Evidence map›Paper›PMID 30882022›Full record

Observational studyNeurology(R) neuroimmunology & neuroinflammation2019

Real-world persistence and benefit-risk profile of fingolimod over 36 months in Germany.

Tjalf Ziemssen, Michael Lang, Björn Tackenberg, Stephan Schmidt, Holger Albrecht, Luisa Klotz, Judith Haas, Christoph Lassek, C Anne-Marie Couto, John A Findlay and 2 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Neurology(R) neuroimmunology & neuroinflammation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Tjalf ZiemssenCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Michael LangCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Björn TackenbergCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Stephan SchmidtCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Holger AlbrechtCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Luisa KlotzCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Judith HaasCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Christoph LassekCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
C Anne-Marie CoutoCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
John A FindlayCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
Christian CornelissenCenter of Clinical Neuroscience (T.Z.), Neurological University Clinic Carl Gustav Carus, University of Technology, Dresden; NeuroPoint Patient Academy and Neurological Practice (M.L.), Ulm; Department of Neurology (B.T.), Center of Neuroimmunology, Philipps-University, Marburg; Bonn Neurological Practice (S.S.); Neurological Practice (H.A.), Munich; Department of Neurology (L.K.), University Hospital Münster, Münster; Centre for Multiple Sclerosis (J.H.), Jewish Hospital Berlin; Kassel and Vellmar Neurology Practice (C.L.), Vellmar, Germany; Oxford PharmaGenesis (C.A-M.C.); Oxford PharmaGenesis (J.A.F.), United Kingdom; and Novartis Pharma GmbH (C.C.), Nuremberg, Germany.
PANGAEA study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To assess the long-term real-world benefit-risk profile of fingolimod in patients with relapsing MS in Germany. Methods: This analysis used data from the noninterventional real-world study, Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA), to assess prospectively the persistence, effectiveness, and safety of fingolimod over 36 months (±90 days) in Germany. For inclusion in the effectiveness analysis (n = 2,537), patients were required to have received fingolimod for the first time in PANGAEA, to have at least 12 months of data, and to have completed each 12-month follow-up period. For the safety analysis (n = 3,266), patients were additionally allowed to have received fingolimod before enrollment. Results: At baseline, 94.7% of patients in the effectiveness analysis had received a previous disease-modifying therapy. After 36 months, 70.4% of patients were still receiving fingolimod. Over this period, annualized relapse rates decreased to 0.265 (95% CI: 0.244-0.286) from 1.79 (95% CI: 1.75-1.83), and mean Expanded Disability Status Scale scores remained stable (mean change from baseline: +0.049 [95% CI: -0.015 to +0.114]). In total, 16% of patients had 6-month confirmed disability improvement, 12.5% had 6-month confirmed disability worsening, and 52.4% were free from relapses and 6-month confirmed disability worsening. Adverse events (AEs) and serious AEs were experienced by up to 23.4% and 3.9% of patients, respectively, during any of the 12-month follow-up periods. The frequency and nature of AEs were in line with previous findings. Conclusions: Using systematically collected data from PANGAEA, this analysis demonstrates the sustained effectiveness, high persistence, and manageable safety profile of fingolimod over 36 months.

Indexed as

Drug-Related Side Effects and Adverse ReactionsOutcome Assessment, Health CareAdultFingolimod HydrochlorideGermanyHumansImmunosuppressive AgentsMultiple Sclerosis, Relapsing-RemittingProspective StudiesTime FactorsFingolimod HydrochlorideImmunosuppressive Agents

Identifiers

PMID30882022
PMCPMC6410931

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.