Ann Lab Med 2020; 40(2): 101-113
Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of Immunogenicity
Maurizio Benucci, M.D.1, Valentina Grossi, Mbiol2, Mariangela Manfredi, Mbiol2, Arianna Damiani, M.D.1, Maria Infantino, M.D.2, Paolo Moscato, M.D.3, Luigi Cinquanta, M.D.5, Elisa Gremese, M.D.4,6, Barbara Tolusso, B.Sc.4, Luca Petricca, M.D.4, Anna Laura Fedele, M.D.4, Stefano Alivernini, M.D.4,6, Fabiola Atzeni, M.D., Ph.D.7, Giovanni Minisola, M.D.8, and Roberto Verna, M.D., Ph.D.9,10
1Rheumatology Unit and 2Immunology and Allergology Laboratory Unit, S.Giovanni di Dio Hospital, Florence, Italy; 3Department of Medicine, University Hospital San Giovanni di Dio e Ruggi d’Aragona, Salerno, Italy; 4Division of Rheumatology, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy; 5SDN SPA-Synlab Laboratory, Pagani, Salerno, Italy; 6Division of Rheumatology, Università Cattolica del Sacro Cuore, Rome, Italy; 7Rheumatology Unit, University of Messina, Messina, Italy; 8Italian Society of Rheumatology, Milan, Italy; 9World Association of Societies of Pathology and Laboratory Medicine, Milan, Italy; 10Department of Experimental Medicine Sapienza University of Rome, Rome, Italy
Corresponding author: Roberto Verna, M.D., Ph.D.
Department of Experimental Medicine, Sapienza University of Rome, Viale Regina Elena 324, Rome 00161, Italy
Tel: +393711547775 Fax: +0082313898817 E-mail:
Received: March 4, 2019; Revised: June 9, 2019; Accepted: October 15, 2019; Published online: March 1, 2020.
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This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Biological drugs, such as proteins and immunogens, are increasingly used to treat various diseases, including tumors and autoimmune diseases, and biological molecules have almost completely replaced synthetic drugs in rheumatology. Although biological treatments such as anti-tumor necrosis factor (TNF) drugs seem to be quite safe, they cause some undesirable effects, such as the onset of infections due to weakening of the immune system. Given the biological nature of these drugs, they might be recognized as extraneous; this would induce an immune reaction that neutralizes their effectiveness or lead to more serious consequences. Laboratories play a pivotal role in appropriate therapeutic management. The aim of this review was to underline the production of anti-drug antibodies during treatment with biological drugs and highlight the role of laboratories in ensuring appropriate use of these drugs.
Keywords: Anti-tumor necrosis factor (TNF) drugs, Antibodies, Anti-drug antibodies, Biological drugs

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