Contributions
Abstract: EP1662
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Introduction: Dimethyl fumarate (DMF) is an oral medication effective as a first-line treatment of relapsing-remitting multiple sclerosis (RRMS). However efficacy and safety profile of DMF as a second-line treatment is controversial. In this study DMF administration was compared in naïve patients and in patients switching from another first line therapy.
Methods: MS patients with relapsing remitting MS consecutively treated for at least 8 months with dimethyl fumarate at the Multiple Sclerosis Regional Reference Center of the Careggi University Hospital, were included and followed for a median time of 15 months. For the analysis the patients were stratified in three groups:
1) treatment naïve;
2) switching from another treatment because of:
a) low efficacy;
b) adverse events.
The primary end-point of the study was DMF efficacy in terms of annualized relapse rate (ARR). Others end points were EDSS score change over 12 months, safety and tolerability.
Results: The patients included were n= 81: 19 naïve (group 1) and 62 switching from other treatments (group 2) .Out of these, 20 switched for efficacy failure (group 2a) and 42 because of adverse events (group 2b). Group 1 had a ARR in the year before therapy higher than Group 2a and Group 2b (p=0,027 and p=0,03), lower disease duration (p=0,003 and p=0,01) and EDSS (p=0,001 and p=0,0001). During treatment ARR was 0,06, 0,04 and 0,13 respectively in each group (p= 0,78.; p= 0,29; p= 0,44); the median EDSS change after 12 months of treatment was 0,16, 0,06 and 0,10 respectively in each group (p= 0,448); the percentage of patients showing a progression of disability was very similar between group 1 and 2b (10,5% vs 9,5%), but tended to be lower in group 2a (5%, not significant).
Adverse events occurred in 36% of the patients. The most common were leucopenia, flushing or gastrointestinal disorders, mainly of mild entity and without difference among groups. The percentage of patients who interrupted the treatment because of adverse events was 9%.
Discussion: DMF seems effective in naive as well as in patients switching from other treatments; the type and number of adverse events are consistent with previous data.
Disclosure: This study received no funding.
Benedetta Forci received funding travel from Novartis, Biogen and Genzyme
Alice Mariottini received funding travel from Novartis, Biogen and Genzyme
Claudia Mechi received consulting fees by Novartis and Genzyme
Eliana Magnani received funding travel from Novartis
Alessandro Barilaro has nothing to disclosure
Luca Massacesi received educational grants for participation in international meetings from Biogen, Teva, Merk-Serono, Novartis, Genzyme, Roche; honoraria for symposia, advisory boards, preceptorship, consultation from Biogen, Teva, Merk-Serono, Novartis, Genzyme, Roche, Mylan.
Anna Repice received consulting fees by Merk-Serono, Biogen, Novartis and Genzyme, and funding travel from Teva, Biogen and Novartis.
Abstract: EP1662
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Introduction: Dimethyl fumarate (DMF) is an oral medication effective as a first-line treatment of relapsing-remitting multiple sclerosis (RRMS). However efficacy and safety profile of DMF as a second-line treatment is controversial. In this study DMF administration was compared in naïve patients and in patients switching from another first line therapy.
Methods: MS patients with relapsing remitting MS consecutively treated for at least 8 months with dimethyl fumarate at the Multiple Sclerosis Regional Reference Center of the Careggi University Hospital, were included and followed for a median time of 15 months. For the analysis the patients were stratified in three groups:
1) treatment naïve;
2) switching from another treatment because of:
a) low efficacy;
b) adverse events.
The primary end-point of the study was DMF efficacy in terms of annualized relapse rate (ARR). Others end points were EDSS score change over 12 months, safety and tolerability.
Results: The patients included were n= 81: 19 naïve (group 1) and 62 switching from other treatments (group 2) .Out of these, 20 switched for efficacy failure (group 2a) and 42 because of adverse events (group 2b). Group 1 had a ARR in the year before therapy higher than Group 2a and Group 2b (p=0,027 and p=0,03), lower disease duration (p=0,003 and p=0,01) and EDSS (p=0,001 and p=0,0001). During treatment ARR was 0,06, 0,04 and 0,13 respectively in each group (p= 0,78.; p= 0,29; p= 0,44); the median EDSS change after 12 months of treatment was 0,16, 0,06 and 0,10 respectively in each group (p= 0,448); the percentage of patients showing a progression of disability was very similar between group 1 and 2b (10,5% vs 9,5%), but tended to be lower in group 2a (5%, not significant).
Adverse events occurred in 36% of the patients. The most common were leucopenia, flushing or gastrointestinal disorders, mainly of mild entity and without difference among groups. The percentage of patients who interrupted the treatment because of adverse events was 9%.
Discussion: DMF seems effective in naive as well as in patients switching from other treatments; the type and number of adverse events are consistent with previous data.
Disclosure: This study received no funding.
Benedetta Forci received funding travel from Novartis, Biogen and Genzyme
Alice Mariottini received funding travel from Novartis, Biogen and Genzyme
Claudia Mechi received consulting fees by Novartis and Genzyme
Eliana Magnani received funding travel from Novartis
Alessandro Barilaro has nothing to disclosure
Luca Massacesi received educational grants for participation in international meetings from Biogen, Teva, Merk-Serono, Novartis, Genzyme, Roche; honoraria for symposia, advisory boards, preceptorship, consultation from Biogen, Teva, Merk-Serono, Novartis, Genzyme, Roche, Mylan.
Anna Repice received consulting fees by Merk-Serono, Biogen, Novartis and Genzyme, and funding travel from Teva, Biogen and Novartis.