Contributions
Abstract: EP1642
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod is a disease modifying drug used as a second line treatment in very active relapsing remitting multiple sclerosis (MS). It has been used in France since 2011 and we now can provide data about its efficacy and safety in real life.
Objectives: This study describes the real life data of efficacy and safety in patients treated with oral Fingolimod from 2011 to 2017 in the cities of Bordeaux, Tours, Toulouse and the Auvergne region.
Methods: We retrospectively collected data from the EDMUS database and from patient's medical files in the universities hospitals of Bordeaux, Toulouse, Tours and Clermont-Ferrand, general hospitals and neurologists in Auvergne.
We focused on the population characteristics, efficacy (Annualized Relapse Rate (ARR), MRI and the Expanded Disability Status Scale (EDSS) evolution) and safety of Fingolimod.
Results: Baseline characteristics of the 432 patients : mean age 39.9 ± 10 years; sex ratio women/men 3.8; duration of MS when Fingolimod is introduced 10.28 ±7.8 years, numbers of relapses during the past two years 1.5 ±1.3; ARR during the past two years 0.76; mean EDSS 2.68 (0-8.5); 29% MRI contrast enhancing.
6.25% received Fingolimod as a first line treatment, 36,8% after a natalizumab cure. ARR was decreased by 67,1% after a two years following. Mean EDSS was slightly increased after 1 year of treatment (2,7) and stable after 2 years (2,6). 78,7% patients were free from MRI progression the first year.
27% of patients interrupted the treatment, mainly because of a lack of efficacy or severe adverse events.
Severe infections were the reason for the interruption for 10 patients.
The others adverse events for which Fingolimod was stopped are: 4 atrioventricular block during the first introduction, 16 severe lymphopenia, 7 hepatitis, 4 macular oedema, 3 severe asthenia, 3 cancers ( 1 tongue epidermoid carcinoma, one basocelular carcinoma, one uterine cancer ), 2 headaches, 3 vomitings/diarrhea, 1 interstitial pneumoniae, 1 autoimmune hemolytic anemia. We did not report any case of progressive multifocal leukoencephalopathy in our cohort.
Conclusions: Fingolimod shows efficacy on the ARR with an important reduction during the first two years. In our cohort, most of the patients were also free from disability progression during these two years.
Fingolimod is overall well tolerated, even if it was stopped because of severe adverse events in 12,5% of patients.
Disclosure:
Roux: nothing to disclose
Simeoni: nothing to disclose
Thomas: nothing to disclose
Brassat: nothing to disclose
Guennoc: nothing to disclose
Brochet: nothing to disclose
Clavelou: nothing to disclose
Abstract: EP1642
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod is a disease modifying drug used as a second line treatment in very active relapsing remitting multiple sclerosis (MS). It has been used in France since 2011 and we now can provide data about its efficacy and safety in real life.
Objectives: This study describes the real life data of efficacy and safety in patients treated with oral Fingolimod from 2011 to 2017 in the cities of Bordeaux, Tours, Toulouse and the Auvergne region.
Methods: We retrospectively collected data from the EDMUS database and from patient's medical files in the universities hospitals of Bordeaux, Toulouse, Tours and Clermont-Ferrand, general hospitals and neurologists in Auvergne.
We focused on the population characteristics, efficacy (Annualized Relapse Rate (ARR), MRI and the Expanded Disability Status Scale (EDSS) evolution) and safety of Fingolimod.
Results: Baseline characteristics of the 432 patients : mean age 39.9 ± 10 years; sex ratio women/men 3.8; duration of MS when Fingolimod is introduced 10.28 ±7.8 years, numbers of relapses during the past two years 1.5 ±1.3; ARR during the past two years 0.76; mean EDSS 2.68 (0-8.5); 29% MRI contrast enhancing.
6.25% received Fingolimod as a first line treatment, 36,8% after a natalizumab cure. ARR was decreased by 67,1% after a two years following. Mean EDSS was slightly increased after 1 year of treatment (2,7) and stable after 2 years (2,6). 78,7% patients were free from MRI progression the first year.
27% of patients interrupted the treatment, mainly because of a lack of efficacy or severe adverse events.
Severe infections were the reason for the interruption for 10 patients.
The others adverse events for which Fingolimod was stopped are: 4 atrioventricular block during the first introduction, 16 severe lymphopenia, 7 hepatitis, 4 macular oedema, 3 severe asthenia, 3 cancers ( 1 tongue epidermoid carcinoma, one basocelular carcinoma, one uterine cancer ), 2 headaches, 3 vomitings/diarrhea, 1 interstitial pneumoniae, 1 autoimmune hemolytic anemia. We did not report any case of progressive multifocal leukoencephalopathy in our cohort.
Conclusions: Fingolimod shows efficacy on the ARR with an important reduction during the first two years. In our cohort, most of the patients were also free from disability progression during these two years.
Fingolimod is overall well tolerated, even if it was stopped because of severe adverse events in 12,5% of patients.
Disclosure:
Roux: nothing to disclose
Simeoni: nothing to disclose
Thomas: nothing to disclose
Brassat: nothing to disclose
Guennoc: nothing to disclose
Brochet: nothing to disclose
Clavelou: nothing to disclose