No evidence of disease activity status over 3 years in a real-world cohort of relapsing remitting MS patients in Germany

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Details zur Publikation

Autorinnen und Autoren: Huhn K, Senger D, Utz KS, Schmidt M, Fröhlich KM, Waschbisch A, Seifert F, Dörfler A, Lee DH, Linker RA
Zeitschrift: Multiple Sclerosis and Related Disorders
Jahr der Veröffentlichung: 2019
Band: 27
Seitenbereich: 133-138
ISSN: 2211-0348


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.

FAU-Autorinnen und Autoren / FAU-Herausgeberinnen und Herausgeber

Dörfler, Arnd Prof. Dr.
Neuroradiologische Abteilung im Radiologischen Institut
Fröhlich, Katharina Maria
Medizinische Fakultät
Lee, De-Hyung PD Dr.
Medizinische Fakultät
Schmidt, Manuel Dr. med.
Neuroradiologische Abteilung im Radiologischen Institut
Seifert, Frank Prof. Dr.
Medizinische Fakultät
Waschbisch, Anne PD Dr.
Medizinische Fakultät

Einrichtungen weiterer Autorinnen und Autoren

Universität Regensburg


Huhn, K., Senger, D., Utz, K.S., Schmidt, M., Fröhlich, K.M., Waschbisch, A.,... 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.

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 27 (2019): 133-138.


Zuletzt aktualisiert 2019-06-03 um 11:08