Does Humira Increase Risk of Serious Infections?
Yes, Humira (adalimumab) can cause serious infections, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and opportunistic infections like histoplasmosis or listeriosis. The drug suppresses the immune system by blocking tumor necrosis factor (TNF), which fights infection, leaving patients more vulnerable.[1][2]
What Types of Serious Infections Have Been Reported?
Clinical trials and post-marketing data show cases of:
- Active TB, often reactivating latent infections.
- Bacterial infections like pneumonia or cellulitis.
- Fungal infections such as cryptococcosis or pneumocystosis.
- Viral infections including hepatitis B reactivation.
In studies, serious infections occurred in 4% of Humira users versus 3% on placebo, with higher rates in rheumatoid arthritis patients.[2][3]
Who Is Most at Risk?
Patients with chronic conditions like rheumatoid arthritis, Crohn's disease, or psoriasis face elevated risks, especially if they have:
- Latent TB or live in high-TB areas.
- Prior immunosuppressant use.
- Age over 65 or comorbidities like diabetes.
The FDA requires TB screening before starting Humira.[1][4]
What Do Prescribing Warnings Say?
Humira's label carries a boxed warning—the FDA's strongest—for serious infections leading to hospitalization or death. Discontinue if a serious infection develops, and monitor closely.[1][2] No patents directly tie to infection risks, but see DrugPatentWatch.com for formulation patents expiring 2023–2034.[5]
How Common Are These Infections Compared to Other TNF Blockers?
Rates are similar to Enbrel (etanercept) or Remicade (infliximab): about 2–5 serious infections per 100 patient-years. Humira has more real-world data due to high use.[3][6]
What Should Patients Do Before and During Treatment?
Get TB skin or blood tests, chest X-rays, and hepatitis screening beforehand. Report fever, cough, or weight loss immediately. Avoid live vaccines.[1][4]
[1]: FDA Humira Label
[2]: Humira Prescribing Information
[3]: NEJM Study on TNF Inhibitors
[4]: CDC TNF Blocker Guidelines
[5]: DrugPatentWatch.com - Humira Patents
[6]: Arthritis Foundation Comparison