Contributions
Abstract: EP1730
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: In the last years several reports about a possible rebound after fingolimod discontinuation in patients with Multiple Sclerosis (MS) were reported. On the other side, no rebound was found in the fingolimod randomized clinical trials, including more than 2000 subjects. It is still debated if the so-called rebound is really related to fingolimod discontinuation rather than the natural course of highly active MS.
Objective: The study aimed to survey the prevalence of severe reactivation and rebound after fingolimod discontinuation in a large cohort of MS Italian patients.
Methods: Patients with RRMS treated with fingolimod since at least 6 months, who stopped treatment for reasons not related to inefficacy were included in this analysis. A severe reactivation was defined as a relapse with an associated EDSS increase of at least 2 points or 2 or more relapses in the 6 months following fingolimod discontinuation. A severe reactivation was considered a rebound if these criteria have never been fulfilled in the patient's previous medical history.
Results: A total of 108 patients (mean age: 37.3 (SD:10); females: 79.6%; median EDSS: 2.5 (0-8.5); disease duration: 10.6 years) satisfied the inclusion criteria; we selected 90 patients with no relapses in the last 6 months under fingolimod. 13 out of 90 (14.4%) patients had a relapse within 3 months after fingolimod discontinuation (9 without any new therapy), and further 10 (11.1%) had a relapse within 6 months (6 without any new therapy). Six out of 90 (6.5%) patients had a severe reactivation. Among them, 1 had a relapse associated with an EDSS increase of 6 points, 2 had a relapse associated with an EDSS increase of 2 points and 1 had 3 relapses over 6 months. Four patients out of 90 (4.4%) were defined as rebound.
Conclusions: The present study showed that more than 25% of patients risk to have a relapse within 6 months after fingolimod discontinuation. This is an expected result, being fingolimod approved in Italy as second line therapy in MS. Nevertheless, the risk of severe reactivations and rebound is lower than previously described.
Reference: Hatcher SE, et al. Rebound syndrome in patients with multiple sclerosis after cessation of fingolimod treatment
Disclosure:
J Frau serves on scientific advisory boards for Biogen, received honoraria for speaking from Merck Serono, Biogen and Teva and received research grant from Serono.
G Fenu received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Novartis.
R Lanzillo received personal fees for public speaking or consultancy from Biogen, Novartis, Teva, Genzyme, Merck, Almirall.
D Baroncini received speaking honoraria and fees for advisory board, travel and editorial projects from Almirall, Sanofi-Genzyme, Merck, Novartis, Teva
P Annovazzi received speaking honoraria and/or fees for partecipating to advisory boards and7or travel expenses for partecipating to congresses and meetings fron Teva, Biogen, Novartis, Roche, Almirall, Sanofi Genzyme and Merck
A Sartori received honoraria for speaking from Novartis and funding for travel from Teva, Merck Serono, Sanofi-Genzyme, Novartis, Almirall.
G.T. Maniscalco has received travel assistance and/or honoraria from, and provided advice to Biogen Idec, Novartis, Genzyme, Sanofi-Aventis and Merck-Serono.
MP Sormani received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Roche, Novartis.
E Cocco reports personal fees and non-financial supportfrom
Bayer, Biogen, Novartis, Genzyme, Merck Serono, Roche, and Teva.
The other authors have nothing to disclose about this work.
Abstract: EP1730
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Background: In the last years several reports about a possible rebound after fingolimod discontinuation in patients with Multiple Sclerosis (MS) were reported. On the other side, no rebound was found in the fingolimod randomized clinical trials, including more than 2000 subjects. It is still debated if the so-called rebound is really related to fingolimod discontinuation rather than the natural course of highly active MS.
Objective: The study aimed to survey the prevalence of severe reactivation and rebound after fingolimod discontinuation in a large cohort of MS Italian patients.
Methods: Patients with RRMS treated with fingolimod since at least 6 months, who stopped treatment for reasons not related to inefficacy were included in this analysis. A severe reactivation was defined as a relapse with an associated EDSS increase of at least 2 points or 2 or more relapses in the 6 months following fingolimod discontinuation. A severe reactivation was considered a rebound if these criteria have never been fulfilled in the patient's previous medical history.
Results: A total of 108 patients (mean age: 37.3 (SD:10); females: 79.6%; median EDSS: 2.5 (0-8.5); disease duration: 10.6 years) satisfied the inclusion criteria; we selected 90 patients with no relapses in the last 6 months under fingolimod. 13 out of 90 (14.4%) patients had a relapse within 3 months after fingolimod discontinuation (9 without any new therapy), and further 10 (11.1%) had a relapse within 6 months (6 without any new therapy). Six out of 90 (6.5%) patients had a severe reactivation. Among them, 1 had a relapse associated with an EDSS increase of 6 points, 2 had a relapse associated with an EDSS increase of 2 points and 1 had 3 relapses over 6 months. Four patients out of 90 (4.4%) were defined as rebound.
Conclusions: The present study showed that more than 25% of patients risk to have a relapse within 6 months after fingolimod discontinuation. This is an expected result, being fingolimod approved in Italy as second line therapy in MS. Nevertheless, the risk of severe reactivations and rebound is lower than previously described.
Reference: Hatcher SE, et al. Rebound syndrome in patients with multiple sclerosis after cessation of fingolimod treatment
Disclosure:
J Frau serves on scientific advisory boards for Biogen, received honoraria for speaking from Merck Serono, Biogen and Teva and received research grant from Serono.
G Fenu received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Novartis.
R Lanzillo received personal fees for public speaking or consultancy from Biogen, Novartis, Teva, Genzyme, Merck, Almirall.
D Baroncini received speaking honoraria and fees for advisory board, travel and editorial projects from Almirall, Sanofi-Genzyme, Merck, Novartis, Teva
P Annovazzi received speaking honoraria and/or fees for partecipating to advisory boards and7or travel expenses for partecipating to congresses and meetings fron Teva, Biogen, Novartis, Roche, Almirall, Sanofi Genzyme and Merck
A Sartori received honoraria for speaking from Novartis and funding for travel from Teva, Merck Serono, Sanofi-Genzyme, Novartis, Almirall.
G.T. Maniscalco has received travel assistance and/or honoraria from, and provided advice to Biogen Idec, Novartis, Genzyme, Sanofi-Aventis and Merck-Serono.
MP Sormani received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Roche, Novartis.
E Cocco reports personal fees and non-financial supportfrom
Bayer, Biogen, Novartis, Genzyme, Merck Serono, Roche, and Teva.
The other authors have nothing to disclose about this work.