PROMONITOR®
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REFERENCES 1. IMPORTANCE OF MONITORING BIOLOGICAL THERAPIES - RHEUMATOLOGY 1.1. Pascual-Salcedo, D., Plasencia, C., Ramiro, S., Nuño, L., Bonilla, G., Nagore, D., Ruiz Del Agua, A., Martínez, A., Aarden, L., Martín-Mola, E., Balsa, A.. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford). 2011 Aug; 50(8):1445-52. 1.2. Plasencia, C., Pascual-Salcedo, D., Nuño, L., Bonilla, G., Villalba, A., Peiteado, D., Díez, J., Nagore, D., del Agua, AR., Moral, R., Martin-Mola, E., Balsa, A.. Influence of immunogenicity on the efficacy of long-term treatment of spondyloarthritis with infliximab. Ann Rheum Dis. 2012 Dec; 71(12):1955-60. 1.3. Wendling, D., Lukas, C., Paccou, J., Claudepierre, P., Carton, L., Combe, B., Goupille, P., Guillemin, F., Hudry, C., Miceli-Richard, C., Dougados, M.; French Society for Rheumatology (SFR). Recommendations of the French Society for Rheumatology (SFR) on the everyday management of patients with spondyloarthritis. Joint Bone Spine. 2014; 81, 6–14. 1.4. Mazilu, D., Opriş, D., Gainaru, C., Iliuta, M., Apetrei, N., Luca, G., Borangiu, A., Gudu, T., Peltea, A., Groseanu, L., Constantinescu, C., Saulescu, I., Bojinca, V., Balanescu, A., Predeteanu, D., Ionescu, R.. Monitoring Drug and Antidrug Levels: A Rational Approach in Rheumatoid Arthritis Patients Treated with Biologic Agents Who Experience Inadequate Response While Being on a Stable Biologic Treatment. Biomed.Res.Int. 2014; 702701. 1.5. Rosas, J., Llinares-Tello, F., de la Torre, I., Santos-Ramírez, C., Senabre-Gallego, JM., Valor, L., Barber-Vallés, X., Hernández-Flórez, D., Santos-Soler, G., Salas-Heredia, E., Carreño, L.; AIRE-MB Group.. Clinical relevance of monitoring serum levels of adalimumab in patients with rheumatoid arthritis in daily practice. Clin Exp Rheumatol. 2014 Nov-Dec / Epub 2014 Oct; 32(6):942-8. 1.6. Arstikyte, I., Kapleryte, G., Butrimiene, I., Venalis, A. . Influence of Immunogenicity on the Efficacy of Long-Term Treatment with TNF α Blockers in Rheumatoid Arthritis and Spondyloarthritis Patients. Biomed Res Int. 2015; 2015:604872. 1.7. Sanmarti, R., Inciarte-Mundo, J., Estrada-Alarcon, P., Garcia-Manrique, M., Narvaez, J., Rodriguez-Moreno, J., Gomez-Centeno, A., Pascal, M., Yagüe, J.. Towards optimal cut-off trough levels of adalimumab and etanercept for a good therapeutic response in rheumatoid arthritis. Results of the INMUNOREMAR study. Ann Rheum Dis. 2015 Aug / Epub 2015 Mar; 74(8):e42. 1.8. Jani, M., Chinoy, H., Warren, RB., Griffiths, CE., Plant, D., Fu, B., Morgan, AW., Wilson, AG., Isaacs, JD., Hyrich, K., Barton, A.; Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate Collaborators.. Clinical utility of random anti-tumor necrosis factor drug-level testing and measurement of antidrug antibodies on the long-term treatment response in rheumatoid arthritis. Arthritis Rheumatol. 2015 May; 67(8):2011-9. 1.9. Chen, DY., Chen, YM., Hsieh, TY., Hung, WT., Hsieh, CW., Chen, HH., Tang, KT., Lan, JL.. Drug trough levels predict therapeutic responses to dose reduction of adalimumab for rheumatoid arthritis patients during 24 weeks of follow-up. Rheumatology (Oxford). 2015 Aug; pii: kev298. 1.10. Chen DY, Chen YM, Hung WT, Chen HH, Hsieh CW, Chen YH, Huang WN, Hsieh TY.. Immunogenicty, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment. Ann Rheum Dis. 2015 Dec; Vol 74 No 12. 2. IMPORTANCE OF MONITORING BIOLOGICAL THERAPIES - GASTROENTEROLOGY 2.1. Afif, W., Loftus, EV. Jr, Faubion, WA., Kane, SV., Bruining, DH., Hanson, KA., Sandborn, WJ.. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May / Epub 2010 Feb; 105(5):1133-9. 2.2. Vincent, FB., Morand, EF., Murphy, K., Mackay, F., Mariette, X., Marcelli, C.. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis. 2013 Feb / Epub 2012 Nov; 72(2):165-78. 