Contributions
Abstract: P1190
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Introduction: Alemtuzumab had superior effect over interferon beta-1a in 3 phase 3 studies. It has been approved by the European Medicines Agency for relapsing-remitting multiple sclerosis (RRMS). Considering its safety profile the French National authority for health (HAS) has restricted its use to very active RRMS characterized by at least 2 relapses under treatment and currently, its use relies on special authorization.
Objectives: To characterize the efficacy and safety profile of alemtuzumab in patients with active RRMS treated in France.
Methods: We retrospectively recorded clinical and radiological data of 104 patients who underwent Alemtuzumab treatment since January 2015.
Results: One hundred and four patients (79 women/25 men) have been treated (mean age at treatment: 36.4 years). All but one had RRMS (probable progressive form in 1). Mean age at onset of the disease was 25.4 years (range: 13-54). Indications of alemtuzumab (explicit for 101 patients) were either treatment failure (first line: n=3; second line: n=47) or high risk of PML (n=51). 84 patients were JCV positive. Mean time from MS onset to treatment was 10.6 years (range: 1-30). Mean EDSS was 4.9 (range 0-9.5) at treatment onset. During the year preceding the treatment, EDSS increased by 0.65 point and mean number of relapses was 1.7. Gadolinium-enhancing lesions were found in 83 / 104 patients. During a mean follow-up 11.8 months, 48 patients were relapse-free whereas 13 patients had at least one relapse (missing data for 42 patients). Mean EDSS decreased by 0.15 after one year. Infusion associated reactions were found in 70% of the cases (mainly rash and headache/pyrexia). Six patients suffered from infections whereas one developed immune thrombocytopenia at 11 months and another a thyroid disorder. Thirteen patients had other adverse events.
Conclusion: In France, Alemtuzumab is given to patients with very active disease characterized by mean EDSS of 4.9 and mean annualized relapse rate of 1.7. Alemtuzumab seems to be effective and relatively safe after 1 year of follow-up.
Disclosure: X Ayrignac has received honoraria for speaker and travel fees from Novartis, Biogen-Idec, Merck-Serono, Bayer Schering and Genzyme
N Collongues: nothing to disclose
J De Seze: nothing to disclose
P Vermersch: Honoraria and consulting fees from Biogen, Genzyme-Sanofi, Bayer,
Novartis, Teva, Merck-Serono, GSK and Almirall. Research supports from Biogen, Bayer, Novartis and Merck-Serono
D Biotti: nothing to disclose
D Brassat: nothing to disclose
C Carra-Dallière: nothing to disclose
S Vukusic: nothing to disclose
F Durand Dubief: nothing to disclose
G Edan: nothing to disclose
E Le Page participated to
scientific meetings and perceived honorarium as speaker or
consultant from Biogen, Genzyme, Merck Serono, Novartis,
Sanofi, Teva
V Deburghgraeve participated to
scientific meetings and perceived honorarium as speaker or
consultant from Biogen, Genzyme, Merck Serono, Novartis,
Sanofi, Teva
E Maillart: conference fees by Teva Biogen Genzyme Merck and Novartis
Travel Grants by Teva Biogen Novartis Genzyme
C Papeix: advisory board, conférence, consulting
with Roche, Biogen , novartis , Teva, genzyme
Ph Alla: nothing to disclose
E Berger : served as consultant and board for Genzyme
B Bourre: had served on scientific advisory board for Biogen Idec, Merck
Serono, Novartis, Sanofi-Genzyme and has received funding
for travel and honoraria from Biogen Idec, Merck Serono,
Novartis, Sanofi-Genzyme and Teva
O Casez: Has received fees, travel facilities, meeting registration fees from novartis, biogen, Genzyme, teva, allergan
S Pittion: nothing to disclose
M Debouverie: served as consultant, board and therapeutical trials for
Genzyme
M Theaudin received speaker honoraria from Genzyme, and grant
for travel from Novartis
N Derache: has received funding for speakers
honoraria from Merck-Serono, Biogen-Idec, Novartis, Teva and
Genzyme
G Defer: nothing to disclose
O Gout: nothing to disclose
R Deschamps: nothing to disclose
