Contributions
Abstract: P1178
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Key words: Multiple Sclerosis, Dimethyl Fumarate, annual relapse rates, lesion load, lymphopenia.
Background: Dimethyl Fumarate (DMF), is licensed as a first line oral therapy for relapsing-remitting Multiple Sclerosis (RRMS). Real life studies confirming the favourable safety and tolerability profiles from the phase three trials are required.
Objectives: To determine the efficacy and tolerability of DMF as a therapy for RRMS in a university MS clinic population.
Methods: A retrospective audit of people with RRMS receiving at least one dose of DMF, either as initial disease modifying therapy (DMT) or after a previous first line DMT, over an 18 month period was performed. Medical records were reviewed and data on annual relapse rates (ARR), change in MRI lesion load, side effects, with particular reference to lymphocyte counts, and discontinuation rates were collected in addition to demographics, treatment history etc.
Results: Ninety-two patients were identified who met the criteria for inclusion, 75 female; mean age (SD) 39 (±10); mean EDSS (SD) 1.5 (±1.0); average time since diagnosis: 6 years (±6 years). 39 patients were treatment naïve prior to DMF, 53 had at least one prior DMT. 20 of 92 (22%) patients discontinued DMF after a mean duration of 5±6 months due to GI symptoms (n=8), sustained lymphopenia (n=4), unspecified tolerability issues (n=4), flushing (n=3), allergic reaction (n=1). Two additional patients stopped for planned pregnancy. Of 78 patients who completed one year of therapy, ARR decreased by 95% 12 months post commencing DMF. Total number of relapses 12 months (12M) pre-DMF: 21 (ARR= 0.27); Total number of relapses 12M post-DMF: 1 (ARR = 0.01, ** P< 0.01). The most commonly reported side effects were: flushing (n=42), GI symptoms (n=37), grade 2 lymphopenia (n=13), grade 3 lymphopenia (n=4) and headaches (n=5). At month 6 (M6) n=57, Total White Cell Count decreased by 20% (6.0±0.2 10^9/L) compared to baseline n=83 (7.5±0.8 10^9/L n=83). At M6 n=57, Lymphocyte decreased by 30% (1.43±0.1 10^9/L) compared to baseline n=83 (2.03±0.1 10^9/L).
Conclusions: This real world audit of DMF showed it significantly reduced relapse rates in treatment naïve and previously treated people with RRMS. The discontinuation rate was 22% which is consistent with the previously reported phrase 3 trial. No unexpected side effects were seen.
Disclosure: Stephen Cox: Nothing to disclose
Sinead Jordan: Nothing to disclose
Deepti Sharma: Nothing to disclose
Gillian O´Boyle: Nothing to disclose
Niall Tubridy: Nothing to disclose
Michael Hutchinson: Nothing to disclose
Christopher McGuigan: Nothing to disclose
Abstract: P1178
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Key words: Multiple Sclerosis, Dimethyl Fumarate, annual relapse rates, lesion load, lymphopenia.
Background: Dimethyl Fumarate (DMF), is licensed as a first line oral therapy for relapsing-remitting Multiple Sclerosis (RRMS). Real life studies confirming the favourable safety and tolerability profiles from the phase three trials are required.
Objectives: To determine the efficacy and tolerability of DMF as a therapy for RRMS in a university MS clinic population.
Methods: A retrospective audit of people with RRMS receiving at least one dose of DMF, either as initial disease modifying therapy (DMT) or after a previous first line DMT, over an 18 month period was performed. Medical records were reviewed and data on annual relapse rates (ARR), change in MRI lesion load, side effects, with particular reference to lymphocyte counts, and discontinuation rates were collected in addition to demographics, treatment history etc.
Results: Ninety-two patients were identified who met the criteria for inclusion, 75 female; mean age (SD) 39 (±10); mean EDSS (SD) 1.5 (±1.0); average time since diagnosis: 6 years (±6 years). 39 patients were treatment naïve prior to DMF, 53 had at least one prior DMT. 20 of 92 (22%) patients discontinued DMF after a mean duration of 5±6 months due to GI symptoms (n=8), sustained lymphopenia (n=4), unspecified tolerability issues (n=4), flushing (n=3), allergic reaction (n=1). Two additional patients stopped for planned pregnancy. Of 78 patients who completed one year of therapy, ARR decreased by 95% 12 months post commencing DMF. Total number of relapses 12 months (12M) pre-DMF: 21 (ARR= 0.27); Total number of relapses 12M post-DMF: 1 (ARR = 0.01, ** P< 0.01). The most commonly reported side effects were: flushing (n=42), GI symptoms (n=37), grade 2 lymphopenia (n=13), grade 3 lymphopenia (n=4) and headaches (n=5). At month 6 (M6) n=57, Total White Cell Count decreased by 20% (6.0±0.2 10^9/L) compared to baseline n=83 (7.5±0.8 10^9/L n=83). At M6 n=57, Lymphocyte decreased by 30% (1.43±0.1 10^9/L) compared to baseline n=83 (2.03±0.1 10^9/L).
Conclusions: This real world audit of DMF showed it significantly reduced relapse rates in treatment naïve and previously treated people with RRMS. The discontinuation rate was 22% which is consistent with the previously reported phrase 3 trial. No unexpected side effects were seen.
Disclosure: Stephen Cox: Nothing to disclose
Sinead Jordan: Nothing to disclose
Deepti Sharma: Nothing to disclose
Gillian O´Boyle: Nothing to disclose
Niall Tubridy: Nothing to disclose
Michael Hutchinson: Nothing to disclose
Christopher McGuigan: Nothing to disclose