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Article ; Online: Exploring the role of oxidative stress and the effect of N-acetylcysteine in thiopurine-induced liver injury in inflammatory bowel disease: A randomized crossover pilot study.

van Asseldonk, Dirk P / Crouwel, Femke / Seinen, Margien L / Scheffer, Peter G / Veldkamp, Agnes I / de Boer, Nanne K / Lissenberg-Witte, Birgit / Peters, Godefridus J / van Bodegraven, Adriaan A

Basic & clinical pharmacology & toxicology

2024 Volume 134, Issue 4, Page(s) 507–518

Abstract: ... concentrations (33.6-24.5 pmol/L, p = 0.038). The other biomarkers remained unchanged, including thiopurine ...

Abstract	Thiopurine treatment is regularly complicated by drug-induced liver injury. It has been suggested that oxidative stress may play a synergistic role. To assess whether thiopurine-induced liver injury coincides with increased oxidative stress and whether co-administration with N-acetylcysteine is protective, we performed a randomized open label crossover pilot study in inflammatory bowel disease patients with thiopurine-induced increased serum liver tests. The study comprised four stages of 4 weeks. Patients received no additional therapy followed by N-acetylcysteine 1200 mg twice a day, or the other way around, alongside ongoing thiopurine treatment. The third and fourth stages comprised a washout period and thiopurine reintroduction period. Nine patients completed the study, and the addition of N-acetylcysteine decreased myeloperoxidase concentrations (33.6-24.5 pmol/L, p = 0.038). The other biomarkers remained unchanged, including thiopurine metabolites, xanthine oxidase activity, thiopurine S-methyltransferase activity and serum liver enzyme activity tests. Reintroduction of thiopurines led to an increase of F2-isoprostanes (101-157 ng/mmol, p = 0.038), but not of serum liver enzyme activity tests. Results suggests that thiopurines may increase oxidative stress and although the addition of N-acetylcysteine led to a decrease in plasma myeloperoxidase concentrations, it does not protect from thiopurine-induced increase of serum liver tests.
MeSH term(s)	Humans ; Acetylcysteine/therapeutic use ; Chemical and Drug Induced Liver Injury, Chronic ; Immunosuppressive Agents ; Inflammatory Bowel Diseases/drug therapy ; Peroxidase ; Pilot Projects ; Purines/adverse effects ; Sulfhydryl Compounds/adverse effects ; Cross-Over Studies
Chemical Substances	2-mercaptopurine (81XK02929C) ; Acetylcysteine (WYQ7N0BPYC) ; Immunosuppressive Agents ; Peroxidase (EC 1.11.1.7) ; Purines ; Sulfhydryl Compounds
Language	English
Publishing date	2024-01-29
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2134679-3
ISSN	1742-7843 ; 1742-7835
ISSN (online)	1742-7843
ISSN	1742-7835
DOI	10.1111/bcpt.13978
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Article ; Online: A plea for TDM-based optimisation for treatment of Crohn's disease.

Seinen, Margien L / de Boer, Nanne K

The lancet. Gastroenterology & hepatology

2017 Volume 2, Issue 2, Page(s) 81

Language	English
Publishing date	2017-02
Publishing country	Netherlands
Document type	Letter
ISSN	2468-1253
ISSN (online)	2468-1253
DOI	10.1016/S2468-1253(16)30210-2
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Article ; Online: Key insights from therapeutic drug monitoring in Crohn's disease patients.

Seinen, Margien L / De Boer, Nanne K / van Bodegraven, Adriaan A

Expert opinion on drug metabolism & toxicology

2019 Volume 15, Issue 5, Page(s) 399–406

Abstract: Introduction: The incidence and prevalence of Crohn's disease are increasing causing a significant disease burden. Therapeutic drug monitoring (TDM) is advocated as a promising tool for personalized or individual-tailored therapy strategies and has been ...

