,3, and 4 4
• Maintenance: 300 mg every 4 weeks thereafter 4
• The 300 mg dose demonstrates superior efficacy compared to 150 mg and should be prioritized 4

Hidradenitis Suppurativa

• Loading phase: 300 mg subcutaneously at weeks 0,1,2,3, and 4 3
• Maintenance: 300 mg every 4 weeks, with potential escalation to every 2 weeks if inadequate response 3

Ankylosing Spondylitis

• 150 mg subcutaneously with loading at weeks 0,1,2,3, and 4, then every 4 weeks 6

Formulations Available

• 300 mg/2 mL UnoReady pen (subcutaneous) 1
• 150 mg/mL Sensoready pen (subcutaneous) - contains latex in needle cap 1
• Prefilled syringes: 300 mg/2 mL, 150 mg/mL, 75 mg/0.5 mL (subcutaneous) - 150 mg and 75 mg syringes contain latex in needle cap 1
• 125 mg vials for intravenous infusion after dilution 1

Safety Profile and Monitoring

Pre-Treatment Screening

• Tuberculosis screening (PPD or interferon-gamma release assay) is mandatory before initiating therapy 3, 8
• Baseline complete blood count to assess for neutropenia risk 8
• Assess for inflammatory bowel disease history, as this is a contraindication 3, 8

Common Adverse Events

• Upper respiratory tract infections (very common, ≥1/10 patients) 3, 8
• Mucocutaneous and oral candidiasis (typically mild-to-moderate, responsive to standard antifungals) 3, 9
• Headache, rhinorrhea, diarrhea, nausea, and fatigue 3

Serious Risks

• Serious infections occur at a rate of 0.015 per patient-year, including bacterial, fungal, and viral infections 3, 1, 5
• Neutropenia occurs more frequently than placebo but is usually mild, transient, and reversible; rare Grade 4 cases reported 3, 8
• Inflammatory bowel disease: New cases or exacerbations have been reported; secukinumab should not be used in patients with active IBD 3, 8, 1
• Rare hypersensitivity reactions including anaphylaxis 3

Ongoing Monitoring

• Periodic CBC monitoring during maintenance therapy to detect neutropenia 8
• Clinical monitoring for signs of infection at each visit 8
• Monitor inflammatory markers (CRP) to assess disease activity 8

Critical Contraindications

• Active tuberculosis infection 1
• Active inflammatory bowel disease (Crohn's disease or ulcerative colitis) 3, 8, 1
• Severe allergic reaction to secukinumab or any component 1
• Active serious infection unless specifically instructed by healthcare provider 1

Important Clinical Considerations

• Secukinumab is first-in-class as an IL-17A inhibitor and represents the first biologic approved for first-line systemic treatment of moderate-to-severe plaque psoriasis in the EU 2
• Neutralizing anti-secukinumab antibodies develop rarely (<0.4% of patients) and are not associated with loss of efficacy 4
• Long-term data through 5 years demonstrates sustained efficacy with consistent safety profile 5
• Dose escalation from 150 mg to 300 mg can be considered for patients with inadequate response, with improvements typically seen 24-84 weeks after escalation 5