Monitoring von Blutparametern unter verlaufsmodifizierender MS-Therapie

Klotz, Luisa; Berthele, Achim; Brück, Wolfgang; Chan, Andrew; Flachenecker, Peter; Gold, Ralf; Haghikia, Aiden; Hellwig, Kerstin; Hemmer, Bernhard; Hohlfeld, Reinhard; Korn, Thomas; Kümpfel, Tania; Lang, Michael; Limmroth, Volker; Linker, Ralf A.; Meier, Uwe; Meuth, Sven G.; Paul, Friedemann; Salmen, Anke; Stangel, Martin; Tackenberg, Björn; Tumani, Hayrettin; Warnke, Clemens; Weber, Martin; Ziemssen, Tjalf; Zipp, Frauke; Wiendl, Heinz

doi:10.1007/s00115-016-0077-1

Cited by 13 publications

(12 citation statements)

References 100 publications

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“…CIS does not fulfill anamnestic or MRI tomographic criteria for MS and does not always convert into clinically definitive MS, the risk of which can be assessed by evaluating additional biomarkers, such as MRI, CSF composition, or electrophysiologic studies, among others. 28,29 …”

Section: Resultsmentioning

confidence: 99%

Dynamic regulation of serum aryl hydrocarbon receptor agonists in MS

Rothhammer

Borucki

Sánchez

et al. 2017

Neurol Neuroimmunol Neuroinflamm

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Objective:Several factors influence the clinical course of autoimmune inflammatory diseases such as MS and inflammatory bowel disease. Only recently, the complex interaction between the gut microbiome, dietary factors, and metabolism has started to be appreciated with regard to its potential to modulate acute and chronic inflammation. One of the molecular sensors that mediates the effects of these environmental signals on the immune response is the aryl hydrocarbon receptor (AHR), a ligand-activated transcription factor with key functions in immune cells.Methods:In this study, we analyzed the levels of AHR agonists in serum samples from patients with MS and healthy controls in a case-control study.Results:We detected a global decrease of circulating AHR agonists in relapsing-remitting MS patients as compared to controls. However, during acute CNS inflammation in clinically isolated syndrome or active MS, we measured increased AHR agonistic activity. Moreover, AHR ligand levels in patients with benign MS with relatively mild clinical impairment despite longstanding disease were unaltered as compared to healthy controls.Conclusions:Collectively, these data suggest that AHR agonists in serum are dynamically modulated during the course of MS. These findings may guide the development of biomarkers to monitor disease activity as well as the design of novel therapeutic interventions for MS.

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Section: Resultsmentioning

confidence: 99%

Dynamic regulation of serum aryl hydrocarbon receptor agonists in MS

Rothhammer

Borucki

Sánchez

et al. 2017

Neurol Neuroimmunol Neuroinflamm

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“…Based on the known excellent safety profile of NAT, hepatic, or kidney dysfunction is not common. Nevertheless, frequent testing of routine lab parameters is recommended and part of the monitoring program applied in NAT treated patients (45). During our observation period of 6 years, there were no relevant or long lasting abnormalities in serological testing of liver enzymes or kidney function.…”

Section: Discussionmentioning

confidence: 99%

Real-World Lab Data in Natalizumab Treated Multiple Sclerosis Patients Up to 6 Years Long-Term Follow Up

et al. 2018

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Natalizumab inhibits the transmigration of immune cells across the blood-brain barrier thus inhibiting inflammation in the central nervous system. Generally, this blockade at the blood-brain barrier has significant influence on the circulating lymphocytes. Up to date, only short-term data on peripheral blood parameters are available which are mostly from controlled clinical trials and not from real-world experience. Real-world lab data of 120 patients diagnosed with highly active disease course of relapsing-remitting multiple sclerosis (RRMS) were analyzed during natalizumab treatment. Patient sampling was performed by consecutive recruitment in the Multiple Sclerosis Center Dresden. Lab testing was performed before and at every third infusion up to 72 months follow-up. After first natalizumab infusion, absolute numbers of all major lymphocyte populations including CD4+ T-cells, CD8+ T-cells, CD19+ B-cells, and NK-cells significantly increased and remained stable during the whole observation period of 72 months. Upon lymphocyte subsets, CD19+ B-cells presented a disproportionate increase up to levels higher than normal level in most of the treated patients. Neutralizing antibodies to natalizumab abrogated the described changes. Intra-individual variation of lymphocytes and its subsets remained in a narrow range for the whole treatment period. CD4/CD8 ratio did not change compared to baseline measurement up to 6 years of natalizumab treatment. Monocytes, eosinophils, and basophils, but not neutrophils persistently increased during natalizumab treatment. Hematological parameters including erythrocyte, platelet count, hemoglobin, and hematocrit remained unchanged compared to baseline. Interestingly, immature precursor cells including erythroblasts were detectable in 36,8% of the treated patients during natalizumab therapy, but not in the pretreatment period. Asymptomatic elevations of liver enzymes were rare, mostly only transient and lower than 3x upper normal limit. Kidney function parameters remained stable within physiological ranges in most patients. CRP levels >20 mg/dl were recognized only in 10 patients during natalizumab therapy and were mostly linked to respiratory tract infections. In our present analysis, we report persistent, but stable increases of peripheral immune cell subtypes in natalizumab treated patients. Additional serological analyses confirm excellent tolerability and safety even 6 years after natalizumab initiation in post-marketing experience.

