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CD62L and JCV index for PML risk management in treated MS patients
Author(s): ,
B. Pignolet
Affiliations:
CRC-SEP, Pole des Neurosciences Hopital Pierre Paul Riquet, CHU Toulouse; UMR U1043 Université de Toulouse
,
F. Bucciarelli
Affiliations:
CRC-SEP, Pole des Neurosciences Hopital Pierre Paul Riquet, CHU Toulouse; UMR U1043 Université de Toulouse
,
L. Scandella
Affiliations:
CRC-SEP, Pole des Neurosciences Hopital Pierre Paul Riquet, CHU Toulouse; UMR U1043 Université de Toulouse
,
J. Ciron
Affiliations:
CRC-SEP, Pole des Neurosciences Hopital Pierre Paul Riquet, CHU Toulouse
,
D. Biotti
Affiliations:
CHU Toulouse, Toulouse, France
,
G. Dorcet
Affiliations:
CRC-SEP, Pole des Neurosciences Hopital Pierre Paul Riquet, CHU Toulouse; UMR U1043 Université de Toulouse
,
M. Comabella
Affiliations:
VHIR, Barcelona, Spain
,
M. Rigal
Affiliations:
CHG, Auch
,
B. Brochet
Affiliations:
CHU Bordeaux; INSERM U1215, Neurocentre Magendie, Bordeaux
,
N. Derache
Affiliations:
CHU Caen, Caen
,
A. Robinson
Affiliations:
CH Carcassonne, Carcassonne, France
,
I. Patry
Affiliations:
CH Sud Francilien, Corbeille-Essonne, Cook Islands
,
O. Casez
Affiliations:
CHU Grenoble, Grenoble
,
A. Montcuquet
Affiliations:
CHU Limoges, Limoges
,
G. Angibaud
Affiliations:
Clinique du Pont de Chaume, Montauban
,
L. Cabrejo
Affiliations:
AP-HP, Hôpital Bichat, Paris
,
D. Sablot
Affiliations:
CH Perpignan, Perpignan
,
A.-M. Guennoc
Affiliations:
CHRU Bretenneau; Université de Tours, Tours
,
J.-M. Larrieu
Affiliations:
CH Tarbes-Vic, Tarbes
,
F. Formosa
Affiliations:
CH Rodez, Rodez
,
Z. Elias
Affiliations:
Cabinet Médical, Toulon
,
M. Debouverie
Affiliations:
CHRU Nancy, Nancy
,
S. Pittion
Affiliations:
CHRU Nancy, Nancy
,
S. Vukusic
Affiliations:
Service de Neurologie, Sclérose en Plaques, Pathologies de la Myéline et Neuro-Inflammation and Fondation Eugène Devic EDMUS, Hôpital Neurologique Pierre Wertheimer, Hospices de Lyon; Centre des Neurosciences, INSERM U1028, CNRS UMR5292, Lyon; Université Claude Bernard Lyon 1, Faculté de Médecine Lyon-Est, Villeurbanne
,
A. Rico
Affiliations:
Aix Marseille Univ, APHM, Hôpital de La Timone, Pôle de Neurosciences Cliniques, Marseille
,
J. Pelletier
Affiliations:
Aix Marseille Univ, APHM, Hôpital de La Timone, Pôle de Neurosciences Cliniques, Marseille
,
P. Clavelou
Affiliations:
CHU Clermont-Ferrand, Clermont-Ferrand, France
,
N. Schwab
Affiliations:
University of Münster, Münster, Germany
,
C. Lebrun-Frenay
Affiliations:
CHU Nice, Nice, France
,
D. Brassat
Affiliations:
CRC-SEP, Pole des Neurosciences Hopital Pierre Paul Riquet, CHU Toulouse; UMR U1043 Université de Toulouse
on the behalf of BEST-MS and SF-SEP
on the behalf of BEST-MS and SF-SEP
Affiliations:
ECTRIMS Online Library. Pignolet B. Oct 12, 2018; 229096
Beatrice Pignolet
Beatrice Pignolet
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Abstract: P1256

