Contributions
Abstract: P641
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Dimethyl fumarate (DMF) efficacy in relapsing multiple sclerosis (RMS) has been demonstrated in 2 randomized clinical trials (RCT), these outcomes could be influenced in clinical practice by factors controlled in RCT, such as comorbidities and disease duration. Post-marketing studies are needed to assess its effectiveness in a real clinical practice.
Objective: The aim of this observational, prospective, multicenter and post-marketing study was to evaluate DMF effectiveness in a real-world clinical setting.
Methods: RMS patients on DMF treatment and at least one year of follow-up were included. Three subgroups were considered: naïve, switching to DMF for suboptimal response (SR) and for adverse effects (EA). The main efficacy endpoints were annualized relapses rate (ARR) and number of gadolinium-enhancing lesions (T1gd). Secondary objectives included: proportion of patients without relapses, disability progression and new T2 lesions. Negative binomial regression was used for evaluating effect on relapses and T1gd lesions.
Results: A total 456 patients (70.6% women, aged 39.6±9.7, baseline EDSS 2.06±1.07, duration disease 8.9±7.5) completed 1 and 233 two years of follow-up. Twenty four percent belong to naïve, 46.7% to SR and 29,2% to EA subgroups. Comparing to prior year, at 12 months after DMF treatment, ARR was significant lower in total population (76.3%, 0.69 to 0.16 -95%CI:0.12-0.21-p=.000), SR (75%) and naïve (92%,1.06 to 0.09-95%CI:0.04-0.18-p=.000). T1gad lesions number was significantly reduced a 79% in total population and 92% in naïve. These rates were maintained at 24 months. Eighty-five percent and 89% of patients were free-relapses by 12 and 24 months on DMF, respectively. The 86% and 77.6% were free of disability progression, 80% and 86% of new T2 lesions, after 12 and 24 months on treatment.
Conclusions: Our results suggest that DMF may be an effective treatment option over the first two year in both RMS, naïve and those switching from other MS treatment.
Disclosure: The investigators do not have any conflict of interests to disclose
Abstract: P641
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Dimethyl fumarate (DMF) efficacy in relapsing multiple sclerosis (RMS) has been demonstrated in 2 randomized clinical trials (RCT), these outcomes could be influenced in clinical practice by factors controlled in RCT, such as comorbidities and disease duration. Post-marketing studies are needed to assess its effectiveness in a real clinical practice.
Objective: The aim of this observational, prospective, multicenter and post-marketing study was to evaluate DMF effectiveness in a real-world clinical setting.
Methods: RMS patients on DMF treatment and at least one year of follow-up were included. Three subgroups were considered: naïve, switching to DMF for suboptimal response (SR) and for adverse effects (EA). The main efficacy endpoints were annualized relapses rate (ARR) and number of gadolinium-enhancing lesions (T1gd). Secondary objectives included: proportion of patients without relapses, disability progression and new T2 lesions. Negative binomial regression was used for evaluating effect on relapses and T1gd lesions.
Results: A total 456 patients (70.6% women, aged 39.6±9.7, baseline EDSS 2.06±1.07, duration disease 8.9±7.5) completed 1 and 233 two years of follow-up. Twenty four percent belong to naïve, 46.7% to SR and 29,2% to EA subgroups. Comparing to prior year, at 12 months after DMF treatment, ARR was significant lower in total population (76.3%, 0.69 to 0.16 -95%CI:0.12-0.21-p=.000), SR (75%) and naïve (92%,1.06 to 0.09-95%CI:0.04-0.18-p=.000). T1gad lesions number was significantly reduced a 79% in total population and 92% in naïve. These rates were maintained at 24 months. Eighty-five percent and 89% of patients were free-relapses by 12 and 24 months on DMF, respectively. The 86% and 77.6% were free of disability progression, 80% and 86% of new T2 lesions, after 12 and 24 months on treatment.
Conclusions: Our results suggest that DMF may be an effective treatment option over the first two year in both RMS, naïve and those switching from other MS treatment.
Disclosure: The investigators do not have any conflict of interests to disclose