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1. Clinical consequences of infliximab immunogenicity and the effect of proactive therapeutic drug monitoring: exploratory analyses of the randomised, controlled NOR-DRUM trials

Author

Brun, Marthe Kirkesæther, Gehin, Johanna E, Bjørlykke, Kristin Hammersbøen, Warren, David John, Klaasen, Rolf A, Sexton, Joseph, Sandanger, Øystein, Kvien, Tore K, Mørk, Cato, Jahnsen, Jørgen, Bolstad, Nils, Jørgensen, Kristin Kaasen, Haavardsholm, Espen A, Goll, Guro Løvik, and Syversen, Silje Watterdal

Published
2024
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4. Effects of prednisolone tapering on effectiveness of infliximab in patients with ulcerative colitis: data from a retrospective cohort

Author

Ovesen, Pernille Dige, primary, Attauabi, Mohamed, additional, Ilvemark, Johan F K F, additional, Wewer, Mads Damsgaard, additional, Warren, David J, additional, Burisch, Johan, additional, Klaasen, Rolf A, additional, Bolstad, Nils, additional, Steenholdt, Casper, additional, and Seidelin, Jakob Benedict, additional

Published
2024
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7. Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial

Author

Randel, Kristin R., Schult, Anna L., Botteri, Edoardo, Hoff, Geir, Bretthauer, Michael, Ursin, Giske, Natvig, Erik, Berstad, Paula, Jørgensen, Anita, Sandvei, Per Kristian, Olsen, Marie Ek, Frigstad, Svein Oskar, Darre-Næss, Ole, Norvard, Espen R., Bolstad, Nils, Kørner, Hartwig, Wibe, Arne, Wensaas, Knut-Arne, de Lange, Thomas, and Holme, Øyvind

Published
2021
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8. Effects of prednisolone tapering on effectiveness of infliximab in patients with ulcerative colitis:Data from a retrospective cohort

Author

Dige Ovesen, Pernille, Attauabi, Mohamed, Ilvemark, Johan F.K.F., Wewer, Mads Damsgaard, Warren, David J., Burisch, Johan, Klaasen, Rolf A., Bolstad, Nils, Steenholdt, Casper, Seidelin, Jakob Benedict, Dige Ovesen, Pernille, Attauabi, Mohamed, Ilvemark, Johan F.K.F., Wewer, Mads Damsgaard, Warren, David J., Burisch, Johan, Klaasen, Rolf A., Bolstad, Nils, Steenholdt, Casper, and Seidelin, Jakob Benedict

