Does Cosentyx Increase Infection Risk?
Cosentyx (secukinumab), an IL-17 inhibitor for psoriasis, psoriatic arthritis, and ankylosing spondylitis, carries a boxed warning for serious infections. It suppresses immune responses, raising susceptibility to bacterial, viral, fungal, and tuberculosis infections. Clinical trials showed higher infection rates (e.g., upper respiratory infections in 18-28% of patients vs. 13-15% placebo), including cases of candidiasis and herpes zoster.[1][2]
Patients with a history of recurrent or serious infections face elevated risks. Prescribing information advises against starting Cosentyx in active infections and recommends screening for latent TB before initiation. Post-marketing reports include fatal infections like sepsis and pneumonia.[3]
What Do Guidelines Say for Patients with Infection History?
The FDA label contraindicates Cosentyx in patients with active inflammatory infections. For those with past infections:
- Assess risk-benefit; avoid if history includes severe or opportunistic infections (e.g., prior TB, chronic fungal disease).
- Rheumatology societies (e.g., ACR) recommend caution, with pre-treatment TB testing (Quantiferon or PPD) and monitoring for reactivation.
- No absolute ban, but many clinicians pause biologics post-infection until resolved, especially if recent hospitalization occurred.[1][4]
Common Infections Linked to Cosentyx
| Infection Type | Frequency in Trials | Notes for At-Risk Patients |
|---------------|---------------------|----------------------------|
| Upper respiratory | 14-28% | Mild, but signals broader vulnerability |
| Candidiasis (oral/genital) | 3-5% | Dose-related; higher in psoriasis patients |
| Herpes zoster | 1-2% | Risk doubles vs. placebo; history of shingles warrants prophylaxis discussion |
| Serious (sepsis, TB) | <1% | Black-box warning; screen history rigorously |
Real-world data from registries like BADBIR confirm 2-3x higher infection odds in biologic users with prior history.[2][5]
How Do Doctors Decide for High-Risk Patients?
Physicians weigh factors like infection recency, severity, comorbidities (e.g., diabetes, COPD), and prophylaxis options (e.g., antivirals for zoster). Alternatives like methotrexate may be safer short-term. Live vaccines are prohibited during treatment.[1]
Patient reports on forums note flares post-infection pauses, with some switching to TNF inhibitors (lower infection profile in head-to-head studies).[6]
Monitoring and When to Stop
Monthly checks for signs like fever, cough, or wounds. Discontinue if serious infection develops. Risk persists up to 6 months post-last dose due to half-life.[3]
No DrugPatentWatch data directly on safety, but patents expire 2032-2034 in major markets, potentially enabling biosimilars with similar profiles.[7]
Sources
[1]: FDA Cosentyx Label
[2]: Novartis Prescribing Info
[3]: FDA Post-Marketing Surveillance
[4]: ACR Guidelines on Biologics
[5]: BADBIR Registry Data
[6]: Psoriasis Association Studies
[7]: DrugPatentWatch: Cosentyx