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Record W4286008638 · doi:10.1093/brain/awac252

Effect of nusinersen on motor, respiratory and bulbar function in early-onset spinal muscular atrophy

2022· article· en· W4286008638 on OpenAlexafffund
Astrid Pechmann, Max Behrens, Katharina Dörnbrack, Adrian Tassoni, Sabine Stein, Sibylle Emilie Vogt, Daniela Zöller, Günther Bernert, Tim Hagenacker, Ulrike Schara‐Schmidt, Inge Schwersenz, Maggie C. Walter, Matthias Baumann, Manuela Baumgärtner, Marcus Deschauer, Astrid Eisenkölbl, Marina Flotats‐Bastardas, Andreas Hahn, Veronka Horber, Ralf A. Husain, Sabine Illsinger, Jessika Johannsen, Cornelia Köhler, Heike Kölbel, Monika Müller, Arpad von Moers, Kurt Schlachter, Gudrun Schreiber, Oliver Schwartz, Martin Smitka, Elisabeth Steiner, Eva Stögmann, Regina Trollmann, Katharina Vill, Claudia Weiß, Gert Wiegand, Andreas Ziegler, Hanns Lochmüller, Janbernd Kirschner, Thea Beatrice Abele, Bárbara Andres, Daniela Angelova-Toshkina, Petra Baum, Tobias Baum, Ute Baur, Benedikt Becker, Bettina Behring, Theresa Birsak, Julia Bellut, Astrid Bertsche, Markus Blankenburg, Astrid Blaschek, Nathalie Braun, Sarah Braun, Nadine Burgenmeister, Nicole Claus, Isabell Cordts, Heike de Vries, Timo Deba, Adela Della Marina, Jonas Denecke, Joenna Driemeyer, Matthias Eckenweiler, Barbara Fiedler, Michal Fischer, Maren Freigang, Johannes Friese, Philippa Gaiser, Axel Gebert, Stephanie Geitmann, Klaus Goldhahn, Michael Grässl, Kristina Gröning, Julian Großkreutz, U Gruber‐Sedlmayr, Helene Guillemot, René Günther, Maja von der Hagen, H. Hartmann, Miriam Hiebeler, Elke Hobbiebrunken, Georg F. Hoffmann, Britta Holtkamp, Dorothea Holzwarth, Eva Jansen, Angela M. Kaindl, Nadja Kaiser, Jennifer Klamroth, Jan Christoph Koch, Kirsten Kolzter, Brigitte Korschinsky, Hanna Küpper, Thorsten Langer, Ilka Lehnert, Paul Lingor, Wolfgang N. Löscher, Dana Loudovici-Krug, Κyriakos Martakis, Iris Mayer, Moritz Metelmann, Sascha Meyer, Katharina Mueller-Kaempffer, P Müller, Wolfgang Müller‐Felber, Christoph Neuwirth, Johanna Niederschweiberer, Anja Nölte, Thorsten Odorfer, Heymut Omran, Josefine Pauschek, Katrin Pickrodt, Barbara Plecko, Manuel Pühringer, Anna Lisa Quinten, Mika Rappold, Christof Reihle, Tabea Reinhardt, Annekathrin Rödiger, Gerda Roetmann, Afshin Saffari, Mareike Schimmel, Joanna Schneider, Christoph Schoene-Bake, David Schorling, A. Schwerin-Nagel, Robert Steinbach, Daniela Steuernagel, Benjamin Stolte, Corinna Stoltenburg, Burkhard Stüve, Manuela Theophil, Simone Thiele, Raffi Topakian, Matthias Türk, Lieske van der Stam, Peter Vollmann, Birgit Warken, Markus Weber, Markus Weiler, Deike Weiss, Simone Weiss, Franziska Wenzel, Sabine Wider, Nils Ole Wiebe, Ekkehard Wilichowski, Bernd Wilken, Katarzyna Wochner, Fiona Zeiner, Daniela Zeisler, Daniel Zeller, Michael Zemlin

Bibliographic record

VenueBrain · 2022
Typearticle
Languageen
FieldMedicine
TopicNeurogenetic and Muscular Disorders Research
Canadian institutionsOttawa HospitalChildren's Hospital of Eastern OntarioUniversity of Ottawa
FundersEisaiAlbert-Ludwigs-Universität FreiburgCanada Research ChairsMuscular Dystrophy CanadaSarepta TherapeuticsCanadian Institutes of Health ResearchGW PharmaceuticalsSanofiPTC TherapeuticsUltragenyx PharmaceuticalAveXisBiogenAlnylam PharmaceuticalsF. Hoffmann-La RocheAlexion PharmaceuticalsPfizer
KeywordsSpinal muscular atrophyMedicinePediatricsAtrophyWeaknessProgressive muscular atrophyNeuromuscular diseaseClinical trialPhysical therapyPhysical medicine and rehabilitationSurgeryDiseaseInternal medicineAmyotrophic lateral sclerosis

Abstract

fetched live from OpenAlex

5q-associated spinal muscular atrophy is a rare neuromuscular disorder with the leading symptom of a proximal muscle weakness. Three different drugs have been approved by the European Medicines Agency and Food and Drug Administration for the treatment of spinal muscular atrophy patients, however, long-term experience is still scarce. In contrast to clinical trial data with restricted patient populations and short observation periods, we report here real-world evidence on a broad spectrum of patients with early-onset spinal muscular atrophy treated with nusinersen focusing on effects regarding motor milestones, and respiratory and bulbar insufficiency during the first years of treatment. Within the SMArtCARE registry, all patients under treatment with nusinersen who never had the ability to sit independently before the start of treatment were identified for data analysis. The primary outcome of this analysis was the change in motor function evaluated with the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders and motor milestones considering World Health Organization criteria. Further, we evaluated data on the need for ventilator support and tube feeding, and mortality. In total, 143 patients with early-onset spinal muscular atrophy were included in the data analysis with a follow-up period of up to 38 months. We observed major improvements in motor function evaluated with the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders. Improvements were greater in children >2 years of age at start of treatment than in older children. 24.5% of children gained the ability to sit independently. Major improvements were observed during the first 14 months of treatment. The need for intermittent ventilator support and tube feeding increased despite treatment with nusinersen. Our findings confirm the increasing real-world evidence that treatment with nusinersen has a dramatic influence on disease progression and survival in patients with early-onset spinal muscular atrophy. Major improvements in motor function are seen in children younger than 2 years at the start of treatment. Bulbar and respiratory function needs to be closely monitored, as these functions do not improve equivalent to motor function.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.514
Threshold uncertainty score0.350

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.013
GPT teacher head0.290
Teacher spread0.278 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations70
Published2022
Admission routes2
Has abstractyes

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