Contributions
Abstract: 265
Type: Scientific Session
Abstract Category: Therapy - Risk management for disease modifying treatments
Background: A particularly high reactivation of MS has been reported in patients who received alemtuzumab after fingolimod, in particular when a short washout between the two treatments occurred.1,2
We aimed to understand whether this shift enhances the risk for MS reactivation, or if such possible reactivation has simply to be expected when a treatment is changed due to inefficacy.
Methods: Subjects with relapsing-MS, shifting from fingolimod to alemtuzumab due to inefficacy and referring to 11 Italian MS centers were enrolled. We collected the following clinical and demographic data: age; gender; age at onset; relapse before, during and after fingolimod (during washout period and during alemtuzumab treatment); time to first relapse during washout and alemtuzumab treatment; new T2/Gd enhancing lesions in the last brain MRI during fingolimod and in the first one during alemtuzumab; number of lymphocytes at alemtuzumab start.
Results: We enrolled 77 patients (age: 38 years (SD:9.7); 20-66 years; females: 61(79%), disease duration: 13.7 years (7.3)). 37 patients received more than one course of alemtuzumab. The ARR during fingolimod was 0.60 (SD:0.76), during washout 1.33 (SD:2.34), after alemtuzumab 0.20 (SD:0.46). After alemtuzumab, seven patients experienced one relapse, and two subjects two relapses. The median time to first relapse during washout was 28 days, while after the initiation of alemtuzumab315 days. We did not observe drop-outs from alemtuzumab.
The last MRI during fingolimod showed new T2 and Gd enhancing lesions in 45/65 (69.2%) and 34/58 (58.6%) patients, respectively. The first MRI during alemtuzumab showed new T2 and Gd enhancing lesions in 5/48 (10.4%) and in 1/46(2.2%) patients. Mean washout period was 2.7 (SD:2.7) months. Before alemtuzumab start, lymphocyte count was: < 0.5 x 103/mL in 10/53(18.9%) patients; 0.5-< 0.8 in 10(18.9%); 0.8-1.0 in 4(7.5); and >1.0 in 29(54.7).
Conclusions: In our cohort, alemtuzumab was able to dramatically reduce MS inflammation, both in terms of relapses and new T2/Gd enhancing lesions, as compared to the previous fingolimod treatment and the washout period. This was true despite washout and a normal lymphocyte count in about half of our cohort. Thus, a rapid initiation of alemtuzumab after fingolimod does not seem to be a risk factor for MS reactivation.
References:
1. Willis M, et al. NeurolNeuroimmunolNeuroinflamm. 2017
2. Huhn K, et al. J Neurol. 2018
Disclosure: Frau J: serves on scientific advisory boards for Biogen and Genzyme, has received honoraria for speaking from Merck Serono, Genzyme, Biogen and Teva.
Saccà F: received personal compensations for advisory boards, public speaking, or travel grants from Almirall, Biogen Idec, Forward Pharma, Merk Serono, Novartis, Pomona, Sanofi Genzyme, Teva.
Signori A: has nothing to disclose
Baroncini D: received travel grants from Genzyme, Merck and Biogen for participation at national and international congresses; he received speaking honoraria from Sanofi and Novartis, and personal compensation from Almirall for scientific publication.
Fenu G: has received honoraria for consultancy from Novartis and Biogen, and for speaking from Merck Serono and Teva.
Annovazzi P: received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Mylan, Almirall, Roche and Novartis.
Capobianco M: received personal compensation for speaking honoraria or partecipating in advisory board from: Almirall, Biogen, Merck, Novartis, Roche, Sanofi, Teva
Signoriello E: eceived travel funding and speaker honoraria from Biogen, Novartis, Sanofi Genzyme, Bayer, Teva.
Laroni A: has received personal compensation from Novartis, Genzyme, Biogen, Merck and TEVA for public speaking and/or advisory boards.
La Gioia S: has received grants from Novartis
Sartori A: AS has received funding for travel and/or speaker honoraria from Novartis, Teva, Merk, Genzyme, Almirall, Roche.
Maniscalco GT: has served on advisory boards and/or received travel grants and speaker honoraria from Almirall, Biogen, Merck Serono, Novartis and Teva.
Bonavita S: speaker honoraria and advisory board fee from Teva, Genzyme, Biogen, Merck Serono, Novartis, Roche, Almirall
Clerico M: received personal compensations for advisory boards, public speaking, editorial commitments or travel grants from Biogen Idec, Merck Serono, Fondazione Serono, Novartis, Pomona, Sanofi-Genzyme and Teva.
Russo CV: scientific advisory board for Merk Serono and Sanofi Genzyme
Gallo A: received travel grants and consulting fees from Biogen, Merck Serono, Roche, Sanof-Genzyme, Teva
Lapucci C: has received travel funds from Roche
Sormani MP: received consulting fees from TEVA, Biogen, Merck, Sanofi Genzyme, Roche, GeNeuro, Novartis, Medday, Actelion
Cocco E: has received honoraria for consultancy or speaking from Bayer, Biogen, Novartis, Sanofi, Genzyme, Merck and Teva.
