What are the management and monitoring recommendations for a patient on Infliximab (Infliximab is a TNF-alpha inhibitor)?

Management and Monitoring of Patients on Infliximab

Before initiating infliximab, all patients must undergo tuberculosis screening with chest radiograph and tuberculin skin testing, and infliximab should not be started in the presence of active infection. 1

Pre-Treatment Screening Requirements

Tuberculosis Screening (Mandatory)

• Obtain chest radiograph prior to treatment 1
• Perform tuberculin skin test to screen for latent TB (note: may be unreliable if patient already on immunosuppressants) 1, 2
• For patients with abnormal chest radiographs, positive tuberculin skin test, or high-risk status (institutional workers, frequent international travelers, certain ethnic groups), exclude active TB infection before starting infliximab 1, 2
• Initiate prophylactic TB treatment following published guidelines before starting infliximab if latent TB is identified 1
• The rate of TB development may be greater with infliximab than other anti-TNF agents, with higher likelihood of extrapulmonary involvement 1
• Half of TB cases occur after three or more infusions at median of 12 weeks, suggesting reactivation disease 1, 2

Hepatitis Screening

• Screen patients at risk for viral hepatitis with serologic testing for hepatitis B before treatment 1
• Do not administer infliximab to patients with active hepatitis B virus infection 1
• Monitor HBV carriers during therapy and for several months after discontinuation; if reactivation occurs, stop infliximab and begin anti-viral therapy 3

Cardiac Assessment

• Infliximab is contraindicated in patients with NYHA class III or IV heart failure at doses >5 mg/kg 1, 3
• The ATTACH trial demonstrated increased risk of death or hospitalization for heart failure in patients receiving 10 mg/kg infliximab 1
• For patients with history of CHF, close observation for exacerbation is required during therapy 1

Neurological History

• Do not administer infliximab to patients with history of demyelinating disease (Grade 2C recommendation) 1
• CNS demyelination disorders have been reported sporadically with TNF-α inhibitors 1

Malignancy History

• Exercise caution in patients with history of malignancy 1
• Hepatosplenic T-cell lymphomas reported particularly in adolescent/young adult males with Crohn's disease receiving concomitant azathioprine or 6-mercaptopurine 1

During Treatment Monitoring

Infection Surveillance

• Maintain clinical awareness for TB throughout treatment and for 6 months after cessation 1, 2
• Discontinue infliximab immediately if serious infection develops 1
• Risk of infection is increased approximately twofold, with upper respiratory and urinary tract infections most common 1
• Infliximab carries higher risk of opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis, cryptococcosis, aspergillosis, candidiasis, pneumocystis) compared to etanercept 1, 4
• Consider prophylaxis against Pneumocystis jiroveci pneumonia in patients receiving concomitant immunosuppressive agents 5, 6

Laboratory Monitoring

• Monitor platelet counts regularly as thrombocytopenia occurs in small percentage of patients 2
• Monitor complete blood count for cytopenias; advise patients to seek immediate medical attention if signs/symptoms develop 3
• Monitor liver function tests; stop infliximab if jaundice or marked liver enzyme elevations occur 1, 3
• After 24 weeks, 6% and 2% of patients had markedly abnormal ALT and AST elevations respectively 1
• For patients with hepatitis C, monitor serum aminotransferases and viral load at intervals 1

Clinical Response Assessment

• Assess patients at 12 weeks to determine whether therapy should be continued 2
• Continue assessment at 3-6 month intervals thereafter 2
• Withdraw therapy if adequate response (significant symptom reduction and quality of life improvement) is not achieved after 3 months 2

Infusion Reaction Monitoring

• Monitor for infusion reactions including headache, fever, chills, myalgia during first few weeks of treatment 2
• Watch for delayed hypersensitivity reactions (4% incidence in clinical trials) 1
• Serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur 3
• Cardiovascular accidents, myocardial infarctions, and arrhythmias reported during and within 24 hours of infusion; monitor patients during infusion 3

Dermatologic Monitoring

• Watch for transient acute pruritic eruption between weeks 4-10 in flexural sites, arms, neck, and trunk 2

Patient Education and Self-Monitoring

• Instruct patients to check temperature frequently and report fever immediately 1
• Report signs of infection: cough, aches, fever, chills, wound redness/pain/discharge, urinary burning, nausea, vomiting, diarrhea 1
• Report shortness of breath or breathing changes immediately 1
• If lupus-like symptoms develop, discontinue therapy 1

Special Contraindications and Precautions

Vaccination Considerations

• Do not administer live vaccines or therapeutic infectious agents during infliximab therapy 1, 3
• Bring pediatric patients up to date with all vaccinations prior to initiating infliximab 3
• Wait at least 6 months after birth before administering live vaccines to infants exposed in utero to infliximab 3

Pregnancy

• Use infliximab in pregnancy only if alternatives cannot be used 1

Drug Interactions

• Avoid concomitant use with anakinra or abatacept due to increased risk of serious infections 3
• Concomitant use with azathioprine or 6-mercaptopurine increases risk of hepatosplenic T-cell lymphoma, particularly in young males with inflammatory bowel disease 1

Common Pitfalls to Avoid

• Do not start infliximab in presence of active infection 1
• Do not rely solely on tuberculin skin testing in patients already on immunosuppressants; individualize risk assessment 2
• Do not overlook extrapulmonary TB presentations, which are more common with infliximab 1
• Do not dismiss subtle infectious symptoms; opportunistic infections may present atypically and progress rapidly 6
• Do not continue infliximab if serious infection develops; withhold for infections requiring antibiotics and discontinue for serious/opportunistic infections 1