Abstract: P1596
Type: LB Poster
Abstract Category: Late Breaking News
Progressive Multifocal Leukoencephalopathy (PML) is a potentially fatal complication of MS immunotherapeutics and a challenge for modern treatment strategies. MRI is very sensitive to PML and can detect asymptomatic PML. However lesion differentiation is challenging and requires dedicated neuroradiology expertise, scarce outside specialised centres. In addition, unstructured transfer of MR scans hampers patient"s confidentiality and effective communication between neurologists and radiologists. A digital platform will be developed to provide a scalable expert opinion reading service for rapid, reliable access to 2nd opinion neuroradiology expertise to identify PML suspicion. It is being piloted in clinical centres in Europe. The authors held a structured workshop which formed a consensus position of the use of this digital platform in a clinical setting:
Core platform purpose is to increase patient safety, physician confidence in using drugs with known risk of PML, and compliance with information governance requirements to protect patient data through pseudonymisation.
Patients referred are those treated with drugs associated with PML risk and any of the following
- High risk based on JCV serology and treatment duration
- Unexplained / atypical new neurological symptoms
- Suspicious new brain lesion with MS deviating characteristics
- Demographic, referral reason, treatment/disease duration, number of drug administrations, previous immunosuppressant treatment, symptomatology brain MRI, laboratory data (CSF analysis)
- Local brain MRI read (transcribed if needed)
- Current and previous MRI scans (performed following MAGNIMS screening protocol)
- Insufficient data for read -MRI is low quality
- No-suspicion-typical MRI features of a patient with MS (preferably unchanged)
- Suspicion of PML-identification of suspicious lesions; MRI follow-up advised
- Continuing PML suspicion -continuing suspicious lesions on MRI, likely PML
- Lab-confirmed-CSF confirmed PML
- Follow-up after confirmation-suspected IRIS
- Abnormal otherwise-unusual white matter lesions with some features in the absence of/not consistent with PML
Disclosure: F. Barkhof: consulting fees from Bayer-Schering Pharma, Sanofi-Aventis, Biogen Idec, TEVA, Merck-Serono, Novartis, Roche, Synthon BV, Janssen Research, Genzyme, consultancy honoraria for Dutch MS Society, development of educational presentations for Serono Symposia Foundation and MedScape.
S. Llufriu has received speaker honoraria from Sanofi-Genzyme, Merck-Serono, Teva Pharmaceutical Industries Ltd, and Biogen Idec.
A. Rovira serves on scientific advisory boards for Biogen Idec, Novartis, Genzyme, and OLEA Medical, has received speaker honoraria from Bayer, Sanofi-Genzyme, Bracco, Merck-Serono, Teva Pharmaceutical Industries Ltd, OLEA Medical, Stendhal, Novartis and Biogen Idec, and has research agreements with Siemens AG.
J. Killestein has accepted speaker and consulting fees from Merck-Serono, TEVA, Biogen, Genzyme, Roche and Novartis. The VUmc MS Center Amsterdam has received financial support for research activities from Bayer Schering Pharma, Biogen, Glaxo Smith Kline, Merck Serono, Genzyme, Roche, Novartis, and Teva.
T. Ziemssen has served on scientific advisory boards, and has received scientific grants and speaker honoraria from Bayer, Biogen Idec, Genzyme, TEVA, Merck Serono and Novartis.
P. Vermersch: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Almirall. Research supports from Biogen, Bayer, Novartis, Sanofi-Genzyme and Merck-Serono
A. Gass has received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Bayer Schering, Biogen Idec, Merck Serono, Novartis and TEVA Neurosciences.
C. Gasperini serves on scientific advisory boards for Biogen Idec and Bayers, has received speaker honoraria from Bayer, Sanofi-Genzyme, Merck-Serono, Teva Pharmaceutical Industries Ltd, OLEA, and Biogen Idec.
H. Kitzler served on scientific advisory boards for Novartis, has received speaker honoraria from Novartis, Biogen Idec and TEVA Pharmaceutical Industries Ltd, and has research agreements with Novartis Pharma GmbH and the Siemens AG.
J. Hodel has received speaker honoraria from General Electric, Biogen Idec and Novartis.
M. Wattjes: consultancy for Roche, Novartis and Biogen.
J. Chataway: has received support from the Efficacy and Mechanism Evaluation Programme (NIHR) and UK Multiple Sclerosis Society. He acknowledges support from the National Institute for Health Research (NIHR) University College London Hospitals/UCL Biomedical Research Research Centres funding scheme. He is the local principal investigator for trials in multiple sclerosis funded by Novartis, Biogen, and GSK, and has received an investigator grant from Novartis outside this work. He has taken part in Advisory Boards for Roche and Merck.
