Immune thrombocytopenia in alemtuzumab-treated MS patients: Incidence, detection, and management.
| Autor: | Cuker A; Departments of Medicine and Pathology & Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA., Bass AD; Neurology Center of San Antonio, San Antonio, TX, USA., Nadj C; Institute of Neurology, Novi Sad, Serbia., Agius MA; Woodland Clinic, Dignity Health, Woodland, CA, USA., Steingo B; Fort Lauderdale MS Center, Pompano Beach, FL, USA., Selmaj KW; University of Warmia and Mazury in Olsztyn, Olsztyn, Poland., Thoits T; College of Human Medicine, MSU Spectrum Health, Grand Rapids, MI, USA., Guerreiro A; Instituto de Doenças Neurológicas do Hospital Mãe de Deus, Porto Alegre, Brazil., Van Wijmeersch B; Rehabilitation and MS Centre Overpelt, BIOMED, University of Hasselt, Hasselt, Belgium., Ziemssen T; Center of Clinical Neuroscience, University Hospital Carl Gustav Carus, Dresden, Germany., Meuth SG; Department of Neurology, University of Münster, Münster, Germany., LaGanke CC; North Central Neurology Associates, Cullman, AL, USA., Thangavelu K; Sanofi, Cambridge, MA, USA., Rodriguez CE; Sanofi, Cambridge, MA, USA.; Current affiliation: Sunovion Pharmaceuticals, Marlborough, MA, USA., Baker DP; Sanofi, Cambridge, MA, USA., Margolin DH; Sanofi, Cambridge, MA, USA.; Current affiliation: Cerevance, Inc., Boston, MA, USA., Jannsens A; Department of Haematology, University Hospitals Leuven, Leuven, Belgium. |
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| Jazyk: | angličtina |
| Zdroj: | Multiple sclerosis (Houndmills, Basingstoke, England) [Mult Scler] 2020 Jan; Vol. 26 (1), pp. 48-56. Date of Electronic Publication: 2019 Feb 20. |
| DOI: | 10.1177/1352458518816612 |
| Abstrakt: | Background: Alemtuzumab is a highly effective therapy for relapsing-remitting multiple sclerosis (RRMS), and immune thrombocytopenia (ITP) has been identified as a risk. Objective: To examine ITP incidence, treatment, and outcomes during the clinical development of alemtuzumab for RRMS and discuss postmarketing experience outside clinical trials. Methods: CAMMS223 and Comparison of Alemtuzumab and Rebif ® Efficacy in Multiple Sclerosis (CARE-MS) I and II investigated two annual courses of alemtuzumab 12 mg (or 24 mg in CAMMS223/CARE-MS II) versus subcutaneous interferon beta-1a three times per week. Patients completing core studies could enroll in an extension. Monthly monitoring for ITP continued until 48 months after the last alemtuzumab infusion. Results: Of 1485 alemtuzumab-treated MS patients in the clinical development program, 33 (2.2%) developed ITP (alemtuzumab 12 mg, 24 [2.0%]; alemtuzumab 24 mg, 9 [3.3%]) over median 6.1 years of follow-up after the first infusion; most had a sustained response to first-line ITP therapy with corticosteroids, platelets, and/or intravenous immunoglobulin. All cases occurred within 48 months of the last alemtuzumab infusion. Postmarketing surveillance data suggest that the ITP incidence is not higher in clinical practice than in clinical trials. Conclusion: Alemtuzumab-associated ITP occurs in approximately 2% of patients and is responsive to therapy. Careful monitoring is key for detection and favorable outcomes. |
| Databáze: | MEDLINE |
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