Does Stelara Increase Infection Risk?
Stelara (ustekinumab) suppresses parts of the immune system by blocking IL-12 and IL-23 cytokines, which can raise susceptibility to infections. Clinical trials and post-marketing data show higher rates of serious infections, including bacterial, viral, fungal, and tuberculosis reactivation, compared to placebo. The FDA label warns of this risk, advising screening for latent TB and monitoring patients.[1]
Common Infections Linked to Stelara
Patients on Stelara report upper respiratory infections (around 20-25% in trials), nasopharyngitis, and sinusitis most frequently. Serious cases include pneumonia, cellulitis, herpes zoster (shingles), and sepsis. In psoriasis studies, serious infections occurred in 2.8% of Stelara users versus 0.6% on placebo over 76 weeks.[1][2]
How Stelara's Mechanism Drives This Risk
By targeting Th1 and Th17 immune pathways, Stelara impairs defenses against intracellular pathogens like Mycobacterium tuberculosis. This mirrors risks with other biologics like TNF inhibitors. Risk rises with doses over 90 mg, concurrent immunosuppressants, or comorbidities like diabetes.[1]
Who Faces Higher Infection Risks?
Elderly patients, those with chronic lung disease, or on corticosteroids see elevated odds. In Crohn's disease trials, serious infections hit 5.4% on Stelara versus 3% on placebo. Avoid in active infections; discontinue if serious ones develop.[1][3]
Real-World Data and Patient Reports
Post-approval surveillance via FDA's FAERS database logs thousands of infection cases, including opportunistic ones like Pneumocystis jirovecii pneumonia. Patient forums note frequent mild infections, with some switching drugs due to recurrent issues. Long-term studies (up to 5 years) confirm sustained risk without tolerance buildup.[2][4]
Prevention and Management Tips
Screen for TB before starting. Use prophylaxis for shingles in at-risk patients. Report fever or worsening symptoms promptly. Live vaccines are contraindicated during treatment.[1]
Comparisons to Similar Drugs
Stelara's infection rate (3-5% serious) is lower than TNF blockers like Humira (up to 8%) but similar to other IL inhibitors like Cosentyx. Head-to-head data is limited.[3]
[1]: FDA Stelara Label
[2]: Janssen Stelara Safety Data
[3]: NEJM Ustekinumab Trials
[4]: FAERS Public Dashboard