Starting Orencia (Abatacept) in Patients with Fatty Liver Disease
Yes, it is safe to initiate Orencia (abatacept) in patients with fatty liver disease, provided the patient has normal liver enzymes, normal liver function tests, and no evidence of advanced liver fibrosis or decompensated cirrhosis. 1
Evidence-Based Guidance from Rheumatology Guidelines
The 2021 American College of Rheumatology guideline for rheumatoid arthritis specifically addresses DMARD use in patients with nonalcoholic fatty liver disease (NAFLD). The guideline conditionally recommends methotrexate over alternative DMARDs for DMARD-naive patients with NAFLD who have normal liver enzymes, normal liver function tests, and no evidence of advanced liver fibrosis. 1 This recommendation establishes that the presence of fatty liver disease alone is not a contraindication to starting DMARDs, including biologics like abatacept.
Importantly, the guideline does not single out abatacept or other biologics as contraindicated in fatty liver disease. In fact, abatacept is specifically conditionally recommended over other biologics in certain clinical scenarios (such as nontuberculous mycobacterial lung disease), demonstrating its favorable safety profile. 1
Critical Pre-Treatment Assessment Required
Before initiating Orencia in a patient with fatty liver, you must stratify the patient's fibrosis risk:
- Check baseline liver enzymes (ALT, AST) and liver function tests (albumin, bilirubin, INR) to ensure they are normal or near-normal 1
- Calculate the FIB-4 score to assess fibrosis risk: scores <1.3 indicate low risk, 1.3-2.67 indicate intermediate risk, and >2.67 indicate high risk 2, 3
- Consider liver stiffness measurement (transient elastography) if available: <8.0 kPa indicates low risk, 8.0-12.0 kPa indicates intermediate risk, and >12.0 kPa indicates high risk 2, 3
When Orencia Can Be Started Safely
Orencia can be initiated in patients with:
- Simple hepatic steatosis (fatty liver without inflammation or fibrosis) 1
- NAFLD with normal or mildly elevated liver enzymes 1
- Low fibrosis risk (FIB-4 <1.3 or LSM <8.0 kPa) 2, 3
- Compensated liver disease without cirrhosis 1
When to Exercise Caution or Avoid
Do not start Orencia in patients with:
- Decompensated cirrhosis (ascites, hepatic encephalopathy, variceal bleeding) 1
- Significantly elevated liver enzymes (>3x upper limit of normal) without clear explanation 1
- Evidence of advanced fibrosis (F3-F4) without hepatology consultation 2, 3
For patients with intermediate or high fibrosis risk, refer to hepatology before initiating biologic therapy to confirm the stage of liver disease and ensure appropriate monitoring. 2, 3
Monitoring Strategy After Initiation
Once Orencia is started in a patient with fatty liver disease:
- Monitor liver enzymes every 3 months initially, then every 6 months once stable 1, 2
- Reassess fibrosis risk annually using FIB-4 or liver stiffness measurement 2, 3
- Emphasize lifestyle modifications: 7-10% weight loss improves steatohepatitis and fibrosis, Mediterranean diet, 150-300 minutes of moderate-intensity exercise weekly, and complete alcohol abstinence 2, 3
- Optimize metabolic comorbidities: use GLP-1 receptor agonists for diabetes if present, statins for dyslipidemia (safe in compensated liver disease) 1, 2
Common Pitfalls to Avoid
Do not assume all fatty liver disease is the same. The critical distinction is between simple steatosis (fat accumulation alone) versus steatohepatitis with fibrosis. 2 Simple steatosis poses minimal risk for medication-related hepatotoxicity, while advanced fibrosis fundamentally changes drug metabolism and clearance. 1
Do not avoid statins in these patients. Statins are safe and strongly recommended for cardiovascular risk reduction in patients with fatty liver disease and compensated cirrhosis. 1, 2 Cardiovascular disease is the leading cause of death in NAFLD patients before cirrhosis develops. 2, 4
Do not overlook the need for hepatology referral in intermediate/high-risk patients. These patients require specialized assessment and may benefit from liver biopsy to accurately stage disease before starting immunosuppressive therapy. 2, 3