Abstract	Introduction: The incidence and prevalence of Crohn's disease are increasing causing a significant disease burden. Therapeutic drug monitoring (TDM) is advocated as a promising tool for personalized or individual-tailored therapy strategies and has been welcomed as a new means to improve current therapy strategies. Nevertheless, pharmacokinetic-based TDM has limitations, and straightforward target concentrations for most therapies are lacking. Areas covered: In the following concise review of literature, key insights of TDM in thiopurine, methotrexate, anti-TNF, vedolizumab and ustekinumab therapy for Crohn's disease are being described. Expert opinion: Therapeutic drug monitoring may, up till now, be helpful to adjust thiopurine and infliximab therapy, primarily in a reactive setting, in case of inefficacy and of occurrence of adverse event. With this restricted application, the goal of individualized therapy based on TDM has not yet been achieved.
MeSH term(s)	Crohn Disease/drug therapy ; Drug Monitoring/methods ; Gastrointestinal Agents/administration & dosage ; Gastrointestinal Agents/pharmacokinetics ; Humans ; Infliximab/administration & dosage ; Infliximab/pharmacokinetics ; Purines/administration & dosage ; Purines/pharmacokinetics
Chemical Substances	Gastrointestinal Agents ; Purines ; Infliximab (B72HH48FLU)
Language	English
Publishing date	2019-04-21
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2214462-6
ISSN	1744-7607 ; 1742-5255
ISSN (online)	1744-7607
ISSN	1742-5255
DOI	10.1080/17425255.2019.1597054
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Article ; Online: Nodular regenerative hyperplasia in inflammatory bowel disease patients with allopurinol-thiopurine cotherapy.

Simsek, Melek / Seinen, Margien L / de Boer, Nanne K H

European journal of gastroenterology & hepatology

2018 Volume 30, Issue 10, Page(s) 1254–1255

MeSH term(s)	Adult ; Allopurinol/adverse effects ; Crohn Disease/drug therapy ; Drug Therapy, Combination/adverse effects ; Enzyme Inhibitors/adverse effects ; Focal Nodular Hyperplasia/chemically induced ; Focal Nodular Hyperplasia/complications ; Focal Nodular Hyperplasia/diagnosis ; Humans ; Hypertension, Portal/etiology ; Immunosuppressive Agents/adverse effects ; Male ; Mercaptopurine/adverse effects
Chemical Substances	Enzyme Inhibitors ; Immunosuppressive Agents ; Allopurinol (63CZ7GJN5I) ; Mercaptopurine (E7WED276I5)
Language	English
Publishing date	2018-08-27
Publishing country	England
Document type	Case Reports ; Letter
ZDB-ID	1034239-4
ISSN	1473-5687 ; 0954-691X
ISSN (online)	1473-5687
ISSN	0954-691X
DOI	10.1097/MEG.0000000000001218
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Article ; Online: The continuous rediscovery and the benefit-risk ratio of thioguanine, a comprehensive review.

Bayoumy, Ahmed B / Simsek, Melek / Seinen, Margien L / Mulder, Chris J J / Ansari, Azhar / Peters, Godefridus J / De Boer, Nanne K

Expert opinion on drug metabolism & toxicology

2020 Volume 16, Issue 2, Page(s) 111–123

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/adverse effects ; Antimetabolites, Antineoplastic/pharmacokinetics ; Dose-Response Relationship, Drug ; Humans ; Leukemia/drug therapy ; Thioguanine/administration & dosage ; Thioguanine/adverse effects ; Thioguanine/pharmacokinetics
Chemical Substances	Antimetabolites, Antineoplastic ; Thioguanine (FTK8U1GZNX)
Language	English
Publishing date	2020-02-24
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2214462-6
ISSN	1744-7607 ; 1742-5255
ISSN (online)	1744-7607
ISSN	1742-5255
DOI	10.1080/17425255.2020.1719996
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Article ; Online: Reply: To PMID 23333660.

Seinen, Margien L / De Boer, Nanne K H / van Bodegraven, Adriaan A

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

2013 Volume 11, Issue 8, Page(s) 1039

MeSH term(s)	Crohn Disease/drug therapy ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Male ; Mercaptopurine/therapeutic use ; Methotrexate/therapeutic use
Chemical Substances	Immunosuppressive Agents ; Mercaptopurine (E7WED276I5) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2013-08
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2119789-1
ISSN	1542-7714 ; 1542-3565
ISSN (online)	1542-7714
ISSN	1542-3565
DOI	10.1016/j.cgh.2013.05.005
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Zs.A 5836: Show issues

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Article ; Online: Optimizing Thiopurine Therapy in Inflammatory Bowel Disease Among 2 Real-life Intercept Cohorts: Effect of Allopurinol Comedication?

Meijer, Berrie / Seinen, Margien L / van Egmond, Remco / Bouma, Gerd / Mulder, Chris J J / van Bodegraven, Adriaan A / de Boer, Nanne K H

Inflammatory bowel diseases

2017 Volume 23, Issue 11, Page(s) 2011–2017

Abstract: Background: Thiopurines (azathioprine and mercaptopurine) are frequently used immunosuppressive drugs to maintain remission in patients with inflammatory bowel disease. Half of the conventional thiopurine-derivative users have to discontinue treatment ... ...

