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No evidence of disease activity status over 3 years in a real-world cohort of relapsing remitting MS patients in Germany.
Mult Scler Relat Disord. 2019 Jan; 27:133-138.MS

Abstract

BACKGROUND

Over the last decade, therapy of relapsing remitting multiple sclerosis (RRMS) has evolved with the approval of several new treatment concepts. Thus, treatment goals have become more ambitious aiming at "no evidence of disease activity" (NEDA). As NEDA-3, this concept comprises freedom of clinical disease progression and relapses as well as inflammatory MRI activity. So far, data on NEDA status mainly stem from post-hoc analyses of drug approval studies. Yet, less is known about the significance of NEDA in "real-world" clinical settings. Hence, our study aims at investigation of NEDA in a heterogeneous cohort of relapsing MS patients.

METHODS

This is a retrospective single-center study at the Department of Neurology of the University Hospital Erlangen, Germany, including data of 306 patients with relapsing forms of MS (RMS) or clinical isolated syndrome (CIS) from 2009 to 2016. Inclusion required sufficient clinical information and in house cranial MRI follow-up data sets at baseline and at follow-up after one year with a potential extension to two and three year follow-up, if possible. NEDA-3 status, its correlation to clinical features, associated medication and NEDA failure (EDA) were analyzed.

RESULTS

In a cohort of RMS patients at the early stages of the disease (median EDSS 1.5, mean disease duration 30 months) at baseline, 45% retained NEDA-3 status after one year. This percentage decreased in year two (29%) and three (21%) of follow-up. MRI criteria were responsible for loss of NEDA status in 64% of cases and CIS patients were more likely to sustain NEDA status. Therapy with monoclonal antibodies appeared superior in sustaining NEDA status as compared to injectables or oral treatment options.

DISCUSSION

In our real-world analysis, we confirm the potential of NEDA for the evaluation and surveillance of MS disease activity, progression and therapy efficacy. Despite highly efficient immunomodulatory treatment, NEDA-3 was only preserved in a minority of patients. Monoclonal antibodies may yield best NEDA rates. Further studies are warranted to evaluate the value of the NEDA concept in real-world settings beyond standardized clinical studies.

Authors+Show Affiliations

Department of Neurology, University of Erlangen, Germany. Electronic address: Konstantin.Huhn@uk-erlangen.de.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Erlangen, Germany.Department of Neurology, University of Regensburg, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30384198

Citation

Huhn, Konstantin, et al. "No Evidence of Disease Activity Status Over 3 Years in a Real-world Cohort of Relapsing Remitting MS Patients in Germany." Multiple Sclerosis and Related Disorders, vol. 27, 2019, pp. 133-138.
Huhn K, Senger D, Utz KS, et al. No evidence of disease activity status over 3 years in a real-world cohort of relapsing remitting MS patients in Germany. Mult Scler Relat Disord. 2019;27:133-138.
Huhn, K., Senger, D., Utz, K. S., Schmidt, M., Fröhlich, K., Waschbisch, A., Seifert, F., Dörfler, A., Lee, D. H., & Linker, R. A. (2019). No evidence of disease activity status over 3 years in a real-world cohort of relapsing remitting MS patients in Germany. Multiple Sclerosis and Related Disorders, 27, 133-138. https://doi.org/10.1016/j.msard.2018.10.020
Huhn K, et al. No Evidence of Disease Activity Status Over 3 Years in a Real-world Cohort of Relapsing Remitting MS Patients in Germany. Mult Scler Relat Disord. 2019;27:133-138. PubMed PMID: 30384198.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - No evidence of disease activity status over 3 years in a real-world cohort of relapsing remitting MS patients in Germany. AU - Huhn,Konstantin, AU - Senger,Daniela, AU - Utz,Kathrin S, AU - Schmidt,Manuel, AU - Fröhlich,Kilian, AU - Waschbisch,Anne, AU - Seifert,Frank, AU - Dörfler,Arnd, AU - Lee,De-Hyung, AU - Linker,Ralf A, Y1 - 2018/10/23/ PY - 2018/07/27/received PY - 2018/10/19/revised PY - 2018/10/22/accepted PY - 2018/11/2/pubmed PY - 2019/4/17/medline PY - 2018/11/2/entrez KW - Disease modifying treatment KW - Multiple sclerosis KW - NEDA KW - No evidence of disease activity SP - 133 EP - 138 JF - Multiple sclerosis and related disorders JO - Mult Scler Relat Disord VL - 27 N2 - BACKGROUND: Over the last decade, therapy of relapsing remitting multiple sclerosis (RRMS) has evolved with the approval of several new treatment concepts. Thus, treatment goals have become more ambitious aiming at "no evidence of disease activity" (NEDA). As NEDA-3, this concept comprises freedom of clinical disease progression and relapses as well as inflammatory MRI activity. So far, data on NEDA status mainly stem from post-hoc analyses of drug approval studies. Yet, less is known about the significance of NEDA in "real-world" clinical settings. Hence, our study aims at investigation of NEDA in a heterogeneous cohort of relapsing MS patients. METHODS: This is a retrospective single-center study at the Department of Neurology of the University Hospital Erlangen, Germany, including data of 306 patients with relapsing forms of MS (RMS) or clinical isolated syndrome (CIS) from 2009 to 2016. Inclusion required sufficient clinical information and in house cranial MRI follow-up data sets at baseline and at follow-up after one year with a potential extension to two and three year follow-up, if possible. NEDA-3 status, its correlation to clinical features, associated medication and NEDA failure (EDA) were analyzed. RESULTS: In a cohort of RMS patients at the early stages of the disease (median EDSS 1.5, mean disease duration 30 months) at baseline, 45% retained NEDA-3 status after one year. This percentage decreased in year two (29%) and three (21%) of follow-up. MRI criteria were responsible for loss of NEDA status in 64% of cases and CIS patients were more likely to sustain NEDA status. Therapy with monoclonal antibodies appeared superior in sustaining NEDA status as compared to injectables or oral treatment options. DISCUSSION: In our real-world analysis, we confirm the potential of NEDA for the evaluation and surveillance of MS disease activity, progression and therapy efficacy. Despite highly efficient immunomodulatory treatment, NEDA-3 was only preserved in a minority of patients. Monoclonal antibodies may yield best NEDA rates. Further studies are warranted to evaluate the value of the NEDA concept in real-world settings beyond standardized clinical studies. SN - 2211-0356 UR - https://www.unboundmedicine.com/medline/citation/30384198/No_evidence_of_disease_activity_status_over_3_years_in_a_real_world_cohort_of_relapsing_remitting_MS_patients_in_Germany_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2211-0348(18)30386-9 DB - PRIME DP - Unbound Medicine ER -