Is a person taking adalimumab (adalimumab) considered immunocompromised?

Adalimumab Therapy and Immunocompromised Status

Yes, a person taking adalimumab is considered immunocompromised due to its mechanism of action as a TNF-alpha inhibitor that suppresses immune function and increases risk of serious infections.

Mechanism of Immunosuppression

Adalimumab is a fully human monoclonal antibody that blocks tumor necrosis factor alpha (TNF-α), a key inflammatory cytokine in the immune system 1. This mechanism results in:

• Suppression of normal immune responses
• Increased susceptibility to infections, particularly certain types of infections
• Impaired ability to mount effective immune responses against pathogens

Evidence of Immunocompromised Status

Infection Risk

The immunosuppressive effects of adalimumab are well-documented:

• Patients receiving anti-TNF agents like adalimumab are particularly at risk for reactivation of latent infections, especially tuberculosis 1
• Serious infections have been associated with adalimumab use, including bacterial, viral, and fungal infections 1
• The FDA label includes a boxed warning about serious infections and malignancy 2
• A systematic review and meta-analysis found an increased risk of general infections with adalimumab (RR: 1.10,95% CI: 1.02-1.18) 3

Specific Infection Concerns

1. Tuberculosis reactivation:

   • Patients require tuberculin skin testing and chest radiograph prior to therapy 1, 4
   • Annual QuantiFERON-TB Gold testing is recommended for ongoing monitoring 4
   • Prophylactic isoniazid is recommended for patients with latent TB 1, 4

2. Other opportunistic infections:

   • Increased risk of Legionella pneumophila pneumonia 1
   • Cases of Pneumocystis jeroveci pneumonia have been reported 1
   • Risk of atypical mycobacterial infections 1
   • Hepatitis B virus reactivation 1

Classification of Immunosuppression

According to the ECCO guidelines, TNF inhibitors like adalimumab are classified as causing significant immunosuppression 1:

• Combination therapies involving adalimumab with other immunosuppressants pose an even higher risk (OR increasing from 2.9 for one drug to 14.5 for multiple drugs) 1
• Specific patterns of infection risk are associated with anti-TNF agents, particularly fungal and mycobacterial infections 1

Clinical Management Implications

The immunocompromised status of patients on adalimumab requires specific precautions:

1. Pre-treatment screening:

   • TB screening (tuberculin skin test or QuantiFERON-TB Gold) 1, 4
   • Hepatitis B serology 1
   • Assessment for active infections 1

2. Ongoing monitoring:

   • Annual TB screening 4
   • Vigilance for signs of infection 1
   • Monitoring for autoimmune reactions 1

3. Vaccination considerations:

   • Live vaccines should be avoided while on adalimumab 1
   • Complete all necessary vaccinations before initiating therapy when possible

4. Infection management:

   • Prompt evaluation of fever or other signs of infection 1
   • Temporary discontinuation during serious infections 1
   • Lower threshold for initiating antimicrobial therapy

Special Considerations

• Age factors: Patients >65 years on adalimumab have up to 20-fold increased risk of severe infections (11% vs 0.5%) 1
• Combination therapy: Risk of opportunistic infections increases substantially when adalimumab is combined with other immunosuppressants, particularly steroids and thiopurines 1
• Disease activity: Higher disease activity (e.g., in Crohn's disease) further increases infection risk 1

Practical Implications

For patients on adalimumab:

• Monitor temperature regularly and report fever immediately
• Report signs of infection promptly (cough, fever, chills, wounds with redness/discharge)
• Report changes in breathing or shortness of breath
• Avoid individuals with active infections when possible
• Consider prophylactic antibiotics for high-risk procedures

In conclusion, the evidence clearly establishes that patients on adalimumab therapy should be considered immunocompromised and managed accordingly to mitigate infection risks.