A Tourbah: has received consulting and lecturing fees, travel grants and research support from Medday, Biogen Idec, Sanofi-Genzyme, Novartis, Merck Serono, Teva Pharma, and Roche
F Sagnoli: nothing to disclose
A ruet: Funding for research or consulting fees from Biogen Idec, Merck Serono,
Sanofi-Genzyme, Bayer, Roche, Teva, and Novartis. Other financial support for the institution from LabeX Trail, and OFSEP
JC Ouallet has received consultancy fees, speaker fees, research grants (non-personal), and honoraria from Novartis, Biogen-Idec, Merck-Serono, Bayer Schering, Roche, Almirall, Teva and Genzyme
B Brochet Has received fees, travel facilities from Bayer, teva, Merck, Biogen,
medday, Roche, Novartis and genzyme
E Manchon: nothing to disclose
T Moreau reports receiving consulting fees and speaking fees
from Biogen Idec, Sanofi Aventis, Genzyme, Teva Pharma,
Bayer Schering, Merck Serono, Roche, Almirall and Novartis,
Roche
A Fromont reports receiving consulting fees and speaking fees
from Biogen Idec, Sanofi Aventis, Genzyme, Teva Pharma,
Bayer Schering, Merck Serono, Roche, Almirall and Novartis,
Roche
P Clavelou: received consulting fees and serves on
scientific advisory boards from Almirall, Bayer Health,
Biogen, Genzyme-Sanofi, Merck, Novartis, Teva Pharma
F Taithe: nothing to disclose
A-M Guennoc: nothing to disclose
J-P Camdessanche: nothing to disclose
A Carpentier: nothing to disclose
I Coman: nothing to disclose
B Audoin: nothing to disclose
J Pelletier: nothing to disclose
A Rico: nothing to disclose
L Magy: nothing to disclose
J Ciron: nothing to disclose
S Wiertlewski: nothing to disclose
D Laplaud: nothing to disclose
Th de Broucker: consulting fees for Novartis,
Bayer, Genzyme, Biogen
C Lebrun reports receiving consulting fees for Almirall, Merck, Novartis,
Biogen, MEDDAY, Roche, Teva
M Cohen reports receiving consulting fees for Merck, Novartis, Biogen, Roche, Teva, Genzyme
P Labauge: nothing to disclose
Abstract: P1190
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Introduction: Alemtuzumab had superior effect over interferon beta-1a in 3 phase 3 studies. It has been approved by the European Medicines Agency for relapsing-remitting multiple sclerosis (RRMS). Considering its safety profile the French National authority for health (HAS) has restricted its use to very active RRMS characterized by at least 2 relapses under treatment and currently, its use relies on special authorization.
Objectives: To characterize the efficacy and safety profile of alemtuzumab in patients with active RRMS treated in France.
Methods: We retrospectively recorded clinical and radiological data of 104 patients who underwent Alemtuzumab treatment since January 2015.
Results: One hundred and four patients (79 women/25 men) have been treated (mean age at treatment: 36.4 years). All but one had RRMS (probable progressive form in 1). Mean age at onset of the disease was 25.4 years (range: 13-54). Indications of alemtuzumab (explicit for 101 patients) were either treatment failure (first line: n=3; second line: n=47) or high risk of PML (n=51). 84 patients were JCV positive. Mean time from MS onset to treatment was 10.6 years (range: 1-30). Mean EDSS was 4.9 (range 0-9.5) at treatment onset. During the year preceding the treatment, EDSS increased by 0.65 point and mean number of relapses was 1.7. Gadolinium-enhancing lesions were found in 83 / 104 patients. During a mean follow-up 11.8 months, 48 patients were relapse-free whereas 13 patients had at least one relapse (missing data for 42 patients). Mean EDSS decreased by 0.15 after one year. Infusion associated reactions were found in 70% of the cases (mainly rash and headache/pyrexia). Six patients suffered from infections whereas one developed immune thrombocytopenia at 11 months and another a thyroid disorder. Thirteen patients had other adverse events.
Conclusion: In France, Alemtuzumab is given to patients with very active disease characterized by mean EDSS of 4.9 and mean annualized relapse rate of 1.7. Alemtuzumab seems to be effective and relatively safe after 1 year of follow-up.
