Contributions
Abstract: P1164
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: Aim of this study is to evaluate post-marketing Dimethyl fumarate (DMF) safety, tolerability and efficacy profile in a real world setting.
Materials and methods: We enrolled all patients receiving DMF in three northern Italy MS centres. Patients were prospectively followed, collecting demographic and clinical data as well as laboratory assessment.
Results: We included 240 patients (70.8% F; mean age: 38.6+10.5 years; mean disease duration: 10.5+0.7 years). Mean annual relapse rate (ARR) in the two years before DMF was 0.56+0.6, median baseline EDSS was 2 (range 0-6.5).
Seventy-two patients (30%) were treatment naïve or quitted disease modifying drugs (DMDs) more than 12 months before DMF start. One hundred and thirty-three patients (55%) switched to DMF from first line DMDs (84% of whom from injectables and 16% from orals) due to loss of tolerability (74%) or inefficacy (26%). Thirty-five patients (15%) switched to DMF from second line DMDs due to loss of tolerability (83%) or safety reasons (17%).
The overall mean DMF treatment follow-up was 11+5 months, 102 patients (42%) had at least 12 months of follow-up. Most frequent adverse events (AEs) were flushing/pruritus (37.1%), gastrointestinal side effects (20.8%), rush (2.9%) and fatigue (2%). Only one severe AE was reported (breast cancer). Most frequent laboratory testing abnormality was lymphopenia (6.3%, none severe).
Forty-eight patients (20%) stopped DMF after a mean of 4.1+3 months; causes of stop were AEs (70.8%), disease activity (25%) and pregnancy planning (4.2%). AEs were more frequent in patients that stopped DMF treatment compared to those patients that continue DMF treatment (p=0.045).
Among patients completing one year of follow-up, 70.6% were relapse free. Median interval between DMF start and first relapse was 109 days (range 11-623). The overall mean ARR during treatment was reduced compared to baseline (0.59+0.6 vs 0.30+0.5, p=0.0004). But, mean ARR of patients switching to DMF from a second line therapy remained stable.
Discussion and conclusion: Despite the incidence of some AEs (such as flushing and gastrointestinal side effects) and the frequency of treatment discontinuation were mildly increased than that reported in previous studies, our observational data confirm the good tolerability and safety of DMF. Moreover, a positive clinical effect (ARR decrease) was achieved, although in a short treatment period.
Disclosure: G. Mallucci received support to travel to scientific meetings from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva.
P. Annovazzi served on the scientific advisory board for Merck Serono, Novartis, Biogen, and Genzyme, and received speaker honoraria from Biogen, Genzyme, Novartis, and Teva.
M. Matta has nothing to disclose.
V. D"Ambrosio has nothing to disclose.
M. Zaffaroni received honoraria for consultancy, participation in advisory boards or travel grants from Genzyme, Biogen Idec, Merck Serono, Sanofi Aventis, Teva, Novartis.
A. Ghezzi has served on scientific advisory boards for Merck Serono, Biogen Idec Teva Pharmaceutical Industries Ltd, has received speaker honoraria from Merck Serono, Biogen Idec, Bayer Schering Pharma and Novartis, Serono Symposia International, served as a consultant for Novartis, and receives research support from Sanofi-Aventis, Biogen Idec and Merck Serono.
A. Bertolotto served on the scientific advisory boards of Almirall, Bayer, BiogenIdec, and Genzyme; received speaker honoraria from BiogenIdec, Genzyme, Novartis, and Teva; his institution has received grant support from Bayer, BiogenIdec, Merck, Novartis, Teva, the Italian Multiple Sclerosis Society, Fondazione Ricerca Biomedica ONLUS, and San Luigi ONLUS; received speaker honoraria from BiogenIdec, Genzyme, Novartis, Sanofi-Aventis, and Teva; is on the editorial board of Multiple Sclerosis International, Progress in Neuroscience, Dataset Papers in Neuroscience, Journal of Multiple Sclerosis, Neurology and Therapy, and Multiple Sclerosis and Demyelinating Disorders; and received research support from Regione Piemonte, Italian Multiple Sclerosis Society, Associazione Ricerca Biomedica ONLUS, and San Luigi ONLUS.
C. Montomoli received teaching grants from Biogen Idec and Merck Serono.
R. Bergamaschi received research grants from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis, Teva received lecture honoraria from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; and received support to travel to scientific meetings from Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva.
