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Article: Mixed Experiences with Commercial Calibrators and Controls for COVID-19 Drugs.

Martens-Lobenhoffer, Jens / Bode-Böger, Stefanie M

The journal of applied laboratory medicine

2022 Volume 7, Issue 2, Page(s) 617–619

MeSH term(s)	COVID-19 ; Calibration ; Chromatography, Liquid ; Humans ; SARS-CoV-2 ; Tandem Mass Spectrometry
Language	English
Publishing date	2022-02-08
Publishing country	England
Document type	Journal Article
ISSN	2576-9456
ISSN	2576-9456
DOI	10.1093/jalm/jfab130
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Article ; Online: Quantification of ceftazidime/avibactam in human plasma and dried blood spots: Implications on stability and sample transport.

Martens-Lobenhoffer, Jens / Angermair, Stefan / Bode-Böger, Stefanie M

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

2022 Volume 1193, Page(s) 123164

Abstract: Ceftazidime is an established third-generation cephalosporin antibiotic frequently administered to intensive care patients. To overcome drug resistance of pathogens, it is combined with the newly developed non-ß-lactam ß-lactamase inhibitor avibactam ... ...

Abstract	Ceftazidime is an established third-generation cephalosporin antibiotic frequently administered to intensive care patients. To overcome drug resistance of pathogens, it is combined with the newly developed non-ß-lactam ß-lactamase inhibitor avibactam under the brand name Zavicefta®. To facilitate therapeutic drug monitoring (TDM), we developed a method for the simultaneous quantification of these substances by LC-MS/MS. A problem for TDM is the low stability of the analytes in plasma, requiring transport times of less than 6 h at 23 °C. Thus, we evaluated dried blood spots (DBS) as matrix for better stability. For both analytes, stable isotope labelled internal standards were applied. Plasma samples were prepared by protein precipitation, DBS by liquid extraction. The chromatographic separation took place on a polar-modified C18 column, and detection was achieved by tandem mass spectrometry with ESI ionization in positive mode for ceftazidime and negative mode for avibactam. Calibration was linear in the ranges of 5 - 100 µg/mL for ceftazidime and 1.25 - 25 µg/mL for avibactam in plasma and 2.5 - 50 µg/mL and 0.625 - 12.5 µg/mL in DBS, respectively. Precision was better than 7 % and accuracy better than 10% for plasma as well as for DBS. The stability of ceftazidime and avibactam was better in DBS than in plasma or full blood, extending maximal transport times at 23 °C from 6 h in plasma or full blood to 24 h for DBS samples. However, robust estimation of plasma concentrations from DBS measurements requires validation by future clinical studies.
Language	English
Publishing date	2022-02-17
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1180823-8
ISSN	1873-376X ; 0378-4347 ; 1570-0232 ; 1387-2273
ISSN (online)	1873-376X
ISSN	0378-4347 ; 1570-0232 ; 1387-2273
DOI	10.1016/j.jchromb.2022.123164
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Article: Quantification of ceftazidime/avibactam in human plasma and dried blood spots: Implications on stability and sample transport

Martens-Lobenhoffer, Jens / Angermair, Stefan / Bode-Böger, Stefanie M.

Journal of chromatography. 2022 Mar. 15, v. 1193

2022

Abstract	Ceftazidime is an established third-generation cephalosporin antibiotic frequently administered to intensive care patients. To overcome drug resistance of pathogens, it is combined with the newly developed non-ß-lactam ß-lactamase inhibitor avibactam under the brand name Zavicefta®. To facilitate therapeutic drug monitoring (TDM), we developed a method for the simultaneous quantification of these substances by LC-MS/MS. A problem for TDM is the low stability of the analytes in plasma, requiring transport times of less than 6 h at 23 °C. Thus, we evaluated dried blood spots (DBS) as matrix for better stability. For both analytes, stable isotope labelled internal standards were applied. Plasma samples were prepared by protein precipitation, DBS by liquid extraction. The chromatographic separation took place on a polar-modified C18 column, and detection was achieved by tandem mass spectrometry with ESI ionization in positive mode for ceftazidime and negative mode for avibactam. Calibration was linear in the ranges of 5 – 100 µg/mL for ceftazidime and 1.25 – 25 µg/mL for avibactam in plasma and 2.5 – 50 µg/mL and 0.625 – 12.5 µg/mL in DBS, respectively. Precision was better than 7 % and accuracy better than 10% for plasma as well as for DBS. The stability of ceftazidime and avibactam was better in DBS than in plasma or full blood, extending maximal transport times at 23 °C from 6 h in plasma or full blood to 24 h for DBS samples. However, robust estimation of plasma concentrations from DBS measurements requires validation by future clinical studies.
Keywords	ceftazidime ; chemical species ; drug resistance ; humans ; ionization ; liquids ; stable isotopes ; tandem mass spectrometry ; therapeutics
Language	English
Dates of publication	2022-0315
Publishing place	Elsevier B.V.
Document type	Article
ISSN	1570-0232
DOI	10.1016/j.jchromb.2022.123164
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Article: Quantification of the janus kinase 1 inhibitor upadacitinib in human plasma by LC-MS/MS

Martens-Lobenhoffer, Jens / Tomaras, Stylianos / Feist, Eugen / Bode-Böger, Stefanie M.