Abstract

Background and objective The influence of concomitant prednisolone on clinical outcomes and safety in infliximab-treated ulcerative colitis (UC) patients is unknown. Design, setting, participants and outcome measures A retrospective cohort study was performed, including 147 UC patients treated with infliximab at a tertiary inflammatory bowel disease (IBD) centre. Primary outcome was corticosteroid-free clinical remission (CFCR) at week 14 and week 52. Patients were grouped according to prednisolone tapering regimens: standard (≤5 mg/week), fast (>5 mg/week), direct discontinuation or no prednisolone. Patients intolerant to corticosteroids and patients stopping corticosteroids in preparation for surgery including colectomy during their initial admission were excluded. Results There was no overall association between prednisolone exposure or no exposure and CFCR at weeks 14 or 52 of infliximab. The proportion of patients with C reactive protein ≤5 mg/L was higher in the standard tapering at week 14 as compared with faster regimens or no prednisolone. In subgroup analyses, the standard tapering was associated with a higher rate of CFCR at week 14 compared with the fast-tapering regimen in patients receiving ≥40 mg prednisolone at initiation of infliximab (64.3% vs 26.3%, p=0.04) and among patients admitted with acute severe UC (66.6% vs 23.5%, p<0.05). Similar data were seen at week 52. Prednisolone did not affect infliximab trough levels but increased infection rates (10/77 vs 2/70, p=0.03), in particular C. difficile infection. Conclusion In UC patients with limited disease burden, prednisolone did not affect effectiveness of infliximab. However, patients with increased disease burden seem to benefit from corticosteroid combination therapy., Background and objective The influence of concomitant prednisolone on clinical outcomes and safety in infliximab-Treated ulcerative colitis (UC) patients is unknown. Design, setting, participants and outcome measures A retrospective cohort study was performed, including 147 UC patients treated with infliximab at a tertiary inflammatory bowel disease (IBD) centre. Primary outcome was corticosteroid-free clinical remission (CFCR) at week 14 and week 52. Patients were grouped according to prednisolone tapering regimens: standard (≤5 mg/ week), fast (>5 mg/week), direct discontinuation or no prednisolone. Patients intolerant to corticosteroids and patients stopping corticosteroids in preparation for surgery including colectomy during their initial admission were excluded. Results There was no overall association between prednisolone exposure or no exposure and CFCR at weeks 14 or 52 of infliximab. The proportion of patients with C reactive protein ≤5 mg/L was higher in the standard tapering at week 14 as compared with faster regimens or no prednisolone. In subgroup analyses, the standard tapering was associated with a higher rate of CFCR at week 14 compared with the fast-Tapering regimen in patients receiving ≥40 mg prednisolone at initiation of infliximab (64.3% vs 26.3%, p=0.04) and among patients admitted with acute severe UC (66.6% vs 23.5%, p<0.05). Similar data were seen at week 52. Prednisolone did not affect infliximab trough levels but increased infection rates (10/77 vs 2/70, p=0.03), in particular C. difficile infection. Conclusion In UC patients with limited disease burden, prednisolone did not affect effectiveness of infliximab. However, patients with increased disease burden seem to benefit from corticosteroid combination therapy.

Published
2024

9. Managing hemolysis in serum neuron-specific enolase measurements – an automated algorithm for routine practice.

Author

Nome, Ragnhild V., Paus, Elisabeth, Gehin, Johanna E., Bolstad, Nils, and Bjøro, Trine

Subjects
NEUROENDOCRINE cells, NEUROENDOCRINE tumors, CARDIAC arrest, ENOLASE, HEMOLYSIS & hemolysins
Abstract

Neuron-specific enolase (NSE) derived from neurons and peripheral neuroendocrine cells is a biomarker for neuroendocrine tumors and for prognostication in comatose cardiac arrest survivors. However, as platelets and erythrocytes contain NSE, hemolysis causes falsely elevated NSE. We used native serum and hemolysate derived from the same patients to make serial dilutions, and subsequently measured NSE (mNSE) and hemolytic index (HI) in each dilution. An algorithm suitable for the laboratory information system was developed based on the mNSE, HI and the estimated gradient of hemolytic interference from 30 patients. We estimated the associated uncertainty of the corrected NSE (cNSE) results based on the observed range of the gradient and derived an equation for cNSE for samples with limited hemolysis (i.e. 5 < HI ≤ 30): cNSE = mNSE − HI × (0.34 ± 0.23) µg/L. By semi-quantitatively grading the contribution from limited hemolysis, a texted result noting the hemolysis-associated degree of uncertainty can accompany the cNSE result. The major challenge of hemolysis when using serum NSE as a biomarker can be managed using an automated algorithm for correction of NSE results based on degree of hemolysis. However, laboratorians and clinicians should be aware of the limitations associated with in vivo hemolysis. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Adalimumab serum levels and anti-drug antibodies: associations to treatment response and drug survival in inflammatory joint diseases.

