Therapeutic monoclonal antibodies in clinical laboratory
Authors:
K. Malíčková
Authors‘ workplace:
Ústav lékařské biochemie a laboratorní diagnostiky Všeobecné fakultní nemocnice a 1. lékařské fakulty Univerzity Karlovy, Praha
Published in:
Klin. Biochem. Metab., 25, 2017, No. 3, p. 101-107
Overview
Monoclonal antibody therapy is a form of immunotherapy that uses monoclonal antibodies to bind monospecifically to certain proteins or cells. This may then stimulate the patient’s immune system to attack those targets. About 50 monoclonal antibodies are currently accepted for clinical use as therapeutics, with many others been at various trial stages. Therapeutic monoclonal antibodies display an interindividual variability in their efficacy and side effects, which must be taken into consideration in clinical praxis. Biological monitoring of serum drug levels and antibodies to these drugs allowing for individualized prescription and dose adjustments may lead to therapeutic optimization and limitation of the high costs of this kind of treatment.
Keywords:
Monoclonal antibodies, efficacy, side effects, trough levels, immunogenicity, anti-drug antibodies.
Sources
1. Köhler, G., Milstein, C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature. 1975, 256(5517), p. 495-7.
2. Debure, A., Chkoff, N., Chatenoud, L., Lacombe, M., Campos, H., Noël, L. H. et al. Preventive treatment of rejection by the prolonged administration of OKT3: decrease of the immune response of the host. Nephrologie 1987, 8(3), p. 87-94.
3. Baldo, B. A. Monoclonal antibodies in therapy. In: Safety of biologics therapy. Springer International Publishion Switzerland 2016, ISBN 978-3-319-30470-0, p. 29-56.
4. Kopp-Kubel, S. International Nonproprietary Names (INN) for pharmaceutical substances. Bull World Health Organ., 1995, 73(3), p. 275-9.
5. Chaigne, B., Watier, H. Theranostic of biopharmaceuticals. Pharmacol. Ther. 2017, pii: S0163-7258(17)30049-9.
6. Mould, D. R., Meibohm, B. Drug development of thera-peutic monoclonal antibodies. BioDrugs, 2016, 30(4), p. 275-93.
7. Ecker, D. M., Jones, S. D., Levine, H. L. The therapeutic monoclonal antibody market. MAbs, 2015, 7(1), p. 9-14.
8. www.vzp.cz
9. Hindryckx, P., Novak, G., Vande Casteele, N., Khanna, R., Laukens, D., Vipul, J. et al. Incidence, prevention and management of anti-drug antibodies against therapeutic antibodies in inflammatory bowel disease: a practical overview. Drugs., 2017, 77(4), p. 363
10. Paul, S., Moreau, A. C., Del Tedesco, E., Rinaudo, M., Phelip, J. M., Genin, C. et al. Pharmacokinetics of adalimumab in inflammatory bowel diseases: a systematic review and meta-analysis. Inflamm. Bowel. Dis., 2014, 20(7), p. 1288-95.
11. Nanda, K. S., Cheifetz, A. S., Moss, A. C. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel di-sease (IBD): a meta-analysis. Am. J Gastroenterol., 2013, 108(1), p. 40-7
12. Gao, B., Yeap, S., Clements, A., Balakrishnar, B., Wong, M., Gurney, H. Evidence for therapeutic drug monitoring of targeted anticancer therapies. J Clin. Oncol., 2012, 30 (32), p. 4017-25
13. Sivamani, R. K., Goodarzi, H., Garcia, M. S., Raychaudhuri, S. P., Wehrli, L. N., Ono, Y. et al. Biologic therapies in the treatment of psoriasis: a comprehensive evidence-based basic science and clinical review and a practical guide to tuberculosis monitoring. Clin. Rev. Allergy Immunol., 2013, 44(2), p. 121-40.
14. Zhang, X., Peck, R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Expert Rev. Clin. Pharmacol., 2011, 4(5), p. 539-58.
