| Return Create A Forum - Home | |
| --------------------------------------------------------- | |
| MS Speaks | |
| https://msspeaks.createaforum.com | |
| --------------------------------------------------------- | |
| ***************************************************** | |
| Return to: LEMTRADA (Campath, alemtuzumab) | |
| ***************************************************** | |
| #Post#: 967-------------------------------------------------- | |
| (ECTRIMS abst.) Long-term follow-up of early cohorts (alemtuzuma | |
| b in MS) | |
| By: agate Date: October 11, 2015, 1:17 pm | |
| --------------------------------------------------------- | |
| Presented at the ECTRIMS conference in Barcelona, October 7-10, | |
| 2015: | |
| [quote]Alemtuzumab in multiple sclerosis: long-term follow-up of | |
| the early cohorts | |
| J.W.L. Brown1,2, O. Tuohy1, O. Kousin-Ezewu1, L. Azzopardi1, T. | |
| Button1, C. Mccarthy1, T. Alli3, C. Callan3, M. Folks3, S. | |
| Heller3, H. Laidley3, B. Nourallah3, C. O�Neill3, D. Obute3, R. | |
| Piper3, O. Prankerd Smith3, H. Wickham3, X. Zheng3, K. May1, A. | |
| Gerritz1, D.A.S. Compston1, J.L. Jones1, A.J. Coles1 | |
| 1Department of Clinical Neurosciences, University of Cambridge, | |
| Cambridge, 2University College London Institute of Neurology, | |
| Queen Square Multiple Sclerosis Centre, NMR Research Unit, | |
| London, 3University of Cambridge School of Clinical Medicine, | |
| Cambridge, United Kingdom | |
| Background: | |
| In relapsing remitting multiple sclerosis (RRMS) alemtuzumab is | |
| highly effective at reducing relapses and disability accrual, | |
| and is now widely licensed. We present the efficacy and safety | |
| data from two early single-arm studies of alemtuzumab in RRMS | |
| (median follow-up 10.1 years), and contrast the findings with a | |
| secondary progressive (SPMS) cohort (median follow-up 19.8 | |
| years). These cohorts informed the design of subsequent clinical | |
| trials. | |
| Methods: | |
| We treated 86 patients with highly active RRMS (median two | |
| relapses per year before treatment; median (standard deviation | |
| (SD)) Expanded Disability Status Scale (EDSS) score at baseline: | |
| 3.5 (2.0)) plus 36 patients with SPMS (baseline EDSS: 6 (0.9)). | |
| Relapses, change in disability and adverse events were recorded. | |
| Univariate and logistic regression analyses were used to | |
| identify baseline variables associated with a higher risk of | |
| disability progression. | |
| Results: | |
| RRMS | |
| After 10.1 years, 39/86 patients (45%) remained relapse-free. | |
| Forty-one patients (48%) required two cycles of alemtuzumab (the | |
| standard treatment course), while relapses triggered | |
| re-treatment to a total of three cycles (in 33 patients (38%)), | |
| four cycles (in nine patients (10%)) and five cycles (in three | |
| patients (3%)). The EDSS remained largely unchanged 10.1 years | |
| later (3.5, SD 2.2; p NS). One patient died, unrelated to | |
| multiple sclerosis. | |
| SPMS | |
| Patients received one (n=28), two (n=7) or three (n=1) cycles of | |
| alemtuzumab. After 19.8 years, the median EDSS had significantly | |
| increased from 6 (SD 0.9) to 8.75 (SD 1.4), p< 0.0001, and 13 | |
| patients had died. | |
| Adverse events | |
| Secondary clinical autoimmunity occurred in 41/86 (48%) of the | |
| RRMS cohort and 16/36 (44%) of the SPMS cohort, a median 18.0 | |
| and 28.5 months respectively after the last alemtuzumab | |
| treatment. The thyroid gland was most commonly affected. | |
| Conclusions: | |
| Alemtuzumab causes long-lasting disease stabilization in highly | |
| active RRMS, but has no effect on disability progression in | |
| SPMS. Secondary clinical autoimmunity occurs in approximately | |
| half of patients. | |
| __________________ | |
| Disclosure | |
| J William L Brown: nothing to disclose; | |
| Orla Tuohy: nothing to disclose; | |
| Onajite Kousin-Ezewu: nothing to disclose; | |
| Laura Azzopardi: nothing to disclose; | |
| Tom Button: nothing to disclose; | |
| Claire McCarthy: nothing to disclose; | |
| Theo Alli: nothing to disclose; | |
| Caitriona Callan: nothing to disclose; | |
| Matthew Folks: nothing to disclose; | |
| Simon Heller: nothing to disclose; | |
| Hannah Laidley: nothing to disclose; | |
| Basil Nourallah: nothing to disclose; | |
| Cormac O�Neill: nothing to disclose; | |
| Daniel Obute: nothing to disclose; | |
| Robert Piper: nothing to disclose; | |
| Olivia Prankerd Smith: nothing to disclose; | |
| Helena Wickham: nothing to disclose; | |
| Xueying Zheng: nothing to disclose; | |
| Karen May: nothing to disclose; | |
| Anna Gerritz: nothing to disclose; | |
| D Alastair S Compston has received lecture fees and travel | |
| reimbursements from Genzyme (a Sanofi company) on behalf of | |
| himself and the University of Cambridge; and he is a paid | |
| scientific adviser to the Lundbeck Foundation; | |
| Joanne L Jones has received consulting fees and lecture fees | |
| from Genzyme (a Sanofi company). | |
| Alasdair J Coles has received honoraria and travel expenses and | |
| the department has received research grants, from Genzyme (a | |
| Sanofi company).[/quote] | |
| ***************************************************** |