Author

Jyssum, Ingrid, Gehin, Johanna E, Sexton, Joseph, Kristianslund, Eirik Klami, Hu, Yi, Warren, David John, Kvien, Tore K, Haavardsholm, Espen A, Syversen, Silje Watterdal, Bolstad, Nils, and Goll, Guro Løvik

Subjects
ANTI-inflammatory agents, FLUORESCENCE polarization immunoassay, RESEARCH funding, RHEUMATOID arthritis, SCIENTIFIC observation, BLOOD collection, LONG-term health care, IMMUNOGLOBULINS, TREATMENT duration, TREATMENT effectiveness, DESCRIPTIVE statistics, DRUG monitoring, ODDS ratio, ADALIMUMAB, COMPARATIVE studies, CONFIDENCE intervals
Abstract

Objectives To explore associations between serum adalimumab level, treatment response and drug survival in order to identify optimal drug levels for therapeutic drug monitoring of adalimumab. Also, to assess the occurrence and risk factors of anti-drug antibody (ADAb) formation. Methods Non-trough adalimumab and ADAb levels were measured by automated fluorescence assays in serum collected after 3 months of adalimumab treatment in patients with RA, PsA or axial SpA (axSpA) included in the observational NOR-DMARD study. Treatment response was evaluated after 3 months and drug survival was evaluated during long-term follow-up. Results In 340 patients (97 RA, 69 PsA, 174 axSpA), the median adalimumab level was 7.3 mg/l (interquartile range 4.0–10.3). A total of 33 (10%) patients developed ADAbs. Findings were comparable across diagnoses. In RA and PsA, adalimumab levels ≥6.0 mg/l were associated with treatment response [odds ratio (OR) 2.2 (95% CI 1.0, 4.4)] and improved drug survival [hazard ratio 0.49 (95% CI 0.27, 0.80)]. In axSpA, a therapeutic level could not be identified, but higher adalimumab levels were associated with response. Factors associated with ADAb formation were previous bDMARD use, no methotrexate comedication and the use of adalimumab originator compared with GP2017. Conclusion Higher adalimumab levels were associated with a better response and improved drug survival for all diagnoses, with a suggested lower threshold of 6.0 mg/l for RA/PsA. This finding, the large variability in drug levels among patients receiving standard adalimumab dose and the high proportion of patients developing ADAbs encourages further investigations into the potential role of therapeutic drug monitoring of adalimumab. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Coeliac disease in the Trøndelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients

Author

Lukina, Polina, primary, Andersen, Ina Lervåg, additional, Eggen, Petter Tinbod, additional, Mjønes, Patricia Gjertrud, additional, Rønne, Elin, additional, Bolstad, Nils, additional, Klaasen, Rolf Anton, additional, Warren, David J, additional, Iversen, Rasmus, additional, Hveem, Kristian, additional, Bernklev, Tomm, additional, Jelsness-Jørgensen, Lars Petter, additional, Pedersen, Lise, additional, Jonkers, Iris, additional, Lagergren, Pernilla, additional, Sollid, Ludvig Magne, additional, Lundin, Knut, additional, and Ness-Jensen, Eivind, additional

Published
2024
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13. Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials

Author

Jørgensen, Kristin K., Goll, Guro L., Sexton, Joe, Bolstad, Nils, Olsen, Inge C., Asak, Øivind, Berset, Ingrid P., Blomgren, Ingrid M., Dvergsnes, Katrine, Florholmen, Jon, Frigstad, Svein O., Henriksen, Magne, Hagfors, Jon, Huppertz-Hauss, Gert, Haavardsholm, Espen A., Klaasen, Rolf A., Moum, Bjørn, Noraberg, Geir, Prestegård, Ulf, Rydning, Jan H., Sagatun, Liv, Seeberg, Kathrine A., Torp, Roald, Vold, Cecilia, Warren, David J., Ystrøm, Carl M., Lundin, Knut E. A., Kvien, Tore, and Jahnsen, Jørgen

Published
2020
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15. Adalimumab serum levels and anti-drug antibodies: associations to treatment response and drug survival in inflammatory joint diseases

Author

Jyssum, Ingrid, primary, Gehin, Johanna E, additional, Sexton, Joseph, additional, Kristianslund, Eirik Klami, additional, Hu, Yi, additional, Warren, David John, additional, Kvien, Tore K, additional, Haavardsholm, Espen A, additional, Syversen, Silje Watterdal, additional, Bolstad, Nils, additional, and Goll, Guro Løvik, additional

Published
2023
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18. Therapeutic Drug Monitoring: A Tool to Optimize Treatment of Inflammatory Joint Diseases.

