Contributions
Abstract: P576
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Dimethyl fumarate (DMF) is a licensed oral disease modifying therapy (DMT) approved by the National Institute for Health and Care Excellence (NICE) for relapsing multiple sclerosis (RMS), with a favourable efficacy and safety profile established in phase III clinical trials.
Objectives: To evaluate real-world data and prevalence of lymphopenia in people with multiple sclerosis (pwMS) treated with DMF in a specialist London multiple sclerosis centre.
Methods: Retrospective analysis of 280 pwRMS treated with DMF at the Royal London Hospital with a minimum of three month follow-up data. Demographic, laboratory and clinical information, regarding MS history and follow-up, was extracted from the BartsMS database and patient's medical records.
Results: 280 pwMS were included (67% female; mean age: 39.8+10.2 years). Mean disease duration was 8.9+6.2 years. 55% pwMS were treatment naïve. 42% and 3% switched from first and second line DMTs respectively. The mean duration of DMF exposure was 21.5±11.5 months. The discontinuation rate was 36%. 38 pwMS (14%) discontinued due to adverse events. Most frequent adverse events were lymphopenia (n = 18), mild gastrointestinal side-effects and flushing (n = 8), proteinuria (n = 2) and alopecia (n = 2). 31 pwMS (11%) discontinued due to disease activity and 30 (11%) due to patient's own wish. In 192 pwMS (69%), absolute lymphocyte counts (ALC) were within normal limits at all post-baseline visits (CTCAE/ Common Terminology Criteria for Adverse Events grade 0). 88 pwMS (31%) experienced lymphopenia, which was sustained for ≥3 months in 47 pwMS (53%). Mean duration of lymphopenia was 281.4±185.2 days. The incidence of grade I and II post-baseline CTCAE grade I and II lymphopenia was 41 (15%) and 40 (14%) respectively. 7 pwMS (2.5%) had CTCAE grade 3 lymphopenia. CTCAE grade 4 lymphopenia was not experienced by any pwMS. Persistent (>3months) lymphopenia (post-cessation of DMF) was experienced by 15 pwMS (5%). ALCs recovered over time following discontinuation of DMF. Mean baseline EDSS was 2.3±1.5 (range = 0 - 6.5 in 118 pwMS). At one year of follow-up, 86% of pwMS were relapse free and 9 pwMS (3%) had MRI activity. No new safety signals were identified.
Conclusions: Our real world observational data confirms the low discontinuation rate due to adverse events from the pivotal clinical trials, however lymphopenia was more frequent than in these original studies.
Disclosure: Kimberley Allen-Philbey: nothing to disclose. Qao Minn Lee: nothing to disclose.
Michaela Francis: nothing to disclose. Gavin Giovannoni has received research support from Takeda and compensation for participating on Advisory Boards from Abbvie, Almirall, Atara Bio, Biogen, Sanofi-Genzyme, Genentech, GSK, Merck, Novartis, Roche and Teva.
Klaus Schmierer has been a PI of trials sponsored by Medday, Roche and Teva and involved in trials sponsored by Biogen, Sanofi-Genzyme, Novartis and Canbex.
Ben Turner has received travel bursaries, grants and advisory boards fees from Biogen, Roche, Sanofi-Aventis, Novartis and Merck.
Abstract: P576
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Dimethyl fumarate (DMF) is a licensed oral disease modifying therapy (DMT) approved by the National Institute for Health and Care Excellence (NICE) for relapsing multiple sclerosis (RMS), with a favourable efficacy and safety profile established in phase III clinical trials.
Objectives: To evaluate real-world data and prevalence of lymphopenia in people with multiple sclerosis (pwMS) treated with DMF in a specialist London multiple sclerosis centre.
Methods: Retrospective analysis of 280 pwRMS treated with DMF at the Royal London Hospital with a minimum of three month follow-up data. Demographic, laboratory and clinical information, regarding MS history and follow-up, was extracted from the BartsMS database and patient's medical records.
Results: 280 pwMS were included (67% female; mean age: 39.8+10.2 years). Mean disease duration was 8.9+6.2 years. 55% pwMS were treatment naïve. 42% and 3% switched from first and second line DMTs respectively. The mean duration of DMF exposure was 21.5±11.5 months. The discontinuation rate was 36%. 38 pwMS (14%) discontinued due to adverse events. Most frequent adverse events were lymphopenia (n = 18), mild gastrointestinal side-effects and flushing (n = 8), proteinuria (n = 2) and alopecia (n = 2). 31 pwMS (11%) discontinued due to disease activity and 30 (11%) due to patient's own wish. In 192 pwMS (69%), absolute lymphocyte counts (ALC) were within normal limits at all post-baseline visits (CTCAE/ Common Terminology Criteria for Adverse Events grade 0). 88 pwMS (31%) experienced lymphopenia, which was sustained for ≥3 months in 47 pwMS (53%). Mean duration of lymphopenia was 281.4±185.2 days. The incidence of grade I and II post-baseline CTCAE grade I and II lymphopenia was 41 (15%) and 40 (14%) respectively. 7 pwMS (2.5%) had CTCAE grade 3 lymphopenia. CTCAE grade 4 lymphopenia was not experienced by any pwMS. Persistent (>3months) lymphopenia (post-cessation of DMF) was experienced by 15 pwMS (5%). ALCs recovered over time following discontinuation of DMF. Mean baseline EDSS was 2.3±1.5 (range = 0 - 6.5 in 118 pwMS). At one year of follow-up, 86% of pwMS were relapse free and 9 pwMS (3%) had MRI activity. No new safety signals were identified.
Conclusions: Our real world observational data confirms the low discontinuation rate due to adverse events from the pivotal clinical trials, however lymphopenia was more frequent than in these original studies.
Disclosure: Kimberley Allen-Philbey: nothing to disclose. Qao Minn Lee: nothing to disclose.
Michaela Francis: nothing to disclose. Gavin Giovannoni has received research support from Takeda and compensation for participating on Advisory Boards from Abbvie, Almirall, Atara Bio, Biogen, Sanofi-Genzyme, Genentech, GSK, Merck, Novartis, Roche and Teva.
Klaus Schmierer has been a PI of trials sponsored by Medday, Roche and Teva and involved in trials sponsored by Biogen, Sanofi-Genzyme, Novartis and Canbex.
Ben Turner has received travel bursaries, grants and advisory boards fees from Biogen, Roche, Sanofi-Aventis, Novartis and Merck.