Real-World Effectiveness of Infliximab: An Updated Review for Pharmacists

Background: Infliximab, a chimeric monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α), is widely used for immune-mediated inflammatory disorders. Its clinical effectiveness is influenced by immunogenicity, pharmacokinetics, and safety considerations. Aim: This review aims to summarize updated evidence on infliximab’s real-world effectiveness, approved indications, off-label uses, mechanism of action, pharmacokinetics, administration, adverse effects, and monitoring strategies for pharmacists. Methods: A comprehensive literature review was conducted, integrating regulatory guidelines, clinical trial data, and real-world practice insights to evaluate infliximab’s therapeutic role and safety profile. Results: Infliximab is FDA-approved for conditions including Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, with weight-based intravenous dosing schedules. Off-label applications extend to Behçet disease, pyoderma gangrenosum, and refractory sarcoidosis. Its mechanism involves TNF-α neutralization, reducing cytokine-driven inflammation. Pharmacokinetics reveal a prolonged half-life (7–12 days), supporting intermittent dosing. Adverse effects include infusion reactions, hepatotoxicity, infection risk (notably tuberculosis and hepatitis B reactivation), and rare neurologic or autoimmune phenomena. Boxed warnings highlight infection and malignancy risks. Monitoring protocols emphasize TB and hepatitis screening, cardiac assessment, and vaccination planning. Conclusion: Infliximab remains a cornerstone biologic therapy, offering substantial clinical benefit when used with rigorous screening, structured monitoring, and interprofessional collaboration. Pharmacists play a pivotal role in optimizing dosing, preventing drug interactions, and educating patients to enhance adherence and safety.