Author

Syversen, Silje W., Gehin, Johanna E., Goll, Guro L., Bolstad, Nils, Haavardsholm, Espen A., and Lillegraven, Siri

Subjects
DRUG therapy for arthritis, ANTI-inflammatory agents, TREATMENT effectiveness, DECISION making, DRUG monitoring, JOINT diseases, INDIVIDUALIZED medicine, PHARMACODYNAMICS
Abstract

The article focuses on Therapeutic Drug Monitoring (TDM) as a strategy to optimize the treatment of inflammatory joint diseases, particularly emphasizing the use of Tumor Necrosis Factor inhibitors (TNFi). It discusses the rationale behind TDM, its proactive and reactive approaches, how TDM improves care for patients with arthritis, challenges in its implementation, and future perspectives.

Published
2024
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19. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial

Author

Berset, Ingrid P, Fevang, Bjørg TS, Florholmen, Jon, Kalstad, Synøve, Mørk, Nils J, Ryggen, Kristin, Tveit, Kåre S, Sæther, Sigrun K, Gulbrandsen, Bjørn, Hagfors, Jon, Waksvik, Kenneth, Warren, David, Henanger, Karoline J., Asak, Øivind, Baigh, Somyeh, Blomgren, Ingrid M, Bruun, Trude J, Dvergsnes, Katrine, Frigstad, Svein O, Gjesdal, Clara G, Grandaunet, Berit H J, Hansen, Inger M, Hatten, Ingvild S H, Huppertz-Hauss, Gert, Henriksen, Magne, Hoie, Sunniva S, Krogh, Jan, Kruse, Julia R, Ljoså, Maud-Kristine A, Midtgard, Irina P, Mielnik, Pawel, Moum, Bjørn, Noraberg, Geir, Poyan, Armin, Prestegård, Ulf, Rashid, Haroon U, Rydning, Jan Henrik, Sagatun, Liv, Seeberg, Kathrine A, Skjetne, Kristine, Strand, Eldri K, Stray, Hilde, Stray, Njaal, Torp, Roald, Vold, Cecilia, Ystrøm, Carl M, Zettel, Camilla C, Jørgensen, Kristin K, Olsen, Inge C, Goll, Guro L, Lorentzen, Merete, Bolstad, Nils, Haavardsholm, Espen A, Lundin, Knut E A, Mørk, Cato, Jahnsen, Jørgen, and Kvien, Tore K

Published
2017
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21. The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial

Author

Gjefsen, Elisabeth, Bråten, Lars Christian Haugli, Goll, Guro Løvik, Wigemyr, Monica, Bolstad, Nils, Valberg, Morten, Schistad, Elina Iordanova, Marchand, Gunn Hege, Granviken, Fredrik, Selmer, Kaja Kristine, Froholdt, Anne, Haugen, Anne Julsrud, Dagestad, Magnhild Hammersland, Vetti, Nils, Bakland, Gunnstein, Lie, Benedicte Alexandra, Haavardsholm, Espen A., Nilsen, Aksel Thuv, Holmgard, Thor Einar, Kadar, Thomas Istvan, Kvien, Tore, Skouen, Jan Sture, Grøvle, Lars, Brox, Jens Ivar, Espeland, Ansgar, Storheim, Kjersti, and Zwart, John Anker

Published
2020
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26. HLA‐DQ2 is associated with anti‐drug antibody formation to infliximab in patients with immune‐mediated inflammatory diseases

