Monoclonal Antibodies and Its Clinical Aspects

  • Mohamadu Maharuf Mohamed Shafras Postgraduate Institute of Science University of Peradeniya
  • Mohamed Rafeek Rukshan Ahamed Department of Microbiology, Faculty of Medicine, University of Peradeniya, Sri Lanka
  • Geetika Pant Department of Biotechnology, Indian Academy Degree College-Autonomous, Bangalore-43, India
Keywords: Monoclonal Antibody, Indications, Review


With the emergence of various developments in determining pathophysiology behind diseases, emergence of resistance against diseases and to utilize drugs for the long-term effects, and the need to design an effective treatment against most common infectious and non-infectious diseases, the need of developing more effective drug comes under the limelight. At present, more studies are being carried out on the utilization of monoclonal antibodies as successful therapeutic agents and to design them in such a way to target specific health-related conditions. This include conditions which affect livelihood of people, the most common an widespread diseases, infectious diseases caused by more virulent or drug-resistant micro organisms and viruses and also inherited diseases. Current review thus targets cancer, diabetes, autoimmune diseases, hypercholesterolemia, ophthalmology and infectious diseases and briefly discusses the pathophysiology behind the mode of action of the therapeutic agents based on monoclonal antibodies and the benefits and drawbacks of such developed agents. This also focuses on the areas where studies can be carried out to determine effective use of monoclonal antibodies in the future to answer and treat major medical related issues. 


Schwartz, Robert SMD. Paul Ehrlich’s magic bullets. N Engl J Med 2004;350: 1079-80.

Zhiqiang An. Monoclonal antibodies a proven and rapidly expanding therapeutic modality for human diseases. Protein Cell 2010;1(4):319-30

Oldham RK, Dillman RO. Monoclonal Antibodies in Cancer Therapy: 25 Years of Progress. Journal of Clinical Oncology 2008;26(11):1774-77.

Geng X, Kong X, Hu H, et al. Research and development of therapeutic mAbs: An analysis based on pipeline projects. Hum Vaccin Immunother 2015;11(12):2769-76.

Weiner LM, Surana R, Wang S. Monoclonal antibodies: versatile platforms for cancer immunotherapy. Nat Rev Immunol 2010;10(5):317-27.

Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Disc 2010;9(10):767-74.

Reichert JM. Monoclonal antibodies as innovative therapeutics. Curr Pharm Biotech 2008; 9(10): 423-30.

Reichert JM, Rosensweig CJ, Faden LB, Dewitz, MC. Monoclonal antibody successes in the clinic. Nat Biotech 2005;23(9):1073-78.

Reichert JM. Antibodies to watch in 2010. Mabs1(2;010 2 ):84-100.

Scolnik PA. mAbs: a business perspective. MAbs2(1;2009 ):179-84.

Breedveld FC. Therapeutic monoclonal antibodies. Lancet 2 0 0 0 ; 3 5 5 ( 9 2 0 5 ) : 7 3 5 - 4 0 .

Buchwald UK, Pirofski L. Immune therapy for infectious diseases at the dawn of the twenty-first century: the past, present and future role of antibody therapy, therapeutic vaccination and biological response modifiers. Curr Pharm Des 2003;9(12):945-68.

Anonymous. Medical News Today - What is Cancer? Available from: URL:

Alison MR. Cancer. eLS 2001.

Wu H, Chang D, Huang C. Targeted Therapy for Cancer. J Cancer Mol 2006;2(2):57-66.

Schrama D, Reisfeld RA, Becker JC. Antibody targeted drugs as cancer therapeutics. Nat Rev Drug Discov 2006;5(2):147-59

Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs 2015;7(1):9–14.

Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer4(12;2012 ):278-87.

Motta G, Cea M, Moran E, et al. Monoclonal Antibodies for Non- Hodgkin’s Lymphoma: State of the Art and Perspectives. Clin Dev Immunol 2010;2010: 428253.

Grillo-Lopez AJ, Hedrick E, Rashford M, Benyunes M. Rituximab: ongoing and future clinical development. Semin Oncol 2002;29(1):105-12.

Breedveld, FC. Therapeutic monoclonal antibodies. Lancet 2 0 0 0 ; 3 5 5 ( 9 2 0 5 ) : 7 3 5 – 4 0 .

Wang W, Erbe AK, Hank JA, Morris ZS, Sondel PM. NK CellMediated Antibody-Dependent Cellular Cytotoxicity in Cancer Immunotherapy. Front Immunol 2015;6:368.

Horta ZP, Goldberg JL, Sondel PM. Anti-GD2 mAbs and next-generation mAb-based agents for cancer therapy. Immunotherapy 2016;8(9):1097– 1117.

Funaro A, Horenstein AL, Santoro P, Cinti C, Gregorini A, Malavasi F. Monoclonal antibodies and therapy of human cancers. Biotechnol Adv 2000;18(5): 385-401.