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“…The expert panel recommended to follow monitoring rules according to the product information and local guidelines [51, 52]: In addition to laboratory tests normally required for monitoring patients with MS, complete blood and differential blood cell counts, platelet counts, and blood chemistries including liver enzyme tests (e.g. AST, ALT), renal and thyroid function are recommended prior to initiation, at regular quarterly intervals within the first year following introduction of interferon therapy and then periodically thereafter in the absence of clinical symptoms, 1-2x per year (Table 3) [51, 52]. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, including differential and platelet counts.…”

Section: Main Textmentioning

confidence: 99%

An update on Peginterferon beta-1a Management in Multiple Sclerosis: results from an interdisciplinary Board of German and Austrian Neurologists and dermatologists

Kolb‐Mäurer

Sunderkötter²,

Kukowski

et al. 2019

BMC Neurol

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Background Interferon (IFN) beta drugs have been approved for the treatment of relapsing forms of multiple sclerosis (RMS) for more than 20 years and are considered to offer a favourable benefit-risk profile. In July 2014, subcutaneous (SC) peginterferon beta-1a 125 μg dosed every 2 weeks, a pegylated form of interferon beta-1a, was approved by the EMA for the treatment of adult patients with RRMS and in August 2014 by the FDA for RMS. Peginterferon beta-1a shows a prolonged half-life and increased systemic drug exposure resulting in a reduced dosing frequency compared to other available interferon-based products in MS. In the Phase 3 ADVANCE trial peginterferon beta-1a demonstrated significant positive effects on clinical and MRI outcome measures versus placebo after one year. Furthermore, in the ATTAIN extension study, sustained efficacy with long-term treatment for nearly 6 years was shown. Main text In July 2016, an interdisciplinary panel of German and Austrian experts convened to discuss the management of side effects associated with peginterferon beta-1a and other interferon beta-based treatments in MS in daily practice. The panel was composed of experts from university hospitals and private clinics comprised of neurologists, dermatologists, and an MS nurse. In this paper we report recommendations regarding best practices for adverse event management, focussing on peginterferon beta-1a. Injection site reactions (ISRs) and influenza-like illness are the most common adverse effects of interferon beta therapies and can present a burden for MS patients leading to non-adherence and discontinuation of therapy. Peginterferon beta-1a shows improved pharmacological properties. In clinical trials, the adverse event (AE) profile of peginterferon beta-1a was similar to other interferon beta formulations. The most common AEs were mild to moderate ISRs, influenza-like illness, pyrexia, and headache. Current information on the underlying cause of skin reactions associated with SC interferon treatment, and the management strategies for these AEs are limited. In pivotal trials, ISRs were mainly characterized and classified by neurologists, while dermatologists were only rarely consulted. Conclusions This report addresses expert recommendations on the management of most relevant adverse effects related to peginterferon beta-1a and other interferon betas, based on literature and interdisciplinary experience.

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Monitoring von Blutparametern unter verlaufsmodifizierender MS-Therapie

Cited by 13 publications

References 100 publications

Dynamic regulation of serum aryl hydrocarbon receptor agonists in MS

Dynamic regulation of serum aryl hydrocarbon receptor agonists in MS

Real-World Lab Data in Natalizumab Treated Multiple Sclerosis Patients Up to 6 Years Long-Term Follow Up

An update on Peginterferon beta-1a Management in Multiple Sclerosis: results from an interdisciplinary Board of German and Austrian Neurologists and dermatologists

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