Author

Brun, Marthe Kirkesæther, primary, Bjørlykke, Kristin Hammersbøen, additional, Viken, Marte K., additional, Stenvik, Grethe‐Elisabeth, additional, Klaasen, Rolf A., additional, Gehin, Johanna E., additional, Warren, David John, additional, Sexton, Joseph, additional, Sandanger, Øystein, additional, Kvien, Tore K., additional, Mørk, Cato, additional, Haavardsholm, Espen A., additional, Jahnsen, Jørgen, additional, Goll, Guro Løvik, additional, Lie, Benedicte A., additional, Bolstad, Nils, additional, Jørgensen, Kristin Kaasen, additional, and Syversen, Silje Watterdal, additional

Published
2023
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28. Humoral immune response to SARS-CoV-2 vaccination in patients with inflammatory bowel disease on immunosuppressive medication: association to serum drug levels and disease type

Author

Jørgensen, Kristin Kaasen, primary, Høivik, Marte Lie, additional, Chopra, Adity, additional, Benth, Jūratė Šaltytė, additional, Ricanek, Petr, additional, Moum, Prof Bjørn, additional, Jyssum, Ingrid, additional, Bolstad, Nils, additional, Warren, David John, additional, Vaage, Prof John T., additional, Munthe, Prof Ludvig A., additional, Lundin, Prof Knut E.A, additional, Anisdahl, Karoline, additional, Syversen, Silje Watterdal, additional, Goll, Guro Løvik, additional, Lund-Johansen, Fridtjof, additional, Medhus, Asle W., additional, and Jahnsen, Prof Jørgen, additional

Published
2023
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32. 231: PROACTIVE THERAPEUTIC DRUG MONITORING IS SUPERIOR TO STANDARD TREATMENT DURING MAINTENANCE THERAPY WITH INFLIXIMAB; RESULTS FROM A 52-WEEK MULTICENTRE RANDOMISED TRIAL OF 450 PATIENTS

Author

Joergensen, Kristin K., primary, Syversen, Silje W, additional, Goll, Guro L., additional, Bj⊘rlykke, Kristin H., additional, Sandanger, Øystein, additional, Sexton, Joe, additional, Brun, Marthe K., additional, M⊘rk, Cato, additional, Kvien, Tore K., additional, Gehin, Johanna E., additional, Olsen, Inge C, additional, Bolstad, Nils, additional, Haavardsholm, Espen A., additional, and Jahnsen, Jorgen, additional

Published
2022
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33. 101: GENETIC PREDISPOSITION TO INFLIXIMAB IMMUNOGENICITY IN PATIENTS WITH IMMUNE-MEDIATED INFLAMMATORY DISEASES – SECONDARY ANALYZES FROM A RANDOMIZED TRIAL

Author

Bj⊘rlykke, Kristin H., primary, Brun, Marthe K., additional, Viken, Marte K., additional, Stenvik, Grethe-Elisabeth, additional, Klaasen, Rolf A., additional, Gehin, Johanna E., additional, Warren, David J., additional, Sexton, Joe, additional, Haavardsholm, Espen A., additional, Jahnsen, Jorgen, additional, Lie, Benedicte A., additional, Goll, Guro L., additional, Bolstad, Nils, additional, Syversen, Silje W, additional, and J⊘rgensen, Kristin K., additional

Published
2022
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34. Sa1248: SCREENING FOR ADULT CELIAC DISEASE IN THE GENERAL POPULATION

Author

Andersen, Ina L., primary, Klaasen, Rolf A., additional, Warren, David J., additional, Lukina, Polina, additional, Mjones, Patricia G., additional, R⊘nne, Elin, additional, Iversen, Rasmus, additional, Sollid, Ludvig M., additional, Lundin, Knut E., additional, Bolstad, Nils, additional, and Ness-Jensen, Eivind, additional