Abstract: 265
Type: Scientific Session
Abstract Category: Therapy - Risk management for disease modifying treatments
Background: A particularly high reactivation of MS has been reported in patients who received alemtuzumab after fingolimod, in particular when a short washout between the two treatments occurred.1,2
We aimed to understand whether this shift enhances the risk for MS reactivation, or if such possible reactivation has simply to be expected when a treatment is changed due to inefficacy.
Methods: Subjects with relapsing-MS, shifting from fingolimod to alemtuzumab due to inefficacy and referring to 11 Italian MS centers were enrolled. We collected the following clinical and demographic data: age; gender; age at onset; relapse before, during and after fingolimod (during washout period and during alemtuzumab treatment); time to first relapse during washout and alemtuzumab treatment; new T2/Gd enhancing lesions in the last brain MRI during fingolimod and in the first one during alemtuzumab; number of lymphocytes at alemtuzumab start.
Results: We enrolled 77 patients (age: 38 years (SD:9.7); 20-66 years; females: 61(79%), disease duration: 13.7 years (7.3)). 37 patients received more than one course of alemtuzumab. The ARR during fingolimod was 0.60 (SD:0.76), during washout 1.33 (SD:2.34), after alemtuzumab 0.20 (SD:0.46). After alemtuzumab, seven patients experienced one relapse, and two subjects two relapses. The median time to first relapse during washout was 28 days, while after the initiation of alemtuzumab315 days. We did not observe drop-outs from alemtuzumab.
The last MRI during fingolimod showed new T2 and Gd enhancing lesions in 45/65 (69.2%) and 34/58 (58.6%) patients, respectively. The first MRI during alemtuzumab showed new T2 and Gd enhancing lesions in 5/48 (10.4%) and in 1/46(2.2%) patients. Mean washout period was 2.7 (SD:2.7) months. Before alemtuzumab start, lymphocyte count was: < 0.5 x 103/mL in 10/53(18.9%) patients; 0.5-< 0.8 in 10(18.9%); 0.8-1.0 in 4(7.5); and >1.0 in 29(54.7).
Conclusions: In our cohort, alemtuzumab was able to dramatically reduce MS inflammation, both in terms of relapses and new T2/Gd enhancing lesions, as compared to the previous fingolimod treatment and the washout period. This was true despite washout and a normal lymphocyte count in about half of our cohort. Thus, a rapid initiation of alemtuzumab after fingolimod does not seem to be a risk factor for MS reactivation.
References:
1. Willis M, et al. NeurolNeuroimmunolNeuroinflamm. 2017
2. Huhn K, et al. J Neurol. 2018
Disclosure: Frau J: serves on scientific advisory boards for Biogen and Genzyme, has received honoraria for speaking from Merck Serono, Genzyme, Biogen and Teva.
Saccà F: received personal compensations for advisory boards, public speaking, or travel grants from Almirall, Biogen Idec, Forward Pharma, Merk Serono, Novartis, Pomona, Sanofi Genzyme, Teva.
Signori A: has nothing to disclose
Baroncini D: received travel grants from Genzyme, Merck and Biogen for participation at national and international congresses; he received speaking honoraria from Sanofi and Novartis, and personal compensation from Almirall for scientific publication.
Fenu G: has received honoraria for consultancy from Novartis and Biogen, and for speaking from Merck Serono and Teva.
Annovazzi P: received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Mylan, Almirall, Roche and Novartis.
Capobianco M: received personal compensation for speaking honoraria or partecipating in advisory board from: Almirall, Biogen, Merck, Novartis, Roche, Sanofi, Teva
Signoriello E: eceived travel funding and speaker honoraria from Biogen, Novartis, Sanofi Genzyme, Bayer, Teva.
Laroni A: has received personal compensation from Novartis, Genzyme, Biogen, Merck and TEVA for public speaking and/or advisory boards.
La Gioia S: has received grants from Novartis
Sartori A: AS has received funding for travel and/or speaker honoraria from Novartis, Teva, Merk, Genzyme, Almirall, Roche.
Maniscalco GT: has served on advisory boards and/or received travel grants and speaker honoraria from Almirall, Biogen, Merck Serono, Novartis and Teva.
Bonavita S: speaker honoraria and advisory board fee from Teva, Genzyme, Biogen, Merck Serono, Novartis, Roche, Almirall
Clerico M: received personal compensations for advisory boards, public speaking, editorial commitments or travel grants from Biogen Idec, Merck Serono, Fondazione Serono, Novartis, Pomona, Sanofi-Genzyme and Teva.
Russo CV: scientific advisory board for Merk Serono and Sanofi Genzyme
Gallo A: received travel grants and consulting fees from Biogen, Merck Serono, Roche, Sanof-Genzyme, Teva
Lapucci C: has received travel funds from Roche
Sormani MP: received consulting fees from TEVA, Biogen, Merck, Sanofi Genzyme, Roche, GeNeuro, Novartis, Medday, Actelion
Cocco E: has received honoraria for consultancy or speaking from Bayer, Biogen, Novartis, Sanofi, Genzyme, Merck and Teva.