Evidence map›Paper›PMID 39527163›Full record

ArticleNeurology and therapy2025

TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program.

Pierre Labauge, Alain Créange, Thibault Moreau, Jocelyne Nouvet-Gire, Bernard Pedespan, Olivier Heinzlef, Nathalie Texier, Marilyn Gros, Catherine Marti, Marta Ruiz and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Neurology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04221191 (Study on the Dimethyl Fumarate), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT04221191 completednot on this map

Study on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEP

TypeobservationalSponsorBiogenRan2019 to 2022Enrolled353ConditionsMultiple Sclerosis, Relapsing-RemittingArmsDimethyl Fumarate, PSP
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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.

Pierre LabaugeCHU de Montpellier-Hôpital Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier, France. p-labauge@chu-montpellier.fr.
Alain CréangeHôpital Henri Mondor APHP, 1 Rue Gustave Eiffel, 94010, Créteil, France.
Thibault MoreauCHU de Dijon, 2 Boulevard Maréchal de Lattre de Tassigny, 21000, Dijon, France.
Jocelyne Nouvet-GireL'Association Française Des Sclérosés En Plaques (AFSEP), 8 Rue Chevreul, 75011, Paris, France.
Bernard PedespanCentre Hospitalier Agen-Nerac, 21 Route de Villeneuve, 47923, Agen, France.
Olivier HeinzlefCHI de Poissy, 10 Rue Du Champ Gaillard, 78300, Poissy, France.
Nathalie TexierKappa Santé, 4 Rue De Cléry, 75002, Paris, France.
Marilyn GrosBiogen, 20 Place de La Défense-Tour Légende, 92800, Puteaux, France.
Catherine MartiBiogen, 20 Place de La Défense-Tour Légende, 92800, Puteaux, France.
Marta RuizBiogen, 20 Place de La Défense-Tour Légende, 92800, Puteaux, France. marta.ruiz@biogen.com.ORCID http://orcid.org/0009-0007-7744-4207
Mikel MartinezCentre Hospitalier Dax-Côte d'Argent, Bd Yves du Manoir, 40100, Dax, France.
Giovanni CastelnovoCHU de Nȋmes, 4 Rue du Professeur Robert Debré, 30900, Nȋmes, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTreatment persistence and adherence are essential for achieving therapeutic goals in patients with multiple sclerosis (MS). OroSEP is an independent patient-support program (PSP) in France for patients with relapsing-remitting MS (RRMS) receiving oral disease-modifying therapies.

methodsTEC-ADHERE (NCT04221191; 08/19/2019-09/15/2022) was a prospective, non-interventional, phase 4 study to assess the effect of OroSEP on persistence and adherence to dimethyl fumarate (DMF; Tecfidera™) in patients with RRMS. Outcomes were compared for patients in OroSEP versus non-OroSEP patients who received their neurologists' standard of care (SoC). Patients initiated DMF at month 0 (M0); follow-up visits occurred at M3 and M6. Primary outcome was persistence at M6. Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs).

resultsPer-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). Persistence was similar for OroSEP vs SoC (M6, 75.9% vs 76.6%; M1, 96.0% vs 92.4%; M3, 85.5% vs 89.0%). At M6, mean adherence was higher for OroSEP (5.4) vs SoC (4.7; p < 0.0001), and good adherence (Girerd score = 6) was achieved by more OroSEP patients (55.7%) than SoC patients (29.6%; p < 0.01). Mean anxiety scores were lower in the OroSEP group than in the SoC group at baseline (7.1 vs 8.8; p = 0.02) and M6 (3.4 vs 6.1; p < 0.001). Mean satisfaction scores at M6 were higher for OroSEP (77.4) vs SoC (64.2; p < 0.01). Most neurologists (n = 11/14) agreed that OroSEP helped improve adherence. Treatment-related AEs occurred in 62 (36.3%) OroSEP patients and 76 (42.9%) SoC patients; most common were flushing, diarrhea, hot flush, and abdominal pain.

conclusionThese outcomes support the value of PSPs in encouraging adherence, alleviating anxiety, improving patient satisfaction, and supporting patients to be more independent in managing MS.

trial registrationClinicalTrials.gov identifier, NCT04221191.

Indexed as

Dimethyl fumarateMultiple sclerosisNeurologistPatient-reported outcomePatient-support programPersistence

Identifiers

PMID39527163
PMCPMC11762029

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Registered trials

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.