Published
2022
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36. Drug Levels Associated with Optimal Discrimination between Remission and Nonremission and Comparison of Antibody Assays during First Year of Stable Infliximab Maintenance Therapy in Inflammatory Bowel Disease

Author

Dorn-Rasmussen, Maria, Buhl, Sine, Brynskov, Jørn, Bay, Jakob T., Bolstad, Nils, Klausen, Tobias W., Warren, David J., Ainsworth, Mark A., Steenholdt, Casper, Dorn-Rasmussen, Maria, Buhl, Sine, Brynskov, Jørn, Bay, Jakob T., Bolstad, Nils, Klausen, Tobias W., Warren, David J., Ainsworth, Mark A., and Steenholdt, Casper

Abstract

Background:To implement therapeutic drug monitoring-based strategies for infliximab (IFX) in inflammatory bowel disease, the authors assessed IFX levels for optimal discrimination between remission and nonremission and compared assays for anti-IFX antibodies (Abs).Methods:The retrospective cohort comprised 163 bionaive patients with inflammatory bowel disease who received stable IFX maintenance therapy (5 mg/kg every 8 weeks [q8w]) for 1 year. The clinical and biochemical remission status was assessed at all infusions (weeks 14-22-30-38-46-54), and IFX and anti-IFX Abs were estimated using a time-resolved fluorometric assay (n = 690; 88% of infusions). Samples positive for anti-IFX Abs or IFX levels < limit of detection (n = 102) were analyzed by 2 binding assays [enzyme-linked immunosorbent assay (ELISA)] and functional reporter gene assay/drug-tolerant enzyme immunoassay.Results:At all assessed time points, IFX levels were more than double in patients presenting clinical or biochemical remission. An IFX concentration of 4.5 mcg/mL was associated with clinical remission during the entire first year of therapy [sensitivity 54% (49-59), specificity 73% (67-78), AUCROC0.65 (0.60-0.69), P < 0.0001]; these values were comparable with biochemical remission. Exploratory assessments for endoscopic remission (n = 131) were performed at the discretion of the treating physician. Anti-IFX Abs were associated with undetectable IFX and treatment failure [OR 2.9 (1.4-6.0), P < 0.01], irrespective of persistency or transiency. All performed assays detected anti-IFX Abs were picked up by all assays in ∼2/3 of samples. Binding assays demonstrated a higher sensitivity to anti-IFX Abs.Conclusions:IFX at ∼5 mcg/mL was associated with clinical and biochemical remission during the first year of maintenance therapy. During this phase of therapy, standard binding assays are appropriate for therapeutic drug monitoring.

Published
2022

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

Author

Brun, Marthe Kirkesæther, primary, Goll, Guro Løvik, additional, Jørgensen, Kristin Kaasen, additional, Sexton, Joseph, additional, Gehin, Johanna Elin, additional, Sandanger, Øystein, additional, Olsen, Inge Christoffer, additional, Klaasen, Rolf Anton, additional, Warren, David John, additional, Mørk, Cato, additional, Kvien, Tore K., additional, Jahnsen, Jørgen, additional, Bolstad, Nils, additional, Haavardsholm, Espen A., additional, and Syversen, Silje Watterdal, additional

Published
2022
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38. Drug Levels Associated With Optimal Discrimination Between Remission and Nonremission and Comparison of Antibody Assays During First Year of Stable Infliximab Maintenance Therapy in Inflammatory Bowel Disease

Author

Dorn-Rasmussen, Maria, primary, Buhl, Sine, additional, Brynskov, Jørn, additional, Bay, Jakob T., additional, Bolstad, Nils, additional, Klausen, Tobias W., additional, Warren, David J., additional, Ainsworth, Mark A., additional, and Steenholdt, Casper, additional

Published
2022
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39. Effect of Therapeutic Drug Monitoring vs Standard Therapy During Maintenance Infliximab Therapy on Disease Control in Patients With Immune-Mediated Inflammatory Diseases

