Publications related to BIOPIA

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Biopharmaceutical Drug Monitoring

Practical recommendations for the use of therapeutic drug monitoring of biopharmaceuticals in inflammatory diseases.
Dreesen E, Bossuyt P, Mulleman D, Gils A, Pascual-Salcedo D
Clin Pharmacol 2017 ;9():101-111

Change Over Time in the Pattern of Clinical Response to First-line Biologic Drugs in Patients with Rheumatoid Arthritis: Observational Data in a Real-life Setting.
Favalli EG, Becciolini A, Meroni PL
J. Rheumatol. 2017 02;44(2):262-263

Current Practice of Therapeutic Drug Monitoring of Biopharmaceuticals in Psoriasis Patients.
Hermans C, Herranz P, Segaert S, Gils A
Ther Drug Monit 2017 08;39(4):356-359

Meta-analysis of treatment termination rates among rheumatoid arthritis patients receiving disease-modifying anti-rheumatic drugs.
Maetzel A, Wong A, Strand V, Tugwell P, Wells G, Bombardier C
Rheumatology (Oxford) 2000 Sep;39(9):975-81

Reviews on Biopharmaceutical Immunogenicity

The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis.
Garcês S, Demengeot J, Benito-Garcia E
Ann. Rheum. Dis. 2013 Dec;72(12):1947-55

Biological anti-TNF drugs: immunogenicity underlying treatment failure and adverse events.
Prado MS, Bendtzen K, Andrade LEC
Expert Opin Drug Metab Toxicol 2017 Sep;13(9):985-995

Maillard reaction and immunogenicity of protein therapeutics.
Tsekovska, R., Sredovska-Bozhinov, A., Niwa, T., Ivanov, I., & Mironova, R.
World Journal of Immunology, 6(1), 19. (2016).

Risk Assessment and Monitoring of Antibody Responses to Biosimilars in Chronic Inflammatory Diseases.
Detrez I, Gils A
Curr. Pharm. Des. 2017 ;23(44):6739-6745

Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.
Wadhwa M, Knezevic I, Kang HN, Thorpe R
Biologicals 2015 Sep;43(5):298-306

A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies.
Garcês S, Antunes M, Benito-Garcia E, da Silva JC, Aarden L, Demengeot J
Ann. Rheum. Dis. 2014 Jun;73(6):1138-43


Validation of a Drug-Resistant Anti-Adalimumab Antibody Assay to Monitor Immunogenicity in the Presence of High Concentrations of Adalimumab.
Bian S, Ferrante M, Gils A
AAPS J 2017 03;19(2):468-474

THU0349 Methotrexate reduces adalimumab immunogenicity in patients with spondyloarthritis: a randomized clinical trial. Ducourau, E., Rispens, T., Dernis, E., Guilchard, F. L., Andras, L., Perdriger, A., . . . Mulleman, D. Annals of the Rheumatic Diseases 76(Suppl 2):335.3-336. Psoster presentation (2017) doi:10.1136/annrheumdis-2017-eular.1527

Towards an individualised target concentration of adalimumab in rheumatoid arthritis.
Ducourau E, Ternant D, Lequerré T, Fuzibet P, Le Loët X, Watier H, et al
Ann. Rheum. Dis. 2014 Jul;73(7):1428-9

Pharmacokinetics and concentration-effect relationship of adalimumab in rheumatoid arthritis.
Ternant D, Ducourau E, Fuzibet P, Vignault C, Watier H, Lequerré T, et al
Br J Clin Pharmacol 2015 Feb;79(2):286-97


Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab.
Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, Saxne T
Arthritis Rheum. 2006 Dec;54(12):3782-9


Rituximab in multiple sclerosis: Frequency and clinical relevance of anti-drug antibodies.
Dunn N, Juto A, Ryner M, Manouchehrinia A, Piccoli L, Fink K, et al
Mult. Scler. 2018 08;24(9):1224-1233


Development and validation of cell-based luciferase reporter gene assays for measuring neutralizing anti-drug antibodies against interferon beta.
Hermanrud C, Ryner M, Luft T, Jensen PE, Ingenhoven K, Rat D, et al
J. Immunol. Methods 2016 Mar;430():1-9

Interferon-beta responders and non-responders. A biological approach.
Bertolotto A, Gilli F
Neurol. Sci. 2008 Sep;29 Suppl 2():S216-7

Immunogenicity of interferon beta: differences among products.
Bertolotto A, Deisenhammer F, Gallo P, Sölberg Sørensen P
J. Neurol. 2004 Jun;251 Suppl 2():II15-II24

Advanced glycation end products contribute to the immunogenicity of IFN-β pharmaceuticals.
Bozhinov A, Handzhiyski Y, Genov K, Daskalovska V, Niwa T, Ivanov I, et al
J. Allergy Clin. Immunol. 2012 Mar;129(3):855-858.e6

Interferon-Beta: Neutralizing Antibodies, Binding Antibodies, Pharmacokinetics and Pharmacodynamics, and Clinical Outcomes.
Deisenhammer F
J. Interferon Cytokine Res. 2014 Dec;34(12):938-945

Cross-reactivity of antibodies against interferon beta in multiple sclerosis patients and interference of the JAK-STAT signaling pathway.
Hurtado-Guerrero I, Pinto-Medel MJ, Urbaneja P, Rodriguez-Bada JL, Ortega-Pinazo J, Serrano P, et al
Sci Rep 2017 11;7(1):16585

Development and validation of an ELISA for quantification of soluble IFN-β receptor: assessment in multiple sclerosis.
Órpez-Zafra T, Pavía J, Pinto-Medel MJ, Hurtado-Guerrero I, Rodriguez-Bada JL, Martín Montañez E, et al
Bioanalysis 2015 ;7(22):2869-80

Cross-reactivity of antibodies against interferon beta in multiple sclerosis patients and interference of the JAK-STAT signaling pathway.
Hurtado-Guerrero I, Pinto-Medel MJ, Urbaneja P, Rodriguez-Bada JL, Ortega-Pinazo J, Serrano P, et al
Sci Rep 2017 11;7(1):16585


Characterization of anti-natalizumab antibodies in multiple sclerosis patients.
Lundkvist M, Engdahl E, Holmén C, Movérare R, Olsson T, Hillert J, et al
Mult. Scler. 2013 May;19(6):757-64

Early development of anti-natalizumab antibodies in MS patients.
Oliver-Martos B, Órpez-Zafra T, Urbaneja P, Maldonado-Sanchez R, Leyva L, Fernández O
J. Neurol. 2013 Sep;260(9):2343-7

Kinetics and incidence of anti-natalizumab antibodies in multiple sclerosis patients on treatment for 18 months.
Oliver B, Fernández O, Orpez T, Alvarenga MP, Pinto-Medel MJ, Guerrero M, et al
Mult. Scler. 2011 Mar;17(3):368-71