Contributions
Abstract: EP1520
Type: ePoster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Post-marketing case reports of Dimethyl Fumarate (DMF) suggest a link between prolonged lymphopaenia and risk of progressive multifocal leukoencephalopathy. European guidelines recommend DMF discontinuation if grade III lymphopaenia (Absolute Lymphocyte Count, ALC< 0.5x109/l) is present for 6 months. Data on the recovery of ALC following DMF discontinuation due to lymphopaenia is limited. The aim of this study was to describe ALC recovery in patients who discontinued DMF due to lymphopaenia in our centre, which has been using DMF since April 2014 and now has 594 treated patients.
Methods: A retrospective review of electronic patient records was conducted. Patients who had discontinued DMF due to lymphopaenia between December 2014 and March 2016 were included. Demographic data, treatment information and ALC before and after stopping DMF was assessed.
Results: 30 patients (5.1%) discontinued DMF due to lymphopaenia. In this cohort median age was 44.5 years (Range: 31-60), and 80% of subjects were female. Median age for the entire DMF cohort was 39.5 years, with 74% female. DMF was the first Disease-Modifying Therapy (DMT) for 47%(n=14), and was second- or third-line in 37% (n=11) and 16% (n=5) respectively. Median ALC before and at the time of stopping DMF was 1.5x109/l (range 1-3.1) and 0.6x109/l (range 0.2-0.8) respectively. DMF was given for a median of 331 days (Range 169-597). Discontinuation occurred with Grades I
(< 0.91 to ≥0.8), II (< 0.8 to ≥0.5) and III lymphopaenia in 2 (6%), 23 (78%) and 5 (16%) patients respectively.
Median follow-up after DMF discontinuation was 3 months (range 0-14). Four patients (13%), two of whom were treatment naive, had prolonged lymphopaenia (ALC< 0.91x109/l for >6 months) after discontinuing DMF despite no new DMTs being commenced. There were no clear predictive factors for prolonged lymphopaenia. 60% of patients (n=18) commenced a new DMT. Patients given fingolimod (n=8) and interferons (n=8) after DMF discontinuation had a decline in ALC associated with their new therapy.
Conclusion: 5.1% of our DMF patients discontinued DMF due to lymphopaenia. Median lymphocyte nadir in this group was 0.6 x109/l. Four patients (13%) had prolonged lymphopaenia following DMF discontinuation, despite no further treatments. The possibility of prolonged lymphopaenia (and its attendant risks) should be considered and excluded after DMF is discontinued. Lymphocyte recovery should be confirmed before new therapies are commenced.
Disclosure:
Frederik Winsløw has nothing to disclose.
Paul Gallagher has received funding for research and travel from Genzyme and travel funding for educational activities from Biogen, UCB Pharma and Teva.
Niall MacDougall has received travel funding and educational grants from Biogen, Novartis and Genzyme.
James Overell has received honoraria for speaking engagements and attendance at advisory boards from Teva, Novartis, Merck-Serono, Genzyme, Biogen and Roche. Additionally his department has received educational grants and funds to provide nursing and administrative staff from these companies.
Abstract: EP1520
Type: ePoster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Background: Post-marketing case reports of Dimethyl Fumarate (DMF) suggest a link between prolonged lymphopaenia and risk of progressive multifocal leukoencephalopathy. European guidelines recommend DMF discontinuation if grade III lymphopaenia (Absolute Lymphocyte Count, ALC< 0.5x109/l) is present for 6 months. Data on the recovery of ALC following DMF discontinuation due to lymphopaenia is limited. The aim of this study was to describe ALC recovery in patients who discontinued DMF due to lymphopaenia in our centre, which has been using DMF since April 2014 and now has 594 treated patients.
Methods: A retrospective review of electronic patient records was conducted. Patients who had discontinued DMF due to lymphopaenia between December 2014 and March 2016 were included. Demographic data, treatment information and ALC before and after stopping DMF was assessed.
Results: 30 patients (5.1%) discontinued DMF due to lymphopaenia. In this cohort median age was 44.5 years (Range: 31-60), and 80% of subjects were female. Median age for the entire DMF cohort was 39.5 years, with 74% female. DMF was the first Disease-Modifying Therapy (DMT) for 47%(n=14), and was second- or third-line in 37% (n=11) and 16% (n=5) respectively. Median ALC before and at the time of stopping DMF was 1.5x109/l (range 1-3.1) and 0.6x109/l (range 0.2-0.8) respectively. DMF was given for a median of 331 days (Range 169-597). Discontinuation occurred with Grades I
(< 0.91 to ≥0.8), II (< 0.8 to ≥0.5) and III lymphopaenia in 2 (6%), 23 (78%) and 5 (16%) patients respectively.
Median follow-up after DMF discontinuation was 3 months (range 0-14). Four patients (13%), two of whom were treatment naive, had prolonged lymphopaenia (ALC< 0.91x109/l for >6 months) after discontinuing DMF despite no new DMTs being commenced. There were no clear predictive factors for prolonged lymphopaenia. 60% of patients (n=18) commenced a new DMT. Patients given fingolimod (n=8) and interferons (n=8) after DMF discontinuation had a decline in ALC associated with their new therapy.
Conclusion: 5.1% of our DMF patients discontinued DMF due to lymphopaenia. Median lymphocyte nadir in this group was 0.6 x109/l. Four patients (13%) had prolonged lymphopaenia following DMF discontinuation, despite no further treatments. The possibility of prolonged lymphopaenia (and its attendant risks) should be considered and excluded after DMF is discontinued. Lymphocyte recovery should be confirmed before new therapies are commenced.
Disclosure:
Frederik Winsløw has nothing to disclose.
Paul Gallagher has received funding for research and travel from Genzyme and travel funding for educational activities from Biogen, UCB Pharma and Teva.
Niall MacDougall has received travel funding and educational grants from Biogen, Novartis and Genzyme.
James Overell has received honoraria for speaking engagements and attendance at advisory boards from Teva, Novartis, Merck-Serono, Genzyme, Biogen and Roche. Additionally his department has received educational grants and funds to provide nursing and administrative staff from these companies.