Disclosure: X Ayrignac has received honoraria for speaker and travel fees from Novartis, Biogen-Idec, Merck-Serono, Bayer Schering and Genzyme
N Collongues: nothing to disclose
J De Seze: nothing to disclose
P Vermersch: Honoraria and consulting fees from Biogen, Genzyme-Sanofi, Bayer,
Novartis, Teva, Merck-Serono, GSK and Almirall. Research supports from Biogen, Bayer, Novartis and Merck-Serono
D Biotti: nothing to disclose
D Brassat: nothing to disclose
C Carra-Dallière: nothing to disclose
S Vukusic: nothing to disclose
F Durand Dubief: nothing to disclose
G Edan: nothing to disclose
E Le Page participated to
scientific meetings and perceived honorarium as speaker or
consultant from Biogen, Genzyme, Merck Serono, Novartis,
Sanofi, Teva
V Deburghgraeve participated to
scientific meetings and perceived honorarium as speaker or
consultant from Biogen, Genzyme, Merck Serono, Novartis,
Sanofi, Teva
E Maillart: conference fees by Teva Biogen Genzyme Merck and Novartis
Travel Grants by Teva Biogen Novartis Genzyme
C Papeix: advisory board, conférence, consulting
with Roche, Biogen , novartis , Teva, genzyme
Ph Alla: nothing to disclose
E Berger : served as consultant and board for Genzyme
B Bourre: had served on scientific advisory board for Biogen Idec, Merck
Serono, Novartis, Sanofi-Genzyme and has received funding
for travel and honoraria from Biogen Idec, Merck Serono,
Novartis, Sanofi-Genzyme and Teva
O Casez: Has received fees, travel facilities, meeting registration fees from novartis, biogen, Genzyme, teva, allergan
S Pittion: nothing to disclose
M Debouverie: served as consultant, board and therapeutical trials for
Genzyme
M Theaudin received speaker honoraria from Genzyme, and grant
for travel from Novartis
N Derache: has received funding for speakers
honoraria from Merck-Serono, Biogen-Idec, Novartis, Teva and
Genzyme
G Defer: nothing to disclose
O Gout: nothing to disclose
R Deschamps: nothing to disclose
A Tourbah: has received consulting and lecturing fees, travel grants and research support from Medday, Biogen Idec, Sanofi-Genzyme, Novartis, Merck Serono, Teva Pharma, and Roche
F Sagnoli: nothing to disclose
A ruet: Funding for research or consulting fees from Biogen Idec, Merck Serono,
Sanofi-Genzyme, Bayer, Roche, Teva, and Novartis. Other financial support for the institution from LabeX Trail, and OFSEP
JC Ouallet has received consultancy fees, speaker fees, research grants (non-personal), and honoraria from Novartis, Biogen-Idec, Merck-Serono, Bayer Schering, Roche, Almirall, Teva and Genzyme
B Brochet Has received fees, travel facilities from Bayer, teva, Merck, Biogen,
medday, Roche, Novartis and genzyme
E Manchon: nothing to disclose
T Moreau reports receiving consulting fees and speaking fees
from Biogen Idec, Sanofi Aventis, Genzyme, Teva Pharma,
Bayer Schering, Merck Serono, Roche, Almirall and Novartis,
Roche
A Fromont reports receiving consulting fees and speaking fees
from Biogen Idec, Sanofi Aventis, Genzyme, Teva Pharma,
Bayer Schering, Merck Serono, Roche, Almirall and Novartis,
Roche
P Clavelou: received consulting fees and serves on
scientific advisory boards from Almirall, Bayer Health,
Biogen, Genzyme-Sanofi, Merck, Novartis, Teva Pharma
F Taithe: nothing to disclose
A-M Guennoc: nothing to disclose
J-P Camdessanche: nothing to disclose
A Carpentier: nothing to disclose
I Coman: nothing to disclose
B Audoin: nothing to disclose
J Pelletier: nothing to disclose
A Rico: nothing to disclose
L Magy: nothing to disclose
J Ciron: nothing to disclose
S Wiertlewski: nothing to disclose
D Laplaud: nothing to disclose
Th de Broucker: consulting fees for Novartis,
Bayer, Genzyme, Biogen
C Lebrun reports receiving consulting fees for Almirall, Merck, Novartis,
Biogen, MEDDAY, Roche, Teva
M Cohen reports receiving consulting fees for Merck, Novartis, Biogen, Roche, Teva, Genzyme
P Labauge: nothing to disclose