Journal of chromatography. 2022 Jan. 01, v. 1188

2022

Abstract: Upadacitinib is a selective janus-kinase-1 inhibitor effective in the treatment of autoimmune related diseases like rheumatoid arthritis or psoriatic arthritis. Here, we described a LC-MS/MS method for the quantification of upadacitinib in human plasma ... ...

Abstract	Upadacitinib is a selective janus-kinase-1 inhibitor effective in the treatment of autoimmune related diseases like rheumatoid arthritis or psoriatic arthritis. Here, we described a LC-MS/MS method for the quantification of upadacitinib in human plasma applicable for therapeutic drug monitoring. Pexidartinib was used as internal standard. Plasma samples were prepared by acidic protein precipitation and the analytes were separated on a C-18 reversed phase column. Detection took place by tandem mass spectroscopy after ionization in the positive mode and collision induced fragmentation at m/z 381 → 256, 213 for upadacitinib and m/z 418 → 258, 165 for pexidartinib. The calibration function was linear in the range of 0.15 – 150 ng/mL. Precisions and accuracies were better than 10% in intra- as well as inter-day evaluations. The method was applied in therapeutic drug monitoring of patients undergoing treatment for rheumatoid arthritis with the standard dose of 15 mg upadacitinib extended release formulation once daily. At steady state, we found trough levels of 4.13 (3.51 – 11.0) ng/mL, which is comparable to values found in healthy volunteers receiving the same dose (2.8 ± 1.2 ng/mL).
Keywords	chemical species ; drugs ; humans ; ionization ; non-specific protein-tyrosine kinase ; rheumatoid arthritis ; tandem mass spectrometry ; therapeutics
Language	English
Dates of publication	2022-0101
Publishing place	Elsevier B.V.
Document type	Article
ISSN	1570-0232
DOI	10.1016/j.jchromb.2021.123076
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Article ; Online: Simultaneous quantification of nirmatrelvir and ritonavir by LC-MS/MS in patients treated for COVID-19.

Martens-Lobenhoffer, Jens / Böger, Corinna R / Kielstein, Jan / Bode-Böger, Stefanie M

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

2022 Volume 1212, Page(s) 123510

Abstract: Nirmatrelvir is an antiviral agent active against SARS-CoV-2, the virus causing the pandemic disease COVID-19. It is administrated in combination with the protease inhibitor ritonavir, which acts in case of COVID-19 mainly as enzyme blocking agent ... ...

Abstract	Nirmatrelvir is an antiviral agent active against SARS-CoV-2, the virus causing the pandemic disease COVID-19. It is administrated in combination with the protease inhibitor ritonavir, which acts in case of COVID-19 mainly as enzyme blocking agent preventing the premature metabolic elimination of nirmatrelvir. The combination of the two drugs in separate tablets is marketed under the brand name Paxlovid® and shows good effectivity in preventing the progression of COVID-19 to severe disease state. In this work, we described a LC-MS/MS method for the simultaneous quantification of nirmatrelvir and ritonavir in human plasma of patients treated for COVID-19 with Paxlovid®. After addition of D
MeSH term(s)	Humans ; Chromatography, Liquid/methods ; Ritonavir/therapeutic use ; Tandem Mass Spectrometry/methods ; Chromatography, High Pressure Liquid/methods ; COVID-19/drug therapy ; COVID-19/epidemiology ; SARS-CoV-2
Chemical Substances	Ritonavir (O3J8G9O825)
Language	English
Publishing date	2022-10-17
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1180823-8
ISSN	1873-376X ; 0378-4347 ; 1570-0232 ; 1387-2273
ISSN (online)	1873-376X
ISSN	0378-4347 ; 1570-0232 ; 1387-2273
DOI	10.1016/j.jchromb.2022.123510
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Article ; Online: Cerebrospinal fluid penetration of fosfomycin in patients with ventriculitis: an observational study.

