Does Stelara Increase Infection Risk?
Stelara (ustekinumab) suppresses parts of the immune system by blocking IL-12 and IL-23, raising susceptibility to infections. Clinical trials and post-marketing data show higher rates of serious infections compared to placebo, including bacterial, viral, fungal, and tuberculosis cases.[1][2]
Common Infections Reported
Patients on Stelara experience upper respiratory infections (around 20-25% in psoriasis trials), nasopharyngitis, and sinusitis most often. In Crohn's disease studies, rates reach 21-49% across doses, versus 15-29% on placebo.[1][3]
Serious Infection Rates
Serious infections occur in 2-5% of patients annually, depending on indication:
- Psoriasis: 3% vs. 1% placebo.
- Psoriatic arthritis: 1.8/100 patient-years.
- Crohn's/colitis: Up to 5.7/100 patient-years at higher doses.
Opportunistic infections like tuberculosis or fungal sepsis are rare but documented, with warnings for screening before starting.[1][2][4]
Factors Raising Risk
- Higher doses (90 mg) or IV induction increase odds.
- Concurrent immunosuppressants (steroids, methotrexate) amplify risk.
- Age over 65, diabetes, or prior infections elevate vulnerability.
Real-world data from registries confirm 1.5-2x higher serious infection rates versus non-biologic therapies.[3][5]
How Does Risk Compare to Other Biologics?
Stelara has a lower infection risk profile than TNF inhibitors like Humira (adalimumab), where serious infections hit 4-8/100 patient-years. It matches or undercuts IL-17 inhibitors like Cosentyx in head-to-head data.[3][6]
| Drug | Serious Infection Rate (/100 patient-years) |
|------|---------------------------------------------|
| Stelara | 1.8-5.7 |
| Humira | 4.0-8.0 |
| Skyrizi (IL-23) | 1.5-3.0 |
Precautions and Monitoring
Screen for latent TB, hepatitis B/C, and HIV before treatment. Discontinue if active infection develops. Vaccinate against preventable diseases (e.g., pneumococcal, influenza) pre-treatment, avoiding live vaccines during therapy.[1][2]
Patient Experiences and Long-Term Data
Forum reports and studies note mild infections as common but manageable; severe cases often tie to comorbidities. Five-year extension trials show stable risk without cumulative rise.[4][5]
[1]: Stelara Prescribing Information, Janssen, 2023. https://www.stelara.com/
[2]: FDA Label, Ustekinumab. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761044s033lbl.pdf
[3]: Papp et al., Lancet 2018 (psoriasis safety review). https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30559-6/fulltext
[4]: Sandborn et al., NEJM 2012 (Crohn's trial). https://www.nejm.org/doi/full/10.1056/NEJMoa1202772
[5]: EADV PReSENT registry data, 2022. https://www.eadv.org/
[6]: McInnes et al., Lancet 2017 (TNF comparison). https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31247-5/fulltext