Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis
<p><strong>Objective:</strong> Dimethyl fumarate is a medication approved for the treatment of relapsing-remitting multiple sclerosis. The purpose of the study was to evaluate the safety and persistence of dimethyl fumarate in clinical practice and analyze the occurrence of ly...
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Elsevier
2021-03-01
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| Series: | Farmacia Hospitalaria |
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| Online Access: | http://www.aulamedica.es/fh/pdf/11567.pdf |
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| author | Silvia Boullosa-Lale Lara González-Freire Luciano Martínez-Martínez Carlos Crespo-Diz |
| author_facet | Silvia Boullosa-Lale Lara González-Freire Luciano Martínez-Martínez Carlos Crespo-Diz |
| author_sort | Silvia Boullosa-Lale |
| collection | DOAJ |
| description | <p><strong>Objective:</strong> Dimethyl fumarate is a medication approved for the treatment of relapsing-remitting multiple sclerosis. The purpose of the study was
to evaluate the safety and persistence of dimethyl fumarate in clinical practice and analyze the occurrence of lymphopenia is patients treated with dimethyl fumarate over
a period of at least 6 months.</p><p><strong>Method:</strong> This is a retrospective longitudinal observational study carried out between August 2015 and March
2019. The study cohort was made up of patients who had been treated with dimethyl fumarate for at least 6 months. Lymphocyte counts were recorded at different points
of time (pre-treatment, at 3, 6, 12 months, and at the end of the study period). The evolution of lymphopenia was evaluated by means of a logistic regression statistical
model. An analysis was performed of the relationship between a decreased lymphocyte count over the first 6 months of treatment and the development, by the end of the
study, of grade II-III lymphopenia necessitating discontinuation of dimethyl fumarate. Other safety indicators were also evaluated including adverse events and
interruptions or discontinuations of treatment. Persistence was determined by measuring the time to discontinuation of treatment.</p><p><strong>Results:</strong>
The study included a total of 55 patients, of whom 80% were female. The most common adverse events were lymphopenia (27), rubefaction (16), digestive symptoms
(11), fatigue (9), headache (3) and sleep disturbances (2). Eleven subjects interrupted/discontinued their treatment during the study period; reasons were as follows:
pregnancy (2), personal decision (2), John Cunningham virus infection (1), allergy to the drug (2), and lymphopenia (4). Median duration of treatment was 23 months
(4-43 months). A statistically significant association was found between a lower lymphocyte count over the first 6 months of treatment and the development of severe
lymphopenia by the end of the study [OR = 1.34 (0.35-2.60); 95% CI (p = 0.001)].</p><p><strong>Conclusions:</strong> The adverse events observed in the present
study are in line with those reported in previous analyses. Lymphopenia was the most common adverse event. The persistence of the medication was similar to that
found in pivotal trials. The significant association found between a decreased lymphocyte count over the first 6 months of treatment and the development of severe
lymphopenia by the end of the study suggests a connection between both variables, which could be instrumental in being able to predict and even prevent the
occurrence of such lymphopenias.</p><p> </p> |
| format | Article |
| id | doaj-art-9e0e047fa75d4d858d636b1d93616f26 |
| institution | Kabale University |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2021-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-9e0e047fa75d4d858d636b1d93616f262025-01-02T16:24:36ZengElsevierFarmacia Hospitalaria1130-63432171-86952021-03-01452737610.7399/fh.11567Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosisSilvia Boullosa-Lale0Lara González-Freire1Luciano Martínez-Martínez2Carlos Crespo-Diz3Complejo Hospitalario Universitario de Pontevedra, Pontevedra. Spain.Complejo Hospitalario Universitario de Pontevedra, Pontevedra. Spain. Instituto de Investigación Sanitaria Galicia Sur, Fundación Biomédica Galicia Sur, Vigo. Spain.Complejo Hospitalario Universitario de Pontevedra, Pontevedra. Spain.Complejo Hospitalario Universitario de Pontevedra, Pontevedra. Spain. Instituto de Investigación Sanitaria Galicia Sur, Fundación Biomédica Galicia Sur, Vigo. Spain.<p><strong>Objective:</strong> Dimethyl fumarate is a medication approved for the treatment of relapsing-remitting multiple sclerosis. The purpose of the study was to evaluate the safety and persistence of dimethyl fumarate in clinical practice and analyze the occurrence of lymphopenia is patients treated with dimethyl fumarate over a period of at least 6 months.</p><p><strong>Method:</strong> This is a retrospective longitudinal observational study carried out between August 2015 and March 2019. The study cohort was made up of patients who had been treated with dimethyl fumarate for at least 6 months. Lymphocyte counts were recorded at different points of time (pre-treatment, at 3, 6, 12 months, and at the end of the study period). The evolution of lymphopenia was evaluated by means of a logistic regression statistical model. An analysis was performed of the relationship between a decreased lymphocyte count over the first 6 months of treatment and the development, by the end of the study, of grade II-III lymphopenia necessitating discontinuation of dimethyl fumarate. Other safety indicators were also evaluated including adverse events and interruptions or discontinuations of treatment. Persistence was determined by measuring the time to discontinuation of treatment.</p><p><strong>Results:</strong> The study included a total of 55 patients, of whom 80% were female. The most common adverse events were lymphopenia (27), rubefaction (16), digestive symptoms (11), fatigue (9), headache (3) and sleep disturbances (2). Eleven subjects interrupted/discontinued their treatment during the study period; reasons were as follows: pregnancy (2), personal decision (2), John Cunningham virus infection (1), allergy to the drug (2), and lymphopenia (4). Median duration of treatment was 23 months (4-43 months). A statistically significant association was found between a lower lymphocyte count over the first 6 months of treatment and the development of severe lymphopenia by the end of the study [OR = 1.34 (0.35-2.60); 95% CI (p = 0.001)].</p><p><strong>Conclusions:</strong> The adverse events observed in the present study are in line with those reported in previous analyses. Lymphopenia was the most common adverse event. The persistence of the medication was similar to that found in pivotal trials. The significant association found between a decreased lymphocyte count over the first 6 months of treatment and the development of severe lymphopenia by the end of the study suggests a connection between both variables, which could be instrumental in being able to predict and even prevent the occurrence of such lymphopenias.</p><p> </p>http://www.aulamedica.es/fh/pdf/11567.pdfdimethyl fumaraterelapsing remitting multiple sclerosisdrug safetylymphopeniaadverse drug eventstoxicity |
| spellingShingle | Silvia Boullosa-Lale Lara González-Freire Luciano Martínez-Martínez Carlos Crespo-Diz Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis Farmacia Hospitalaria dimethyl fumarate relapsing remitting multiple sclerosis drug safety lymphopenia adverse drug events toxicity |
| title | Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis |
| title_full | Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis |
| title_fullStr | Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis |
| title_full_unstemmed | Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis |
| title_short | Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis |
| title_sort | safety and persistence of dimethyl fumarate as a treatment for relapsing remitting multiple sclerosis |
| topic | dimethyl fumarate relapsing remitting multiple sclerosis drug safety lymphopenia adverse drug events toxicity |
| url | http://www.aulamedica.es/fh/pdf/11567.pdf |
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