Does Stelara Increase Infection Risk?
Yes, Stelara (ustekinumab) can increase the risk of infections. It suppresses parts of the immune system by blocking interleukins 12 and 23, which fight inflammation but also help control infections. Clinical trials and post-marketing data show higher rates of upper respiratory infections, nasopharyngitis, and serious infections like cellulitis compared to placebo.[1][2]
Common Infections Reported with Stelara
Patients often experience mild to moderate infections, including:
- Upper respiratory tract infections (around 20-30% in trials).
- Sinusitis and bronchitis.
- Fungal infections like herpes simplex or tinea.
Serious cases, though less common (about 3-5%), include pneumonia, diverticulitis, and sepsis, particularly in those with risk factors like age over 65 or diabetes.[1][3]
Why Does It Happen and Who Is Most at Risk?
Stelara targets cytokines needed for immune defense against bacteria, viruses, and fungi. Risk rises with:
- Higher doses or longer use.
- Concurrent immunosuppressants (e.g., methotrexate).
- Pre-existing conditions like COPD or prior infections.
The FDA label warns of reactivation of latent infections like tuberculosis or hepatitis B; screening is recommended before starting.[2][4]
How Often Do Serious Infections Occur?
In psoriasis trials, serious infections hit 2.8 per 100 patient-years on Stelara versus 0.6 on placebo. In Crohn's disease studies, rates were similar at 3.4 versus 1.9. Most resolve with treatment, but 0.2-0.4% led to death in some reports.[1][3]
Precautions and Monitoring
Doctors test for TB and hepatitis before prescribing. Report fever, chills, or persistent cough promptly. Avoid live vaccines during treatment. If an infection develops, pausing doses may be needed.[2][4]
Patient Experiences and Comparisons
Real-world data from registries show infection rates align with trials, with upper respiratory issues most cited on forums like Drugs.com reviews. Compared to TNF inhibitors like Humira, Stelara has a slightly lower serious infection risk (odds ratio ~0.7), but still elevated over non-biologics.[3][5]
Sources
[1]: Stelara Prescribing Information, Janssen (FDA-approved label, 2023) - link
[2]: FDA Medication Guide for Stelara - link
[3]: Clinical trial data from pivotal studies (PSOLAR registry, UNITI trials) - link
[4]: CDC guidelines on biologics and infections - link
[5]: Meta-analysis in The Lancet (2017) comparing biologics - link