Abstract	Background: Thiopurines (azathioprine and mercaptopurine) are frequently used immunosuppressive drugs to maintain remission in patients with inflammatory bowel disease. Half of the conventional thiopurine-derivative users have to discontinue treatment within 5 years, mainly because of intolerable adverse events. Over recent years, different strategies to optimize thiopurine treatment were suggested, yet, studies describing the clinical effectiveness of these strategies remain scarce. The aims of this study were to compare tolerability and sustained clinical benefit of conventional thiopurine derivatives therapy among two 5-year real-life intercept cohorts and to assess the clinical value of specifically allopurinol cotherapy. Methods: In this retrospective single-center cohort study, we analyzed data from patients in whom weight-based thiopurine monotherapy was initiated between 2005 and 2009 (cohort 1) or between 2010 and 2014 (cohort 2). The initiation of the second cohort was synchronic to the start of allopurinol-based optimization in our center. Optimization strategies were extracted from patient charts. Results: In total, 105 patients were included (60 in cohort 1, and 45 in cohort 2). Metabolite measurement was performed in 37% versus 84% of the patients (P < 0.001). Subsequent optimization strategies were applied in 33% versus 58% of the patients because of inadequate metabolite concentrations, intolerance, or ineffectiveness (P = 0.01). Allopurinol was coadministered to therapy in 18 patients (40%) in the second cohort. Therapy was switched to thioguanine in 11 versus 6 patients (P > 0.05). Overall, total duration was longer in the second cohort (10.8 versus 34.1 months, P < 0.001). The number of ongoing thiopurine users (20% versus 49%) and sustained clinical benefit (13% versus 38%) were higher in the second cohort (both P < 0.05). This was mainly because of a decrease in hepatotoxicity after optimization (P < 0.01). Conclusions: Optimization of thiopurine therapy by the use of therapeutic drug monitoring with subsequent administration of allopurinol cotherapy successfully enhanced sustained clinical benefit and tolerability in patients with inflammatory bowel disease.
MeSH term(s)	Adult ; Allopurinol/administration & dosage ; Azathioprine/administration & dosage ; Drug Monitoring ; Drug Therapy, Combination ; Drug-Related Side Effects and Adverse Reactions ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Inflammatory Bowel Diseases/drug therapy ; Male ; Mercaptopurine/administration & dosage ; Middle Aged ; Retrospective Studies ; Thioguanine/administration & dosage ; Treatment Outcome ; Young Adult
Chemical Substances	Immunosuppressive Agents ; Allopurinol (63CZ7GJN5I) ; Mercaptopurine (E7WED276I5) ; Thioguanine (FTK8U1GZNX) ; Azathioprine (MRK240IY2L)
Language	English
Publishing date	2017-06-15
Publishing country	England
Document type	Comparative Study ; Journal Article
ZDB-ID	1340971-2
ISSN	1536-4844 ; 1078-0998
ISSN (online)	1536-4844
ISSN	1078-0998
DOI	10.1097/MIB.0000000000001168
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Zs.A 4530: Show issues

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Article ; Online: Oxidation-mediated DNA crosslinking contributes to toxicity of 6-thioguanine in human cells -- letter.

de Boer, Nanne K H / van Asseldonk, Dirk P / Seinen, Margien L / van Bodegraven, Adriaan A

Cancer research

2013 Volume 73, Issue 4, Page(s) 1445

MeSH term(s)	Antimetabolites, Antineoplastic/pharmacology ; DNA/drug effects ; Humans ; Oxidation-Reduction/drug effects ; Thioguanine/pharmacology
Chemical Substances	Antimetabolites, Antineoplastic ; DNA (9007-49-2) ; Thioguanine (FTK8U1GZNX)
Language	English
Publishing date	2013-02-15
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	1432-1
ISSN	1538-7445 ; 0008-5472
ISSN (online)	1538-7445
ISSN	0008-5472
DOI	10.1158/0008-5472.CAN-12-3120
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Article ; Online: Clinical Value of Mercaptopurine After Failing Azathioprine Therapy in Patients With Inflammatory Bowel Disease.

Meijer, Berrie / Seinen, Margien L / Leijte, Niek N W / Mulder, Chris J J / van Bodegraven, Adriaan A / de Boer, Nanne K H

Therapeutic drug monitoring

2016 Volume 38, Issue 4, Page(s) 463–470

Abstract: Background: Thiopurines have been widely accepted as immunosuppressive therapy in inflammatory bowel disease. However, many patients have to discontinue thiopurines due to intolerance or ineffectiveness. A therapeutically beneficial effect of switching ... ...

