Contributions
Abstract: P961
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Dimethyl fumarate (DMF) tolerability and safety in relapsing multiple sclerosis (RMS) has been analyzed in randomized clinical trials (RCT), these outcomes could be influenced in clinical practice by factors controlled in RCT, such as comorbidities. Post-marketing studies are needed to assess tolerability and safety in a real clinical practice.
Objective: The aim of this observational, prospective, multicenter and post-marketing study was to evaluate DMF tolerability and safety in a real-world clinical setting.
Methods: RMS patients on DMF treatment and at least one year of follow-up were included. A specific database was elaborated to register type, severity, duration and treatment required for adverse events (EA). Clinical AEs (flushing and gastrointestinal events), analytical abnormalities (lymphopenia, hypertransaminemia and proteinuria), infections and neoplasia are collected. Other EAs referred by researchers and their potential relationship to DMF are also considered. The dropout rate has been analyzed.
Results: A total 456 RMS patients were included (70.6% women, aged 39.6±9.7, baseline EDSS 2±1,6, duration disease 8.9±7.5). Time on DMF treatment was 2.15±1.01 years. Gastrointestinal-related events were reported by 42,8% of patients (195), 30% required pharmacological treatment, and were cause of drug discontinuation in 9.2%. Flushing was reported by 53,5% of patients (244), 18,4% needed therapy with acetylsalicylic acid, was persistent in 42,6% and cause of withdrawal in 3,7%. Lymphopenia < 1000/mm3 was present in 27% of the patients (123 cases), grade 3 in 4.8%. Neither hypertransaminemia (≥ 3 LSN, 1 patient) nor proteinuria (1.75%) were cause for drug withdrawal. DMF was discontinued in 104 patients (22,9%), AEs explained the 52.9% of the dropouts and suboptimal response the 36,5%. Two patients were diagnosed of breast cancer and one of pneumonia.
Conclusions: AEs were the main cause of DMF discontinuation. The safety and tolerability profile of DMF was similar to RCT except for higher frequency and persistence of flushing.
Disclosure: The investigators do not have any conflict of interests to disclose
Abstract: P961
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Dimethyl fumarate (DMF) tolerability and safety in relapsing multiple sclerosis (RMS) has been analyzed in randomized clinical trials (RCT), these outcomes could be influenced in clinical practice by factors controlled in RCT, such as comorbidities. Post-marketing studies are needed to assess tolerability and safety in a real clinical practice.
Objective: The aim of this observational, prospective, multicenter and post-marketing study was to evaluate DMF tolerability and safety in a real-world clinical setting.
Methods: RMS patients on DMF treatment and at least one year of follow-up were included. A specific database was elaborated to register type, severity, duration and treatment required for adverse events (EA). Clinical AEs (flushing and gastrointestinal events), analytical abnormalities (lymphopenia, hypertransaminemia and proteinuria), infections and neoplasia are collected. Other EAs referred by researchers and their potential relationship to DMF are also considered. The dropout rate has been analyzed.
Results: A total 456 RMS patients were included (70.6% women, aged 39.6±9.7, baseline EDSS 2±1,6, duration disease 8.9±7.5). Time on DMF treatment was 2.15±1.01 years. Gastrointestinal-related events were reported by 42,8% of patients (195), 30% required pharmacological treatment, and were cause of drug discontinuation in 9.2%. Flushing was reported by 53,5% of patients (244), 18,4% needed therapy with acetylsalicylic acid, was persistent in 42,6% and cause of withdrawal in 3,7%. Lymphopenia < 1000/mm3 was present in 27% of the patients (123 cases), grade 3 in 4.8%. Neither hypertransaminemia (≥ 3 LSN, 1 patient) nor proteinuria (1.75%) were cause for drug withdrawal. DMF was discontinued in 104 patients (22,9%), AEs explained the 52.9% of the dropouts and suboptimal response the 36,5%. Two patients were diagnosed of breast cancer and one of pneumonia.
Conclusions: AEs were the main cause of DMF discontinuation. The safety and tolerability profile of DMF was similar to RCT except for higher frequency and persistence of flushing.
Disclosure: The investigators do not have any conflict of interests to disclose