T. Yousry: Grant funding with Medical Research Council, MS Society of Great Britain and Northern Ireland, PSP Association, Stroke Association, British Heart Foundation, Wellcome Trust, and consultancy for GlaxoSmithKline, Biogen Idec, Novartis, ESOR, King Abdullah Medical City, Merck, MS Society Australia
D, Hill: board member and shareholder for IXICO plc, employee of IXICO Technologies Limited
J, Hall: shareholder for IXICO plc, employee of IXICO Technologies Limited
S, Grootonk: employee of IXICO Technologies Limited
N, Royle: employee of IXICO Technologies Limited
Funding for the development of the digital platform technology has been provided by Biogen
Abstract: P1596
Type: LB Poster
Abstract Category: Late Breaking News
Progressive Multifocal Leukoencephalopathy (PML) is a potentially fatal complication of MS immunotherapeutics and a challenge for modern treatment strategies. MRI is very sensitive to PML and can detect asymptomatic PML. However lesion differentiation is challenging and requires dedicated neuroradiology expertise, scarce outside specialised centres. In addition, unstructured transfer of MR scans hampers patient"s confidentiality and effective communication between neurologists and radiologists. A digital platform will be developed to provide a scalable expert opinion reading service for rapid, reliable access to 2nd opinion neuroradiology expertise to identify PML suspicion. It is being piloted in clinical centres in Europe. The authors held a structured workshop which formed a consensus position of the use of this digital platform in a clinical setting:
Core platform purpose is to increase patient safety, physician confidence in using drugs with known risk of PML, and compliance with information governance requirements to protect patient data through pseudonymisation.
Patients referred are those treated with drugs associated with PML risk and any of the following
- High risk based on JCV serology and treatment duration
- Unexplained / atypical new neurological symptoms
- Suspicious new brain lesion with MS deviating characteristics
- Demographic, referral reason, treatment/disease duration, number of drug administrations, previous immunosuppressant treatment, symptomatology brain MRI, laboratory data (CSF analysis)
- Local brain MRI read (transcribed if needed)
- Current and previous MRI scans (performed following MAGNIMS screening protocol)
- Insufficient data for read -MRI is low quality
- No-suspicion-typical MRI features of a patient with MS (preferably unchanged)
- Suspicion of PML-identification of suspicious lesions; MRI follow-up advised
- Continuing PML suspicion -continuing suspicious lesions on MRI, likely PML
- Lab-confirmed-CSF confirmed PML
- Follow-up after confirmation-suspected IRIS
- Abnormal otherwise-unusual white matter lesions with some features in the absence of/not consistent with PML
Disclosure: F. Barkhof: consulting fees from Bayer-Schering Pharma, Sanofi-Aventis, Biogen Idec, TEVA, Merck-Serono, Novartis, Roche, Synthon BV, Janssen Research, Genzyme, consultancy honoraria for Dutch MS Society, development of educational presentations for Serono Symposia Foundation and MedScape.
S. Llufriu has received speaker honoraria from Sanofi-Genzyme, Merck-Serono, Teva Pharmaceutical Industries Ltd, and Biogen Idec.
A. Rovira serves on scientific advisory boards for Biogen Idec, Novartis, Genzyme, and OLEA Medical, has received speaker honoraria from Bayer, Sanofi-Genzyme, Bracco, Merck-Serono, Teva Pharmaceutical Industries Ltd, OLEA Medical, Stendhal, Novartis and Biogen Idec, and has research agreements with Siemens AG.
J. Killestein has accepted speaker and consulting fees from Merck-Serono, TEVA, Biogen, Genzyme, Roche and Novartis. The VUmc MS Center Amsterdam has received financial support for research activities from Bayer Schering Pharma, Biogen, Glaxo Smith Kline, Merck Serono, Genzyme, Roche, Novartis, and Teva.
T. Ziemssen has served on scientific advisory boards, and has received scientific grants and speaker honoraria from Bayer, Biogen Idec, Genzyme, TEVA, Merck Serono and Novartis.
P. Vermersch: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Almirall. Research supports from Biogen, Bayer, Novartis, Sanofi-Genzyme and Merck-Serono
A. Gass has received honoraria for lecturing, travel expenses for attending meetings, and financial support for research from Bayer Schering, Biogen Idec, Merck Serono, Novartis and TEVA Neurosciences.
C. Gasperini serves on scientific advisory boards for Biogen Idec and Bayers, has received speaker honoraria from Bayer, Sanofi-Genzyme, Merck-Serono, Teva Pharmaceutical Industries Ltd, OLEA, and Biogen Idec.
H. Kitzler served on scientific advisory boards for Novartis, has received speaker honoraria from Novartis, Biogen Idec and TEVA Pharmaceutical Industries Ltd, and has research agreements with Novartis Pharma GmbH and the Siemens AG.
J. Hodel has received speaker honoraria from General Electric, Biogen Idec and Novartis.
M. Wattjes: consultancy for Roche, Novartis and Biogen.
J. Chataway: has received support from the Efficacy and Mechanism Evaluation Programme (NIHR) and UK Multiple Sclerosis Society. He acknowledges support from the National Institute for Health Research (NIHR) University College London Hospitals/UCL Biomedical Research Research Centres funding scheme. He is the local principal investigator for trials in multiple sclerosis funded by Novartis, Biogen, and GSK, and has received an investigator grant from Novartis outside this work. He has taken part in Advisory Boards for Roche and Merck.
T. Yousry: Grant funding with Medical Research Council, MS Society of Great Britain and Northern Ireland, PSP Association, Stroke Association, British Heart Foundation, Wellcome Trust, and consultancy for GlaxoSmithKline, Biogen Idec, Novartis, ESOR, King Abdullah Medical City, Merck, MS Society Australia
D, Hill: board member and shareholder for IXICO plc, employee of IXICO Technologies Limited
J, Hall: shareholder for IXICO plc, employee of IXICO Technologies Limited
S, Grootonk: employee of IXICO Technologies Limited
N, Royle: employee of IXICO Technologies Limited
Funding for the development of the digital platform technology has been provided by Biogen