| RESEARCH ARTICLE |
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| Year : 2017 | Volume
: 2
| Issue : 2 | Page : 31-35 |
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99mTc-anti-TNF-α scintigraphy in the assessment of rheumatic disease activity
Bianca Gutfilen Ph.D. 1, Sergio Augusto Lopes de Souza1, Gianluca Valentini2
1 Departamento de Radiologia, Laboratório de Marcação de Células e Moléculas (LMCM), Universidade Federal do Rio de Janeiro, Brazil
2 Advanced Center Oncology Macerata (ACOM), Località Cavallino, Montecosaro, Italy
Correspondence Address:
Bianca Gutfilen
Departamento de Radiologia, Laboratório de Marcação de Células e Moléculas (LMCM), Universidade Federal do Rio de Janeiro
Brazil
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/2542-3975.209684
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Background: 99mTc-anti-TNF-α scintigraphy may recognize the molecule involved in the inflammatory process and provide crucial information to help physicians to make decisions about which drugs to be used based on biological evidence, and which are cost-effective and appropriate for the treatment of choice. This study protocol for phase I/II clinical trials was designed to investigate the efficacy and safety of 99mTc-anti-TNF-α scintigraphy in the detection of disease activity.
Methods: This case analysis, single-center prospective phase I/II clinical trial has been performed at the Department of Radiology of the Federal University of Rio de Janeiro, Brazil. 99mTc-anti-TNF-α scintigraphy and MRI were carried out in 12 rheumatoid arthritis (RA) patients, 2 axial spondyloarthritis (axSpA) patients, 8 ankylosing spondylitis (AS) patients, and 3 healthy volunteers. MRI was used as gold standard.
Results: 99mTc-anti-TNF-α scintigraphy was well tolerated without any side effects in all patients. No radiopharmaceutical uptake was observed in the joints or skin of healthy volunteers. 99mTc-anti-TNF-α scintigraphy results corresponded to MRI findings in 12 patients with RA, in two axSpA patients, in six AS patients (two positive for and four negative for active disease), but it did not correspond to MRI findings in two AS patients (one false negative for and one false positive for active disease). All three patients with mechanical lombalgia were negative for active disease in both scintigraphy and MRI.
Conclusion: We have developed a novel approach to label a fully human monoclonal anti-TNF-α antibody (Adalimumab) with 99mTc, with high labeling efficiency (95%). This technique has shown great success in evaluating disease activity in patients with RA, axSpA and AS, avoiding unnecessary biological therapy. The findings from this trial will provide valuable evidence for the use of 99mTc-anti-TNF-α scintigraphy in rheumatic diseases.
Trial registration: ClinicalTrials.gov identifier: NCT02134613; registered on April 28, 2014. |
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