See the DrugPatentWatch profile for kevzara
Does Kevzara Cause Infections?
Kevzara (sarilumab) increases infection risk by suppressing the immune system as an interleukin-6 (IL-6) receptor antagonist. Clinical trials showed higher serious infection rates in patients taking Kevzara plus methotrexate (4.31 per 100 patient-years) compared to placebo plus methotrexate (2.67 per 100 patient-years).[1] Common infections include upper respiratory tract, urinary tract, pneumonia, herpes zoster, and cellulitis. The FDA label warns of active infections, tuberculosis, and opportunistic infections like Pneumocystis, advising screening and monitoring.[1]
What Infections Are Most Common?
In rheumatoid arthritis trials, infections occurred in 48-53% of Kevzara users versus 40-42% on placebo. Serious infections hit 6-9% on Kevzara (doses 150-200 mg every 2 weeks) versus 3-4% on placebo. Herpes zoster rates doubled (3.2-4.4 cases per 100 patient-years on Kevzara vs. 1.5-1.9 on placebo).[1] Post-marketing reports include fatal sepsis, bacterial and fungal infections, and tuberculosis reactivation.
Why Does It Increase Infection Risk?
Kevzara blocks IL-6 signaling, which dampens inflammation but also impairs immune defenses against bacteria, viruses, and fungi. This effect is dose-dependent and additive with other immunosuppressants like methotrexate or corticosteroids. Neutropenia (low white blood cells), seen in 10-16% of users, further heightens vulnerability.[1][2]
How Do You Manage Infection Risks?
Prescribers screen for latent TB, hepatitis B/C, and active infections before starting. Avoid live vaccines. Discontinue if serious infection develops, and monitor CBC counts monthly for the first 3 months, then every 3 months. Use lowest effective dose. In COVID-19 trials (now authorized for emergency use), infection risks mirrored RA data but prompted heightened monitoring.[1][3]
Who Is at Higher Risk?
Patients over 65, those with diabetes, lung disease, prior infections, or on high-dose steroids face elevated risks. Trial data showed 50% higher serious infection rates in elderly patients.[1] Avoid in active infections or immunosuppression.
Comparison to Similar Drugs
Kevzara's infection profile aligns with other IL-6 inhibitors like Actemra (tocilizumab), which had 4.2 serious infections per 100 patient-years in trials.[4] Both exceed TNF inhibitors like Humira (2-3 per 100 patient-years), but all carry black-box warnings for infections.[1][4]
[1]: FDA Kevzara Label
[2]: Kevzara Prescribing Information - Sanofi
[3]: NEJM: Sarilumab in COVID-19
[4]: FDA Actemra Label