What is the infection risk for patients taking Cosentyx (secukinumab) compared to the general population?

Infection Risk with Cosentyx (Secukinumab) Compared to General Population

Patients taking Cosentyx (secukinumab) have a moderately increased risk of infections compared to the general population, with upper respiratory tract infections being the most common, occurring in approximately 11.4% of patients versus 8.6% in placebo groups. 1

Infection Risk Profile

Common Infections

• Very common (≥1/10): Upper respiratory tract infections 2, 1
• Common (≥1/100 to <1/10): 2, 1
  • Oral herpes
  • Nasopharyngitis
  • Rhinorrhea
  • Diarrhea

Less Common Infections

• Uncommon (>1/1,000 to <1/100): 2, 1
  • Oral candidiasis
  • Lower respiratory tract infections
  • Mucosal and cutaneous candidiasis (including esophageal)

Serious Infections

• Serious infections occur in approximately 1.2% of patients (0.015 per patient-year of follow-up) 1
• In long-term studies (median follow-up of 3.9 years), serious infections were reported in 4.5% of patients (1.4 per 100 subject-years) 1

Specific Infection Types

Candida Infections

• Increased risk of mucocutaneous candida infections compared to placebo (1.2% versus 0.3%) 1
• In comparative studies with TNF inhibitors, candida infections occurred more frequently with secukinumab (4%) compared to adalimumab (2%) 2
• Most candida infections are mild to moderate in severity, non-serious, and responsive to standard treatment 2
• Interestingly, a small case series of 16 patients did not show increased occurrence of Candida infections after one year of secukinumab treatment 3

Tuberculosis

• Patients should be evaluated for active or latent TB prior to initiating treatment 1
• Cases of TB reactivation have been reported in the postmarketing setting 1

Risk Factors for Infections

The risk of infections with Cosentyx appears to be dose-dependent, with higher serum concentrations associated with increased risk of:

• Candida infections
• Herpes viral infections
• Staphylococcal skin infections 1

Neutropenia and Infection Risk

• Neutropenia occurs more frequently with secukinumab than placebo 2, 1
• Most cases are mild, transient, and reversible 2
• Some cases of serious infections were associated with neutropenia, though causal relationship is not established 1

Long-Term Safety Data

In long-term studies with up to 5 years of follow-up:

• Exposure-adjusted incidence rate for Candida infections was 1.0 per 100 patient-years (95% CI 0.4-1.9) 4
• The overall safety profile remained consistent over time 4, 5

Clinical Implications and Recommendations

1. Pre-treatment evaluation:

   • Screen for active infections before starting Cosentyx 1
   • Evaluate for latent or active TB 1

2. During treatment:

   • Monitor for signs and symptoms of infection 2, 1
   • Be particularly vigilant for upper respiratory tract infections and candidiasis
   • Advise patients to seek medical advice if infection symptoms occur 1

3. Management of infections:

   • Most infections are mild to moderate and don't require discontinuation of therapy 2
   • For serious infections, discontinue Cosentyx until the infection resolves 1

4. Special considerations:

   • Use with caution in patients with chronic infection or history of recurrent infection 1
   • Cosentyx is contraindicated in patients with clinically important, active infections 2
   • Consider the increased risk in patients with other risk factors for infection (e.g., diabetes, immunosuppressive comorbidities) 2

Comparison to Other Biologics

• Secukinumab has a different infection risk profile compared to TNF inhibitors:
  • TNF inhibitors: higher risk of mycobacterial and bacterial infections
  • IL-17 inhibitors like secukinumab: higher risk of mucocutaneous candidiasis 2
• In head-to-head trials with adalimumab, secukinumab showed similar rates of serious infections (1.6% vs 1.4%) but higher rates of candida infections 6

In summary, while Cosentyx increases infection risk compared to the general population, most infections are mild to moderate upper respiratory tract infections. The most distinctive infection risk is for mucocutaneous candidiasis. Serious infections are relatively uncommon but require vigilance and appropriate management.