Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab
Abstract
:1. Introduction
2. Material and Methods
Statistical Analysis
3. Results
3.1. Rapid Assays And ELISAS Are Equivalent To Determine ADA Trough Levels
3.2. A Rapid POC Assay Is Not Useful in All Clinical Situations During the Follow-Up of Adalimumab-Treated IBD Patients
4. Discussion
Author Contributions
Funding
Conflicts of Interest
References
- Ordás, I.; Mould, D.R.; Feagan, B.G.; Sandborn, W.J. Anti-TNF monoclonal antibodies in inflammatory bowel disease: Pharmacokinetics-based dosing paradigms. Clin. Pharmacol. Ther. 2012, 91, 635–646. [Google Scholar] [CrossRef] [PubMed]
- Monaco, C.; Nanchahal, J.; Taylor, P.; Feldmann, M. Anti-TNF therapy: Past, present and future. Int Immunol. 2015, 27, 55–62. [Google Scholar] [CrossRef] [PubMed]
- Podolsky, M.D.; Daniel, K. Inflammatory bowel disease. N. Engl. J. Med. 2002, 347, 417–429. [Google Scholar] [CrossRef] [PubMed]
- Morey, S. World Pharmaceutical Market Outlook: UK–Summary of NICE Approvals in September 2009; NICE: London, UK, 2009; Retrieved 2014-02-04. [Google Scholar]
- Zeba Siddiqui. India’s Cadila Launches First Cheaper Copy of World’s Top-Selling Drug. Available online: https://www.reuters.com/article/us-cadila-health-humira-india/indias-cadila-launches-first-cheaper-copy-of-worlds-top-selling-drug-idUSKBN0JN0X820141209 (accessed on 9 December 2014).
- Roda, G.; Jharap, B.; Neeraj, N.; Colombel, J.-F. Loss of Response to Anti-TNFs: Definition, Epidemiology, and Management. Clin. Transl. Gastroenterol. 2016, 7, e135. [Google Scholar] [CrossRef] [PubMed]
- Imaeda, H.; Takahashi, K.; Fujimoto, T.; Bamba, S.; Tsujikawa, T.; Sasaki, M.; Fujiyama, Y.; Andoh, A. Clinical utility of newly developed immunoassays for serum concentrations of adalimumab and anti-adalimumab antibodies in patients with Crohn’s disease. J. Gastroenterol. 2014, 49, 100–109. [Google Scholar] [CrossRef] [PubMed]
- Mazor, Y.; Almog, R.; Kopylov, U.; Hur, D.B.; Blatt, A.; Dahan, A.; Waterman, M.; Ben-Horin, S.; Chowers, Y. Adalimumab drug and antibody levels as predictors of clinical and laboratory response in patients with Crohn’s disease. Aliment. Pharmacol. Ther. 2014, 40, 620–628. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Papamichael, K.; Cheifetz, A.S. Higher Adalimumab Drug Levels are Associated with Mucosal Healing in Patients with Crohn’s Disease. J. Crohns Colitis. 2016, 10, 507–509. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Roblin, X.; Marotte, H.; Rinaudo, M.; Del Tedesco, E.; Moreau, A.; Phelip, J.M.; Genin, C.; Peyrin-Biroulet, L.; Paul, S. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin. Gastroenterol. Hepatol. 2014, 12, 80.e2–84.e2. [Google Scholar] [CrossRef] [PubMed]
- Nakase, H.; Motoya, S.; Matsumoto, T.; Watanabe, K.; Hisamatsu, T.; Yoshimura, N.; Ishida, T.; Kato, S.; Nakagawa, T.; Esaki, M.; et al. Significance of measurement of serum trough level and anti-drug antibody of adalimumab as personalised pharmacokinetics in patients with Crohn’s disease: A subanalysis of the DIAMOND trial. Aliment Pharmacol. Ther. 2017, 46, 873–882. [Google Scholar] [CrossRef] [PubMed]
