TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program
Abstract Introduction Treatment 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 therapie...
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Adis, Springer Healthcare
2024-11-01
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| Series: | Neurology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40120-024-00674-x |
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| author | Pierre Labauge Alain Créange Thibault Moreau Jocelyne Nouvet-Gire Bernard Pedespan Olivier Heinzlef Nathalie Texier Marilyn Gros Catherine Marti Marta Ruiz Mikel Martinez Giovanni Castelnovo |
| author_facet | Pierre Labauge Alain Créange Thibault Moreau Jocelyne Nouvet-Gire Bernard Pedespan Olivier Heinzlef Nathalie Texier Marilyn Gros Catherine Marti Marta Ruiz Mikel Martinez Giovanni Castelnovo |
| author_sort | Pierre Labauge |
| collection | DOAJ |
| description | Abstract Introduction Treatment 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. Methods TEC-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). Results Per-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. Conclusion These 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 Registration ClinicalTrials.gov identifier, NCT04221191. |
| format | Article |
| id | doaj-art-085d4b964c6243bb803624a2042ae036 |
| institution | Kabale University |
| issn | 2193-8253 2193-6536 |
| language | English |
| publishDate | 2024-11-01 |
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| series | Neurology and Therapy |
| spelling | doaj-art-085d4b964c6243bb803624a2042ae0362025-01-26T12:58:41ZengAdis, Springer HealthcareNeurology and Therapy2193-82532193-65362024-11-0114117719210.1007/s40120-024-00674-xTEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support ProgramPierre Labauge0Alain Créange1Thibault Moreau2Jocelyne Nouvet-Gire3Bernard Pedespan4Olivier Heinzlef5Nathalie Texier6Marilyn Gros7Catherine Marti8Marta Ruiz9Mikel Martinez10Giovanni Castelnovo11CHU de Montpellier-Hôpital Gui de ChauliacHôpital Henri Mondor APHPCHU de DijonL’Association Française Des Sclérosés En Plaques (AFSEP)Centre Hospitalier Agen-NeracCHI de PoissyKappa SantéBiogenBiogenBiogenCentre Hospitalier Dax-Côte d’ArgentCHU de NȋmesAbstract Introduction Treatment 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. Methods TEC-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). Results Per-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. Conclusion These 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 Registration ClinicalTrials.gov identifier, NCT04221191.https://doi.org/10.1007/s40120-024-00674-xDimethyl fumarateMultiple sclerosisNeurologistPatient-reported outcomePatient-support programPersistence |
| spellingShingle | Pierre Labauge Alain Créange Thibault Moreau Jocelyne Nouvet-Gire Bernard Pedespan Olivier Heinzlef Nathalie Texier Marilyn Gros Catherine Marti Marta Ruiz Mikel Martinez Giovanni Castelnovo TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program Neurology and Therapy Dimethyl fumarate Multiple sclerosis Neurologist Patient-reported outcome Patient-support program Persistence |
| title | TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program |
| title_full | TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program |
| title_fullStr | TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program |
| title_full_unstemmed | TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program |
| title_short | TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program |
| title_sort | tec adhere real world persistence and adherence on dimethyl fumarate in patients with relapsing remitting multiple sclerosis in the french orosep patient support program |
| topic | Dimethyl fumarate Multiple sclerosis Neurologist Patient-reported outcome Patient-support program Persistence |
| url | https://doi.org/10.1007/s40120-024-00674-x |
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