Ann Lab Med.  2020 Mar;40(2):101-113. 10.3343/alm.2020.40.2.101.

Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of Immunogenicity

Affiliations
  • 1Rheumatology Unit, S.Giovanni di Dio Hospital, Florence, Italy.
  • 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. roberto.verna@fondazione.uniroma1.it
  • 10Department of Experimental Medicine Sapienza University of Rome, Rome, Italy.

Abstract

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.

Keyword

Anti-tumor necrosis factor (TNF) drugs; Antibodies; Anti-drug antibodies; Biological drugs

MeSH Terms

Antibodies
Autoimmune Diseases
Biological Therapy*
Immune System
Necrosis
Rheumatology*
Antibodies

Figure

  • Fig. 1 Biological disease-modifying anti-rheumatic drugs (bDMARDs) are associated with immunogenicity, leading to the development of anti-drug antibodies that affect drug efficacy and may affect drug safety and tolerability. The development of anti-drug antibodies seems to be influenced by multiple risk factors and may be modulated by the concomitant use of conventional synthetic DMARDs (cs-DMARDs).


Cited by  1 articles

Therapeutic Drug Monitoring of Biologic Agents in the Era of Precision Medicine
Soo-Youn Lee
Ann Lab Med. 2020;40(2):95-96.    doi: 10.3343/alm.2020.40.2.95.


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