2.3. Ben-Horin, S., Chowers, Y.. Tailoring anti-TNF therapy in IBD: drug levels and disease activity. Nat Rev Gastroenterol Hepatol. 2014 Apr / Epub 2014 Jan; 11(4):243-55. 2.4. Kobayashi, T., Suzuki, Y., Motoya, S., Hirai, F., Ogata, H., Ito, H., Sato, N., Ozaki, K., Watanabe, M., Hibi, T.. First trough level of infliximab at week 2 predicts future outcomes of induction therapy in ulcerative colitis-results from a multicenter prospective randomized controlled trial and its post hoc analysis. J Gastroenterol. 2015 Jul. 2.5. Vande Casteele N, Ferrante M, Van Assche G, Ballet V, Compernolle G, Van Steen K, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015;148D7]:1320–9.e3. 3. IMPORTANCE OF MONITORING BIOLOGICAL THERAPIES - DERMATOLOGY 3.1. Elberdín, L., Outeda, M., Salvador, P., Paradela, S., Fernández-Torres, RM., Iglesias, R., Fonseca, E., Martín, I. Infliximab drug and antibody levels in patients with dermatological conditions. Int J Clin Pharm. 2015 Apr / Epub 2015 Jan; 37(2):320-6. 4. COST-EFECTIVENESS OF MONITORING BIOLOGICAL THERAPIES 4.1. Krieckaert, CL., Nair, SC., Nurmohamed, MT., van Dongen, CJ., Lems, WF., Lafeber, FP., Bijlsma, JW., Koffijberg, H., Wolbink, G., Welsing, PM.. Personalized treatment using serum drug levels of adalimumab in patients with rheumatoid arthritis an evaluation of costs and effects. Ann Rheum Dis. 2013 Nov 21. 4.2. Steenholdt, C., Brynskov, J., Thomsen, O., Munck, LK., Fallingborg, J., Christensen, LA., Pedersen, G., Kjeldsen, J., Jacobsen, BA., Oxholm, AS., Kjellberg, J., Bendtzen, K., Ainsworth MA.. Individualised therapy is more cost-effective than dose intensification in patients with Crohn’s Disease who lose response to anti-TNF treatment: a randomized, controlled trial. Gut 2014; 63:919–927. 5. MAIN COMPARATIVE/EVALUATION STUDIES INCLUDING PROMONITOR OUR TECHNOLOGY + YOUR EXPERTISE = 5.1. Llinares-Tello, F., de Salazar, JR., Gallego, JM., Soler, GS., Ramírez, CS., Heredia, ES., García, JM.. Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of infliximab and adalimumab. Clin Chem Lab Med. 2012 Oct; 50(10):1845-7. 5.2. Ruiz-Argüello, B., del Agua, AR., Torres, N., Monasterio, A., Martínez, A., Nagore, D. Comparison study of two commercially available methods for the determination of infliximab, adalimumab, etanercept and anti-drug antibody levels. Clin Chem Lab Med. 2013 Dec; 51(12):e287-9. 5.3. Chen, DY., Chen, YM., Tsai, WC., Tseng, JC., Chen, YH., Hsieh, CW., Hung, WT., Lan, JL.. Significant associations of antidrug antibody levels with serum drug trough levels and therapeutic response of adalimumab and etanercept treatment in rheumatoid arthritis. Ann Rheum Dis. 2015 Mar; 74(3):e16. 5.4. Schmitz EM, van de Kerkhof D, Hamann D, van Dongen JL, Kuijper PH, Brunsveld L, Scharnhorst V, Broeren MA. Therapeutic drug monitoring of infliximab: performance evaluation of three commercial ELISA kits. Clin Chem Lab Med. 2015 Nov 20. 5.5. Fabris M, Pistis C,Zabotti A, Picco L, Curcio F, Tonutti E, Vita SD.. The Detection of Anti-adalimumab Antibodies in a Series of Inflammatory Polyarthritis: three ELISA Methods Compared. Drug Metab Lett. 2015; 9(2):132-7. BIOLOGICAL DRUG MONITORING Peer-reviewed articles using Promonitor® kits. REGULATORY STATUS • • • EU: PROMONITOR® is sold in the EU for IVD under CE mark certification. USA: Promonitor® is sold in the US for Research Use Only (Not for use in diagnostic procedures). Other countries: Please contact Progenika-Grifols. “All Promonitor products are manufactured by Progenika, a Grifols company”. Grifols International, S.A. Parc Empresarial Can Sant Joan, Av. de la Generalitat, 152-158. 08174 Sant Cugat del Vallès. Barcelona - SPAIN. Tel. (+34) 935 710 400 www.grifols.com Included in this product is a HuCAL® Antibody which is under license from MorphoSys AG. HuCAL® is a registered tradema