15. Leyland-Jones, B., Colomer, R., Trudeau, M. E., Wardley, A., Latreille, J., Cameron, D. et al. Intensive loading dose of trastuzumab achieves higher-than-steady-state serum concentrations and is well tolerated. J Clin. Oncol., 2010, 28(6), 960-6.
16. Mirick, G. R., Bradt, B. M., Denardo, S. J., Denardo, G. L. A review of human anti-globulin antibody (HAGA, HAMA, HACA, HAHA) responses to monoclonal antibodies. Not four letter words. Q J Nucl. Med. Mol. Imaging, 2004, 48(4), p. 251-7.
17. Smolen, J. S., Van Der Heijde, D. M., St Clair, E. W., Emery, P., Bathon, J. M., Keystone, E., Maini, R. N. et al. Active-controlled study of patients receiving iInfli-ximab for the treatment of rheumatoid arthritis of early onset (ASPIRE) study group. Predictors of joint damage in patients with early rheumatoid arthritis treated with high-dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial. Arthritis Rheum., 2006, 54(3), p. 702-10.
18. Hanauer, S. B., Feagan, B. G., Lichtenstein, G. R., Mayer, L. F., Schreiber, S., Colombel, J. F. et al. ACCENT I Study Group. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet, 2002, 359(9317), p. 1541-19.
19. Vande Casteele, N., Khanna, R., Levesque, B. G., Stitt, L., Zou, G. Y., Singh, S. et al. The relationship between infliximab concentrations, antibodies to infli-ximab and disease activity in Crohn’s disease. Gut, 2015, 64(10), p. 1539-45.
20. Steenholdt, C., Brynskov, J., Thomsen, O., Munck, L. K., Fallingborg, J., Christensen, L. A. et al. Indivi-dualised therapy is more cost-effective than dose intensification in patients with Crohn’s disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut, 2014, 63(6), p. 919-27.
21. Ternant, D., Cézé, N., Lecomte, T., Degenne, D., Duveau, A. C., Watier, H. et al. An enzyme-linked immunosorbent assay to study bevacizumab pharmacokinetics. Ther. Drug. Monit., 2010, 32(5), p. 647-52.
22. Baselga, J., Carbonell, X., Castañeda-Soto, N. J., Clemens, M., Green, M., Harvey, V. et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly sche-dule. J Clin. Oncol., 2005, 23(10), p. 2162-71.
23. Berinstein, N. L., Grillo-López, A. J., White, C. A., Bence-Bruckler, I., Maloney, D., Czuczman, M. et al. Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin’s lymphoma. Ann. Oncol., 1998, 9(9), p. 995-1001.
24. Igarashi, T., Kobayashi, Y., Ogura, M., Kinoshita, T., Ohtsu, T., Sasaki, Y. et al. IDEC-C2B8 Study Group in Japan. Factors affecting toxicity, response and progression-free survival in relapsed patients with indolent B-cell lymphoma and mantle cell lymphoma treated with rituximab: a Japanese phase II study. Ann. Oncol., 2002, 13(6), p. 928-43.
25. Tobinai, K., Igarashi, T., Itoh, K., Kobayashi, Y., Taniwaki, M., Ogura, M. et al. IDEC-C2B8 Japan Study Group. Japanese multicenter phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma. Ann, Oncol., 2004, 15(5), p. 821-30.
26. Seznam zdravotních výkonů s bodovými hodnotami 2017. EZ Centrum 2017, ISBN 978-80-9052-365-4
27. Geng, D., Shankar, G., Schantz, A., Rajadhyaksha, M., Davis, H., Wagner, C. Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies. J Pharm. Biomed. Anal., 2005, 39(3-4), p. 364-75.
Labels
Clinical biochemistry Nuclear medicine Nutritive therapistArticle was published in
Clinical Biochemistry and Metabolism
2017 Issue 3
Most read in this issue
- „Normal“ laboratory finding
- Therapeutic monoclonal antibodies in clinical laboratory
- Congenital disorders of glycosylation: alpha-dystroglycanopathies
- Comparison of Measurement Free Light Chains by SPAPLUS and Immage 80