Contributions
Abstract: EP1669
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Dimethyl fumarate (DMF) is an oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) and available in Portugal since April 2015, based on two phase III clinical trials demonstrating its efficacy.
Objectives: The aim of this study is to evaluate post-marketing DMF safety and effectiveness in a real-world clinical population.
Methods: Observational study of patients with RRMS treated with DMF in our centre with at least 6 months of follow-up. Demographic and clinical characteristics, including Annual Relapse Rates (ARR), Expanded Disability Status Score (EDSS), previous treatments, change in Magnetic Resonance Imaging (MRI) lesion load, adverse effects (AE), treatment duration and reason for discontinuation were examined.
Results: Eighty-four patients were included, 57 (67.9%) females. Mean age and mean disease duration were 41.5±11.9 years and 8.9±7.2 years, respectively. Mean baseline EDSS was 1.7±1.7. Seventy (84.5%) patients received prior first-line disease modifying therapies (DMT), 2 (2.4%) patients received prior second-line DMT and 12 (14.3%) were treatment naïve. Mean follow-up was 15.1±7.8 months; 48 (57.1%) patients with at least 12 months of DMF treatment. Most frequent AE were flushing (n=45, 53.5%) and gastrointestinal symptoms (n=47, 55.9%). Lymphopenia was present in 22 (26.2%) patients (11 grade I, 6 grade II and 5 grade III). Eleven (13.1%) patients experienced infections. Ten (11.9%) patients discontinued therapy due to AE (n=7), disease activity (n=2) and own initiative (n=1).
In total, 74 (88.1%) patients were relapse free at the end of follow-up. Mean interval between DMF start and first relapse was 2.2±1.4 months.
Considering the population with at least one year of follow-up (n=48), there was a 62.1% decrease in the ARR (0.58±0.94 vs 0.22±0.55, p=0.002), but no effect was observed regarding mean EDSS (1.92±1.76 vs 1.96±1.91, p=0.667). Among these patients, 27 (56.3%) performed a control MRI, 18 (66.7%) achieved No Evidence Disease Activity (NEDA), 9 (33.3%) had new MRI T2 lesions and 3 (11.2%) had new MRI T1-gadolinium-enhancing lesions.
Conclusions: Despite the incidence of some AEs (such as flushing and gastrointestinal side effects) was mildly increased than that reported in clinical trials, our observational data confirm the good tolerability and safety of DMF. This audit of DMF showed it significantly reduced relapse rates in this RRMS population.
Disclosure:
Ariana Barros: nothing to disclose;
João Sequeira: nothing to disclose;
Ary Sousa: nothing to disclose;
Carlos Capela: nothing to disclose;
Rui Pedrosa: nothing to disclose.
Abstract: EP1669
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Dimethyl fumarate (DMF) is an oral immunomodulator approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) and available in Portugal since April 2015, based on two phase III clinical trials demonstrating its efficacy.
Objectives: The aim of this study is to evaluate post-marketing DMF safety and effectiveness in a real-world clinical population.
Methods: Observational study of patients with RRMS treated with DMF in our centre with at least 6 months of follow-up. Demographic and clinical characteristics, including Annual Relapse Rates (ARR), Expanded Disability Status Score (EDSS), previous treatments, change in Magnetic Resonance Imaging (MRI) lesion load, adverse effects (AE), treatment duration and reason for discontinuation were examined.
Results: Eighty-four patients were included, 57 (67.9%) females. Mean age and mean disease duration were 41.5±11.9 years and 8.9±7.2 years, respectively. Mean baseline EDSS was 1.7±1.7. Seventy (84.5%) patients received prior first-line disease modifying therapies (DMT), 2 (2.4%) patients received prior second-line DMT and 12 (14.3%) were treatment naïve. Mean follow-up was 15.1±7.8 months; 48 (57.1%) patients with at least 12 months of DMF treatment. Most frequent AE were flushing (n=45, 53.5%) and gastrointestinal symptoms (n=47, 55.9%). Lymphopenia was present in 22 (26.2%) patients (11 grade I, 6 grade II and 5 grade III). Eleven (13.1%) patients experienced infections. Ten (11.9%) patients discontinued therapy due to AE (n=7), disease activity (n=2) and own initiative (n=1).
In total, 74 (88.1%) patients were relapse free at the end of follow-up. Mean interval between DMF start and first relapse was 2.2±1.4 months.
Considering the population with at least one year of follow-up (n=48), there was a 62.1% decrease in the ARR (0.58±0.94 vs 0.22±0.55, p=0.002), but no effect was observed regarding mean EDSS (1.92±1.76 vs 1.96±1.91, p=0.667). Among these patients, 27 (56.3%) performed a control MRI, 18 (66.7%) achieved No Evidence Disease Activity (NEDA), 9 (33.3%) had new MRI T2 lesions and 3 (11.2%) had new MRI T1-gadolinium-enhancing lesions.
Conclusions: Despite the incidence of some AEs (such as flushing and gastrointestinal side effects) was mildly increased than that reported in clinical trials, our observational data confirm the good tolerability and safety of DMF. This audit of DMF showed it significantly reduced relapse rates in this RRMS population.
Disclosure:
Ariana Barros: nothing to disclose;
João Sequeira: nothing to disclose;
Ary Sousa: nothing to disclose;
Carlos Capela: nothing to disclose;
Rui Pedrosa: nothing to disclose.