Publications



Therapeutic Drug Monitoring (TDM) 


Therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal disease: a systematic literature review informing EULAR points to consider.

Charlotte Krieckaert#1,Borja Hernández-Breijo#2,Johanna Elin Gehin#3,Guillaume le Mélédo4,Alejandro Balsa5,Meghna Jani67,Denis Mulleman8,Victoria Navarro-Compan5,Gertjan Wolbink9,John Isaac10,Astrid van Tubergen11, 12

RMD Open 2022 Jun;8(2):e002216. doi: 10.1136/rmdopen-2022-002216.


EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases.

Charlotte Lm Krieckaert1,Astrid van Tubergen23,Johanna Elin Gehin#45,Borja Hernández-Breijo#6,Guillaume Le Mélédo#7,Alejandro Balsa68,Peter Böhm9,Sasa Cucnik1011,Ori Elkayam12,Guro L Goll13,Femke Hooijberg14,Meghna Jani1516,Patrick Dw Kiely1718,Neil McCarthy19,Denis Mulleman20,Victoria Navarro-Compán8,Katherine Payne2122,Martin E Perry23,Chamaida Plasencia-Rodriguez8,Simon R Stones24,Silje Watterdal Syversen25,Annick de Vries26,Katherine M Ward27,Gertjan Wolbink128,John D Isaacs2930

Ann Rheum Dis 2022 May 12;annrheumdis-2022-222155. doi: 10.1136/annrheumdis-2022-222155.


Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial.

Silje Watterdal Syversen1,Kristin Kaasen Jørgensen2,Guro Løvik Goll1,Marthe Kirkesæther Brun13,Øystein Sandanger4,Kristin Hammersbøen Bjørlykke23,Joseph Sexton1,Inge Christoffer Olsen5,Johanna Elin Gehin36,David John Warren6,Rolf Anton Klaasen6,Geir Noraberg7,Trude Jannecke Bruun8,Christian Kvikne Dotterud9,Maud Kristine Aga Ljoså10,Anne Julsrud Haugen11,Rune Johan Njålla12,Camilla Zettel13,Carl Magnus Ystrøm14,Yngvill Hovde Bragnes15,Svanaug Skorpe16,Turid Thune17,Kathrine Aglen Seeberg18,Brigitte Michelsen19,Ingrid Marianne Blomgren20,Eldri Kveine Strand21,Pawel Mielnik22,Roald Torp23,Cato Mørk24,Tore K Kvien13,Jørgen Jahnsen23,Nils Bolstad6,Espen A Haavardsholm13

JAMA 2021 Dec 21;326(23):2375-2384. doi: 10.1001/jama.2021.21316.


Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial.

Silje Watterdal Syversen1,Guro Løvik Goll1,Kristin Kaasen Jørgensen2,Øystein Sandanger3,Joseph Sexton1,Inge Christoffer Olsen4,Johanna Elin Gehin56,David John Warren5,Marthe Kirkesæther Brun16,Rolf Anton Klaasen5,Lars Normann Karlsen7,Geir Noraberg8,Camilla Zettel9,Maud Kristine Aga Ljoså10,Anne Julsrud Haugen11,Rune Johan Njålla12,Trude Jannecke Bruun13,Kathrine Aglen Seeberg14,Brigitte Michelsen15,Eldri Kveine Strand16,Svanaug Skorpe17,Ingrid Marianne Blomgren18,Yngvill Hovde Bragnes19,Christian Kvikne Dotterud20,Turid Thune21,Carl Magnus Ystrøm22,Roald Torp23,Pawel Mielnik24,Cato Mørk25,Tore K Kvien16,Jørgen Jahnsen26,Nils Bolstad5,Espen A Haavardsholm16

JAMA 2021 May 4;325(17):1744-1754. doi: 10.1001/jama.2021.4172.


lPractical 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


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


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


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).


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


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


Adalimumab


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


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


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




Infliximab


Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial. 

Marthe Kirkesaether Brun12,Guro Løvik Goll1,Kristin Kaasen Jørgensen3,Joseph Sexton1,Johanna Elin Gehin24,Øystein Sandanger5,Inge Christoffer Olsen6,Rolf Anton Klaasen4,David John Warren4,Cato Mørk7,Tore K Kvien12,Jørgen Jahnsen23,Nils Bolstad4,Espen A Haavardsholm12,Silje Watterdal Syversen1

J Intern Med 2022 Sep;292(3):477-491. doi: 10.1111/joim.13495.





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


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


Interferon-β


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


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 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


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


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


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 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


Natalizumab


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