- Ungar, B.; Levy, I.; Yavne, Y.; Yavzori, M.; Picard, O.; Fudim, E.; Loebstein, R.; Chowers, Y.; Eliakim, R.; Kopylov, U.; et al. Optimizing Anti-TNF-α Therapy: Serum Levels of Infliximab and Adalimumab Are Associated With Mucosal Healing in Patients With Inflammatory Bowel Diseases. Clin. Gastroenterol. Hepatol. 2016, 14, 550–557.e2. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Lázár-Molnár, E.; Delgado, J.C. Immunogenicity Assessment of Tumor Necrosis Factor Antagonists in the Clinical Laboratory. Clin. Chem. 2016, 62, 1186–1198. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Ogrič, M.; Terčelj, M.; Praprotnik, S.; Tomšič, M.; Božič, B.; Sodin-Semrl, S.; Čučnik, S. Detection of adalimumab and anti-adalimumab antibodies in patients with rheumatoid arthritis: A comprehensive overview of methodology pitfalls and benefits. Immunol. Res. 2017, 65, 172–185. [Google Scholar] [CrossRef] [PubMed]
- Lee, M.W.; Connor, S.; Ng, W.; Toong, C.M.-L. Comparison of infliximab drug measurement across three commercially available ELISA kits. Pathology 2016, 48, 608–612. [Google Scholar] [CrossRef] [PubMed]
- Baert, F.; Drobne, D.; Gils, A.; Casteele, N.V.; Hauenstein, S.; Singh, S.; Lockton, S.; Rutgeerts, P.; Vermeire, S. Early trough levels and antibodies to infliximab predict safety and success of reinitiation of infliximab therapy. Clin. Gastroenterol. Hepatol. 2014, 12, 1474–1481.e2. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Afonso, J.; Lopes, S.; Gonçalves, R.; Caldeira, P.; Lago, P.; De Sousa, H.T.; Ramos, J.; Goncalves, A.R.; Ministro, P.; Rosa, I.; et al. Proactive therapeutic drug monitoring of infliximab: A comparative study of a new point-of-care quantitative test with two established ELISA assays. Aliment. Pharmacol. Ther. 2016, 44, 684–692. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Laserna-Mendieta, E.J.; Salvador-Martín, S.; Arias-González, L.; Ruiz-Ponce, M.; Menchen, L.A.; Sanchez, C.; López-Fernández, L.A.; Lucendo, A.J. Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits. Clin. Chem. Lab. Med. 2019. [Google Scholar] [CrossRef] [PubMed]
- Vande Casteele, N.; Ferrante, M.; Van Assche, G.; Ballet, V.; Compernolle, G.; Van Steen, K.; Simoens, S.; Rutgeerts, P.; Gils, A.; Vermeire, S. Trough con-centrations of infliximab guide dosing for patients with inflamma-tory bowel disease. Gastroenterology 2015, 148, 1320–1329.e3. [Google Scholar] [CrossRef] [PubMed]
- D’Haens, G.; Vermeire, S.; Lambrecht, G.; Baert, F.; Bossuyt, P.; Pariente, B.; Buisson, A.; Bouhnik, Y.; Filippi, J.; Vander Woude, J.; et al. Increasing infliximabdose based on symptoms, biomarkers, and serum drug concentra-tions does not increase clinical, endoscopic, and corticosteroid-freeremission in patients with active luminal Crohn’s disease. Gastroenterology 2018, 154, 1343.e1–1351.e1. [Google Scholar] [CrossRef] [PubMed]
- Fumery, M. PAILOT study: Proactive versus Adalimumab Reagent in Children with Crohn’s Disease. La Lettre de l’Hépato-Gastroentérologue, 2019. Available online: https://www.edimark.fr/ecco/2019/ej/etude-pailot-dosage-proactif-versus-reactif-adalimumab-cours-maladie-crohn-chez-enfant (accessed on 8 March 2019).
- Dreesen, E.; Baert, F.; Laharie, D.; Bossuyt, P.; Bouhnik, Y.; Buisson, A.; Lambrecht, G.; Louis, E.; Oldnburg, B.; Pariente, B.; et al. Monitoring a Combination of Calprotectin and Infliximab Identifies Patients with Mucosal Healing of Crohn’s Disease. Clin. Gastroenterol. Hepatol. 2020, 18, 637646. [Google Scholar] [CrossRef] [PubMed]
Type of IBD | 20 CD/11 UC |
---|---|
Age (years) | 30.5 +/− 8 years |
Sex Ratio M/F | 1.2 |
Clinical Remission | 20 (12 CD) |
Other Anti-TNF Before | 12 (9 IFX, 3 Golimumab) |
Other Treatments with ADA | 7 (5 5ASA, 4 steroids) |
Duration of Disease (years) | 5.2 +/−3.5 |
Optimization of ADA (40 mg ew) | 22 |
9 | n |
---|---|
IBD | 37 |
CD/UC | 26/11 |
Age (Years) | 34.5 + /−6.5 |
Duration of Disease (Years) | 6.4 +/−3.5 |
Sex Ratio M/F | 1.2 |
Previous Treatment | Anti-TNF: 12 IFX, 4 Golimumab Vedolizumab: 3 patients Azathioprine: 8 patients |
In Therapeutic Optimization | 14 |
In Therapeutic De-Escalation | 2 |
Clinical Remission | 18 |
ADA at 40 mg every week | 6 |
ADA at 40 mg Every Two Weeks | 30 |
ADA at 40 mg Every Three Weeks | 1 |
Adjuvant Treatment with Imurel | 3 |
Anti-ADA Antibodies Detected | 2 |
Suppliers | Specificity | Range | Dilution | Method | Time (min) |
---|---|---|---|---|---|
Ridascreen (R-Biopharm) | Monoclonal | 0.2–12.6 (μg/mL) | 1/100 | ELISA | 100 min |
Lisa-Tracker (Theradiag) | Polyclonal | 0.3–16 (μg/mL) | 1/200 | ELISA | 150 min |
Lisa-Tracker (Theradiag) | Monoclonal | 0.3–C20 (μg/mL) | 1/200 | ELISA | 150 min |
Ridaquick (R-Biopharm) | Monoclonal | 1–C25 (μg/mL) | 1/50 | Lateral flow assay | 30 min |
Quantum Blue (Buhlmann) | Monoclonal | 1.3–C35 (μg/mL) | 1/20 | Lateral flow assay | 30 min |
ELISA Theradiag (Polyclonal) | ELISA Theradiag (Monoclonal) | ELISA R-Biopharm | POC Buhlmann | POC R-Biopharm | |
---|---|---|---|---|---|
Number of values | 33 | 33 | 33 | 33 | 33 |
Minimum | 0.3 | 0.3 | 0.2 | 1.3 | 1.0 |
25th Percentile | 0.3 | 0.3 | 0.2 | 1.3 | 1.0 |
Median | 2.8 | 2.2 | 2.7 | 2.3 | 2.3 |
75th Percentile | 7.2 | 8.5 | 9.7 | 11.5 | 13.9 |
IQR | 4.5 | 4.7 | 4.8 | 6.4 | 7.9 |
© 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
Share and Cite
Cherry, M.; Dutzer, D.; Nasser, Y.; Berger, A.-E.; Roblin, X.; Paul, S. Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab. J. Clin. Med. 2020, 9, 2739. https://doi.org/10.3390/jcm9092739
Cherry M, Dutzer D, Nasser Y, Berger A-E, Roblin X, Paul S. Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab. Journal of Clinical Medicine. 2020; 9(9):2739. https://doi.org/10.3390/jcm9092739
Chicago/Turabian StyleCherry, Mohamad, Dominique Dutzer, Yara Nasser, Anne-Emmanuelle Berger, Xavier Roblin, and Stephane Paul. 2020. "Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab" Journal of Clinical Medicine 9, no. 9: 2739. https://doi.org/10.3390/jcm9092739
APA StyleCherry, M., Dutzer, D., Nasser, Y., Berger, A.-E., Roblin, X., & Paul, S. (2020). Point-of-Care Assays Could Be Useful for Therapeutic Drug Monitoring of IBD Patients in a Proactive Strategy with Adalimumab. Journal of Clinical Medicine, 9(9), 2739. https://doi.org/10.3390/jcm9092739