Author

Syversen, Silje Watterdal, primary, Jørgensen, Kristin Kaasen, additional, Goll, Guro Løvik, additional, Brun, Marthe Kirkesæther, additional, Sandanger, Øystein, additional, Bjørlykke, Kristin Hammersbøen, additional, Sexton, Joseph, additional, Olsen, Inge Christoffer, additional, Gehin, Johanna Elin, additional, Warren, David John, additional, Klaasen, Rolf Anton, additional, Noraberg, Geir, additional, Bruun, Trude Jannecke, additional, Dotterud, Christian Kvikne, additional, Ljoså, Maud Kristine Aga, additional, Haugen, Anne Julsrud, additional, Njålla, Rune Johan, additional, Zettel, Camilla, additional, Ystrøm, Carl Magnus, additional, Bragnes, Yngvill Hovde, additional, Skorpe, Svanaug, additional, Thune, Turid, additional, Seeberg, Kathrine Aglen, additional, Michelsen, Brigitte, additional, Blomgren, Ingrid Marianne, additional, Strand, Eldri Kveine, additional, Mielnik, Pawel, additional, Torp, Roald, additional, Mørk, Cato, additional, Kvien, Tore K., additional, Jahnsen, Jørgen, additional, Bolstad, Nils, additional, and Haavardsholm, Espen A., additional

Published
2021
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40. Serum etanercept concentrations in relation to disease activity and treatment response assessed by ultrasound, biomarkers and clinical disease activity scores: results from a prospective observational study of patients with rheumatoid arthritis

Author

Gehin, Johanna Elin, primary, Syversen, Silje Watterdal, additional, Warren, David John, additional, Goll, Guro Løvik, additional, Sexton, Joseph, additional, Bolstad, Nils, additional, and Hammer, Hilde Berner, additional

Published
2021
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42. Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases

Author

Syversen, Silje Watterdal, primary, Goll, Guro Løvik, additional, Jørgensen, Kristin Kaasen, additional, Sandanger, Øystein, additional, Sexton, Joseph, additional, Olsen, Inge Christoffer, additional, Gehin, Johanna Elin, additional, Warren, David John, additional, Brun, Marthe Kirkesæther, additional, Klaasen, Rolf Anton, additional, Karlsen, Lars Normann, additional, Noraberg, Geir, additional, Zettel, Camilla, additional, Ljoså, Maud Kristine Aga, additional, Haugen, Anne Julsrud, additional, Njålla, Rune Johan, additional, Bruun, Trude Jannecke, additional, Seeberg, Kathrine Aglen, additional, Michelsen, Brigitte, additional, Strand, Eldri Kveine, additional, Skorpe, Svanaug, additional, Blomgren, Ingrid Marianne, additional, Bragnes, Yngvill Hovde, additional, Dotterud, Christian Kvikne, additional, Thune, Turid, additional, Ystrøm, Carl Magnus, additional, Torp, Roald, additional, Mielnik, Pawel, additional, Mørk, Cato, additional, Kvien, Tore K., additional, Jahnsen, Jørgen, additional, Bolstad, Nils, additional, and Haavardsholm, Espen A., additional

Published
2021
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44. Infliximab clearance decreases in the second and third trimesters of pregnancy in inflammatory bowel disease

Author

Grišić, Ana‐Marija, primary, Dorn‐Rasmussen, Maria, additional, Ungar, Bella, additional, Brynskov, Jørn, additional, Ilvemark, Johan F. K. F., additional, Bolstad, Nils, additional, Warren, David J., additional, Ainsworth, Mark A., additional, Huisinga, Wilhelm, additional, Ben‐Horin, Shomron, additional, Kloft, Charlotte, additional, and Steenholdt, Casper, additional

Published
2021
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45. sj-pdf-1-ueg-10.1177_2050640620964619 - Supplemental material for Infliximab clearance decreases in the second and third trimesters of pregnancy in inflammatory bowel disease

