Real-World Effectiveness of Infliximab: An Updated Review for Pharmacists
Abstract
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.
Full text article
References
Liu Y, Liu S, Liu L, Gong X, Liu J, Sun L, Liu X, Wu L, Chen L, Wang L, Luo L, Lin J, Tie N, Jiang Z, Wu J, Lu F, Sun H, Li X, Yang N, Chai K, Wei H, Da Z, Zhao C, Dai L, Wang Y, Shi G, Zhang Z, Song H, Guo Q, Liu YC, Li Z. Fine Comparison of the Efficacy and Safety Between GB242 and Infliximab in Patients with Rheumatoid Arthritis: A Phase III Study. Rheumatology and therapy. 2022 Feb:9(1):175-189. doi: 10.1007/s40744-021-00396-8.
Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, Smolen J, Emery P, Harriman G, Feldmann M, Lipsky P. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet (London, England). 1999 Dec 4:354(9194):1932-9
Lahad A, Weiss B. Current therapy of pediatric Crohn's disease. World journal of gastrointestinal pathophysiology. 2015 May 15:6(2):33-42. doi: 10.4291/wjgp.v6.i2.33.
Pola S, Patel D, Ramamoorthy S, McLemore E, Fahmy M, Rivera-Nieves J, Chang JT, Evans E, Docherty M, Talamini M, Sandborn WJ. Strategies for the care of adults hospitalized for active ulcerative colitis. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2012 Dec:10(12):1315-1325.e4. doi: 10.1016/j.cgh.2012.07.006.
Alpsoy E, Leccese P, Emmi G, Ohno S. Treatment of Behçet's Disease: An Algorithmic Multidisciplinary Approach. Frontiers in medicine. 2021:8():624795. doi: 10.3389/fmed.2021.624795.
Baughman RP, Valeyre D, Korsten P, Mathioudakis AG, Wuyts WA, Wells A, Rottoli P, Nunes H, Lower EE, Judson MA, Israel-Biet D, Grutters JC, Drent M, Culver DA, Bonella F, Antoniou K, Martone F, Quadder B, Spitzer G, Nagavci B, Tonia T, Rigau D, Ouellette DR. ERS clinical practice guidelines on treatment of sarcoidosis. The European respiratory journal. 2021 Dec:58(6):. pii: 2004079. doi: 10.1183/13993003.04079-2020.
Shih T, Lee K, Grogan T, De DR, Shi VY, Hsiao JL. Infliximab in hidradenitis suppurativa: A systematic review and meta-analysis. Dermatologic therapy. 2022 Sep:35(9):e15691. doi: 10.1111/dth.15691.
Akiho H, Yokoyama A, Abe S, Nakazono Y, Murakami M, Otsuka Y, Fukawa K, Esaki M, Niina Y, Ogino H. Promising biological therapies for ulcerative colitis: A review of the literature. World journal of gastrointestinal pathophysiology. 2015 Nov 15:6(4):219-27. doi: 10.4291/wjgp.v6.i4.219.
You Y, Stelzl P, Joseph DN, Aldo PB, Maxwell AJ, Dekel N, Liao A, Whirledge S, Mor G. TNF-α Regulated Endometrial Stroma Secretome Promotes Trophoblast Invasion. Frontiers in immunology. 2021:12():737401. doi: 10.3389/fimmu.2021.737401.
Ryman JT, Meibohm B. Pharmacokinetics of Monoclonal Antibodies. CPT: pharmacometrics & systems pharmacology. 2017 Sep:6(9):576-588. doi: 10.1002/psp4.12224.
Scott FI, Lichtenstein GR. Therapeutic Drug Monitoring of Anti-TNF Therapy in Inflammatory Bowel Disease. Current treatment options in gastroenterology. 2014 Mar:12(1):59-75. doi: 10.1007/s11938-013-0004-5.
Infliximab. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. 2012
Jiang Y, Lin O, Sinha SR. Use of Tumor Necrosis Factor Alpha Inhibitors for Inflammatory Bowel Disease Patients with Concurrent Heart Failure. Digestive diseases and sciences. 2017 Jun:62(6):1597-1606. doi: 10.1007/s10620-017-4574-2.
