Contributions
Abstract: P1147
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl Fumurate (DMF) has been recently approved as a disease modifying therapy for the treatment of Multiple Sclerosis (MS). Post-marketing studies are important to confirm the findings of pivotal clinical trials.
Objective: To evaluate the effectiveness and safety of DMF in a cohort of relapsing MS patients in a clinical practice setting.
Methods: Using the national MS registry, we retrospectively identified patients who had been prescribed DMF. Data of relapsing MS patients with EDSS ≤ 6 and at least 6 months follow-up were analyzed. Patients with progressive MS were excluded. Primary outcome measure was the proportion of relapse-free patients at last follow-up. Secondary outcome measures included the mean change in the expanded disability status scale (EDSS) scores at last follow-up and the proportion of patients with MRI activity (new T2/flair or gadolinium-enhancing lesions) at 6 months.
Results: Of 134 patients identified, 119 patients were eligible and included in the analysis. Women represented 59.7% of the studied cohort. Mean age and mean disease duration were 33.5 ±11.1 years and 8.3 ±7 years respectively. 75.6% of the patients received prior disease modifying therapies. Mean duration of DMF exposure was 12.4 ±5.5 months. The proportion of relapse-free patients increased significantly from 51.2% to 91.6% (p < 0.0001) while the mean EDSS score decreased from 2.8±1.8 at baseline to 2.1±1.6 at last follow up visit. Among patients (n=90) who had MRI follow-up after 6 months, 14.4% of patients had MRI activity compared to 61.1% at baseline (p < 0.0001). Although no serious adverse events were reported, 13.4% (n=16) of patients discontinued DMF. The most common adverse events leading to discontinuation were gastrointestinal upset (n=6), persistent lymphopenia (n=2), and tolerability (n=2).
Conclusion: In clinical practice, DMF appeared to be effective in reducing disease activity and progression of disability throughout the observational period. DMF was well tolerated with no serious adverse events. Our results are in parallel with what was seen in clinical trials.
Disclosure: The study was not funded. Dr. Alroughani received honoraria as a speaker and for serving on scientific advisory board from Biogen, Bayer, Genzyme, Novartis, Merck-Serono, GSK. Drs. Ahmed, Behbahani and Al-Hashel have nothing to disclose
Abstract: P1147
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Dimethyl Fumurate (DMF) has been recently approved as a disease modifying therapy for the treatment of Multiple Sclerosis (MS). Post-marketing studies are important to confirm the findings of pivotal clinical trials.
Objective: To evaluate the effectiveness and safety of DMF in a cohort of relapsing MS patients in a clinical practice setting.
Methods: Using the national MS registry, we retrospectively identified patients who had been prescribed DMF. Data of relapsing MS patients with EDSS ≤ 6 and at least 6 months follow-up were analyzed. Patients with progressive MS were excluded. Primary outcome measure was the proportion of relapse-free patients at last follow-up. Secondary outcome measures included the mean change in the expanded disability status scale (EDSS) scores at last follow-up and the proportion of patients with MRI activity (new T2/flair or gadolinium-enhancing lesions) at 6 months.
Results: Of 134 patients identified, 119 patients were eligible and included in the analysis. Women represented 59.7% of the studied cohort. Mean age and mean disease duration were 33.5 ±11.1 years and 8.3 ±7 years respectively. 75.6% of the patients received prior disease modifying therapies. Mean duration of DMF exposure was 12.4 ±5.5 months. The proportion of relapse-free patients increased significantly from 51.2% to 91.6% (p < 0.0001) while the mean EDSS score decreased from 2.8±1.8 at baseline to 2.1±1.6 at last follow up visit. Among patients (n=90) who had MRI follow-up after 6 months, 14.4% of patients had MRI activity compared to 61.1% at baseline (p < 0.0001). Although no serious adverse events were reported, 13.4% (n=16) of patients discontinued DMF. The most common adverse events leading to discontinuation were gastrointestinal upset (n=6), persistent lymphopenia (n=2), and tolerability (n=2).
Conclusion: In clinical practice, DMF appeared to be effective in reducing disease activity and progression of disability throughout the observational period. DMF was well tolerated with no serious adverse events. Our results are in parallel with what was seen in clinical trials.
Disclosure: The study was not funded. Dr. Alroughani received honoraria as a speaker and for serving on scientific advisory board from Biogen, Bayer, Genzyme, Novartis, Merck-Serono, GSK. Drs. Ahmed, Behbahani and Al-Hashel have nothing to disclose