Alemtuzumab for relapsing multiple sclerosis in clinical practice: A four-year retrospective one-center study

被引:7
作者
de Castro, Belen Rodriguez [1 ]
Sanchez, Ruben Pampin [1 ]
Martinez, Sonia Tembras [1 ]
Ruiz, Aitor Ayastuy [1 ]
Barbosa, Cristina Martinez-Mugica [1 ]
机构
[1] Hosp Univ Cabuenes, Hosp Pharm, Gijon, Spain
关键词
Alemtuzumab; multiple sclerosis; safety; infusion-related reactions; infections; autoimmune diseases; DISEASE-MODIFYING THERAPIES; FOLLOW-UP; SAFETY; UPDATE;
D O I
10.3233/JRS-191029
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Background: Disease-modifying therapies for multiple sclerosis have been developed tremendously over the last two decades. Objective: The aim of this study was to review the short-, medium-, and long-term safety of alemtuzumab in relapsing remitting multiple sclerosis (RRMS). Method: This retrospective observational study (2015-2019) included all patients with highly active or rapidly progressing and aggressive RRMS who were treated with alemtuzumab at the Cabuefies University Hospital. The short-, medium-, and long-term adverse effects were evaluated following the risk management program of the European Medicines Agency. Results: 39 patients were included, 23 of them received at least two cycles of treatment. Most patients showed at least one adverse event. The following adverse reactions were reported: infusional reactions (17), urinary tract infections (six), thrombopenia (five), and thyroid dysfunction (six). Conclusion: In clinical practice alemtuzumab showed an acceptable safety profile in selected patients even if all of them suffered at least one adverse effect. Thorough and prolonged follow-up is required to further confirm the safety of this drug.
引用
收藏
页码:259 / 265
页数:7
相关论文
共 20 条
  • [1] [Anonymous], EMA6090152019
  • [2] [Anonymous], PTV109042015
  • [3] [Anonymous], EMA2201102019
  • [4] Risk of Natalizumab-Associated Progressive Multifocal Leukoencephalopathy
    Bloomgren, Gary
    Richman, Sandra
    Hotermans, Christophe
    Subramanyam, Meena
    Goelz, Susan
    Natarajan, Amy
    Lee, Sophia
    Plavina, Tatiana
    Scanlon, James V.
    Sandrock, Alfred
    Bozic, Carmen
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2012, 366 (20) : 1870 - 1880
  • [5] Butzkueven H, 2014, J NEUROL NEUROSUR PS, V85, P1190, DOI 10.1136/jnnp-2013-306936
  • [6] Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial
    Cohen, Jeffrey A.
    Coles, Alasdair J.
    Arnold, Douglas L.
    Confavreux, Christian
    Fox, Edward J.
    Hartung, Hans-Peter
    Havrdova, Eva
    Selmaj, Krzysztof W.
    Weiner, Howard L.
    Fisher, Elizabeth
    Brinar, Vesna V.
    Giovannoni, Gavin
    Stojanovic, Miroslav
    Ertik, Bella I.
    Lake, Stephen L.
    Margolin, David H.
    Panzara, Michael A.
    Compston, D. Alastair S.
    [J]. LANCET, 2012, 380 (9856) : 1819 - 1828
  • [7] Coles AJ, 2008, NEW ENGL J MED, V359, P1786, DOI 10.1056/NEJMoa0802670
  • [8] Coles AJ, 2017, NEUROLOGY, V89, P1117, DOI 10.1212/WNL.0000000000004354
  • [9] Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial
    Coles, Alasdair J.
    Twyman, Cary L.
    Arnold, Douglas L.
    Cohen, Jeffrey A.
    Confavreux, Christian
    Fox, Edward J.
    Hartung, Hans-Peter
    Havrdova, Eva
    Selmaj, Krzysztof W.
    Weiner, Howard L.
    Miller, Tamara
    Fisher, Elizabeth
    Sandbrink, Rupert
    Lake, Stephen L.
    Margolin, David H.
    Oyuela, Pedro
    Panzara, Michael A.
    Compston, D. Alastair S.
    [J]. LANCET, 2012, 380 (9856) : 1829 - 1839
  • [10] Alemtuzumab CARE-MS I 5-year follow-up Durable efficacy in the absence of continuous MS therapy
    Havrdova, Eva
    Arnold, Douglas L.
    Cohen, Jeffrey A.
    Hartung, Hans-Peter
    Fox, Edward J.
    Giovannoni, Gavin
    Schippling, Sven
    Selmaj, Krzysztof W.
    Traboulsee, Anthony
    Compston, D. Alastair S.
    Margolin, David H.
    Thangavelu, Karthinathan
    Rodriguez, Claudio E.
    Jody, Darlene
    Hogan, Richard J.
    Xenopoulos, Panos
    Panzara, Michael A.
    Coles, Alasdair J.
    [J]. NEUROLOGY, 2017, 89 (11) : 1107 - 1116