Abstract: P1164
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Objectives: Aim of this study is to evaluate post-marketing Dimethyl fumarate (DMF) safety, tolerability and efficacy profile in a real world setting.
Materials and methods: We enrolled all patients receiving DMF in three northern Italy MS centres. Patients were prospectively followed, collecting demographic and clinical data as well as laboratory assessment.
Results: We included 240 patients (70.8% F; mean age: 38.6+10.5 years; mean disease duration: 10.5+0.7 years). Mean annual relapse rate (ARR) in the two years before DMF was 0.56+0.6, median baseline EDSS was 2 (range 0-6.5).
Seventy-two patients (30%) were treatment naïve or quitted disease modifying drugs (DMDs) more than 12 months before DMF start. One hundred and thirty-three patients (55%) switched to DMF from first line DMDs (84% of whom from injectables and 16% from orals) due to loss of tolerability (74%) or inefficacy (26%). Thirty-five patients (15%) switched to DMF from second line DMDs due to loss of tolerability (83%) or safety reasons (17%).
The overall mean DMF treatment follow-up was 11+5 months, 102 patients (42%) had at least 12 months of follow-up. Most frequent adverse events (AEs) were flushing/pruritus (37.1%), gastrointestinal side effects (20.8%), rush (2.9%) and fatigue (2%). Only one severe AE was reported (breast cancer). Most frequent laboratory testing abnormality was lymphopenia (6.3%, none severe).
Forty-eight patients (20%) stopped DMF after a mean of 4.1+3 months; causes of stop were AEs (70.8%), disease activity (25%) and pregnancy planning (4.2%). AEs were more frequent in patients that stopped DMF treatment compared to those patients that continue DMF treatment (p=0.045).
Among patients completing one year of follow-up, 70.6% were relapse free. Median interval between DMF start and first relapse was 109 days (range 11-623). The overall mean ARR during treatment was reduced compared to baseline (0.59+0.6 vs 0.30+0.5, p=0.0004). But, mean ARR of patients switching to DMF from a second line therapy remained stable.
Discussion and conclusion: Despite the incidence of some AEs (such as flushing and gastrointestinal side effects) and the frequency of treatment discontinuation were mildly increased than that reported in previous studies, our observational data confirm the good tolerability and safety of DMF. Moreover, a positive clinical effect (ARR decrease) was achieved, although in a short treatment period.
Disclosure: G. Mallucci received support to travel to scientific meetings from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva.
P. Annovazzi served on the scientific advisory board for Merck Serono, Novartis, Biogen, and Genzyme, and received speaker honoraria from Biogen, Genzyme, Novartis, and Teva.
M. Matta has nothing to disclose.
V. D"Ambrosio has nothing to disclose.
M. Zaffaroni received honoraria for consultancy, participation in advisory boards or travel grants from Genzyme, Biogen Idec, Merck Serono, Sanofi Aventis, Teva, Novartis.
A. Ghezzi has served on scientific advisory boards for Merck Serono, Biogen Idec Teva Pharmaceutical Industries Ltd, has received speaker honoraria from Merck Serono, Biogen Idec, Bayer Schering Pharma and Novartis, Serono Symposia International, served as a consultant for Novartis, and receives research support from Sanofi-Aventis, Biogen Idec and Merck Serono.
A. Bertolotto served on the scientific advisory boards of Almirall, Bayer, BiogenIdec, and Genzyme; received speaker honoraria from BiogenIdec, Genzyme, Novartis, and Teva; his institution has received grant support from Bayer, BiogenIdec, Merck, Novartis, Teva, the Italian Multiple Sclerosis Society, Fondazione Ricerca Biomedica ONLUS, and San Luigi ONLUS; received speaker honoraria from BiogenIdec, Genzyme, Novartis, Sanofi-Aventis, and Teva; is on the editorial board of Multiple Sclerosis International, Progress in Neuroscience, Dataset Papers in Neuroscience, Journal of Multiple Sclerosis, Neurology and Therapy, and Multiple Sclerosis and Demyelinating Disorders; and received research support from Regione Piemonte, Italian Multiple Sclerosis Society, Associazione Ricerca Biomedica ONLUS, and San Luigi ONLUS.
C. Montomoli received teaching grants from Biogen Idec and Merck Serono.
R. Bergamaschi received research grants from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis, Teva received lecture honoraria from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; and received support to travel to scientific meetings from Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva.