Is a hepatic profile (Liver Function Test, LFT) indicated in patients with Crohn's disease treated with Humira (adalimumab)?

Hepatic Profile (LFT) Monitoring in Crohn's Disease Patients Treated with Humira

Yes, hepatic profile (liver function test) monitoring is strongly recommended for patients with Crohn's disease being treated with Humira (adalimumab). 1, 2

Rationale and Guidelines for LFT Monitoring

Initial Assessment

• All IBD patients initiating Humira (adalimumab) therapy should have baseline liver function tests (LFTs) including:
  • Complete blood count (CBC)
  • Liver profile (ALT, AST, bilirubin, alkaline phosphatase)
  • Renal function tests 1

Monitoring Schedule

• After initiating Humira therapy, LFTs should be monitored:
  • At weeks 2,4,8, and 12 after starting treatment
  • Then at least every 3 months thereafter during maintenance therapy 1
• More frequent monitoring may be necessary in patients with:
  • Pre-existing liver disease
  • Concomitant hepatotoxic medications
  • Abnormal baseline LFTs 1, 3

Evidence of Hepatotoxicity Risk

The FDA label for adalimumab (Humira) specifically mentions the risk of liver enzyme elevations:

• ALT elevations ≥3× ULN occurred in 0.9% of adalimumab-treated patients with Crohn's disease in controlled trials
• Severe hepatic reactions including acute liver failure have been reported in patients receiving TNF-blockers 2

Management of Abnormal LFTs

Grading and Response

1. Mild elevations (< 3× ULN):

   • Continue Humira with close monitoring
   • Consider monitoring labs every 1-2 weeks 3

2. Moderate elevations (3-5× ULN):

   • Consider temporarily holding Humira
   • Investigate other potential causes of liver injury
   • Increase frequency of monitoring to every 3 days 1, 3

3. Severe elevations (> 5× ULN):

   • Discontinue Humira temporarily
   • Prompt hepatology consultation
   • Consider liver biopsy if etiology unclear 1, 3

Special Considerations

Concomitant Immunosuppressants

• Patients on combination therapy with thiopurines may have increased risk of hepatotoxicity
• Methotrexate has been associated with hepatotoxicity in 14% of IBD patients in a dose-dependent manner 4
• Combination therapy requires more vigilant monitoring 1

Hepatitis B Screening

• All patients should be screened for hepatitis B before starting Humira
• Reactivation of hepatitis B can occur during anti-TNF therapy
• Prophylaxis is mandatory in HBsAg positive patients 4, 5

Autoimmune Hepatitis

• Rare cases of autoimmune hepatitis have been reported with anti-TNF therapy including infliximab and adalimumab
• Characterized by elevated autoantibodies and specific histological findings
• May require discontinuation of therapy and corticosteroid treatment 6, 7

Conclusion

Regular monitoring of liver function tests is an essential component of safety monitoring for Crohn's disease patients on Humira therapy. The British Society of Gastroenterology guidelines strongly recommend baseline testing and regular monitoring throughout treatment to detect potential hepatotoxicity early and prevent serious liver-related adverse events.