Abstract	Background: Thiopurines have been widely accepted as immunosuppressive therapy in inflammatory bowel disease. However, many patients have to discontinue thiopurines due to intolerance or ineffectiveness. A therapeutically beneficial effect of switching from azathioprine (AZA) to mercaptopurine (MP) after developing adverse events (AEs) has been reported. The authors assessed the clinical value of MP therapy after AZA discontinuation due to intolerance and, secondary, due to ineffectiveness. Methods: In this retrospective single-center study, the authors analyzed data from patients in whom AZA therapy had failed and who were subsequently treated with MP. Results: Thirty-eight patients initiated MP therapy after intolerance to AZA. Intolerance reoccurred in 22 (58%) patients and the remaining 16 (42%) tolerated MP. In 18 out of 48 patients (38%), the AEs that led to discontinuation of MP were similar to those of AZA. A longer duration of prior AZA use was more common in patients who were subsequently tolerant for MP (5.3 versus 1.2 months; P = 0.04). Twenty-two patients discontinued AZA due to ineffectiveness. Eight (36%) patients had clinical benefit from a switch to MP. Six out of these 8 (75%) patients used allopurinol alongside MP, due to ineffectiveness based on a skewed thiopurine metabolism. Patients were more likely to have clinical benefit if the interval between both thiopurines was longer (4.4 versus 0.01 months; P < 0.05). Conclusions: The authors showed that a noteworthy number of patients benefitted therapeutically from a switch from AZA to MP when failing due to intolerance or ineffectiveness; however, the percentage was lower than previously reported in literature.
Language	English
Publishing date	2016-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	424443-6
ISSN	1536-3694 ; 0163-4356
ISSN (online)	1536-3694
ISSN	0163-4356
DOI	10.1097/FTD.0000000000000312
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Article ; Online: Rac Attack: Modulation of the Small GTPase Rac in Inflammatory Bowel Disease and Thiopurine Therapy.

Seinen, Margien L / van Nieuw Amerongen, Geerten P / de Boer, Nanne K H / van Bodegraven, Adriaan A

Molecular diagnosis & therapy

2016 Volume 20, Issue 6, Page(s) 551–557

Abstract: The incidence and prevalence of inflammatory bowel disease (IBD) are increasing. Although the etiology of IBD is unknown, it is thought that genetically susceptible individuals display an inappropriate inflammatory response to commensal microbes, ... ...

Abstract	The incidence and prevalence of inflammatory bowel disease (IBD) are increasing. Although the etiology of IBD is unknown, it is thought that genetically susceptible individuals display an inappropriate inflammatory response to commensal microbes, resulting in intestinal tissue damage. Key proteins involved in regulating the immune response, and thus in inflammation, are the small triphosphate-binding protein Rac and its regulatory network. Recent data suggest these proteins to be involved in (dys)regulation of the characteristic inflammatory processes in IBD. Moreover, Rac-gene variants have been identified as susceptibility risk factors for IBD, and Rac1 GTPase signaling has been shown to be strongly suppressed in non-inflamed mucosa compared with inflamed colonic mucosa in IBD. In addition, first-line immunosuppressive treatment for IBD includes thiopurine therapy, and its immunosuppressive effect is primarily ascribed to Rac1 suppression. In this review, we focus on Rac modification and its potential role in the development of IBD, Rac as the molecular therapeutic target in current thiopurine therapy, and the modulation of the Rac signal transduction pathway as a promising novel therapeutic strategy.
MeSH term(s)	Genetic Markers ; Genetic Predisposition to Disease ; Humans ; Immunosuppressive Agents/pharmacology ; Inflammation/drug therapy ; Inflammation/genetics ; Inflammatory Bowel Diseases/drug therapy ; Inflammatory Bowel Diseases/genetics ; Mercaptopurine/pharmacology ; NADPH Oxidases/genetics ; NADPH Oxidases/metabolism ; Polymorphism, Single Nucleotide ; Signal Transduction ; rac1 GTP-Binding Protein/genetics ; rac1 GTP-Binding Protein/metabolism
Chemical Substances	Genetic Markers ; Immunosuppressive Agents ; Mercaptopurine (E7WED276I5) ; NADPH Oxidases (EC 1.6.3.-) ; NCF2 protein, human (EC 1.6.3.1) ; rac1 GTP-Binding Protein (EC 3.6.5.2)
Language	English
Publishing date	2016-12
Publishing country	New Zealand
Document type	Journal Article ; Review
ZDB-ID	2232796-4
ISSN	1179-2000 ; 1177-1062
ISSN (online)	1179-2000
ISSN	1177-1062
DOI	10.1007/s40291-016-0232-1
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