Author

Ana-Marija Grišić, Dorn-Rasmussen, Maria, Ungar, Bella, Brynskov, Jørn, Ilvemark, Johan F K F, Bolstad, Nils, Warren, David J, Ainsworth, Mark A, Huisinga, Wilhelm, Shomron Ben-Horin, Kloft, Charlotte, and Steenholdt, Casper

Subjects
FOS: Clinical medicine, FOS: Biological sciences, 111199 Nutrition and Dietetics not elsewhere classified, FOS: Health sciences, 110308 Geriatrics and Gerontology, 69999 Biological Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-pdf-1-ueg-10.1177_2050640620964619 for Infliximab clearance decreases in the second and third trimesters of pregnancy in inflammatory bowel disease by Ana-Marija Grišić, Maria Dorn-Rasmussen, Bella Ungar, Jørn Brynskov, Johan F K F Ilvemark, Nils Bolstad, David J Warren, Mark A Ainsworth, Wilhelm Huisinga, Shomron Ben-Horin, Charlotte Kloft and Casper Steenholdt in United European Gastroenterology Journal

Published
2020
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46. MOESM1 of Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study)

Author

Syversen, Silje, Goll, Guro, Jørgensen, Kristin, Olsen, Inge, Sandanger, Øystein, Gehin, Johanna, Warren, David, Sexton, Joseph, Mørk, Cato, Jahnsen, Jørgen, Kvien, Tore, Bolstad, Nils, and Haavardsholm, Espen

Abstract

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Published
2020
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47. Heterophilic Antibody Interference in Immunometric Assays

Author

Bolstad, Nils

Abstract

Monoclonal and polyclonal antibodies from animals are used in immunological assays to measure concentrations of many clinically relevant proteins, peptides and drugs in blood samples. Heterophilic antibodies are immunoglobulins (present in some blood samples) that bind to the animal antibodies used in immunoassays. This type of assay interference is usually called heterophilic antibody interference. In some cases, false results caused by such interference may go undetected and lead to unnecessary diagnostic and potentially harmful therapeutic interventions, and immunoassay companies invest substantial resources to make their assays resilient to antibody interference. Heterophilic antibodies are found in the blood of both patients and healthy individuals, and are only rarely associated with prior exposure to animal antibodies. While some patient groups have an increased risk of antibody-mediated interference, particularly patients with seropositive rheumatoid arthritis, it is difficult to suspect assay interference before it appears. Bolstad and colleagues tested how resistant 170 commercially available immunoassay kits were to heterophilic antibody interference, and found that 21 assays lacked adequate protection against Fc-reactive heterophilic antibodies, which is the most common reactivity associated with heterophilic antibodies. Since the results were published, several of these vulnerable assays have been relaunched with improved protection against heterophilic antibody interference. Continued focus was put on improving execution and interpretation of tests to detect interference, but also to develop strategies to limit the damage from heterophilic antibodies relevant to both clinical laboratories and immunoassay developers. Finally, the prevalence of heterophilic antibodies in patient samples was examined by screening more than 5000 blood samples in an in house assay designed to detect reactivities to eight different animal antibodies used in immunoassays. Candidate samples identified in the screening assay were subsequently tested in a range of individual assays to identify the individual reactivities in each sample. Heterophilic antibodies with reactivity to rabbit IgG (5.5 %) and murine IgG1 (4.8 %) were the most common, while reactivity to murine IgG2a (0.1 %), murine IgG2b (0.6 %), goat and sheep IgG (both 0.2 %) was rare. When specific blocking of the commonly occurring anti-bovine antibodies was lifted, vast cross-reactivity to sheep and goat IgG was evident. These findings should enable immunoassay developers to further improve protection against heterophilic antibodies in immunoassays, thereby reducing the risk of unnecessary harm to patients.

Published
2020

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