Type: Poster Sessions

Abstract Category: Therapy - Risk management for disease modifying treatments

Background: Natalizumab (NTZ) related PML risk is highly variable depending on studied cohorts. By Feb. 2018, the global incidence if of 4.163/1000. However, it is well-known treatment duration and JC index value increase this risk. Recently, we demonstrated in a retrospective study that CD62L could be used as a marker to minimize this risk (< 10% CD62L; HR = 7; sensibility 80% / specificity 85%) (Pignolet et al., 2016). Currently, we do not know if quitting NTZ based on disease duration and JCV index decrease the PML incidence and prospective study have to be perform to validate JCV index as a marker. PML risk also exists with other biologics. By May 2018, the global risk for Fingolimod (FGL) is of 0.082/1000. However, it is likely that in sub-group patients such as those presenting more than 4y of FGL this risk could be increased knowing that mean FGL exposure at PML diagnosis was 50 months (mean range: 18-84 months). Here, the major unmet need is to find prognosis factors in order to prevent FGL-related PML.
Objectives: To determine the observed number vs expected number of PML when applying an algorithm based on JCV index and CD62L to minimize PML risk.
Methods: In 2014, we started a prospective multicentric ancillary study BEST-MS (NTC01981161). The inclusion criteria were the followings NTZ or FGL >18 months, JCV positive, and for NTZ either with JCV index >0.9 or prior immunosuppressor. Treatment was discarded based on physicians decision if JCV index >1.5 or if CD62L < 10 %.
Results: We included 342 patients for NTZ. In BIONAT cohort of NTZ treated patients, the risk with JCV index >0.9 and < 2 years of NTZ was of 3.3%. Thus, 11 PML were expected in BEST-MS study when in NTZ-treated patients. In this NTZ-treated group, only 12% of the patients experienced a low level of CD62L (< 10%). All patients have been switched to another drug. Currently and after a mean follow-up of 23 months, we observed 2 PML when under NTZ. Since we could not calculate the expected number of PML with FGL, this study is exploratory. None of the FGL treated patients experienced a CD62L < 10%. No PML has been observed (mean follow-up 16.4 months (n=52). Influence of delayed infusion on PML risk into the BIONAT and BEST-MS cohorts will be provided.
Conclusion: Combining JCV index and CD62L should decrease the risk of PML and be proposed to physicians for patients who want to go on with NTZ despite a high risk. However, confirmatory studies still need to be performed.
Disclosure: Dr Pignolet, F Bucciarelli, L Scandella, Dr Ciron, Dr Dorcet, Dr Rigal, Dr Robinson, Dr Patry, Dr Montcuquet, Dr Angibaud, Dr Cabrejo, Dr Sablot, Dr Guennoc, Dr Larrieu, Dr Formosa, Dr Elias, Prof Debouverie, Dr Pittion, Dr Rico, : nothing to disclose. OC: consulting and lecture fees, travel grants from biogen, genzyme, novartis, almogran, BB: consultancy fees, speaker fees, research grants (non-personal), or honoraria from Novartis, Biogen-Idec, Merck, Bayer Schering, Roche, Medday, Bayer, Actelion, Teva and Genzyme Sanofi, MC: has received compensation for consulting services and speaking honoraria from Bayer Schering Pharma.,DBi: received speaker honoraria from Teva, Merck, Roche, Biogen, Novartis. NS: has received travel support from Genzyme and Novartis. JP: Consulting fees and travels from Biogen, Sanofi-Genzyme, Novartis, Teva, Merck-Serono, Roche, Medday , CLF: boards for Biogen, Merck, Teva, Medday, Roche, Novartis, DB: received research grant from EU FP7, 305477-2012, EU Marie Curie action 2008 (Co I) ABIRISK (co I), French ministery of health -2008 (PHRC), French MS society 2009, 2012, 2017. Lectures, congress invitation, board participation with Bayer, Biogen, Medday, Merck, Novartis, Roche, Sanofi-Genzyme and Teva..

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