Journal of Autoimmunity and Cell Responses

Journal of Autoimmunity and Cell Responses

ISSN 2054-989X
Original Research

Biologic therapies in rheumatic diseases: drug and anti-drug antibody levels and clinical efficacy

Stefania Lombardi1*, Cristina Bernardoni6, Daniela Bertolucci2, Riccardo Cecchetti3, Francesca De Giorgio4, GianLuigi Occhipinti5, Andrea Palagi1, Gloria Bertacca1, Isabella Giannelli1, Elena Bonomi1, Marco Friggeri1 and Giancarlo Tartarelli6

*Correspondence: Stefania Lombardi stefania.lombardi@uslnordovest.toscana.it

1. SSD Clinical Analysis and Immunoallergology, Massa Carrara, Italy.

Author Affiliations

2. Center for Rheumatology, Versilia, Italy.

3. Center for Rheumatology, Pontedera, Italy.

4. Center for Rheumatology, Pistoia, Italy.

5. Center for Rheumatology, Livorno, Italy.

6. SSD Rheumatology Massa Carrara, Italy.

Abstract

Background: The aim of this study was to evaluate the relevance of drug and anti-drug antibody detection in the clinical management of patients with rheumatoid arthritis (RA) and spondyloarthropaties (SpA) in treatment with anti- tumor necrosis factor alpha (TNFα) biologics.

Methods and results: The study included 192 adult consecutive patients treated for at least 6 months with adalimumab (ADA) or etanercept (ETN) or infliximab (IFX); patients underwent clinical observations in the Rheumatologic Unit of 5 Hospitals in Tuscany. Their demographic and clinical characteristics to calculate DAS28 and BASDAI scores were collected. Drug levels and anti-drug antibodies (anti-drug Ab) were evaluated immediately before drug injection or infusion. A total of 192 patients were studied: 62 receiving IFX, 64 ADA, and 66 ETN with a mean age of 57 years (range 18-86 years); the study group was composed of 51% women. Forty percent of the patients were affected by RA, 60% by SpA. Altogether, 81% of patients demonstrated therapeutic drug levels. Anti-drug Ab were found in 19% of patients taking IFX, 10% taking ETN and 5% taking ADA. No significant correlation was found between anti-drug Ab presence and low drug levels, between anti-drug Ab and high DAS28 and BASDAI scores, as well as between low drug levels and high DAS28 and BASDAI scores.

Conclusions: Low drug levels were found in 19% of the rheumatic patients and there were not correlations with presence of anti-drug Ab or patient's clinical status.

Keywords: Anti- tumor necrosis factor alpha (TNFα) biologics, anti drug antibodies, rheumatoid arthritis, spondyloarthropaties, drug levels

ISSN 2054-989X
Volume 4
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