Author Topic: (ECTRIMS) Autoimmunity in patients treated w/alemtuzumab for RRMS: 5-year CARE-MS follow-up  (Read 64 times)

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Offline agate

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Presented at the annual ECTRIMS conference (London, September 14-17, 2016):

Quote
Autoimmunity in patients treated With Alemtuzumab for relapsing-remitting multiple sclerosis: 5-Year follow-up of the CARE-MS studies

C. Dayan1, A. Cuker2, C. LaGanke3, O. Fernandez4, R.M.M. Hupperts5, B. Sharrack6, B. Singer7, P. Vermersch8, D.H. Margolin9, E. Chou9, C.L. Twyman10, on behalf of the CARE-MS Investigators

1Cardiff University School of Medicine, Cardiff, United Kingdom, 2University of Pennsylvania, Philadlephia, PA, 3North Central Neurology Associates, Cullman, AL, United States, 4Fundacion IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain, 5Orbis Medisch Centrum, Maastricht University Medical Center, Sittard, The Netherlands, 6Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom, 7MS Center for Innovations in Care, Missouri Baptist Medical Center, St. Louis, MO, United States, 8University of Lille, Lille, France, 9Sanofi Genzyme, Cambridge, MA, 10Saint Joseph Neurology Associates, Lexington, KY, United States

Background:

Alemtuzumab significantly improved clinical and MRI outcomes versus SC IFNB-1a over 2 years in relapsing-remitting multiple sclerosis (RRMS) patients who were treatment-naive (CARE-MS I; NCT00530348) or had an inadequate response (≥1 relapse) to prior therapy at baseline (CARE-MS II; NCT00548405).

Durable efficacy over 5 years was observed in an extension study (NCT00930553) in the absence of continuous treatment.

The most frequent adverse events (AEs) with alemtuzumab were infusion-associated reactions; other AEs of interest included autoimmune AEs. Patient education and the safety monitoring program enable timely detection and treatment of autoimmune AEs in patients treated with alemtuzumab.

Goal:

To evaluate the occurrence of autoimmune AEs over 5 years in patients with RRMS treated with alemtuzumab.

Methods:

Patients received 2 courses of alemtuzumab 12 mg (Month 0: 5 days; Month 12: 3 days) in the CARE-MS core studies, with as-needed alemtuzumab for relapse or MRI activity in the extension. Patients were monitored for autoimmune AEs.

 Safety measures included: quarterly thyroid function testing; monthly complete blood counts with platelets and symptom monitoring for immune thrombocytopenia (ITP); and monthly serum creatinine and urinalysis. Results are reported for pooled data from the CARE-MS I and II studies.

Results:

811 patients received alemtuzumab 12 mg in the CARE-MS I and II core studies; 742 (91%) entered the extension, and 692 (93%) of those remained on study at 5 years.

Most autoimmune AEs were mild or moderate in intensity, and serious autoimmune AEs were uncommon (67 events; 1.8/100 patient-years over 5 years); none led to study withdrawal.

 The most common autoimmune AEs were thyroid AEs, the rate of which peaked in Year 3 (227 events; 31.3/100 patient-years) and subsequently declined in Years 4 (126 events; 17.6/100 patient-years) and 5 (95 events; 13.6/100 patient-years); serious thyroid AE rates remained low.

Over Years 0-5, 22 ITP [idiopathic thrombocytopenic purpura, a medical condition that eventually leads to excessive bruising and bleeding] events were observed (cumulative rate: 0.59) with no fatalities. Two nephropathies were reported over Years 0-5 (cumulative rate: 0.05); serum creatinine remained normal in both cases.

Conclusion:

Autoimmune AEs over 5 years were generally mild or moderate in intensity in alemtuzumab-treated patients from the CARE-MS trials. No patients withdrew from the extension studies due to autoimmune AEs. Consistent with previous reports, most autoimmune AEs were thyroid-related events.

Disclosure:

STUDY SUPPORT: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
[remainder of listing showing financial support omitted]
« Last Edit: September 16, 2016, 11:54:48 am by agate »
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SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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