Bruno V, Battaglia G, Nicoletti F. The advent of monoclonal antibodies in the treatment of chronic autoimmune diseases. Neurol Sci 2011;31(3):283- 8.

Kalden JR. Emerging role of anti-tumor necrosis factor therapy in rheumatic diseases. Arthritis Res 2002;4(2):34–S40.

Scott DL, Wolfe F, Huizinga, TW. Rheumatoid arthritis. Lancet 2010;376(9746):1094-108.

Campbell J, Lowe D, Sleeman MA. Developing the next generation of monoclonal antibodies for the treatment of rheumatoid arthritis. Br J Pharmacol 2011;162(7): 1470-84.

Choy EHS, Kingsley GH, Panayi GS. Monoclonal Antibody Therapy in Rheumatoid Arthritis. Brit J Rheumat 1998;37(5):484-90.

Trapp BD, Peterson J, Ransohoff RM, Rudick R, Mork S, Bo L. Axonal transection in the lesions of multiple sclerosis. N Engl J Med 1998;338:278- 85.

Giovannonia G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord1(9;2016 ):5-48.

Paulo F. Monoclonal antibody therapy in multiple sclerosis, Paradigm shifts and emerging challenges. MAbs 2010;2(6):670-81.

Reichert JM. Monoclonal antibodies as innovative therapeutics. Curr Pharm Biotechnol 2008; 9(6):423-30.

Rommer PS, Dudesek A, Stüve O, Zettl UK. Monoclonal antibodies in treatment of multiple sclerosis. Clin and ExpImmunol 2014;175(3):373– 84.

Gracia-Tello B, Ezeonyeji A, Isenberg D. The use of rituximab in newly diagnosed patients with systemic lupus erythematosus: long-term steroid saving capacity and clinical effectiveness. Lupus Sci Med 2017;4(1):e000182

Isenberg DA. Treating patients with lupus with B-cell depletion. Lupus 2008;17(4): 400-4.

Claudio P, Gabriella M. Monoclonal Antibodies for Systemic Lupus Erythematosus (SLE). Pharmaceuticals 2010;3:300-22.

Brijen S, Lloyd M. Current status of monoclonal antibody therapy for the treatment of inflammatory bowel disease. Expert Rev Clin Immunol 2010; 6(4): 607-20.

Wild RG, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27(10):1047-53.

40. King H, Aubert RE, Herman WH. Global burden of diabetes, 1995- 2025: prevalence, numerical estimates and projections. Diabetes Care 1998;21(9):1414–31.

International Diabetes Federation. World Diabetes Foundation. Diabetes Atlas: executive summary. 2nd ed. Brussels: IDF Executive Office; 2003. p7–11.

Herold KC, Hagopian W, Auger JA, et al. Anti-CD3 monoclonal antibody in new-onset type 1 diabetes mellitus. N Engl J Med 2002;346(22):1692- 98.

Mark DP, Carla JG, Heidi KS, et al. Rituximab, B-Lymphocyte Depletion, and Preservation of Beta-Cell Function. N Engl J Med 2009;361:2143-52.

Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med 2005;352(25):2598-608

Wadhera RK, Steen DL, Khan I, Giugliano RP, Foody JM. A review of low-density lipoprotein cholesterol, treatment strategies, and its impact on cardiovascular disease morbidity and mortality. Journal of Clinical Lipidology. 2016;10(3):472-489.

Mancini GB, Tashakkor AY, Baker S, et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Canadian Working Group Consensus update. Can J Cardiol 2013;29(12):1553-68.

McKenney JM, Koren MJ, Kereiakes DJ, Hanotin C, Ferrand AC, Stein EA. Safety and efficacy of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 serine protease, SAR236553/ REGN727, in patients with primary hypercholesterolemia receiving ongoing stable atorvastatin therapy. J Am Coll Cardiol 2012;59(25):2344-53.

Roth EM, McKenney JM, Hanotin C, Asset G, Stein EA. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med 2012;367(20):1891-900.

Stein EA, Gipe D, Bergeron J, et al. Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial. Lancet 2012;380(9836): 29-36.

Colhoun HM, Robinson JG, Farnier M, et al. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord 2014;14:121.

Kastelein JJ, Robinson JG, Farnier M, et al. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther 2014;28(3):281-89.

Moriarty PM, Jacobson TA, Bruckert E, et al. Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial. J Clin Lipidol 2014;8(6):554-61.

Robinson JG, Colhoun HM, Bays HE, et al. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascularrisk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol 2014;37(10):597-604.

Seidah NG, Benjannet S, Wickham L, et al. The secretory proprotein convertase neural apoptosis-regulated convertase 1 (NARC-1): liver regeneration and neuronal differentiation. Proc Natl AcadSci USA 2003;100(3):928-33.