Lichtenstein L, Ron Y, Kivity S, Ben-Horin S, Israeli E, Fraser GM, Dotan I, Chowers Y, Confino-Cohen R, Weiss B. Infliximab-Related Infusion Reactions: Systematic Review. Journal of Crohn's & colitis. 2015 Sep:9(9):806-15. doi: 10.1093/ecco-jcc/jjv096.
Djokanovic N, Klieger-Grossmann C, Pupco A, Koren G. Safety of infliximab use during pregnancy. Reproductive toxicology (Elmsford, N.Y.). 2011 Jul:32(1):93-7. doi: 10.1016/j.reprotox.2011.05.009.
Penagini F, Cococcioni L, Pozzi E, Dilillo D, Rendo G, Mantegazza C, Zuccotti GV. Biological therapy in pediatric age. Pharmacological research. 2020 Nov:161():105120. doi: 10.1016/j.phrs.2020.105120.
. Infliximab. Drugs and Lactation Database (LactMed®). 2006
Kelsen JR, Grossman AB, Pauly-Hubbard H, Gupta K, Baldassano RN, Mamula P. Infliximab therapy in pediatric patients 7 years of age and younger. Journal of pediatric gastroenterology and nutrition. 2014 Dec:59(6):758-62. doi: 10.1097/MPG.0000000000000533.
Li J, Zhang Z, Wu X, Zhou J, Meng D, Zhu P. Risk of Adverse Events After Anti-TNF Treatment for Inflammatory Rheumatological Disease. A Meta-Analysis. Frontiers in pharmacology. 2021:12():746396. doi: 10.3389/fphar.2021.746396.
Dermawan A, So K, Venugopal K, Picardo S. Infliximab-induced optic neuritis. BMJ case reports. 2020 Dec 22:13(12):. doi: 10.1136/bcr-2020-236041.
Mandarelli G, Iannone F, Ferracuti S, Grattagliano I, Benevento M, Solarino B, Ferorelli D, Catanesi R. Informed consent and biological agents in rheumatology and internal medicine. European journal of clinical investigation. 2022 Sep:52(9):e13805. doi: 10.1111/eci.13805.
Agarwal A, Kedia S, Jain S, Gupta V, Bopanna S, Yadav DP, Goyal S, Mouli VP, Dhingra R, Makharia G, Ahuja V. High risk of tuberculosis during infliximab therapy despite tuberculosis screening in inflammatory bowel disease patients in India. Intestinal research. 2018 Oct:16(4):588-598. doi: 10.5217/ir.2018.00023.
Ulutaş F, Korkmaz C, Yılmaz H, Akça D, Çomut E, Çelık M, Çobankara V. Intestinal Peripheral T-Cell Lymphoma in a Patient with Ankylosing Spondylitis Under Treatment with Infliximab: A Case Report and Review of the Literature. Mediterranean journal of rheumatology. 2022 Jun:33(2):247-251. doi: 10.31138/mjr.33.2.247.
Shah ED, Coburn ES, Nayyar A, Lee KJ, Koliani-Pace JL, Siegel CA. Systematic review: hepatosplenic T-cell lymphoma on biologic therapy for inflammatory bowel disease, including data from the Food and Drug Administration Adverse Event Reporting System. Alimentary pharmacology & therapeutics. 2020 Mar:51(5):527-533. doi: 10.1111/apt.15637.
Lee CK. [Ideal vaccination strategy in inflammatory bowel disease]. The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi. 2015 Mar:65(3):159-64
Choi DK, Rubin DT, Puangampai A, Lach M. Role and Impact of a Clinical Pharmacy Team at an Inflammatory Bowel Disease Center. Crohn's & colitis 360. 2023 Apr:5(2):otad018. doi: 10.1093/crocol/otad018.
Authors
Copyright (c) 2025 Abdulelah Hassan Ayashi Majrashi, Emad Ali Ayoub Hakami, Khaled Alhamidi Alanazi, Intisar Awadh Alanazi, Al Anoud Abdullah Raheel Al Anzi, Ahmed Abubakr Ahmed Bajbair, Amirah Mousa Ali Mokali, Dhaifallah Mohammed Moraya, Khalid Rashed Almutiri, Fahad Jaber Salem Allughbi, Abdulmajeed Fahad Eid Almuqati, Rayan Faisal Falah Al Otaibi

This work is licensed under a Creative Commons Attribution 4.0 International License.
