Contributions
Abstract: P1237
Type: Poster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Background: Up to now, treatment options were poor for primary progressive multiple sclerosis (PPMS) patients, as disease-modifying therapies (DMTs) approved for relapsing-remitting multiple sclerosis (MS) did not show any efficacy in this form. However, many DMTs are proposed off-label, in an attempt to reduce disability progression and answer patients' expectations.
Objectives: To describe the use of DMTs in real-life settings in a large cohort of PPMS patients from the French OFSEP cohort ('Observatoire Français de la Sclérose en Plaques') over 1996-2017 period.
Methods: All OFSEP patients with PPMS were included in the present study, i.e. 6,165 patients among a total of 54,000 MS patients. All DMTs were described, as well as changes and reasons for stopping. To investigate a cohort effect, proportions of treated patients were calculated over time, and demographic and clinical characteristics were compared between treated and untreated patients.
Results: Mean age at MS onset was 42.3±10.9 years and sex ratio was 1.3 (3,492 women and 2,673 men). Mean follow-up duration from MS onset was 13.3±8.9 years. As a whole, 3,566 patients (55.6%) received at least one DMT. Proportion of treated patients was higher in men than in women (60.8% versus 55.6%, p< 0.001) and age at MS onset was younger in treated patients than in untreated ones (40.9±10.6 versus 44.3±10.9 years, p< 0.001). Out of 7,209 initiations, the five most frequent DMTs were: cyclophosphamide (22.7%), beta interferon (20.8%), methotrexate (17.5%), azathioprine (12.1%) and mitoxantrone (8.9%). The mean number of DMTs per patient was 2.0±1.3 and one quarter of patients received 3 or more DMTs. The first DMT was initiated at a mean age of 47.4±10.9 years, after mean MS duration of 5.9±5.6 years. The cumulative DMT duration was 4.6±4.4 years, corresponding to about one third of follow-up duration from MS onset. When documented (n=3,768/5,742 stops), reasons for stopping treatment were: lack of efficacy (36.5%), scheduled stop (31.8%), safety concerns (22.6%), personal choice (6.3%, including desire of pregnancy) and others (2.8%).
Discussion: This study highlights the active attitude of French neurologists regarding use of DMTs in PPMS as well as the diversity of practices. Gathering data from more than 20 years will offer the opportunity to assess changes in daily practice in the future with the perspective of newly approved drugs in PPMS. Comprehensive results will be available in October 2017.
Disclosure: This work has been performed with the help of the French Observatoire of Multiple Sclerosis (OFSEP) which is supported by a grant provided by the French State and handled by the “Agence Nationale de la Recherche” within the framework of the “Investments for the Future” program, under the reference ANR-10-COHO-002.
Dr Leray reports personal fees as speaker or consultant from Novartis and Sanofi Genzyme, outside the submitted work, and travel grants from Novartis and Roche SAS. Sources of funding in the last year came from the French ARSEP Foundation, the French National Security Agency of Medicines and Health Products, the EDMUS Foundation, and donation from Roche SAS.
F. Rollot has nothing to disclose.
R. Casey has nothing to disclose.
Dr de Sèze received personal fees as speaker or consultant from Biogen, Merck Serono, Bayer, LFB, Sanofi-aventis, Teva, Genzyme, Almiral, and Alergan.
Dr Laplaud received honoraria and consulting fees from Biogen, Merck, Novartis, Sanofi-Genzyme and Roche, and grants from Biogen, Medday, Novartis, Roche and Sanofi-Genzyme.
Dr Vukusic received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.
Abstract: P1237
Type: Poster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Background: Up to now, treatment options were poor for primary progressive multiple sclerosis (PPMS) patients, as disease-modifying therapies (DMTs) approved for relapsing-remitting multiple sclerosis (MS) did not show any efficacy in this form. However, many DMTs are proposed off-label, in an attempt to reduce disability progression and answer patients' expectations.
Objectives: To describe the use of DMTs in real-life settings in a large cohort of PPMS patients from the French OFSEP cohort ('Observatoire Français de la Sclérose en Plaques') over 1996-2017 period.
Methods: All OFSEP patients with PPMS were included in the present study, i.e. 6,165 patients among a total of 54,000 MS patients. All DMTs were described, as well as changes and reasons for stopping. To investigate a cohort effect, proportions of treated patients were calculated over time, and demographic and clinical characteristics were compared between treated and untreated patients.
Results: Mean age at MS onset was 42.3±10.9 years and sex ratio was 1.3 (3,492 women and 2,673 men). Mean follow-up duration from MS onset was 13.3±8.9 years. As a whole, 3,566 patients (55.6%) received at least one DMT. Proportion of treated patients was higher in men than in women (60.8% versus 55.6%, p< 0.001) and age at MS onset was younger in treated patients than in untreated ones (40.9±10.6 versus 44.3±10.9 years, p< 0.001). Out of 7,209 initiations, the five most frequent DMTs were: cyclophosphamide (22.7%), beta interferon (20.8%), methotrexate (17.5%), azathioprine (12.1%) and mitoxantrone (8.9%). The mean number of DMTs per patient was 2.0±1.3 and one quarter of patients received 3 or more DMTs. The first DMT was initiated at a mean age of 47.4±10.9 years, after mean MS duration of 5.9±5.6 years. The cumulative DMT duration was 4.6±4.4 years, corresponding to about one third of follow-up duration from MS onset. When documented (n=3,768/5,742 stops), reasons for stopping treatment were: lack of efficacy (36.5%), scheduled stop (31.8%), safety concerns (22.6%), personal choice (6.3%, including desire of pregnancy) and others (2.8%).
Discussion: This study highlights the active attitude of French neurologists regarding use of DMTs in PPMS as well as the diversity of practices. Gathering data from more than 20 years will offer the opportunity to assess changes in daily practice in the future with the perspective of newly approved drugs in PPMS. Comprehensive results will be available in October 2017.
Disclosure: This work has been performed with the help of the French Observatoire of Multiple Sclerosis (OFSEP) which is supported by a grant provided by the French State and handled by the “Agence Nationale de la Recherche” within the framework of the “Investments for the Future” program, under the reference ANR-10-COHO-002.
Dr Leray reports personal fees as speaker or consultant from Novartis and Sanofi Genzyme, outside the submitted work, and travel grants from Novartis and Roche SAS. Sources of funding in the last year came from the French ARSEP Foundation, the French National Security Agency of Medicines and Health Products, the EDMUS Foundation, and donation from Roche SAS.
F. Rollot has nothing to disclose.
R. Casey has nothing to disclose.
Dr de Sèze received personal fees as speaker or consultant from Biogen, Merck Serono, Bayer, LFB, Sanofi-aventis, Teva, Genzyme, Almiral, and Alergan.
Dr Laplaud received honoraria and consulting fees from Biogen, Merck, Novartis, Sanofi-Genzyme and Roche, and grants from Biogen, Medday, Novartis, Roche and Sanofi-Genzyme.
Dr Vukusic received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.