Ischemic stroke with spontaneous multiple cervical artery dissections in a 40-y old woman during a first course of alemtuzumab: cause or coincidence?
(Abstract release date: 09/23/15)
ECTRIMS Online Library. Durand-Dubief F. 10/08/15; 115247; 1422
Françoise Durand-Dubief
Contributions
Contributions
Abstract
Abstract: EP1340
Type: e-Poster
Abstract Category: Risk management for disease modifying treatments
Alemtuzumab, a monoclonal antibody to CD52, has recently been approved in Europe for treating active relapsing multiple sclerosis (MS). Pre-marketing data have underlined some therapy-related adverse events, mainly the occurrence of antibody-mediated auto-immune disorders. There is currently no cardio-vascular signal.
We report on a 40-year old woman with relapsing-remitting MS since 1999, without any relevant personal or familial medical history, except her height (1.85 m) and severe orthostatic hypotension and bradycardia that occurred especially when treated with high-dose steroids. She successively received several disease-modifying drugs that were stopped due to lack of efficacy or intolerance (interferon β1b, mycophenolate mofetil). Although she has been doing well for 4 years while on treatment, natalizumab was stopped in August 2014 because of a high risk of progressive multifocal leucoencephalopathy. Despite dimethylfumarate introduction in October 2014, she experienced severe clinical and radiological rebound of disease activity, leading to a decision of switching to alemtuzumab. The first alemtuzumab course (12 mg/day on 5 consecutive days) was infused in April 2015 with a good tolerance except fatigue and a slight increase in previous neurological disability. Three days after the last infusion, she complained from a painful visual loss suggestive of optic neuritis and developed subacute clumsy movements of the right upper limb. The day after, she suddenly presented acute aphasia and right hemiplegia. Brain MRI revealed an ischemic stroke in the left middle cerebral artery territory with dissections of both carotid arteries (occlusive on the left, sub-occlusive on the right) and of the right vertebral artery. Because of early FLAIR signal abnormalities, she was considered being outside the time-window for thrombolysis. Retrospectively, we found no recent traumatic history. Previous MRI scans were re-analysed and showed no vascular dissection or suspicion of any vascular disease.
To date, no case of vascular dissection has been reported with alemtuzumab. The timing of this unexpected serious adverse event leads to discuss the causality with the recent administration of alemtuzumab.
Disclosure:
Durand-Dubief F declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Marignier R, declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Benoit A declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Roggerone S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Gosset-Janin C declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Ionescu I declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Vukusic S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Type: e-Poster
Abstract Category: Risk management for disease modifying treatments
Alemtuzumab, a monoclonal antibody to CD52, has recently been approved in Europe for treating active relapsing multiple sclerosis (MS). Pre-marketing data have underlined some therapy-related adverse events, mainly the occurrence of antibody-mediated auto-immune disorders. There is currently no cardio-vascular signal.
We report on a 40-year old woman with relapsing-remitting MS since 1999, without any relevant personal or familial medical history, except her height (1.85 m) and severe orthostatic hypotension and bradycardia that occurred especially when treated with high-dose steroids. She successively received several disease-modifying drugs that were stopped due to lack of efficacy or intolerance (interferon β1b, mycophenolate mofetil). Although she has been doing well for 4 years while on treatment, natalizumab was stopped in August 2014 because of a high risk of progressive multifocal leucoencephalopathy. Despite dimethylfumarate introduction in October 2014, she experienced severe clinical and radiological rebound of disease activity, leading to a decision of switching to alemtuzumab. The first alemtuzumab course (12 mg/day on 5 consecutive days) was infused in April 2015 with a good tolerance except fatigue and a slight increase in previous neurological disability. Three days after the last infusion, she complained from a painful visual loss suggestive of optic neuritis and developed subacute clumsy movements of the right upper limb. The day after, she suddenly presented acute aphasia and right hemiplegia. Brain MRI revealed an ischemic stroke in the left middle cerebral artery territory with dissections of both carotid arteries (occlusive on the left, sub-occlusive on the right) and of the right vertebral artery. Because of early FLAIR signal abnormalities, she was considered being outside the time-window for thrombolysis. Retrospectively, we found no recent traumatic history. Previous MRI scans were re-analysed and showed no vascular dissection or suspicion of any vascular disease.
To date, no case of vascular dissection has been reported with alemtuzumab. The timing of this unexpected serious adverse event leads to discuss the causality with the recent administration of alemtuzumab.
