Contributions
Abstract: EP1653
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Delayed-release dimethyl fumarate (DMF) has demonstrated a favorable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS). As of January 31, 2018, >311,000 patients have chosen DMF treatment, representing >544,000 patient-years of exposure. Of these, ~6252 patients (~12,631 patient-years) were from clinical trials. There are no any published data on patient outcomes evaluation on DMF treatment in Russia.
Objective: To evaluate patients' outcomes in patients receiving DMF treatment ≥ 12 months in Russia.
Methods: Data from 96 RRMS patients treated with DMF in Moscow MS center was included in this retrospective analysis. Data starting from the first exposure to DMF are included in the analysis. The data cutoff date was April 09, 2018. The mean patient age - 37 years. 66 (69%) patients - female. Mean time since MS diagnosis - 10 years. Mean EDSS score before DMF treatment was 2.6. 94 (98%) patients were pretreated with the disease modifying therapies: 14 (14,5%) with high dose interferons beta (HDIFNβ), 2 (2%) - low dose interferons beta(LDIFNβ); 35 (36.5%) - glatiramer acetate (GA); 2(2%) - laquinimode, 41(43%) had more than one DMT previously, 2 (2%) - treatment naive. 22 of pretreated patients had 1 relapse in previous 12 months, 18 have active lesions in previous 12 months. 40 (42%) pretreated patients switched to DMF due to lack of efficacy: 11 (12%) from HDIFNβ, 2(2%) from LDIFNβ, 27(28%) from GA. 56 (58%) pretreated patients were switched to DMF due to previous treatment intolerance.
Results: 62 patients received DMF treatment ≥12 months: 54 (87%) have no relapses on DMF treatment; 60 (97%) - without disability progression, 52 (84%) have no active lesions on MRI. 85 patients, received DMF treatment ≥6 months: 12(14%) had gastrointestinal (GI) adverse events (AE), 54 (64%) had “flashing”, 47 (55%) had lymphopenia, 6 (7%) had severe lymphopenia with absolute lymphocyte count (ALC)< 0.5x109/L. Treatment discontinuation of 96 patients due to GI AE was in 4(4.2%), due to “flashing” in 4(4.2%), due to severe lymphopenia in 3 (3.2%), due to lack of efficacy in 2 (2.0%) patients.
Conclusions: Most of patients on DMF treatment were stable without disease activity. DMF treatment was generally good tolerated. AE spectrum was typical for DMF, treatment discontinuation rate due to AE was lower than in phase III studies.
Disclosure: Nothing to disclose
Abstract: EP1653
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Delayed-release dimethyl fumarate (DMF) has demonstrated a favorable benefit-risk profile in patients with relapsing-remitting multiple sclerosis (RRMS). As of January 31, 2018, >311,000 patients have chosen DMF treatment, representing >544,000 patient-years of exposure. Of these, ~6252 patients (~12,631 patient-years) were from clinical trials. There are no any published data on patient outcomes evaluation on DMF treatment in Russia.
Objective: To evaluate patients' outcomes in patients receiving DMF treatment ≥ 12 months in Russia.
Methods: Data from 96 RRMS patients treated with DMF in Moscow MS center was included in this retrospective analysis. Data starting from the first exposure to DMF are included in the analysis. The data cutoff date was April 09, 2018. The mean patient age - 37 years. 66 (69%) patients - female. Mean time since MS diagnosis - 10 years. Mean EDSS score before DMF treatment was 2.6. 94 (98%) patients were pretreated with the disease modifying therapies: 14 (14,5%) with high dose interferons beta (HDIFNβ), 2 (2%) - low dose interferons beta(LDIFNβ); 35 (36.5%) - glatiramer acetate (GA); 2(2%) - laquinimode, 41(43%) had more than one DMT previously, 2 (2%) - treatment naive. 22 of pretreated patients had 1 relapse in previous 12 months, 18 have active lesions in previous 12 months. 40 (42%) pretreated patients switched to DMF due to lack of efficacy: 11 (12%) from HDIFNβ, 2(2%) from LDIFNβ, 27(28%) from GA. 56 (58%) pretreated patients were switched to DMF due to previous treatment intolerance.
Results: 62 patients received DMF treatment ≥12 months: 54 (87%) have no relapses on DMF treatment; 60 (97%) - without disability progression, 52 (84%) have no active lesions on MRI. 85 patients, received DMF treatment ≥6 months: 12(14%) had gastrointestinal (GI) adverse events (AE), 54 (64%) had “flashing”, 47 (55%) had lymphopenia, 6 (7%) had severe lymphopenia with absolute lymphocyte count (ALC)< 0.5x109/L. Treatment discontinuation of 96 patients due to GI AE was in 4(4.2%), due to “flashing” in 4(4.2%), due to severe lymphopenia in 3 (3.2%), due to lack of efficacy in 2 (2.0%) patients.
Conclusions: Most of patients on DMF treatment were stable without disease activity. DMF treatment was generally good tolerated. AE spectrum was typical for DMF, treatment discontinuation rate due to AE was lower than in phase III studies.
Disclosure: Nothing to disclose