Immune thrombocytopenia in alemtuzumab-treated MS patients: Incidence, detection, and management. (January 2020)

• Record Type: Journal Article
• Authors: Cuker, Adam; Bass, Ann D; Nadj, Congor; Agius, Mark A; Steingo, Brian; Selmaj, Krzysztof W; Thoits, Timothy; Guerreiro, Alexandre; Van Wijmeersch, Bart; Ziemssen, Tjalf; Meuth, Sven G; LaGanke, Christopher C; Thangavelu, Karthinathan; Rodriguez, Claudio E; Baker, Darren P; Margolin, David H; Jannsens, Ann
• Is Part Of: Multiple sclerosis. Volume 26:Number 1(2020)
• Page Start: 48
• Page End: 56
• Publication Date: 2020-01
• Subjects: Alemtuzumab -- disease-modifying therapy -- immune thrombocytopenia -- relapsing-remitting multiple sclerosis -- safety; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458518816612
• Languages: English
• ISSNs: 1352-4585

Abstract

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.