König, Christina / Martens-Lobenhoffer, Jens / Czorlich, Patrick / Westphal, Manfred / Bode-Böger, Stefanie M / Kluge, Stefan / Grensemann, Jörn

Annals of clinical microbiology and antimicrobials

2023 Volume 22, Issue 1, Page(s) 29

Abstract: Background: For treatment of ventriculitis, vancomycin and meropenem are frequently used as empiric treatment but cerebrospinal fluid (CSF) penetration is highly variable and may result in subtherapeutic concentrations. Fosfomycin has been suggested for ...

Abstract	Background: For treatment of ventriculitis, vancomycin and meropenem are frequently used as empiric treatment but cerebrospinal fluid (CSF) penetration is highly variable and may result in subtherapeutic concentrations. Fosfomycin has been suggested for combination antibiotic therapy, but data are sparse, so far. Therefore, we studied CSF penetration of fosfomycin in ventriculitis. Methods: Adult patients receiving a continuous infusion of fosfomycin (1 g/h) for the treatment of ventriculitis were included. Routine therapeutic drug monitoring (TDM) of fosfomycin in serum and CSF was performed with subsequent dose adaptions. Demographic and routine laboratory data including serum and CSF concentrations for fosfomycin were collected. Antibiotic CSF penetration ratio as well as basic pharmacokinetic parameters were investigated. Results: Seventeen patients with 43 CSF/serum pairs were included. Median fosfomycin serum concentration was 200 [159-289] mg/L and the CSF concentration 99 [66-144] mg/L. Considering only the first measurements in each patient before a possible dose adaption, serum and CSF concentrations were 209 [163-438] mg/L and 104 [65-269] mg/L. Median CSF penetration was 46 [36-59]% resulting in 98% of CSF levels above the susceptibility breakpoint of 32 mg/L. Conclusion: Penetration of fosfomycin into the CSF is high, reliably leading to appropriate concentrations for the treatment of gram positive and negative bacteria. Moreover, continuous administration of fosfomycin appears to be a reasonable approach for antibiotic combination therapy in patients suffering from ventriculitis. Further studies are needed to evaluate the impact on outcome parameters.
MeSH term(s)	Adult ; Humans ; Fosfomycin ; Cerebral Ventriculitis/drug therapy ; Anti-Bacterial Agents/therapeutic use ; Vancomycin ; Meropenem/therapeutic use ; Cerebrospinal Fluid
Chemical Substances	Fosfomycin (2N81MY12TE) ; Anti-Bacterial Agents ; Vancomycin (6Q205EH1VU) ; Meropenem (FV9J3JU8B1)
Language	English
Publishing date	2023-04-24
Publishing country	England
Document type	Observational Study ; Journal Article
ZDB-ID	2097873-X
ISSN	1476-0711 ; 1476-0711
ISSN (online)	1476-0711
ISSN	1476-0711
DOI	10.1186/s12941-023-00572-4
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Article ; Online: Pharmacokinetics of Remdesivir and GS-441524 during PIRRT and Seraph 100 Therapy.

Schmidt, Julius J / Bode-Böger, Stefanie M / Martens-Lobenhoffer, Jens / Hoeper, Marius M / Kielstein, Jan T

Clinical journal of the American Society of Nephrology : CJASN

2021 Volume 16, Issue 8, Page(s) 1256–1257

MeSH term(s)	Adenosine/analogs & derivatives ; Adenosine/pharmacokinetics ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/pharmacokinetics ; Adult ; Aged ; Alanine/analogs & derivatives ; Alanine/pharmacokinetics ; Female ; Hemofiltration ; Humans ; Intermittent Renal Replacement Therapy ; Male ; SARS-CoV-2 ; COVID-19 Drug Treatment
Chemical Substances	GS-441524 (1BQK176DT6) ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Adenosine (K72T3FS567) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-07-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2226665-3
ISSN	1555-905X ; 1555-9041
ISSN (online)	1555-905X
ISSN	1555-9041
DOI	10.2215/CJN.17601120
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Article ; Online: Quantification of the janus kinase 1 inhibitor upadacitinib in human plasma by LC-MS/MS.

Martens-Lobenhoffer, Jens / Tomaras, Stylianos / Feist, Eugen / Bode-Böger, Stefanie M