Disclosure:
Durand-Dubief F declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Marignier R, declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Benoit A declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Roggerone S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Gosset-Janin C declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Ionescu I declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Vukusic S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Abstract: EP1340
Type: e-Poster
Abstract Category: Risk management for disease modifying treatments
Alemtuzumab, a monoclonal antibody to CD52, has recently been approved in Europe for treating active relapsing multiple sclerosis (MS). Pre-marketing data have underlined some therapy-related adverse events, mainly the occurrence of antibody-mediated auto-immune disorders. There is currently no cardio-vascular signal.
We report on a 40-year old woman with relapsing-remitting MS since 1999, without any relevant personal or familial medical history, except her height (1.85 m) and severe orthostatic hypotension and bradycardia that occurred especially when treated with high-dose steroids. She successively received several disease-modifying drugs that were stopped due to lack of efficacy or intolerance (interferon β1b, mycophenolate mofetil). Although she has been doing well for 4 years while on treatment, natalizumab was stopped in August 2014 because of a high risk of progressive multifocal leucoencephalopathy. Despite dimethylfumarate introduction in October 2014, she experienced severe clinical and radiological rebound of disease activity, leading to a decision of switching to alemtuzumab. The first alemtuzumab course (12 mg/day on 5 consecutive days) was infused in April 2015 with a good tolerance except fatigue and a slight increase in previous neurological disability. Three days after the last infusion, she complained from a painful visual loss suggestive of optic neuritis and developed subacute clumsy movements of the right upper limb. The day after, she suddenly presented acute aphasia and right hemiplegia. Brain MRI revealed an ischemic stroke in the left middle cerebral artery territory with dissections of both carotid arteries (occlusive on the left, sub-occlusive on the right) and of the right vertebral artery. Because of early FLAIR signal abnormalities, she was considered being outside the time-window for thrombolysis. Retrospectively, we found no recent traumatic history. Previous MRI scans were re-analysed and showed no vascular dissection or suspicion of any vascular disease.
To date, no case of vascular dissection has been reported with alemtuzumab. The timing of this unexpected serious adverse event leads to discuss the causality with the recent administration of alemtuzumab.
Disclosure:
Durand-Dubief F declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Marignier R, declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Benoit A declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Roggerone S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Gosset-Janin C declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Ionescu I declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Vukusic S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Type: e-Poster
Abstract Category: Risk management for disease modifying treatments
Alemtuzumab, a monoclonal antibody to CD52, has recently been approved in Europe for treating active relapsing multiple sclerosis (MS). Pre-marketing data have underlined some therapy-related adverse events, mainly the occurrence of antibody-mediated auto-immune disorders. There is currently no cardio-vascular signal.
We report on a 40-year old woman with relapsing-remitting MS since 1999, without any relevant personal or familial medical history, except her height (1.85 m) and severe orthostatic hypotension and bradycardia that occurred especially when treated with high-dose steroids. She successively received several disease-modifying drugs that were stopped due to lack of efficacy or intolerance (interferon β1b, mycophenolate mofetil). Although she has been doing well for 4 years while on treatment, natalizumab was stopped in August 2014 because of a high risk of progressive multifocal leucoencephalopathy. Despite dimethylfumarate introduction in October 2014, she experienced severe clinical and radiological rebound of disease activity, leading to a decision of switching to alemtuzumab. The first alemtuzumab course (12 mg/day on 5 consecutive days) was infused in April 2015 with a good tolerance except fatigue and a slight increase in previous neurological disability. Three days after the last infusion, she complained from a painful visual loss suggestive of optic neuritis and developed subacute clumsy movements of the right upper limb. The day after, she suddenly presented acute aphasia and right hemiplegia. Brain MRI revealed an ischemic stroke in the left middle cerebral artery territory with dissections of both carotid arteries (occlusive on the left, sub-occlusive on the right) and of the right vertebral artery. Because of early FLAIR signal abnormalities, she was considered being outside the time-window for thrombolysis. Retrospectively, we found no recent traumatic history. Previous MRI scans were re-analysed and showed no vascular dissection or suspicion of any vascular disease.
To date, no case of vascular dissection has been reported with alemtuzumab. The timing of this unexpected serious adverse event leads to discuss the causality with the recent administration of alemtuzumab.
Disclosure:
Durand-Dubief F declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Marignier R, declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Benoit A declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Roggerone S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Gosset-Janin C declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Ionescu I declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
Vukusic S declares having conflicts of interest with Bayer-Schering, Biogen Idec, Genzyme, Novartis, Merck Serono, Sanofi Aventis and Teva Pharma laboratories.
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