Abifadel M, Varret M, Rabes JP, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet 2003;34(2):154-6.

Horton JD, Cohen JC, Hobbs HH. PCSK9: a convertase that coordinates LDL catabolism. J Lipid Res 2009;50(Suppl):S172-7.

Qian YW, Schmidt RJ, Zhang Y, et al. Secreted PCSK9 downregulates low density lipoprotein receptor through receptor-mediated endocytosis. J Lipid Res 2007;48:1488-98.

Chan JC, Piper DE, Cao Q, et al. A proprotein convertase subtilisin/ kexin type 9 neutralizing antibody reduces serum cholesterol in mice and nonhuman primates. Proc Natl Acad Sci USA 2009;106(24):9820-5.

Rodrigues EB, Farah ME, Maia M, et al. Therapeutic monoclonal

antibodies in ophthalmology. Prog Retin Eye Res 2009;28(2): 117-44.

Bhat P, Castañeda-Cervantes RA, Doctor PP, Foster CS. Intravenous daclizumab for recalcitrant ocular inflammatory disease. Graefes Arch Clin Exp Ophthalmol 2009;247(5): 687-92.

Bonnekoh B, Böckelmann R, Pommer AJ, Malykh Y, Philipsen L, Gollnick H. The CD11a binding site of efalizumab in psoriatic skin tissue as analyzed by Multi- Epitope Ligand Cartography robot technology. Introduction of a novel biological drug-binding biochip assay. Skin Pharmacol Appn Skin Physiol 2007;20: 96-111.

Casadevall A. Passive Antibody Administration (Immediate Immunity) as a Specific Defense Against Biological Weapons. Emerg Infect Dis 2002;8(8): 833-41.

Oral HB, Akdis CA. Antibody-Based Therapies in Infectious Diseases. In: George A.J.T., Urch C.E. (eds) Diagnostic and Therapeutic Antibodies. Methods in Molecular Medicine 2000;40. Humana Press.

Buchwald UK, Pirofski L. Immune therapy for infectious diseases at the dawn of the twenty-first century: the past, present and future role of antibody therapy, therapeutic vaccination and biological response modifiers. Curr Pharm Des 2003;9(12): 945-68.

Nosanchuk JD, Steenbergen JN, Shi L, Deepe GS, Casadevall, A. Antibodies to a cell surface histone-like protein protect against Histoplasma capsulatum. J Clin Invest 2003;112(8):1164–75.

Matthews RC, Rigg G, Hodgetts S, et al. Preclinical assessment of the efficacy of mycograb, a human recombinant antibody against fungal HSP90. Antimicrob Agents Chemother 2003;47(7):2208–16.

Bowen A, Wear MP, Cordero RJ, Oscarson S, Casadevall A. A Monoclonal Antibody to Cryptococcus neoformans Glucuronoxylomannan Manifests Hydrolytic Activity for Both Peptides and Polysaccharides. J Biol Chem. 2017;292(2):417-34.

Rachini A, Pietrella D, Lupo P, Torosantucci A, Chiani P, Bromuro C, et al. An Anti-β-Glucan Monoclonal Antibody Inhibits Growth and Capsule Formation of Cryptococcus neoformans In Vitro and Exerts Therapeutic, Anticryptococcal Activity In Vivo. Infect Immun 2007;75(11):5085-94.

Bugli F, Cacaci M, Martini C, et al. Human Monoclonal Antibody- Based Therapy in the Treatment of Invasive Candidiasis. Clin Dev Immunol 2013;2013:403121.

Al-Sayyed B, Piperdi S, Yuan X, Li A, Besra GS, Jacobs WR, et al. Monoclonal antibodies to Mycobacterium tuberculosis CDC 1551 reveal sub cellular localization of MPT51. Tuberculosis (Edinb) 2007;87(6):489- 97.

Pethe K, Alonso S, Biet F, et al. The heparin-binding haemagglutinin of M. tuberculosis is required for extrapulmonary dissemination. Nature 2001; 412(6843):190–94.

Mohamed W, Sethi S, Darji A, Mraheil MA, Hain T, Chakraborty T. Antibody Targeting the Ferritin-Like Protein Controls Listeria Infection. Infect Immun 2010;78(7):3306-14

Nejad-Moghaddam A, Abolhassani M. Production and Characterization of Monoclonal Antibodies Recognizing a Common 57-kDa Antigen of Leishmania Species. Iranian Biomedical Journal 2009;13(4): 245-251.

Rogovik AL, Carleton B, Solimano A, Goldman R. Palivizumab for the prevention of respiratory syncytial virus infection. Can Fam Physician 2010; 56(8):769–772.

How to Cite
Mohamed Shafras MM, Rukshan Ahamed MR, Pant G. Monoclonal Antibodies and Its Clinical Aspects. J Pharm Care. 5(1-2):29-36.
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