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

2021 Volume 1188, Page(s) 123076

Abstract	Upadacitinib is a selective janus-kinase-1 inhibitor effective in the treatment of autoimmune related diseases like rheumatoid arthritis or psoriatic arthritis. Here, we described a LC-MS/MS method for the quantification of upadacitinib in human plasma applicable for therapeutic drug monitoring. Pexidartinib was used as internal standard. Plasma samples were prepared by acidic protein precipitation and the analytes were separated on a C-18 reversed phase column. Detection took place by tandem mass spectroscopy after ionization in the positive mode and collision induced fragmentation at m/z 381 → 256, 213 for upadacitinib and m/z 418 → 258, 165 for pexidartinib. The calibration function was linear in the range of 0.15 - 150 ng/mL. Precisions and accuracies were better than 10% in intra- as well as inter-day evaluations. The method was applied in therapeutic drug monitoring of patients undergoing treatment for rheumatoid arthritis with the standard dose of 15 mg upadacitinib extended release formulation once daily. At steady state, we found trough levels of 4.13 (3.51 - 11.0) ng/mL, which is comparable to values found in healthy volunteers receiving the same dose (2.8 ± 1.2 ng/mL).
MeSH term(s)	Aminopyridines ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Chromatography, Liquid/methods ; Drug Monitoring ; Heterocyclic Compounds, 3-Ring/blood ; Heterocyclic Compounds, 3-Ring/therapeutic use ; Humans ; Janus Kinase Inhibitors/blood ; Janus Kinase Inhibitors/therapeutic use ; Limit of Detection ; Linear Models ; Pyrroles ; Reproducibility of Results ; Tandem Mass Spectrometry/methods
Chemical Substances	Aminopyridines ; Antirheumatic Agents ; Heterocyclic Compounds, 3-Ring ; Janus Kinase Inhibitors ; Pyrroles ; upadacitinib (4RA0KN46E0) ; pexidartinib (6783M2LV5X)
Language	English
Publishing date	2021-12-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1180823-8
ISSN	1873-376X ; 0378-4347 ; 1570-0232 ; 1387-2273
ISSN (online)	1873-376X
ISSN	0378-4347 ; 1570-0232 ; 1387-2273
DOI	10.1016/j.jchromb.2021.123076
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Article: Stability of ceftolozane in human plasma and dried blood spots: Implications for transport and storage

Martens-Lobenhoffer, Jens / Hinderhofer, Matthias / Tröger, Uwe / Bode-Böger, Stefanie M.

Journal of pharmacological and toxicological methods. 2020 May, June, v. 103

2020

Abstract: Ceftolozane is a newer β-lactam antibiotic drug effective against gram-negative pathogens. Its pharmacokinetic parameters are dominated by the patients' kidney function. Consequently, in patients with impaired kidney function or those who are treated ... ...

Abstract	Ceftolozane is a newer β-lactam antibiotic drug effective against gram-negative pathogens. Its pharmacokinetic parameters are dominated by the patients' kidney function. Consequently, in patients with impaired kidney function or those who are treated with different forms of renal replacement therapy, therapeutic drug monitoring (TDM) of ceftolozane is strongly recommended to enhance safety and efficiency of the antibiotic treatment. Various methods for the quantification of ceftolozane in plasma samples have been described utilizing HPLC-UV or LC-MS/MS. However, all these methods are impaired by the instability of ceftolozane in plasma samples. In this work, we have determined the stability of ceftolozane in human plasma at temperatures of 40 °C, 23 °C, 6 °C and − 20 °C. At 6 °C and − 20 °C, ceftolozane was stable in human plasma over the observed time range of 7 days. At 23 °C and 40 °C, plasma samples were of acceptable (i.e. less than 15% decay) stability over time ranges of 71.2 h and 5.6 h, requiring expedited sample transport to the laboratory. Dried blood spots (DBS) were reported in the literature as matrix with beneficial properties regarding stabilities of β-lactam antibiotics. However, in this study we found that ceftolozane was of inferior stability in this matrix in comparison to plasma. Thus, DBS cannot be recommended as matrix for ceftolozane in TDM.
Keywords	drugs ; hemodialysis ; humans ; pharmacokinetics ; renal function ; toxicology
Language	English
Dates of publication	2020-05
Publishing place	Elsevier Inc.
Document type	Article
ZDB-ID	1105919-9
ISSN	1873-488X ; 1056-8719
ISSN (online)	1873-488X
ISSN	1056-8719
DOI	10.1016/j.vascn.2020.106692
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Article ; Online: Correction: Association of dimethylarginines and mediators of inflammation after acute ischemic stroke.

Chen, Shufen / Martens-Lobenhoffer, Jens / Weissenborn, Karin / Kielstein, Jan T / Lichtinghagen, Ralf / Deb-Chatterji, Milani / Li, Na / Tryc, Anita B / Goldbecker, Annemarie / Dong, Qiang / Bode-Böger, Stefanie M / Worthmann, Hans

Journal of neuroinflammation

2023 Volume 20, Issue 1, Page(s) 103

Language	English
Publishing date	2023-05-03
Publishing country	England
Document type	Published Erratum
ZDB-ID	2156455-3
ISSN	1742-2094 ; 1742-2094
ISSN (online)	1742-2094
ISSN	1742-2094
DOI	10.1186/s12974-023-02775-0
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