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

Author:

Benucci Maurizio1ORCID,Grossi Valentina2ORCID,Manfredi Mariangela2ORCID,Damiani Arianna1ORCID,Infantino Maria2ORCID,Moscato Paolo3ORCID,Cinquanta Luigi4ORCID,Gremese Elisa56ORCID,Tolusso Barbara5ORCID,Petricca Luca5ORCID,Fedele Anna Laura5ORCID,Alivernini Stefano56ORCID,Atzeni Fabiola7ORCID,Minisola Giovanni8ORCID,Verna Roberto910ORCID

Affiliation:

1. Rheumatology Unit, S.Giovanni di Dio Hospital, Florence, Italy

2. Immunology and Allergology Laboratory Unit, S.Giovanni di Dio Hospital, Florence, Italy

3. Department of Medicine, University Hospital San Giovanni di Dio e Ruggi d’Aragona, Salerno, Italy

4. SDN SPA-Synlab Laboratory, Pagani, Salerno, Italy

5. Division of Rheumatology, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy

6. Division of Rheumatology, Università Cattolica del Sacro Cuore, Rome, Italy

7. Rheumatology Unit, University of Messina, Messina, Italy

8. Italian Society of Rheumatology, Milan, Italy

9. World Association of Societies of Pathology and Laboratory Medicine, Milan, Italy

10. Department of Experimental Medicine Sapienza University of Rome, Rome, Italy

Publisher

Annals of Laboratory Medicine

Subject

Biochemistry, medical,Clinical Biochemistry,General Medicine

Reference94 articles.

1. World Health Organization. International nonproprietary names (INN) for biological and biotechnological substances. Updated 2018. http://www.webcitation.org/6rGAZvnd2

2. Biologics-Based Therapy for the Treatment of Rheumatoid Arthritis

3. U.S. Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product-draft guidance. United States Food and Drug Administration. Updated on Jun 2019. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf

4. The biosimilar approval process: how different is it?

5. Impact of trough serum level on radiographic and clinical response to infliximab plus methotrexate in patients with rheumatoid arthritis: results from the RISING study

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